Tag Archives: H1N1

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).

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

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.”

Corporate clinics scored scarce H1N1 shots

USA Today‘s Alison Young reviewed state H1N1 vaccine distribution information from Florida, Texas and Georgia, finding that “When the swine flu vaccine was most scarce, health officials gave thousands of doses to corporate clinics at Walt Disney World, Toyota, defense contractors, oil companies and cruise lines.”

Young is working on getting the same data for New York and California. The officials Young talked to stressed that they were doing their best to distribute vaccines fairly, but Young quoted legislators and activists who questioned state health department’s ability to ensure that, once vaccines were given to corporations, they were delivered to the folks who needed them most.

Fluportal.org stays on top of H1N1

While H1N1 seems to have peaked in many states – at least for now – Fluportal.org‘s resources to cover the pandemic are still growing. Recent highlights include tips for using American Public Media’s Public Insight Network (which we’ve mentioned before in conjunction with a ProPublica story on health care reform), a few interesting photos with creative commons licenses (like a collection of H1N1 street art).

One of the creative commons licensed shots of H1N1 street art spotlighted by fluportal.org. Photo by Brazilian artist guitavares via Flickr.

Fluportal also has tackled some media ethics issues related to the outbreak, notably in a post where staff from PRI’s The World had to consider how to frame the German medical establishment’s reluctance to recommend the H1N1 vaccine. After all, they did not want to confuse listeners or have a negative impact on public health, but they also weren’t going to “censor” the sincere opinions of German doctors, even if they conflicted with CDC advice.


Public broadcasters have H1N1 site for journalists

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.”