Medical Forum / General / General / November 2005
rumsfield's growing stake in TAMIFLU
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fresh~horses - 01 Nov 2005 08:17 GMT Rumsfeld's growing stake in Tamiflu Defense Secretary, ex-chairman of flu treatment rights holder, sees portfolio value growing. October 31, 2005: 10:55 AM EST By Nelson D. Schwartz, Fortune senior writer
NEW YORK (Fortune) - The prospect of a bird flu outbreak may be panicking people around the globe, but it's proving to be very good news for Defense Secretary Donald Rumsfeld and other politically connected investors in Gilead Sciences, the California biotech company that owns the rights to Tamiflu, the influenza remedy that's now the most-sought after drug in the world.
Rumsfeld served as Gilead (Research)'s chairman from 1997 until he joined the Bush administration in 2001, and he still holds a Gilead stake valued at between $5 million and $25 million, according to federal financial disclosures filed by Rumsfeld.
The forms don't reveal the exact number of shares Rumsfeld owns, but in the past six months fears of a pandemic and the ensuing scramble for Tamiflu have sent Gilead's stock from $35 to $47. That's made the Pentagon chief, already one of the wealthiest members of the Bush cabinet, at least $1 million richer.
Rumsfeld isn't the only political heavyweight benefiting from demand for Tamiflu, which is manufactured and marketed by Swiss pharma giant Roche. (Gilead receives a royalty from Roche equaling about 10% of sales.) Former Secretary of State George Shultz, who is on Gilead's board, has sold more than $7 million worth of Gilead since the beginning of 2005.
Another board member is the wife of former California Gov. Pete Wilson.
"I don't know of any biotech company that's so politically well-connected," says analyst Andrew McDonald of Think Equity Partners in San Francisco.
What's more, the federal government is emerging as one of the world's biggest customers for Tamiflu. In July, the Pentagon ordered $58 million worth of the treatment for U.S. troops around the world, and Congress is considering a multi-billion dollar purchase. Roche expects 2005 sales for Tamiflu to be about $1 billion, compared with $258 million in 2004.
Rumsfeld recused himself from any decisions involving Gilead when he left Gilead and became Secretary of Defense in early 2001. And late last month, notes a senior Pentagon official, Rumsfeld went even further and had the Pentagon's general counsel issue additional instructions outlining what he could and could not be involved in if there were an avian flu pandemic and the Pentagon had to respond.
As the flu issue heated up early this year, according to the Pentagon official, Rumsfeld considered unloading his entire Gilead stake and sought the advice of the Department of Justice, the SEC and the federal Office of Government Ethics.
Those agencies didn't offer an opinion so Rumsfeld consulted a private securities lawyer, who advised him that it was safer to hold on to the stock and be quite public about his recusal rather than sell and run the risk of being accused of trading on insider information, something Rumsfeld doesn't believe he possesses. So he's keeping his shares for the time being.
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Robert - 01 Nov 2005 10:19 GMT > Rumsfeld's growing stake in Tamiflu I don't think Can.politics would be interested in the three posts concerning the FDA or Medicaid in Georgia or Rumsfield would they?
notritenoteri - 01 Nov 2005 14:48 GMT You really are in need of help. Just because USA is insular, unknowing and uncaring about the rest of the world doesn't mean the rest of the world ignores the USA. Canada is effectively joined at the hip to the great baboon to the south. It is really too bad but we're stuck to watch USA f.ck up the world while we try to keep from being rolled on.
