Press releases are the way a lot of scientific information is released today. Straight to the public, no peer review. This has advantages and disadvantages. The advantages are speed and directness. No filtering through reviewers, journal editors, colleagues. And of course that's the disadvantage, too, especially when the news comes from an interested party as it usually does in a press release. This is part of the interpretation of data these days. All that being said, the maker of Tamiflu, Hoffman - La Roche, has released data they have gathered from physicians treating cases of H5N1 in various countries that seem to support the antiviral drug's efficacy. It was reported at the International Symposium on Respiratory Viral Infections (ISRVI) in Singapore:
In Indonesia, of the total of 119 H5N1 human cases reported, 22 survived - an 18 percent survival rate overall. Of these, 33 patients received no Tamiflu, all of whom died. Tamiflu was administered to 86 patients with a 26 percent survival rate overall. Time from onset of illness to initiation of treatment appeared to influence survival. Of the 2 patients who received Tamiflu within 24 hours of illness onset both survived. 55 percent survived if given the drug within four days (6/11), and 35 percent survived if given Tamiflu within six days (13/37). The survival rate of those receiving it later than 6 days after illness onset was 18 percent (9/49) Recent information on 8 Vietnamese patients infected with H5N1, was also presented. All 8 patients received Tamiflu. However, all 8 patients presented to the hospital later than 5 days after onset of illness. Only 3 of the 8 patients survived reinforcing that treatment benefit is reduced for patients that receive the drug later in the course of illness. In 2 patients who were unable to take the drug orally due to the severity of their illness physicians administered the drug by nasogastric tube and found it was well absorbed and there was a reduction in H5N1 virus in these patients. Susceptibility of circulating H5N1 strains to Tamiflu These clinical findings are supported by new animal data, also presented at ISRVI, which shows that oseltamivir treatment was effective against H5N1 influenza viruses representing different clades/subclades. However higher doses were required for the more pathogenic H5N1 viruses.(Press releases [cites omitted])
While Roche is publicizing (and putting its own spin on) these data, they do not appear to be Roche's data but rather part of a study from a highly respected flu scientist, Dr. Elena Govorkova, working out of St. Jude's in Memphis, one of the world's best research groups. Included in the same press release is Roche's view on the likelihood that significant resistance will develop to Tamiflu, making the drug useless. Not surprisingly they minimize the possibility, noting that laboratory evidence of resistance is scant, affecting only a few percent of H5N1 isolates tested. But indications from modeling are that even much lower frequencies of genetically fit resistant strains would spread through the population after the first wave where significant proportions of the population were treated therapeutically or prophylactically with Tamiflu. Despite this, the models show that there is still a substantial benefit during that first wave, so this is not a strong argument against stockpiling. However, in our view it is a strong argument against antivirals as the main line of defense in a pandemic.
This isn't a lot of clinical data to go on and other explanations than the efficacy of the drug are clearly possible. But it's the data we've got and they do suggest that Tamiflu is of benefit in H5N1 infection. Better than a poke in the eye with a sharp stick.
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Included in the same press release is Roche's view on the likelihood that significant resistance will develop to Tamiflu, making the drug useless.
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Which is precisely why I have spent the last three years looking for alternatives. Where do we go when the Tamiflu fails completely? The next pharmaceutical will be based on one or more of these, resveratrol, mullein, papain and/or sambucus.
So Revere, is that the reason you think that they might have only gotten enough for 25% of the US population rather than making the prophylaxis available for all? It isnt going to work much beyond wave one?
Randy: Working through wave one is a big deal as it allows us to be ready for wave 2 much better. We probably don't have the infrastructure to use the amount we have (distribute, etc.) and that proportion will make a real difference in any event (see the math modeling papers). The amount we have probably has no relationship to what we might or might not need. It is just the amount they ordered. I don't give the planners that much credit (or foresight). ow long it will work and how well no one knows.
Yeah, that three year lifespan on Tamiflu really cracks me up. But what else has a better shelf-life? What has any better outcomes?
De Nada...... You still not going to prepare? The irony of this stuff is that you because of your age might survive just long enough to get really hungry.I guess we all go with the Ethiopian cuisine...without.
Still no preps. Didn't even have any Tamiflu when Mrs. R. came down with flu while I was in Canada, talk about irony. If Tamiflu isn't in short supply now I may buy some. The 3 year shelf life is conservative IMO and it will last longer. I hope I do.
It's big pharma pushing this press release, as usual it's the grease my hand and I'll grease yours. Will be nice when those guys bite the dust.
With the financial turn going on now it's possible that: "When the U.S. government can no longer acquire easy debt money, the monopoly-priced spending on pharmaceuticals will have to be halted or significantly reformed".
Does Rummie still get money for Tamiflu sales?
"Tamiflu was invented by Gilead Sciences and licensed to Roche in 1996".
And the resistance to Tamiflu is a no brainer.
Shannon: Had the flu this season and got through it just fine with alternatives.
Lea: Yes, it's a Roche press release, but the data were collected by an independent and reputable scientist (Govorkova). Roche is publicizing it for their own purposes but it would be wrong to dismiss it out of hand. In my view, it has information that is usable and should be taken into account. The stuff on resistance I didn't pay much attention to but the treatment data are something to consider. And nothing is a no brainer when it comes to flu. You will see that despite resistance you still come out ahead with Tamiflu in the first wave. Don't let prejudice (as in prejudgment) blind you.
Even Roche admits that Tamiflu will eventually fail. Their words not mine. What happens if the first wave quickly renders Tamiflu useless? What happens during the second and third waves? We can pray for a vax but that won't help your average third world citizen. And, there won't be enough to go around for richer nations either.
