FDA approves new drug to treat influenza
fda.gov
fda.gov
This is a serious issue with these drugs. In general, I won't go to the doctor in that time frame. This is especially the case if one gets symptoms on a friday afternoon - the doctors do not open until Monday. By the time I decide I*m sick enough to visit the doctor, I've already passed the time frame (Exceptions apply, of course). And I know I'm not the only one.
To me, this is a major downfall of such remedies. This could seriously make a difference in the way the flu spreads, but for that to really happen, we need more ways to get seen by doctors or nurse practitioners. We should encourage folks to see the doctor for "little" things. We need to make sure everyone can get seen. We probably need to make sure folks in service industries get seen immediately and won't lose their jobs over such things. This is mostly because service industry workers can spread these to a wide population easily without controls.
Ideally, I think it would work best if we had a care level that was between normal doctor and urgent care that was open 24 hours a day. It'd mostly be to treat things like this. But until then, surely we can simply do tests for everyone.
The aim isn't to have one magical drug that works for everyone, but an entire set of tools in your arsenal.
A few years ago, I got the the flu while visiting home during the holidays. My family took me to the clinic to get some antibiotics to deal with some secondary infections (I also had wisdom teeth stuff going on at the same time lol). I remember the doctor offering tamiflu to my family as prophylaxis, or to come back the moment they felt symptoms for tamiflu.
Nevertheless, it will help those folks with risks more if folks like me actually use this stuff too. If people like me take this within the time frame and stop spreading, it is much better. This is what I think we should fix.
We should encourage folks like me to use things like this. Not because we are helped so much by the medicine itself, but because it cuts down on transmission. To be able to do that, the problems I mentioned in the original post needs to be addressed.
The duration of flu symptoms, by more than 1 day (median time, 53.7 hours vs 80.2 hours; P <.0001);
The duration of fever, by nearly 1 day (median time, 24.5 hours vs 42.0 hours; P <.0001);
The length of time viruses continued to be released from the body (median time of viral shedding, 24.0 hours vs 96.0 hours; P <.0001); and
The levels of virus in the nose and throat from 24 hours through 120 hours.
Relative to oseltamivir, baloxavir treatment resulted in similar median time to alleviation of symptoms (median, 53.5 hours for baloxavir vs 53.8 hours for oseltamivir; P = .7560) and similar time to resolution of fever reduction (median, 24.4 hours vs 24.0 hours; P = .9225), respectively.
However, baloxavir treatment was associated with significantly reduced viral shedding duration (24.0 hours vs 72.0 hours; P < .0001) and significantly lower levels of virus in the nose and throat at 24 hours and 72 hours.
"It is unclear why the time to alleviation of symptoms was similar in the baloxavir group and the oseltamivir group even though baloxavir showed greater antiviral activity," the authors write. "The findings suggest that the symptom benefit of antiviral agents may have a ceiling in self-limited influenza illness in adults, perhaps because viral replication levels are decreasing by the time of presentation and illness pathogenesis is linked to host proinflammatory responses."
Overall, baloxavir was well-tolerated and had a lower incidence of adverse events reported (20.7%) compared with placebo (24.6%) or oseltamivir (24.8%). The most common adverse events were diarrhea (3%), bronchitis (2.6%), nausea (1.3%), and sinusitis (1.1%).
"The antiviral effects that were observed with baloxavir in patients with uncomplicated influenza provide encouragement with respect to its potential value in treating complicated or severe influenza infections," the authors write.
Isn't that an odd result? Unless the drug is treating underlying viral issues that might not have been identified prior, it should be on par with placebo, no?
> The knowledge about taking medication or the anxiety about medication effects and illness course can cause patients to monitor symptoms in more detail, resulting in an amplified perception of benign sensations and physical symptoms.
I wish the article listed the frequency or likelihood of getting these reactions. Given the choice between flu and bronchitis, I'll take the flu.
Adverse event - Xofluza(%) - Placebo(%)
Diarrhea - 3% - 5% [higher in placebo]
Bronchitis - 2% - 4% [higher in placebo]
The FDA requires that the manufacturer list the most common adverse events, even if they are unrelated to the drug in question.
[1]https://www.gene.com/download/pdf/xofluza_prescribing.pdf
https://www.scientificamerican.com/article/placebo-effect-gr...
I would be more curious about how well does it play together with something like ambroxol hydrochloride - I used to get bronchitis as a complication every time I get cold in the past but as soon as I've discovered ambroxol hydrochloride I've forgotten about ever having bronchitis as a bad dream.
