BMJ wants raw data for all drug trials to be shared

Under the headline “We want raw data, now,” BMJ editor Fiona Godlee recounts the story of how BMJ had to pressure a drug company into releasing full study reports verifying their claims as to the effectiveness of oseltamivir (Tamiflu).

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Tamiflu. Photo by Richard Sunderland via Flickr.

Godlee says that researchers updating their Cochrane review of the drug “failed to verify claims, based on an analysis of 10 drug company trials, that oseltamivir reduced the risk of complications in healthy adults with influenza. These claims have formed a key part of decisions to stockpile the drug and make it widely available.”

Only after Roche was questioned by the BMJ and Channel 4 News did the manufacturer commit to making “full study reports” available. Godlee says that some questions remain, including how patients were recruited and why some neuropsychiatric adverse events were not reported.

Godlee argues that “it can’t be right that the public should have to rely on detective work by academics and journalists to patch together the evidence for such a widely prescribed drug,” saying that “Individual patient data from all trials of drugs should be readily available for scientific scrutiny.”

GAO: Flu-fighting plan needs better measures

Dec. 14th, 2009 by Andrew Van Dam · Leave a Comment
Filed under: Government, Studies 

The United States Government Accountability Office today released the catchily titled “Monitoring and Assessing the Status of the National Pandemic Implementation Plan Needs Improvement” report. See the highlights here.

It does not specifically address the response to the H1N1 pandemic but instead reviews compliance with the Homeland Security Council’s 2006 “Implementation Plan for the National Strategy for Pandemic Influenza.” The GAO analyzed 60 randomly selected action items from the 324 recommended in the report and sought to measure both how the completion of those items was monitored and how many had actually been completed.

The GAO found that while the Homeland Security Council had reported that the majority of the action items were complete in 2008, it was “difficult to determine the actual status of some of the 49 designated as complete.” To rectify this, the GAO recommended that “future progress reports would benefit from using measures of performance that are more consistent with the action items’ descriptions.”

Hoban reports on uneven H1N1 death disclosure

WUNC reporter and AHCJ member Rose Hoban put together a story about uneven disclosure of H1N1 deaths by public health officials and the possible benefits and risks of providing more information. In the end, Hoban reported, it comes down to balancing individual privacy and the public interest.

On the official side, Hoban spoke to Megan Davies, M.D., North Carolina’s epidemiologist, who referred to the lack of a “compelling public health need” to provide H1N1 death data on a county-by-county level, pointing out that in many areas it would be easy for locals to take that information, match it with recent death records and come up with the name of the infected person. Davies said that, in cases like that, she fears the infected person’s family would be stigmatized.

“The fear of contagion’s a really primitive thing that comes up in people,” Davies said.

Additionally, Hoban says, officials are bound by medical ethics, state laws and federal health privacy regulations (which, she notes, generally don’t cover people who are already dead).

For another perspective, Hoban spoke with AHCJ board member Felice Freyer of The Providence Journal. Freyer discussed AHCJ’s report that disclosure had been uneven across the country, and said that officials should share information unless there’s a compelling reason not to.

“Public health officials can’t do their job if they don’t have the trust of the public and no-ones going to trust them if they hide information for no reason,” Freyer said.

Former CDC lead legal counsel Gene Matthews agreed, noting that “Too little information can be a bigger headache than too much.” According to Matthews, this problem has been exacerbated by the Internet where, “If the public health officials don’t provide enough information, the outsiders will simply make it up.”

AHCJ finds uneven disclosure of H1N1 deaths

Dec. 2nd, 2009 by Pia Christensen · 1 Comment
Filed under: Government, Health journalism, Public health 

An informal poll of AHCJ members from across the country, as well as a review of press releases and news reports, reveals that there is a wide variation in what information local and state health officials are disclosing about H1N1 deaths.

In some places, health officials have held press conferences at which they released age, gender, city of residence and the place and time of death. In other places, officials have refused to reveal the age or gender of people who have died. Some states update tallies of deaths on their Web sites, others issue press releases, some release information only if asked and some remain silent even when asked.

“We understand the need for health officials to protect the privacy of those with H1N1,” says Felice J. Freyer, chair of AHCJ’s Right-to-Know Committee. “But, in some places, officials are withholding more information than necessary, perhaps because of a lack of clear guidelines about what should be revealed. This comes at a high cost; health officials lose the public’s trust when they hide information.”

AHCJ is preparing a guide for journalists who have difficulty getting basic information about deaths that are of public interest. The organization also hopes to work with public health officials on national level to encourage greater openness.

Read more …

Tech company aggregates, digitizes H1N1 info

Nov. 20th, 2009 by Andrew Van Dam · Leave a Comment
Filed under: Public records, Tools 

Ebrary, a Silicon Valley outfit that specializes in digitizing and aggregating documents, then making them searchable, has put together a robust collection of H1N1-related documents.

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Photo by nacaseven via Flickr.

Ebrary says it put the free database together because of employees’ personal frustrations over the unavailability of solid H1N1 information online. The database eases that frustration by making resources as varied as public health posters, FAQs and academic studies easy to browse and search.

While the documents are available elsewhere on the Web, journalists might find it helpful to browse this well-organized collection.

Ebrary’s H1N1 sources include Occupational Safety and Health Administration, CDC, the European Centre for Disease Prevention and Control, HHS, National Institute for Occupational Safety and Health, Department of Homeland Security, National Institute of Allergy and Infectious Diseases, the World Health Organization and more.