> > Rumsfeld's growing stake in Tamiflu > > I don't think Can.politics would be interested in the three posts concerning > the FDA or Medicaid in Georgia or Rumsfield would they? Robert - 01 Nov 2005 19:00 GMT > You really are in need of help. Just because USA is insular, unknowing and > uncaring about the rest of the world doesn't mean the rest of the world > ignores the USA. Canada is effectively joined at the hip to the great > baboon to the south. It is really too bad but we're stuck to watch USA f.ck > up the world while we try to keep from being rolled on. The FDA? The state of Georgia? Granted that is a Canadian thing as the cuts in Healthcare up there has made Canada vulnerable to what the FDA does. It can't afford it's own research with research cuts so I guess you have a point there. With more money infused into your healthcare system you would have the ability to strengthen Health Canada to a similar status of the FDA. Canada should be less dependent on the FDA. I think Canada can do better than the state of Georgia although the CDC is located there. Is there a similar institution such as the CDC up in Canada?
tunderbar@hotmail.com - 01 Nov 2005 20:14 GMT > > You really are in need of help. Just because USA is insular, unknowing and > > uncaring about the rest of the world doesn't mean the rest of the world [quoted text clipped - 12 lines] > I think Canada can do better than the state of Georgia although the CDC is > located there. Is there a similar institution such as the CDC up in Canada? What are you doing babbling on about a foreign country in a foreign ng? Mind your own yankee business.
TC
Robert - 01 Nov 2005 20:33 GMT > What are you doing babbling on about a foreign country in a foreign ng? > Mind your own yankee business. > > TC By the way I am posting out of sci.med. I am American now. I am somewhat confused here. the NG Can.politics talking about a foreign countries FDA and the state of Georgia in the US is not foreign? What's a foreign NG? If the OP wanted to limit it to Canadians then I can respect that. Simply post it to Can.politics. NG only.
tunderbar@hotmail.com - 01 Nov 2005 22:41 GMT > > What are you doing babbling on about a foreign country in a foreign ng? > > Mind your own yankee business. [quoted text clipped - 6 lines] > foreign NG? If the OP wanted to limit it to Canadians then I can respect > that. Simply post it to Can.politics. NG only. But it's canadian commentary, yanks have no business commenting on canadian commentary.
TC
notritenoteri - 01 Nov 2005 22:52 GMT The FDA is important simply because if drugs don't get approved by the FDA there is very little chance of them being approved in Canada. I have a very personal interest in what the FDA does. As to Georgia it another marker of what the US collective is thinking about, if anything. There are very few things that I don't have an interested in and just enough knowledge to be dangerous. You really do live in a fools' paradise. Canada has money to spend on research and does so. We have even on occasion given the world such things as Insulin without license. Can USA claim the same? I'm surprised you have so much faith in the FDA given its screw-ups with Vioxx and Celibrex and a few others even more recent. Canada has the equivalent of the CDC and similar bio labs located in Winnipeg. We just don't go all hot and sweaty or nutso about every potential .
> > You really are in need of help. Just because USA is insular, unknowing and > > uncaring about the rest of the world doesn't mean the rest of the world [quoted text clipped - 12 lines] > I think Canada can do better than the state of Georgia although the CDC is > located there. Is there a similar institution such as the CDC up in Canada? Sbharris[atsign]ix.netcom.com - 02 Nov 2005 07:11 GMT > You really do live in a fools' paradise. Canada has money to spend on > research and does so. We have even on occasion given the world such things > as Insulin without license. Can USA claim the same? We funded the first polio vaccine on a private US donation campaign called The March of Dimes. Then it was given away to the world without patent.
By contrast, the Canadians did patent Insulin, and those royalties from the license to Lilly went to the University of Toronto.
Get your facts straight.
SBH
notritenoteri - 02 Nov 2005 12:59 GMT Banting sold the patent to the University of Toronto for one dollar proposing that Connaught Laboratories produce the extract. They did, but the demand was so great that Eli Lilly Company (Canada) Limited, which had worked on the purification of the insulin in 1922, was awarded a contract and produced the first commercial supply in 1923. This company is today a major producer of insulin.