Lea, I see a lot of interest in the aforementioned compounds both by alternatives practitioners as well as traditional researchers doing work for big pharma. Everyone is looking for the next neuraminidase inhibitor.
Shannon-What happens during the second and third waves? Sheesh, what happens during the first. The numbers just dont add up with what Tamiflu says it might be able to do. Many started to get better when the T-Flu was administered and prophylactically and then boom, bloink their conditions worsened and then they shuffled off.
Tamiflu causing mutations? Its a stretch if not a reach and either way, it doesnt seem to have changed the outcomes so far that can/could be attributed to it. Its a study, not a big one, not a fully diverse one but studies cost money and they tossed it out there. I guarantee you there will be no money for studies that might change the outcome of their sales. Elena G. and the others do great work but you produce a paper on what the expectations were and what you got instead or in line with that. Roche seized upon it and we got a press release to add credence to their assertions. Me, I wont be wasting my time or money on Tamiflu. Now that statin stuff? Its already in the war chest here courtesy of the local family MD along with Relenza in large quantities, six different types of antibiotics in the 1000 level doses, anti-inflammatory drugs, syringes, transfusion kits, phlebotomy sets and a case of Jack Black along with one of Stoli. Got to have your supplies and Tamiflu isnt on the list this week.
The latter two are definite hell on viruses in your mouth and throat... pretty much Hell the next day on your head too. Dr. Jack Daniels viral load reduction kit. Comprised of one glass and one bottle.
Batching my replies here:
Everyone is looking for the next neuraminidase inhibitor.
Which, when available, will also promptly be misused in a manner such as to significantly shorten its window of clinical utility.
Now that statin stuff? Its already in the war chest here courtesy of the local family MD
You must have a better working relationship with your physician than I do. ("What would you want *that* for? It's not a listed use in the PDR.")
Any of the statins in particular to be stocking up on? Or are they all pretty much the same?
So far as the alcohol prophylaxis goes, we have plenty of that. I had also thought to make use of BHT, which causes trouble for a number of lipid-enveloped viruses by solubilizing their coatings. No idea whether or not it would work with avian flu, but the stuff is fairly well tolerated.
What we would have to do would be to cut way back on the booze. BHT is a powerful enough synthetic antioxidant as to be able to partially quench the oxidative processes by which the liver breaks down ethanol. Expect to stay drunk for a long time.
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Statin is found Lipitor - taken to reduce cholesterol levels.
Makes sense stocking up on all drugs that you regularly use.
Victoria and Marquar, Randolph may be talking about this proposed treatment.
http://www.flutrackers.com/forum/showthread.php?t=7777
Shannon and others: Yes, statins. We have discussed this here, here, here, here, here.
Thanks Shannon,
Well I have a visit to the doctor penciled in.
Data can be misleading, especially with very small sample sizes, but the 100% fatality for cases who do not get Tamiflu should lead you to question it. No influenza in history has ever come close to a 100% fatality rate, even in the days before antibiotics (secondary bacterial infections are a cause of influenza deaths). Even HIV may not be 100%.
The key to understanding the data lies in why those H5N1 deaths did not receive Tamiflu.
Those 33 who died without receiving any Tamiflu were most likely suspected of having H5N1 only after they were dead or very close to it.
In some cases their contacts became seriously ill after they died, leading Doctors to suspect H5N1 in the index case. Testing as part of their autopsy confirmed this. The sick contacts, if any, received Tamiflu and were tested, and some survived.
Some surviving contacts may have had symptoms at the same time as the H5N1 index cases but recovered, meaning they were infected at the same time as the "index" case, and were likely not tested, or were tested too late to yield a positive result, and so tested as a false negative. So this unknown group of H5N1 Tamiflu-less survivors are not counted as such, and the case fatality rate is 100%, when it should be lower. Thats my theory.
Doctors are more likely to be on alert for H5N1 when there are already some reported outbreaks or clusters, so those presenting with flu or pneumonia are more likely to be treated with Tamiflu and tested for H5N1 than in quieter times. Thus the fatality rate will be less than 100%. It is likely it is much lower than the 55% rate reported in the study due to the problem of false negatives.
The absolute numbers showing better results with earlier usage of Tamiflu is not significant. The sample size is too small. Yet the trend is consistent what is already known, antivirals are more effective the earlier they are taken.
Tamiflu's main use in a pandemic is not as treatment, but as a prophylactic for those performing essential services. Giving Tamiflu to patients infected at the pre-pandemic phase to contain it, just in case it is pandemic seems unwise, since it will promote Tamiflu resistance if or when H5N1 goes pandemic, it will be rendered less effective at best, for prophylactic use.
During a panedmic, those who show up at hospital seriously ill with pneumonia and breathing difficulty, will not receive the same level of care as an isolated suspected H5N1 patient would today. No Tamiflu or respirators for you. Just won't be enough to go around.
On a happy note, almost all of Tamiflu is excreted in the urine, so it could be reused, hopefully after some processing. I imagine Gilead and Roche would probably have some issue with this.
revere: Tamiflu shelf life in capsule: five, not three years.
Tamiflu "real" shelf life (I mentioned that before): not limited. Direct communication during a meeting with panflu experts of our country sponsored by Roche. The gelatine capsule does not last that long, the Tami itself was said to last forever. Well, the person stated "indefinite" but lets not be overtly optimistic. Stockpiles do not come in capsule usually on a governmental level, and for private use, there is an easy solution to the capsule issue. So the main points are legal, and if there is degradation over time, then how much.
It was not in short supply over the last half year, production exceeded demand.
PFT: it cannot be reused, that idea (if you refer to the urine drinking idea) was wrong from the start and retracted by the one who made it up. I doubt that extracting the active Tami from urine and reprocessing it into the prodrug for oral use, makes more sense or is cheaper to do than using current or new processes for production.
Thanx