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How the FDA manipulates the media

 
 
Reply Mon 26 Sep, 2016 05:55 am
http://www.scientificamerican.com/article/how-the-fda-manipulates-the-media/?WT.mc_id=SA_FB_POLE_FEAT

It was a faustian bargain—and it certainly made editors at National Public Radio squirm.
The deal was this: NPR, along with a select group of media outlets, would get a briefing about an upcoming announcement by the U.S. Food and Drug Administration a day before anyone else. But in exchange for the scoop, NPR would have to abandon its reportorial independence. The FDA would dictate whom NPR's reporter could and couldn't interview.
“My editors are uncomfortable with the condition that we cannot seek reaction,” NPR reporter Rob Stein wrote back to the government officials offering the deal. Stein asked for a little bit of leeway to do some independent reporting but was turned down flat. Take the deal or leave it.
NPR took the deal. “I'll be at the briefing,” Stein wrote.
Later that day in April 2014, Stein—along with reporters from more than a dozen other top-tier media organizations, including CBS, NBC, CNN, the Washington Post, the Wall Street Journal and the New York Times—showed up at a federal building to get his reward. Every single journalist present had agreed not to ask any questions of sources not approved by the government until given the go-ahead.
“I think embargoes that attempt to control sourcing are dangerous because they limit the role of the reporter whose job it is to do a full look at a subject,” says New York Times former public editor Margaret Sullivan. “It's really inappropriate for a source to be telling a journalist whom he or she can and can't talk to.” Ivan Oransky, distinguished writer in residence at New York University's Journalism Institute and founder of the Embargo Watch weblog, agrees: “I think it's deeply wrong.”
This kind of deal offered by the FDA—known as a close-hold embargo—is an increasingly important tool used by scientific and government agencies to control the behavior of the science press. Or so it seems. It is impossible to tell for sure because it is happening almost entirely behind the scenes. We only know about the FDA deal because of a wayward sentence inserted by an editor at the New York Times. But for that breach of secrecy, nobody outside the small clique of government officials and trusted reporters would have known that the journalists covering the agency had given up their right to do independent reporting.
Documents obtained by Scientific American through Freedom of Information Act requests now paint a disturbing picture of the tactics that are used to control the science press. For example, the FDA assures the public that it is committed to transparency, but the documents show that, privately, the agency denies many reporters access—including ones from major outlets such as Fox News—and even deceives them with half-truths to handicap them in their pursuit of a story. At the same time, the FDA cultivates a coterie of journalists whom it keeps in line with threats. And the agency has made it a practice to demand total control over whom reporters can and can't talk to until after the news has broken, deaf to protests by journalistic associations and media ethicists and in violation of its own written policies.
By using close-hold embargoes and other methods, the FDA, like other sources of scientific information, are gaining control of journalists who are supposed to keep an eye on those institutions. The watchdogs are being turned into lapdogs. “Journalists have ceded the power to the scientific establishment,” says Vincent Kiernan, a science journalist and dean at George Mason University. “I think it's interesting and somewhat inexplicable, knowing journalists in general as being people who don't like ceding power.”
The press corps is primed for manipulation by a convention that goes back decades: the embargo. The embargo is a back-room deal between journalists and the people they cover—their sources. A source grants the journalist access on condition that he or she cannot publish before an agreed-on date and time.
A surprisingly large proportion of science and health stories are the product of embargoes. Most of the major science journals offer reporters advance copies of upcoming articles—and the contact information of the authors—in return for agreeing not to run with the story until the embargo expires. These embargoes set the weekly rhythm of science coverage: On Monday afternoon, you may see a bunch of stories about the Proceedings of the National Academy of Sciences USA published almost simultaneously. Tuesday, it's the Journal of the American Medical Association. On Wednesday, it's Nature and the New England Journal of Medicine. Science stories appear on Thursday. Other institutions have also adopted the embargo system. Federal institutions, especially the ones science and health journalists report on, have as well. Embargoes are the reason that stories about the National Laboratories, the National Institutes of Health and other organizations often tend to break at the precisely same time.
Embargoes were first embraced by science reporters in the 1920s, in part because they take the pressure off. After all, when everybody agrees to publish their stories simultaneously, a reporter can spend extra time researching and writing a story without fear of being scooped. “[Embargoes] were created at the behest of journalists,” says Kiernan, who has written a book, Embargoed Science, about scientific embargoes. “Scientists had to be convinced to go along.” But scientific institutions soon realized that embargoes could be used to manipulate the timing and, to a lesser extent, the nature of press coverage. The result is a system whereby scientific institutions increasingly control the press corps. “They've gotten the upper hand in this relationship, and journalists have never taken it back,” Kiernan says.