> > You really do live in a fools' paradise. Canada has money to spend on > > research and does so. We have even on occasion given the world such things [quoted text clipped - 10 lines] > > SBH Sbharris[atsign]ix.netcom.com - 02 Nov 2005 22:54 GMT > Banting sold the patent to the University of Toronto for one dollar > proposing that Connaught Laboratories produce the extract. They did, but the > demand was so great that Eli Lilly Company (Canada) Limited, which had > worked on the purification of the insulin in 1922, was awarded a contract > and produced the first commercial supply in 1923. This company is today a > major producer of insulin. Yes, how does that contradict what I said? Eli Lilly in the US produced insulin for the US market under license from U. Toronto, and had to pay them. Thus, buyers of insulin in the US paid royalties for that, to a Canadian University. Nothing wrong with that, so long as you don't pretend otherwise. Which you were. It's not a free gift to the world if the world is required to pay you license fees for it. What part of this don't you understand? Head graft time?
SBH
notritenoteri - 02 Nov 2005 23:09 GMT The patent was sold for $1 perhaps not totally free but pretty close unlike some of the major drugs produced.
> > Banting sold the patent to the University of Toronto for one dollar > > proposing that Connaught Laboratories produce the extract. They did, but the [quoted text clipped - 12 lines] > > SBH Sbharris[atsign]ix.netcom.com - 02 Nov 2005 23:55 GMT > The patent was sold for $1 perhaps not totally free but pretty close unlike > some of the major drugs produced. Earth to Noteri. The inventors (who worked at U. Toronto) might have sold it to U. Toronto for $1 (as commonly is expected to happen with people who work at some institution and invent stuff on the institution's nickel). That doesn't mean U. Toronto sold it to the US or US makers, $1. In fact, they charged them millions over the years for the license to make and sell insulin by this process, in the US. A relative pitance (and again, I'm not saying there's a thing wrong with them doing this). But it wasn't $1 and it's wasn't free.
SBH
notritenoteri - 03 Nov 2005 00:42 GMT Notritenoteri to SBH, whats your point what has USA given away lately in the way of drugs? I know what I pay for US licensed drugs and it ain't free.
> > The patent was sold for $1 perhaps not totally free but pretty close unlike > > some of the major drugs produced. [quoted text clipped - 9 lines] > > SBH Robert - 02 Nov 2005 08:36 GMT Let me rearrange the furniture.
> I'm surprised you have > so much faith in the FDA given its screw-ups with Vioxx and Celibrex and a > few others even more recent. Then let me add this here.
> The FDA is important simply because if drugs don't get >approved by the FDA there is very little chance of them being >approved in Canada.
Canada puts so much faith in the FDA because they want to save money and keep the GNP down spent on healthcare.
>Canada has money to spend on research and does so. We have >even on occasion given the world such things as Insulin without >license. Can USA claim the same?
That is correct in the past before your universal single payer system was instituted. Now the key point is to keep it low and spend all on treatment.
notritenoteri - 02 Nov 2005 13:06 GMT What exactly is your point? Motives are really irrelevant at this juncture. USA spends a lot more relatively of its GDP on healthcare and achieves worse outcomes in terms of longevity, infant mortality etc.. Even some of the smarter people in USA question the current system.
> Let me rearrange the furniture. > [quoted text clipped - 16 lines] > That is correct in the past before your universal single payer system was > instituted. Now the key point is to keep it low and spend all on treatment. Skeptic - 03 Nov 2005 16:05 GMT > What exactly is your point? Motives are really irrelevant at this > juncture. USA spends a lot more relatively of its GDP on healthcare and > achieves worse outcomes in terms of longevity, infant mortality etc.. > Even > some of the smarter people in USA question the current system. That is purely a result of having a system with reduced access to care vs canada. Those who have health care coverage are far better off in the USA than in canada - which is why so many travel from canada to the USA for surgeries, advanced treatments, consults with experts, etc.
Skeptic - 03 Nov 2005 15:59 GMT bitter words from someone stuck in the bitterly cold ice caps north of the greatest country in the world and the most dominant human civilization that ever has or ever will exist.
