This is a great article. I say this as a physician and someone just today returning to work after having been out all week with the flu.
I weigh the evidence similarly to Cochrane/FDA. Though I was aware I had the flu within ~12-24h, I did not elect to take Tamiflu. This is both because I currently have no comorbidities, but also because the side effect profile is quite real. People really do sometimes add nausea and vomiting to their list of flu symptoms because they take these medications.
In the inpatient setting I offer Tamiflu to anyone sick enough to be hospitalized, and I am happy to offer it to outpatients with the flu as well if they understand the potential side effects, but it's definitely not a clear winner.
I trust the FDA and Cochrane Review here more than the CDC.
The small durational effect, high dependence on early-administration, and reliance on observational reports combine to add to my suspicion. Consider especially:
If patients are motivated to seek anything that might help, and they know that a prescription is only given in "first 48 hours", they might report their symptoms as having started later than they really did. Then, when their symptoms end at the usual time, it "observationally" looks like a shorter flu. Or maybe, other placebo/choice-supportive-bias effects cause them to rush to deem their symptoms 'over' – after all they went through the time and cost of acquiring the drug.
Thus a pronouncement like "works if rapidly administered" could become a self-fulfilling prophesy through social/psychological biases in reporting.
Similarly, the CDC is under political/social pressure to "do something", and have active modern recommendations, other than just generic 100-year-old patience/hygiene tips. This is especially the case when, as this year, their flu-strain guesses for the vaccine have been wrong.
Temperamentally and institutionally, the CDC needs to believe there's something else to do, that the stockpiles of antivirals they've bought at great cost are effective, and that these kinds of drugs (from specific companies they often rely upon) will help if something much worse than seasonal flu materializes. So they're going to err in the direction of faith-in-antivirals.
I got the flu this year and looked into it. I'm not sure the CDC's suggestions are well founded. On average, antivirals shorten symptoms by half a day over seven days. Not a huge upside. And the Cochrane Collaboration and the BMJ found that it's unlikely the antivirals reduce hospital admissions or complications[1].
On the flip side, there are a number of side effects, including headaches, nausea, and vomiting, which can't make the flu experience better.
I was at the edge of the 48-hour window, and decided it just wasn't worth it for me. Maybe if someone I knew who was elderly or had a compromised immune system got the flu, I would push them to get the antivirals, but for otherwise healthy adults, it seems like a waste of money.
I have worked in the Biotech industry and worked with both the FDA and CDC.
The CDC and FDA have separate missions. The CDC tries to manage diseases once local authorities become overwhelmed. They maintain the Strategic National Stockpile. The SNS is a stockpile of different drugs, not enough for everyone, but enough to hopefully contain an outbreak. Our particular vaccine was FDA approved, and purchased for the SNS. The CDC also may purchase drugs that have not yet been FDA approved (depending on the political climate).
The FDA is the regulatory agency that polices, in this article's case, drugs. They monitor the clinical trials, and manufacturing process of the drugs (gmp-good manufacturing process). The FDA makes sure that drug companies do not exaggerate the efficacy of their products.
So it is not really that surprising that an agency that monitors and manages diseases would recommend drugs, while the agency that monitors and manages drugs would point to drug efficacy first.
The BMJ have run a campaign to make more clinical trial data about Tamiflu public, along with questioning its effectiveness given the large sum of public money spent on it. It seems to me that their reporting is the main reason this story has seen the light of day.
As of 2015 "Week 1" ending Jan 10th (http://www.cdc.gov/flu/weekly/), almost all the flu tested is type A, almost all of that that is further tested is H3N2, and of those further tested, 35% responds well to the Northern hemisphere vaccine, 65% does not.
What's annoying is that of the 65% that's further tested, it's a good match for the vaccine we're preparing for the 2015 Southern Hemisphere vaccine. So the public health types were on the ball, just not quite fast enough, especially given the very long lead time required for the current major egg based vaccine (both to develop new seed strains that'll grow well in eggs, and then production).
Ah, well, it's a good time for introverts like myself to practice "social distancing", made a lot less onerous by the net. My father mentioned a couple of days ago that the local Catholic high school, wiped out by a tornado in 2011 and finally reopened in its new permanent building for this semester, elected to close and disinfect after not very many days, so many students had or were coming down with the flu.
Isn't this the same old story, as written about by Ben Goldacre for instance, over and over again?
Pharma sees money (everyone gets the flu), tries to come up with something, sort of fails, yet still wants money and somehow manages to push through via official channels and gets a new drug of which the effects are rather questionable into the stores, earns money.
My perception is that the FDA's on the hook if they promote a drug that turns out not so safe/effective, and CDC's on the hook proportional to how much damage the flu wreaks. In which case I'd expect the FDA to be extremely conservative about promoting it, and the CDC to push anything with even a marginal effect, no matter other costs.
I think one aspect of disease management that the CDC probably (I don't have direct proof) cares about more than most is logistics. Specifically, the companies and processes needed to produce and distribute flu vaccines and drugs in volumes sufficient for national response.
This sort of infrastructure is very expensive and time-consuming to create--way longer than a flu strain takes to propagate, or an individual vaccine takes to formulate.
In the back of everyone's mind is the 1918 flu, and the possibility for a similarly deadly (or more deadly) version to develop today. It's possible and essentially unpredictable. If it were to happen, we would need to have that vaccine/drug infrastructure ready to go.
So: get your flu vaccine every year, even though it might not be super effective. Take Tamiflu even though it might not help much with a typical flu. Why? To keep those businesses and factories around for another year, in case we really need them.
As someone who had one of the products mentioned here, the side effects were not slight, and to be honest more annoying than the flu itself. We only received the medication (here in the UK) because at the time there was the fear of an outbreak of avian or swine flu, and the idea at the time was to head things off.