Public broadcasters have H1N1 site for journalists

Nov. 16th, 2009 by Andrew Van Dam · 2 Comments
Filed under: Health journalism, Public health 

Public Radio Exchange’s FluPortal.org, funded by the Corporation for Public Broadcasting and done in collaboration with NPR, aims to provide public media with resources for reporting on H1N1.fluportal

Led by a regularly updated and authoritative blog, the site also impresses with a selection of Web tools, including widgets and embeddable multimedia, for media outlets to use on their own sites, up-to-date reference materials and examples of what others have done. The portal’s handling of new media and both official and unofficial online sources alone makes it worth a visit, especially given its current update frequency and timeliness.

Tracking H1N1 shots, in Texas and beyond

Jeffrey Weiss of The Dallas Morning News reports that he was able, via an open records request, to get a full list of organizations in Texas that have requested H1N1 vaccines, as well as list of all shipments ordered. The list doesn’t include any public health departments, and is led by large hospitals and mass vaccinators.

On a national scale, the HHS-maintained flu.gov has an updated list of the number of doses of H1N1 vaccine that have been shipped to states, territories and regions thus far. And for your readers or viewers who are trying to get the shots, Google has a flu shot finder map for both H1N1 and seasonal flu vaccines.

6-foot rule separates San Diego paramedics, H1N1

Nov. 10th, 2009 by Andrew Van Dam · Leave a Comment
Filed under: Hot Health Headline, Public health 

Voice of San Diego’s Randy Dotinga explains exactly how the fear of H1N1 has transformed every step of the health care delivery process in the Southern California city, which has been hit particularly hard by the virus. Dotinga focuses on how paramedics’ routines have changed. “To protect themselves,” Dotinga writes, “paramedics are essentially using the same precautions they would against infectious tuberculosis – something they hardly ever see.”

Dotinga says the changes become evident as soon as the paramedics arrive on the scene. Before H1N1, they’d walk right up to the patient. Not anymore.

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Photo by Fetchy via Flickr.

Now, paramedics across the county adhere to a “Six-Foot Rule” when they suspect a patient has a respiratory illness. “If you’re six feet away even without your protective equipment for a short period of time, you’re not likely to get infected,” said Haynes, the county official.

If a patient has possible flu symptoms, the paramedics put on N95 respirators. They began wearing the respirators instead of ordinary masks about a month ago. Paramedics will put on eye shields too. Many paramedics hate to wear them, and forget to put them on.

In this environment of extreme care, not even the ambulances are left to go on as usual. These days, in addition to their regular regimen of extreme sanitation, they visit a nearby fire station a few times a month. There, they are nailed with a super-powered germicidal fog that ensures no microbes, nefarious or otherwise, are going to linger for long.

Does the six-foot rule really work? What about masks?

Maybe. Your view of the effectiveness of social distancing likely depends on where you stand on a particularly contentious issue: airborne vs. droplets. If influenza is spread primarily through droplets (as the CDC says it does here, and here), then it’ll have a tough time spreading beyond three feet unless it’s smeared on a surface. In this case, then, the six-foot rule is an effective way to slow the spread of the virus, as are masks.

If, however, you believe the virus is airborne then it would be able to cross the six-foot gap and you would need, at the very least, an N95 respirator (a mask which filters out at least 95 percent of airborne particles) to protect yourself. In this case, though, it’s important to note that according to some recent research, an N95 won’t offer any more protection than a regular mask.

According to the Institute of Medicine, we haven’t yet heard the final word on influenza transmission and further research is required (PDF). In the meantime, most providers are erring on the side of caution. Check out AHCJ’s primer on controlling pandemic flu for further information.

(Hat tip to AHCJ board member Maryn McKenna for pointing us in the right direction.)

NPR answers H1N1 questions

Nov. 4th, 2009 by Andrew Van Dam · Leave a Comment
Filed under: Hot Health Headline, Public health 

With H1N1 and the mini-pandemic of rumors that seem to follow it on the rise, NPR brought out the big guns in an attempt to answer reader/listener questions and get the facts straight.

NPR’s health editors, Joe Neel and Anne Gudenkauf, teamed up with Dr. Andrew Pekosz and Dr. William Schaffner to tackle your questions.
Pekosz is an expert on viruses and immunology and a professor at Johns Hopkins Bloomberg School of Public Health. Schaffner is an infectious disease expert and professor at Vanderbilt University.

They answer questions like “Do H1N1 and other flu vaccines work?”; “Are they dangerous?”; “Who’s immune?”; “Should I be vaccinated for both H1N1 and typical seasonal flu?” and more.

(Hat tip to NPR Health Blog’s Scott Hensley. In that post, Hensley does a great job of summarizing the highlights of the Q&A.)

Heisel: H1N1 reporters should get out the test tubes

Nov. 4th, 2009 by Andrew Van Dam · Leave a Comment
Filed under: Health journalism 

Antidote’s William Heisel recommends that journalists looking to dive deeper in H1N1 issues pull out their test tubes, put on their lab coats and perform a few original acts of science.

In particular, Heisel focuses on possible tests of the link between H1N1 and swine. In that spirit, he adds a list of six recommendations for enterprising reporters to produce original news research on H1N1.

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