The influenza virus, like the weather, is becoming more unpredictable and wreaking havoc around the United States.
As H3N2 swept through almost all 50 states, it became clear that the flu vaccine hadn’t work as planned for the 2015 influenza season. In response to criticism about the ineffectiveness of this year’s influenza vaccine, the CDC issued new guidelines that were disseminated among hospitals nationwide.
One snowy morning in Boston I received the CDC update and was shocked by the recommendations. The updated guidelines advocated for increased widespread usage of antivirals. It stated:
At the time, I was the attending on a busy general pediatric inpatient service. Based on the CDC guidelines, I should have started every single patient, 18 total, on oseltamivir (Tamiflu, Roche).
I didn’t think a well-respected institution such as the CDC would give out non-evidence based recommendations, but their new mantra of treat everyone seemed excessive.
There is a large growing body of evidence that questions the efficacy of influenza antiviral medications and highlights significant side-effect profiles of antivirals such as oseltamivir.
Despite this emerging data, clinicians were being advised to prescribe antivirals as frequently as we give out stickers.
The CDC defended its decision by highlighting studies that showed decreased complication and mortality rates. They disregarded the higher-level evidence including a large 2014 meta-analysis from BMJ and Cochrane collaborators Tom Jefferson and Peter Doshi.
Jefferson and Doshi did things a bit differently. Since previous reviews had identified discrepancies in the data presented in published trial reports, they used data from documents generated during the licensing processes.
After a 4-year battle with Roche Pharmaceuticals, they were finally granted access to the raw data. This allowed them to verify information from published randomized placebo-controlled trials involving adults and children. The data was compiled from more than 160,000 pages.
This extraordinary meta-analysis found insufficient evidence to support prior claims that oseltimivir decreased the duration of flu symptoms and associated complication rates. They also noted that antivirals put children at greater risk of developing neuropsychiatric symptoms and significant vomiting.
Let’s compare this outcome to a study that was released January 2015 in The Lancet. This meta-analysis looked at “all published and unpublished Roche-sponsored randomized placebo-controlled, double-blind trials.”
The second study found that oseltamivir “accelerates time to clinical symptom alleviation, reduces risk of lower respiratory tract complications, and admittance to hospital.”
Here we have two major studies with two completely different results. Which one did the CDC use to promote their guidelines? The Lancet study.
And so as the brunt of the flu season bore down upon the country, physicians were placed in a challenging position with conflicting evidence and recommendations from two different meta-analyses and a trusted source — the CDC.
In times of apparent crisis there is the inherent desire to do something, to do anything. This was very apparent during the first two weeks of January. I realized that we were doing something, but was it the right thing?
When confusion exists and conflicting data abounds, one thing is usually assured. The truth can be found if you follow the money.
The CDC recently launched its Take 3 campaign. Here are the three steps:
- Get your flu shot (this one I agree with)
- Take preventative steps such as washing your hands (I agree with this one, too)
- Take flu antivirals if your doctor prescribes them. They can treat your illness and may prevent serious complications. (Wait, what?)
Who came up with number three of the Take 3 campaign? It turns out, the campaign was directly funded by Roche, the primary manufacturer of oseltamivir. The pharmaceutical company gave $174,800 to “support qualitative research into influenza prevention and treatment messaging.”
What is Roche’s “research into prevention and treatment messaging?” It is The Lancet study that CDC director Thomas Friedman, MD, cited as evidence for using oseltamivir.
Half of the authors involved in the study received consultancy fees, grants or contracts from Roche. The listed funding source for The Lancet study, the Multiparty Group for Advice on Science (MUGAS), received a grant from Roche specifically for the study.
It seems at least to a certain extent that the manufacturer of oseltamivir is in cahoots with the CDC to promote and sell its product, even if it’s not a good one that’s based on sound evidence.
To make matters worse, bad information was perpetuated by major news sources like the New York Times, who quoted Dr. Friedman as saying:
“Doctors did not recommend the antivirals often enough, and should prescribe them even before an office visit for patients with flu symptoms and a high risk of complications. The medicines are safe for children and should be given even to those younger than 2.”
Here in Boston we weren’t immune when WBUR, Boston’s NPR news station, repeated the CDC’s guidelines, making the following quote by Dr. Freidman the highlight of its article:
“If I or one of the members of my family got flu or a flu-like illness, I would get them or me treated with Tamiflu as quickly as possible.”
The 2015 flu season unearthed unsettling information about the complicated relationships between drug manufacturers, evidence-based decisions, and the propagation of information.
The CDC is an organization that should help bridge the expansive gap between drug manufacturers, study results, and consumers.
This flu season should serve as a wake-up call, not only for the CDC but also for front-line physicians, and spark a renewed effort to create accountability and transparency in a job where people’s lives are the ultimate consequence.