Friday, September 23, 2016

FDA Violated Ethics Rules to Censor Dissenting Opinions about Its E-Cigarette Regulations

According to a shocking exposé in the October 16th issue of Scientific American written by Charles Seife, the FDA censored dissenting opinions about its e-cigarette regulations by prohibiting journalists covering the release of these regulations from speaking with anyone who might oppose them.

The FDA's e-cigarette regulations were initially released on April 24, 2014. On April 23, the FDA's Center for Tobacco Products held a press briefing for a select group of reporters to provide information so that they could publish news stories about the regulations at the expiration of the embargo, which was set for April 24th. It is not uncommon to set an embargo date and time for the release of a story by media outlets. It helps ensure that all media outlets have an equal opportunity to publish the story in a timely fashion and not to get "scooped" by one favored media outlet.

However, the FDA went beyond the simple step of setting an embargo date and time for the publication of media stories. First, the agency only invited a select group of reporters to the media briefing, ensuring that only reporters who were "friendly" to the FDA's position would be able to cover the story in a timely fashion and that such "friendly" reporters would get a scoop on the story.

Second, the FDA prohibited the reporters at the media briefing from talking to anyone else about the regulations prior to the embargo, meaning that in the articles coming out about the regulations at the expiration of the embargo, there was no possible way for reporters to provide quotes from individuals who might have dissenting opinions about the regulations. In other words, the FDA ensured that only its own position could be presented to the public.

The article explains that reporters at the briefing were told: "You will not be able to reach out to third parties for comment on this announcement."

In addition, reporters were sent an email stating that: "Third-party outreach of any kind was and is not permitted for this announcement. Everyone who participated agreed to this. ... We take this matter very seriously, and as a consequence any individuals who violated the embargo will be excluded from future embargoed briefings with the agency."

The FDA thought that its little scheme to prevent the public from reading dissenting opinions about the regulations had worked to perfection. It apparently did work to perfection in terms of the nature of the media coverage, which of course failed to present any dissenting opinions from experts. However, one courageous reporter exposed the fact that the FDA was censoring media coverage by not allowing reporters to seek comments from experts who might have dissenting opinions. In  her article, she noted that:

"FDA officials gave journalists an outline of the new rules on Wednesday but required that they not talk to industry or public health groups until after Thursday's formal release of the document."

According to Scientific American: "'I felt like I wanted to be clear with readers,' Sabrina Tavernise, the author of the story, later told Sullivan, the New York Times' public editor at the time. 'Usually you would have reaction in a story like this, but in this case, there wasn't going to be any.'"

The FDA then blasted Tavernise in an email to her, stating: "I have to say while I generally reserve my editorial comments, I was a little surprised by the tone of your article and the swipe you took at the embargo in the paper—when after combing through the coverage no one else felt the need to do so in quite that way."

The FDA was apparently not only prohibiting reporters from presenting an alternative perspective on its regulations but also prohibiting them from informing readers that they were not allowed to seek out alternative opinions. So the FDA was engaging not only in censorship but in a cover-up of that censorship.

At the time, Eric Boehm of wrote about the FDA's censorship: "Essentially, the Times agreed to feed the public information about new regulations, but without being able to talk to any of the people affected by the regulations. What did that leave them in terms of perspective? Only those who favored the new regulations, of course."

According to Seife, the FDA is violating its own ethics policy, established in 2011, which states that: "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."

In a revealing section of his article, Seife explains that:

"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."

Seife concludes that: "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."

The Rest of the Story

The rest of the story is that the FDA, including the Center for Tobacco Products, used censorship to ensure one-sided coverage of its e-cigarette regulations, thus denying the public the opportunity to receive a balanced perspective on the important public health issues at stake. In spite of the First Amendment, this censorship was successfully achieved by offering select reporters a sneak preview of the regulations and an opportunity to "scoop" other reporters, but forcing them to agree not to seek third party comments in order to secure this privileged status. In doing so, it appears that the FDA and CTP violated their own ethics rules. The end result was censoring any dissenting views on the e-cigarette regulations and ensuring that the public would only be presented with the FDA's side of the issue.

In my view, this is a clear violation of scientific ethics as well as the public health code of conduct. This is something you might expect out of the playbook of Big Tobacco or other corporations, not out of a federal agency charged with protecting the public's health.

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