> You really are in need of help. Just because USA is insular, unknowing and > uncaring about the rest of the world doesn't mean the rest of the world [quoted text clipped - 8 lines] > concerning >> the FDA or Medicaid in Georgia or Rumsfield would they? notritenoteri - 03 Nov 2005 16:14 GMT Actually if you knew f.ck-all about f.ck-all you'd know that parts of Canada are south of Detroit. I'm not bitter I just recognize our brden!
> bitter words from someone stuck in the bitterly cold ice caps north of the > greatest country in the world and the most dominant human civilization that [quoted text clipped - 12 lines] > > concerning > >> the FDA or Medicaid in Georgia or Rumsfield would they? Bob - 02 Nov 2005 05:51 GMT >Rumsfeld's growing stake in Tamiflu >Defense Secretary, ex-chairman of flu treatment rights holder, sees [quoted text clipped - 58 lines] >Rumsfeld doesn't believe he possesses. So he's keeping his shares for >the time being. So let's accept the basic premise here that he has at least a perceived conflict of interest.
What do you -- or anyone -- think should be done?
bob
Sbharris[atsign]ix.netcom.com - 02 Nov 2005 07:26 GMT > So let's accept the basic premise here that he has at least a > perceived conflict of interest. > > What do you -- or anyone -- think should be done? > > bob I don't know. If Rumsfeld were the president, or the head of the FDA, there'd be a problem. But since he is secretary of defense, I fail to see the conflict of interest. Is the military being enlisted to force people to take Tamiflu? Last I heard, the only suggested role of the military for Bird Flu was to isolate and quaranteen people so they wouldn't get sick and *wouldn't* have to take Tamiflu. If there's a giant plot here by Rumsfeld to make himself richer, I'm afraid somebody's going to have to explain it.
If Rumsfeld wanted to spend his golden years merely making money he doesn't need, I can think of a lot of corporate jobs he could be doing, rather than the relatively low paying one he has.
SBH
Carey Gregory - 02 Nov 2005 08:03 GMT >I don't know. If Rumsfeld were the president, or the head of the FDA, >there'd be a problem. But since he is secretary of defense, I fail to [quoted text clipped - 8 lines] >doesn't need, I can think of a lot of corporate jobs he could be doing, >rather than the relatively low paying one he has. Yep. As much as I dislike the Bush administration, I can't find anything wrong in the information provided. He took extraordinary steps to keep it above board, but you only learn that at the end of the article. Imagine that -- you have to read beyond the headlines.
And what the hell does this have to do with sci.med or can.politics, anyway? Cross-posted to three newsgroups, only one of which is appropriate.
fresh~horses - 02 Nov 2005 08:21 GMT > >I don't know. If Rumsfeld were the president, or the head of the FDA, > >there'd be a problem. But since he is secretary of defense, I fail to [quoted text clipped - 16 lines] > And what the hell does this have to do with sci.med or can.politics, anyway? > Cross-posted to three newsgroups, only one of which is appropriate. Tamiflu and information related to its development and marketing are of prime interest. To everyone. FORTUNE magazine certainly thinks so.
Carey Gregory - 02 Nov 2005 17:51 GMT >Tamiflu and information related to its development and marketing are of >prime interest. To everyone. FORTUNE magazine certainly thinks so. Oh, then by all means you should cross-post it to all 100,000 newsgroups.
Heck, every issue that Fortune thinks is of "prime interest" to "everyone" should be cross-posted to every single newsgroup, don't you think?
fresh~horses - 02 Nov 2005 18:34 GMT > >Tamiflu and information related to its development and marketing are of > >prime interest. To everyone. FORTUNE magazine certainly thinks so. [quoted text clipped - 3 lines] > Heck, every issue that Fortune thinks is of "prime interest" to "everyone" > should be cross-posted to every single newsgroup, don't you think? Tamiflu being pushed with little evidence it mitigates flu for more than a few hours, and that only in certain populations and at great cost; and who profits from this scam should just be kept quiet. Is that what you're saying Carey?