The embargo system is such an established institution in science journalism that few reporters complain or even think about its darker implications, at least until they themselves feel slighted. This January the California Institute of Technology was sitting on a great story: researchers there had evidence of a new giant planet—Planet Nine—in the outer reaches of our solar system. The Caltech press office decided to give only a dozen reporters, including Scientific American's Michael Lemonick, early access to the scientists and their study. When the news broke, the rest of the scientific journalism community was left scrambling. “Apart from the chosen 12, those working to news deadlines were denied the opportunity to speak to the researchers, obtain independent viewpoints or have time to properly digest the published research paper,” complained BBC reporter Pallab Ghosh about Caltech's “inappropriate” favoritism in an open letter to the World Federation of Science Journalists.
When asked about why Caltech chose to release the news only to a select group of reporters, Farnaz Khadem, Caltech's head of communications, stated that she is committed to being “fair and transparent” about how and when Caltech shares news with journalists. She then refused to talk about the Planet Nine incident or embargoes or press strategy, and she would not grant access to anyone at Caltech who might talk about such matters. As a consequence, it is hard to know for certain why Caltech decided to share the news with only a select group of reporters. But it is not hard to guess why journalists such as Ghosh were excluded. “It wasn't that they were not good enough or not liked enough,” Kiernan speculates. “There was a real effort here to control things, making sure that the elite of the elite covered this story and covered it in a certain way, which would then shape the coverage of all other journalists. It's very clearly a control effort.”
Caltech is not the only institution that steers coverage by briefing a very small subset of reporters. (As I was writing this piece, I received a note from a U.S. Air Force press officer offering a sneak preview of video footage being offered to “a select number of digital publications.”) For years the FDA has been cultivating a small group of journalists who are entrusted with advance notice of certain events while others are left out in the cold. But it was not the game of favorites that ignited a minor firestorm in the journalism community in January 2011—it was the introduction of the close-hold embargo.
Like a regular embargo, a close-hold embargo allows early access to information provided that attendees not publish before a set date and time. In this case, it was a sneak peek at rules about to be published regarding medical devices. But there was an additional condition: reporters were expressly forbidden from seeking outside comment. Journalists would have to give up any semblance of being able to do independent reporting on the matter before the embargo expired.
Even reporters who had been dealing with the FDA for years were incredulous. When one asked the agency's press office if it really was forbidding communications with outside sources, Karen Riley, an official at the FDA, erased all doubt. “It goes without saying that the embargo means YOU CANNOT call around and get comment ahead of the 1 P.M. embargo,” she said in an e-mail.
“Actually it does need some saying, since this is a new version of a journalistic embargo,” wrote Oransky in his Embargo Watch blog. Without the ability to contact independent sources, he continued, “journalists become stenographers.” Kiernan echoes the sentiment: “[When] you can't verify the information, you can't get comment on the information. You have to just keep it among this group of people that I told you about, and you can't use it elsewhere. In that situation, the journalist is allowing his or her reporting hands to be tied in a way that they're not going to be anything, ultimately, other than a stenographer.”
The Association of Health Care Journalists (AHCJ), of which I am a member, publicly objected to the close-hold embargo, noting that it “will be a serious obstacle to good journalism. Reporters who want to be competitive on a story will essentially have to agree to write only what the FDA wants to tell the world, without analysis or outside commentary.” Faced by this opposition, the agency quickly backtracked. After a meeting with AHCJ leaders, Meghan Scott, then the agency's acting associate commissioner for external affairs, wrote: “Prior to your inquiry, the FDA did not have a formal news embargo policy in place.” The FDA was now establishing new ground rules that “will better serve the media and the public.”
Initially published online in June 2011, the FDA's new media policy officially killed the close-hold embargo: “A journalist may share embargoed material provided by the FDA with nonjournalists or third parties to obtain quotes or opinions prior to an embargo lift provided that the reporter secures agreement from the third party to uphold the embargo.” Due diligence would always be allowed, at least at the FDA.
Health and science journalists breathed a sigh of relief. The AHCJ expressed gratitude that the FDA had changed its tune, and Oransky's Embargo Watch congratulated the agency for backing down: “For doing the right thing, the FDA has earned a spot on the Embargo Watch Honor Roll. Kudos.” And the FDA had cleared up the misunderstanding and affirmed that it was committed to “a culture of openness in its interaction with the news media and the public.”
In reality, there was no misunderstanding. The close-hold embargo had become part of the agency's media strategy. It was here to stay—policy or no policy.
It is hard to tell when a close-hold embargo is afoot because, by its very nature, it is a secret that neither the reporters who have been given special access nor the scientific institution that sets up the deal wants to be revealed. The public hears about it only when a journalist chooses to reveal the information.
