Tag Archives: food and drug administration

AHCJ protests FDA surveillance of communication between reporters, scientists

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

Following a New York Times report over the weekend that revealed the federal government secretly tracked communication sent by FDA scientists to “members of Congress, lawyers, labor officials, journalists and even President Obama,” the Association of Health Care Journalists has expressed alarm at the “Orwellian practices” in a letter sent to HHS Secretary Kathleen Sebelius.

From the letter:

” … the pushback on journalists seeking information from HHS and its agencies, coupled with covert monitoring of scientists’ communications with journalists and elected representatives, reflects a culture of cynicism within your department toward the principles of open government, free speech, and the public’s right to know. The actions detailed in the Times story imperil all reporters’ relationships with HHS and its agencies.”

The letter goes on to request that the agency notify all reporters whose communications were intercepted and conduct an audit of all HHS divisions to find out how widespread the monitoring is.

The Times reports that the surveillance grew out of a “narrow investigation into the possible leaking of confidential agency information by five scientists” and “identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and ‘defamatory’ information about the agency.”

The report was especially shocking to AHCJ because the association has been working for years to make it easier for reporters to interview federal employees and get information from HHS agencies. The HHS media office has been receptive to the organization’s concerns and pledged to improve responsiveness. Indeed, many members have reported improvements in access. But the Times story points a deeper culture running contrary to these efforts.

The FDA used software that tracked keystrokes and captured screenshots on the scientists’ computers. The documents were eventually posted on a public website, apparently by mistake, the Times says.

FDA creates embargo policy in response to reporter concerns

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

The Food and Drug Administration has adopted a policy on embargoes that permits reporters to share embargoed information with outside sources, provided the sources agree to uphold the embargo.

The policy explicitly supports embargoes as a way for reporters to add depth and detail to their stories, and conforms to common practice among medical journals and other sources of complex information.

The policy was shared with AHCJ this week after complaints from the organization earlier this year. In January, the FDA barred reporters from interviewing experts about new regulations on medical devices until the embargo lifted. AHCJ wrote to the FDA that such an approach created obstacles to serious journalism.

In an embargo, the group releasing information chooses the time and date that it will be made public, and reporters get an advance look as long as they agree to delay publication or broadcast until that time. Reporters are willing to do this because it allows time digest the information and seek comments from experts.

In a letter this week to AHCJ, the FDA outlined its policy going forward:

“A journalist may share embargoed material provided by the FDA with non-journalists 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.”

The letter, from Meghan H. Scott, FDA’s acting associate commissioner for external affairs, said the FDA did not previously have a policy on embargoed news. After AHCJ’s inquiry, she wrote, the media staff met with AHCJ members, other journalists, and editors of medical and scientific journals as it worked to develop a policy.

“The FDA is committed to a culture of openness in its interaction with the news media and the public,” Scott wrote to Charles Ornstein, AHCJ president, and Felice Freyer, chair of AHCJ’s Right to Know Committee.

She specified that the FDA may provide embargoed information when:

  • the issue is not related to regulatory or enforcement issues and does not contain confidential, commercial information; and
  • the subject is complex or technical and early access to materials and subject matter experts will help reporters prepare their articles in a timely, accurate manner with the context needed to understand the material.

“We’re grateful that the FDA media staff took the time to study the issue and develop a suitable policy,” Freyer said. “The results are clear rules that are reasonable and workable – and a step forward in improving relations between the FDA and the media.”

MSNBC: FDA had concerns 2 years before alcohol wipe outbreak, didn’t act

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

JoNel Aleccia and the folks at MSNBC.com have dug in deep on news of the FDA’s Jan. 5 recall of tainted alcohol wipes, spurred on by the death of a Texas toddler and complaints from across the country. Aleccia’s findings seem to indicate that, more than a month after the recall, the case of Triad Groups’ trainted products and related failures of FDA oversight may run far deeper than the original notice implied.

Aleccia’s been helped in the follow-up investigation by unofficial access to FDA records, validated by outside sources, that indicate inspectors detected problems in 2009, and again in 2010, but didn’t act until this year’s recall.

Documents show that FDA officials expressed concerns following visits to the Triad plantfrom July 15 to July 17, 2009, and again from April 19 to May 18, 2010. Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care.

The inspection documents, known as FDA Form 483s, were obtained by msnbc.com from a confidential source and confirmed by FDAzilla.com, an independent Web site that monitors the FDA. Copies of the documents were sent to the FDA for review; the agency did not deny their authenticity.

For a thorough roundup of all the points at which warnings surfaced, or at which the FDA could have intervened, check out Aleccia’s full report.