I don't even bother with the doctor anymore (unless I have a fever) because I'm not interested in the codeine and I can just buy Primatene (ephedrine + guaifenesin) over the counter. Both my doctor and a pharmacist have admitted they could do no better.
How often do you get the flu (actual flu, not a bad cold) and not have a fever? I've only had the flu once in my life (30-something years), and it was like being hit by a bus, having said bus park on your body, and having said bus catch on fire and slowly burn.
I've had pneumonia at least twice as an adolescent, but which went untreated for awhile because it was typical for me to have prolonged coughing and lethargy after a respiratory illness. So while I'll treat my own bronchitis, I have to be mindful that the bronchitis could be secondary, or could have resulted in an infection.
Would be interesting to see what impact that has during flu season.
Even working on the farm, I rarely could take a sick day. Cows won't milk themselves and you can't tell them to hold it for a few days either.
I don't mean that people should take a few days off, they should, but that may not be possible, I mean that you'll have a period where you're not capable of more than basic tasks.
It was too late to go the doctor, and I only had Vitamin C (as Sodium Ascorbate powder) on hand, so I chugged that down, up to maybe 5 grams every half-hour in orange juice, and about 6 hours later, the worst of the flu was gone. Next morning, I was feeling like I only had a minor cold. The flu never came back, either.
Since then, that's been my go-to strategy.
> In the second trial, there was no difference in the time to alleviation of symptoms between subjects who received Xofluza and those who received the other flu treatment.
I’d be more interested on how it combines with elderberry syrup, which ostensibly does actually work.
https://www.ncbi.nlm.nih.gov/pubmed/15080016
Edit: Symptoms were relieved on average 4 days earlier and use of rescue medication was significantly less in those receiving elderberry extract compared with placebo.
Also, I’m surprised symptoms were alleviated 4 days (96 hours) sooner when the Tamiflu trial said total duration of symptoms were 78 hours for the placebo.
Clearly it wouldn't meet the standards for a phase III clinical trial. But that doesn't necessarily mean it's worse. Pharma studies and plant studies both have their own sets of methodological issues, so it's hard to really compare them on how likely their findings are to be accurate or whatever. E.g. because elderberry isn't patentable, that eliminates most of the incentive to basically make up results like what happened with Tamiflu. But you also don't have the money to run multi-thousand person trials. How do these really compare with one another? It's hard to say.
For me, elderberry seems like the clear winner over Tamiflu because there are no negative side effects. At worst, it just doesn't work, but it only costs ~$0.65 per dose and the evidence that it does work is actually pretty compelling even though it would obviously be better if there were multi-site trials with larger sample sizes.
Fair enough. Perhaps a more appropriate way to phrase that would be that it using it doesn't require any more precaution than trying any other new food for the first time.
Generally the size of the trial scales with the potential population and the statistical power you are shooting for.
Three or four actually.
> Tamiflu trial said total duration of symptoms were 78 hours for the placebo
And again, the Tamiflu data was faked. You can read the background on this here: https://www.bmj.com/content/345/bmj.e7303
When the real data was finally FOIA'd or whatever, it became clear that it no longer had even the minimal efficacy that was originally claimed. The way that FDA trials work is that you need two phase III studies showing a drug is more effective than placebo, but you're allowed to conduct unlimited trials that don't find any advantage over placebo without being required to make the data from these other studies public. That's what happened in this case, there were one or more additional studies that showed it wasn't effective, and when you included the data from the additional studies to calculate the overall effect the advantages disappeared.
There are several books about this, but since every time I link to books people complain that I'm trying to trick them into reading, here's an Internet article about what happened instead: https://articles.mercola.com/sites/articles/archive/2015/10/...
The main caveat on elderberry, other than the lack of FDA monitored clinical trials, is just that the stuff you're likely to find in your local drug store is Sambucol, which isn't the best quality. But you can go and buy this online that's actually good quality and not that expensive:
https://www.amazon.com/Gaia-Herbs-Black-Elderberry-Syrup/dp/...
The flowers of S.N. are OK and can be made into elderberry juice. Your local Ikea probably even carries it ("flädersaft") if you want to taste.
I don't know if the juice from the flowers has antiviral properties but certainly the taste is better than Tamiflu. It actually tastes (subjectively) delicious.
Well sure you obviously need a field guide to edible plants, otherwise you'd likely poison yourself regardless.
And yeah you can't just eat them because the seeds have arsenic, but since that boils off at just over room temperature all you need to do is put them through a food mill to remove the seeds and then sautee the juice for a few min with the exhaust fan on.
So I would not expect a combination of them to do much either.