We have a few rare instances where journalists revealed that close-hold embargoes were being used by scientists and scientific institutions after 2011. In 2012 biologist Gilles-Eric Séralini and his colleagues published a dubious—later retracted and then republished—paper purportedly linking genetically modified foods to cancer in rats. They gave reporters early access under a close-hold embargo, quite likely to hamstring the reporters' ability to explore gaping holes in the article, a situation science journalist Carl Zimmer described as “a rancid, corrupt way to report about science.” In 2014 the U.S. Chemical Safety and Hazard Investigation Board (also called the CSB) released a report to journalists under a close-hold embargo. When challenged, the then managing director of the CSB, Daniel Horowitz, told Oransky's Embargo Watch that the close-hold embargo was used “on the theory that this would provide a more orderly process.” He then stated that the board was going to “drop the policy in its entirety for future reports.” Privately, however, a CSB public affairs specialist noted in an e-mail, “Frankly, I wish we did have more stenographers out there. Government agencies trying to control the information flow is an old story, but the other side of the story is that government agencies that do good work often have a difficult time getting their story told in an era of journalistic skepticism and partisan bickering and bureaucratic infighting.”
Also in 2014 the Harvard-Smithsonian Center for Astrophysics (CfA) used a close-hold embargo when it announced to a dozen reporters that researchers had discovered subtle signals of gravitational waves from the early universe. “You could only talk to other scientists who had seen the papers already; we didn't want them shared unduly,” says Christine Pulliam, the media relations manager for CfA. Unfortunately, the list of approved scientists provided by CfA listed only theoreticians, not experimentalists—and only an experimentalist was likely to see the flaw that doomed the study. (The team was seeing the signature of cosmic dust, not gravitational waves.) “I felt like a fool, in retrospect,” says Lemonick, who, as one of a dozen or so chosen journalists, covered the story for Time (at the time, he was not on the staff of Scientific American).
The FDA, too, quietly held close-hold embargoed briefings, even though its official media policy forbids it. Without a source willing to talk, it is impossible to tell for sure when or why FDA started violating its own rules. A document from January 2014, however, describes the FDA's strategy for getting media coverage of the launch of a new public health ad campaign. It lays out a plan for the agency to host a “media briefing for select, top-tier reporters who will have a major influence on coverage and public opinion of the campaigns.… Media who attend the briefing will be instructed that there is a strict, close-hold embargo that does not allow for contact with those outside of the FDA for comment on the campaign.”
Why? The document gives a glimpse: “Media coverage of the campaign is guaranteed; however, we want to ensure outlets provide quality coverage of the launch,” the document explains. “The media briefing will give us an opportunity to shape the news stories, conduct embargoed interviews with the major outlets ahead of the launch and give media outlets opportunities to prepare more in-depth coverage of the campaign launch.”
Ten reporters—from the New York Times, the Washington Post, USA Today, the Associated Press, Reuters, ABC, NBC, CNN and NPR—were invited to have their stories shaped. The day after the briefing, on February 4, everybody—except for the New York Times—ran with stories about the ad campaign. Independent comment was notably missing. Only NPR, which went live hours after the others, and CNN, in an update to its story midday, managed to get any reaction from anyone outside of the FDA. CBS plunked down an out-of-context quotation from the director of the Centers for Disease Control and Prevention, probably in hopes that readers wouldn't notice that it was two months old. Nobody else seems to have tried to get anyone who could critique the ad campaign.
The result was a set of stories almost uniformly cleaving to the FDA's party line, without a hint of a question about whether the ad campaign would be as ineffective as many other such campaigns. Not one of the media outlets said anything about the close-hold embargo. From the agency's point of view, it was mission accomplished.
The FDA had a much harder task two months later. The agency was about to make public controversial new rules about electronic cigarettes. It was nearly impossible to keep the story from leaking out ahead of time; days before the new rules were going to be published in April 2014, rumors were flying. Reporters around the country could smell the story and began to e-mail the FDA's press office with questions about the e-cigarette rules. The agency flacks would have to use all the powers at their disposal to control the flow of information.
“I've heard a number of rumors that the FDA will be releasing its proposed e-cigarette regulations on Monday,” Clara Ritger, then a reporter with the National Journal asked on Friday, April 18. “I wanted to see if I could confirm that? If that's not accurate, do you have a timeline?” Stephanie Yao, then an FDA press officer, dodged the question: “The proposal is still in draft form and under review. As a matter of policy, the FDA does not share draft rules with outside groups while a rule is still under review.”

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edgarblythe
 
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Reply Mon 26 Sep, 2016 06:46 am
The Young Turks with Farron Cousins and The Ring of Fire.
42 mins ·
The FDA’s decision to approve a useless drug this week sent pharma stocks soaring and caused the resignation of a high-ranking FDA official who is sick of his agency acting as an arm of the pharmaceutical industry.
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Leadfoot
 
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Reply Mon 26 Sep, 2016 08:58 am
@edgarblythe,
Thanks for posting this Edgar. I learned something new.
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