Speaking of FDAzilla.com, it might be a site worth checking out if you’re interested in the FDA’s activities. It’s free and says it has “made millions of pages of FDA data (MAUDE, devices, drugs, 483s listing, FDA employees) more usable and searchable.” The FAQ says most of its data is automatically updated nightly from files posted on FDA.gov.

Reporters urged to insist on response from federal agencies

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

When the FDA would offer only “no comment” on a notorious incident last summer, Felice J. Freyer, a medical writer at The Providence (R.I.) Journal, was disappointed but not surprised. She published her story about an FDA matter (the use of unapproved IUDs) without the FDA’s input.

But Freyer became concerned when, four days after her story came out, the FDA posted on its website a “consumer update” that answered some, but not all, of the questions she had posed to the agency.

“Turns out the FDA’s position was not the ‘no comment’ I received,” Freyer wrote in an account of the incident posted on the AHCJ website.

FDA headquarters in White Oak, Md.
(Photo by thisisbossi via Flickr)

“I don’t think the FDA had anything major to hide,” Freyer added. “It seemed like the agency just couldn’t be bothered with my questions, preferring to focus on a statement for release on its own time.”

But the web-only consumer advisory left questions unanswered and probably reached few consumers.

Freyer, who is an AHCJ board member and chair of AHCJ’s Right to Know Committee, complained about the incident, pursuing the matter up the chain of command. She eventually received an apology, but little by way of explanation. She is sharing her experience in the hope of encouraging other reporters – especially the beleaguered folks who work for the regional media – to persist in seeking information from the federal government.

“The Obama Administration has done some admirable work posting user-friendly information on the Internet,” Freyer said. “But as long as the administration’s press officers ignore and deflect reporters’ questions, the government’s websites begin to function like a state-sponsored press, containing only the information the government wants to share, forever impervious to questioning.

“I urge my fellow journalists to push back against this trend.”

Investigating, localizing salmonella outbreak

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

As some of you may have noticed, there’s an egg recall going on. It all began when the CDC’s PulseNet monitoring program noticed a fourfold jump in the number of salmonella cases being reported, which spurred investigations around the country. This jump is evident in the graph below. Don’t be fooled by the dropoff at the end, it has more to do with the reporting process than with an actual decrease in the number of salmonella cases (which clearly isn’t happening).

Image courtesy of the Centers for Disease Control and Prevention

Image courtesy of the Centers for Disease Control and Prevention

Health officials then traced it all back to a man outlets love to describe as a sort of rogue Iowa egg magnate and his Wright Country Eggs (satellite view?).

As we stand now, the tainted eggs could have been distributed through any number of channels, but constitute a tiny fraction of the national egg supply.

For reporters digging into this national recall story, or looking to localize it to their coverage area, AHCJ has a strong archive of foodborne illness resources.

Start with a classic, the AHCJ article “Fatal Food: A study of illness outbreaks ,” in which Thomas Hargrove details SHNS’ massive investigation into the nation’s food safety monitoring system. Not only is Hargrove’s how-to instructive, his actual findings are useful examinations of state and local food safety systems around the country.

For your own investigation, look at Mining NLM databases: PubMed, Medline and more and the rich set of resources in the sidebar to Hargrove’s story.

If you’re looking for solid numbers and the most up-to-date national context, see Covering Health’s recent post on the CDC’s lates foodborne illness data, as well as our examination of 2009 foodborne illness rates.

Other relevant Covering Health posts include:

Schneider: FDA lacks resources to keep food safe
CDC assembles rogues gallery of food bugs
Private food auditors didn’t stop outbreaks
Lax oversight, complex supply chains aid outbreaks

GAO: FDA designation doesn’t ensure safety

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

gras
Ammonium Hydroxide and Phosphoric Acid, both GRAS. Photo by Benny BNut via Flickr.

On his blog Cold Truth (and on AOL News), Andrew Schneider brought our attention to the GAO’s recent investigation into the well-known FDA loophole created by the “generally regarded as safe” or GRAS designation.

The GRAS designation is meant to spare manufacturers lengthy and expensive testing that might otherwise slow the flow of new products to market. It’s conferred, Schneider writes, as long as a “scientific panel selected by the manufacturer can rule that no harm will result from the intended use of an additive.”

Schneider’s version of the highlights of the GAO report:

  • The FDA generally doesn’t know about most of these determinations of “generally regarded as safe,” or GRAS, because companies are not required to inform the agency.
  • The FDA has not taken steps that could help ensure the safety of additives listed as GRAS.
  • Food products may contain numerous ingredients, including GRAS substances, making it difficult, if not impossible, for public health authorities to attribute a food safety problem to a specific GRAS additive.
  • The FDA does not systematically reconsider the safety of GRAS substances as new information or new methods for evaluating safety become available.

The GAO said nanomaterials and imported additives were of particular concern.

(Hat tip to OMB Watch in general and Matthew Madia in particular)