The following is a guest blog post from Jeanne Lenzer, an independent journalist and an associate editor for The BMJ. Just last week, she published an important piece in that journal about the CDC, the FDA and the antiviral drug Tamiflu (oseltamivir). This piece is related.
The oseltamivir (Tamiflu, Roche/Genentech/Gilead) story is filled with intrigue. There’s Donald Rumsfeld, government stockpiling, Bad Science, more Bad Science and lucre – lots and lots of lucre as I reported for The BMJ in “Why aren’t the US Centers for Disease Control and Food and Drug Administration speaking with one voice on flu?”
I reported on the ambitious CDC campaign to get people to take a flu antiviral drug, in particular, Tamiflu. I quoted CDC Director, Tom Frieden, who said in a CDC telebriefing, “Update on Flu Season 2014-15,” that the bottom line about flu and antivirals is: “ 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.”
In emails to me, one flu expert said he was “shocked” when he heard the news – another said the whole matter was “disgusting.”
Here’s a glimpse of some of the news reports:
Frieden’s comments were initially reported uncritically on January 9 by Carey Goldberg of WBUR Boston, without any experts countering his over-the-top statement. But three days later she filed a more skeptical story, “Quick, Take Tamiflu? Maybe Not a Slam-dunk If You’re Young and Healthy,” in which she wrote:
As I listened to CDC director Dr. Tom Frieden issue a ringing endorsement of the prescription antiviral drug Tamiflu last week, I was also hearing a confused “But, but , but ” in my own head.
The crux of my confusion: I had the decided impression that the data on Tamiflu as a flu-fighter were underwhelming. That it just isn’t all that effective. That doctors prescribe it because they have nothing better, but without a lot of hope that it will do a lot of good.
Unfortunately, it was far more common for journalists to report the CDC’s promotional campaign uncritically, including TampaBay.com, the New York Times, Reuters, and Consumer Reports, which stated that high-risk groups should “get to a doctor right away for prescription antiviral medication ” since the drugs “have been shown to reduce the risk of complications such as pneumonia and respiratory failure.”
One excellent exception to the amen chorus was Christie Aschwanden’s report in FiveThirtyEight, “Why the CDC and FDA are telling you two different things about flu.”
Following the money
Despite CDC’s enthusiastic promotion of oseltamivir/Tamiflu, the Food and Drug Administration continues to say they have never been provided data to support the claim that Tamiflu reduces serious flu complications or death, and the agency directed the company not to make such claims.
But that doesn’t stop the CDC, which cites far less reliable observational data to justify their claim that Tamiflu saves lives (the FDA uses far more reliable randomized controlled trials for its assessments). Indeed, the CDC is pushing an off-label use of Tamiflu when it encourages doctors to prescribe Tamiflu or other flu antiviral drugs as a way to avert hospitalizations and death. That benefit, as the FDA has stated, has never been proven. And while it’s legal for doctors to use drugs for off-label uses, it’s illegal for manufacturers to do so.
And here’s where the story takes a right turn: I followed the money – and it led me to an unexpected place: The CDC.
When I learned that the CDC had launched a “Take 3” campaign (Step 3 tells the public to “take antiviral medicine if your doctor prescribes it,”) I smelled the odor of a commercial campaign. It seemed so, well, PR 101 to me. So, I dug into the money behind the campaign.
I spent almost two weeks researching the funding trail before my story was ready to go. What I found was deeply disturbing. Roche had provided a “directed donation” to the CDC through the CDC Foundation for the Take 3 campaign. And there was more. Substantially more: I learned that the CDC Foundation provides an average of $6.3 million in industry funding annually to the CDC.
I then followed the money trail for the “independent” meta-analysis (a study of studies) that CDC Director, Tom Frieden cited as proof of Tamiflu’s benefit. Once again, I found multiple conflicts of interest. The meta-analysis, published on January 30th by The Lancet, far from being “independent” as the authors claimed and as was widely reported, was actually funded by the manufacturer of Tamiflu.
Of course the researchers claimed they were in no way influenced by Roche funding. The study wasn’t designed by Roche, they said, nor did they release the results of the study to Roche until the results were released to the public. Of course being directly influenced by the commercial sponsor of the study might be almost beside the point; as I reported for The BMJ, three of the four researchers had received funding from Roche or Genentech (manufacturers of Tamiflu) or Gilead (patent holder of Tamiflu).
But I was wrong on that point. I have since learned that all four researchers received industry funding either directly or through industry donations to organizations that directly funded the study (so-called “pass-through” money).
Unfortunately, there has been radio silence on this story. Most doctors think the CDC is above reproach, and that it is one of the few outposts of independent science untainted by commercial influence. As Marcia Angell, former editor-in-chief of the New England Journal of Medicine, told The BMJ: “the CDC has enormous credibility among physicians, in no small part because the agency is generally thought to be free of industry bias.”
It’s time to pull aside the curtain, and journalists could help do that.
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