I think even if they do show any effectiveness in longer term trials (didn't do much for me personally), I would be wary of seeing them widely used, as it seems they should be targeted mostly at those individuals with compromised immune systems, or perhaps in the future, those individuals identified as having a genetic makeup that could aid and abet a flu related fatality.
[+] [-] carbocation|11 years ago|reply
I weigh the evidence similarly to Cochrane/FDA. Though I was aware I had the flu within ~12-24h, I did not elect to take Tamiflu. This is both because I currently have no comorbidities, but also because the side effect profile is quite real. People really do sometimes add nausea and vomiting to their list of flu symptoms because they take these medications.
In the inpatient setting I offer Tamiflu to anyone sick enough to be hospitalized, and I am happy to offer it to outpatients with the flu as well if they understand the potential side effects, but it's definitely not a clear winner.
[+] [-] gojomo|11 years ago|reply
The small durational effect, high dependence on early-administration, and reliance on observational reports combine to add to my suspicion. Consider especially:
If patients are motivated to seek anything that might help, and they know that a prescription is only given in "first 48 hours", they might report their symptoms as having started later than they really did. Then, when their symptoms end at the usual time, it "observationally" looks like a shorter flu. Or maybe, other placebo/choice-supportive-bias effects cause them to rush to deem their symptoms 'over' – after all they went through the time and cost of acquiring the drug.
Thus a pronouncement like "works if rapidly administered" could become a self-fulfilling prophesy through social/psychological biases in reporting.
Similarly, the CDC is under political/social pressure to "do something", and have active modern recommendations, other than just generic 100-year-old patience/hygiene tips. This is especially the case when, as this year, their flu-strain guesses for the vaccine have been wrong.
Temperamentally and institutionally, the CDC needs to believe there's something else to do, that the stockpiles of antivirals they've bought at great cost are effective, and that these kinds of drugs (from specific companies they often rely upon) will help if something much worse than seasonal flu materializes. So they're going to err in the direction of faith-in-antivirals.
[+] [-] tghw|11 years ago|reply
On the flip side, there are a number of side effects, including headaches, nausea, and vomiting, which can't make the flu experience better.
I was at the edge of the 48-hour window, and decided it just wasn't worth it for me. Maybe if someone I knew who was elderly or had a compromised immune system got the flu, I would push them to get the antivirals, but for otherwise healthy adults, it seems like a waste of money.
[1]http://www.cochrane.org/features/tamiflu-relenza-how-effecti...?
[+] [-] molecules|11 years ago|reply
The CDC and FDA have separate missions. The CDC tries to manage diseases once local authorities become overwhelmed. They maintain the Strategic National Stockpile. The SNS is a stockpile of different drugs, not enough for everyone, but enough to hopefully contain an outbreak. Our particular vaccine was FDA approved, and purchased for the SNS. The CDC also may purchase drugs that have not yet been FDA approved (depending on the political climate).
The FDA is the regulatory agency that polices, in this article's case, drugs. They monitor the clinical trials, and manufacturing process of the drugs (gmp-good manufacturing process). The FDA makes sure that drug companies do not exaggerate the efficacy of their products.
So it is not really that surprising that an agency that monitors and manages diseases would recommend drugs, while the agency that monitors and manages drugs would point to drug efficacy first.
[+] [-] con-templative|11 years ago|reply
There are lots of BMJ articles about it here: http://www.bmj.com/tamiflu
[+] [-] fpgaminer|11 years ago|reply
Yikes, is it normally that low? I looked up a quick figure for 2013, and it was 60% effectiveness.
[+] [-] hga|11 years ago|reply
What's annoying is that of the 65% that's further tested, it's a good match for the vaccine we're preparing for the 2015 Southern Hemisphere vaccine. So the public health types were on the ball, just not quite fast enough, especially given the very long lead time required for the current major egg based vaccine (both to develop new seed strains that'll grow well in eggs, and then production).
Ah, well, it's a good time for introverts like myself to practice "social distancing", made a lot less onerous by the net. My father mentioned a couple of days ago that the local Catholic high school, wiped out by a tornado in 2011 and finally reopened in its new permanent building for this semester, elected to close and disinfect after not very many days, so many students had or were coming down with the flu.
[+] [-] DanBC|11 years ago|reply
[+] [-] debacle|11 years ago|reply
[+] [-] josephpmay|11 years ago|reply
[+] [-] stinos|11 years ago|reply
Pharma sees money (everyone gets the flu), tries to come up with something, sort of fails, yet still wants money and somehow manages to push through via official channels and gets a new drug of which the effects are rather questionable into the stores, earns money.
[+] [-] spacecowboy_lon|11 years ago|reply
[+] [-] wcbeard10|11 years ago|reply
[+] [-] snowwrestler|11 years ago|reply
This sort of infrastructure is very expensive and time-consuming to create--way longer than a flu strain takes to propagate, or an individual vaccine takes to formulate.
In the back of everyone's mind is the 1918 flu, and the possibility for a similarly deadly (or more deadly) version to develop today. It's possible and essentially unpredictable. If it were to happen, we would need to have that vaccine/drug infrastructure ready to go.
So: get your flu vaccine every year, even though it might not be super effective. Take Tamiflu even though it might not help much with a typical flu. Why? To keep those businesses and factories around for another year, in case we really need them.
[+] [-] walkamages|11 years ago|reply
[+] [-] 2muchcoffeeman|11 years ago|reply
Can't say if it really worked or not.
[+] [-] hvs|11 years ago|reply
http://en.wikipedia.org/wiki/Pharmaceutical_Benefits_Scheme
[+] [-] dsymonds|11 years ago|reply
[+] [-] debacle|11 years ago|reply
[+] [-] spacecowboy_lon|11 years ago|reply