Sbharris[atsign]ix.netcom.com - 02 Nov 2005 22:50 GMT > Tamiflu being pushed with little evidence it mitigates flu for more > than a few hours, and that only in certain populations and at great > cost; COMMENT:
Yeah, "certain populations" like healthy adults and vaccinated elderly are protected (70% and 92% respectively, as compared with placebo controls) from getting the flu *at all* by Tamiflu, in post-exposure prophylaxis. Which would be damned useful in an outbreak of a killer virus for which there is no effective vaccine.
In children over 12 months old (they didn't test it on younger), Tamiflu not only decreases flu duration and severity, but secondary symptoms like bacterial bronchitis and pneumonia. There is no reason to imagine the same would not happen in populations of adults who get the same problems (ie, the elderly) but this hasn't been explicitly tested, AFAIK.
In healthy non-elderly adults, Tamiflu decreases flu duration and severity. But this is testing in adults who are infected with a non-killer flu virus, so there aren't/weren't enough cases of secondary bronchitis and pneumonia to assess impact.
However, in *animals* exposed to a strain of flu which produces high mortality in the model, Tamiflu *greatly* decreases mortality. As well as disease duration and severity in animal which survive. All this is backed up by a very great deal of knowledge of the effect of Tamiflu on replication of flu virus in culture, which is how the drug was first developed.
Now, given all that information, what do you think? Just hype? Well, you (and your government) are welcome to bet against the odds with your own life. Bon chance, les Canucks. But then, "Dans les champs de l'observation le hasard ne favorise que les esprits préparés." (Pasteur) If you're not prepared to look, you won't see the monster till it eats you. Get out the mighty monster song, cause one rendition's all you get, before the coughing fit makes you stop.
> and who profits from this scam should just be kept quiet. Is that > what you're saying Carey? COMMENT Who profits is irrelvant, so long as they're not making the government decisions, as regards this drug. Which there is no reason to think the US Secretary of Defense is. That's just paranoid nonsense.
SBH
fresh~horses - 02 Nov 2005 22:53 GMT > > Tamiflu being pushed with little evidence it mitigates flu for more > > than a few hours, and that only in certain populations and at great [quoted text clipped - 19 lines] > non-killer flu virus, so there aren't/weren't enough cases of secondary > bronchitis and pneumonia to assess impact. May we have your source please?
> However, in *animals* exposed to a strain of flu which produces high > mortality in the model, Tamiflu *greatly* decreases mortality. As well [quoted text clipped - 20 lines] > > SBH Sbharris[atsign]ix.netcom.com - 02 Nov 2005 22:55 GMT > > > Tamiflu being pushed with little evidence it mitigates flu for more > > > than a few hours, and that only in certain populations and at great [quoted text clipped - 21 lines] > > May we have your source please? Google "Tamiflu and SBH". Sources posted in a thread just last month. And in a message you yourself replied to. But I suppose didn't read.
SBH
fresh~horses - 02 Nov 2005 23:02 GMT > > > > Tamiflu being pushed with little evidence it mitigates flu for more > > > > than a few hours, and that only in certain populations and at great [quoted text clipped - 26 lines] > > SBH I don't find your sources.
Sbharris[atsign]ix.netcom.com - 02 Nov 2005 23:13 GMT > > Google "Tamiflu and SBH". Sources posted in a thread just last month. > > And in a message you yourself replied to. But I suppose didn't read. > > > > SBH > > I don't find your sources. First message from SBH in the thread below. Medline review abstracts quoted. You can find them on medline and look at THEIR sources.
http://groups.google.com/group/sci.med/browse_thread/thread/f50ad40f6155ab5e/b51 34b2293beaf52?lnk=raot
fresh~horses - 02 Nov 2005 23:05 GMT "Well, you (and your government) are welcome to bet against the odds with your own life. Bon chance, les Canucks."
This is such a childish response Steve. I fail to see where this is an issue of my government against your government. But if you want to go with the paranoia theme...
Sbharris[atsign]ix.netcom.com - 02 Nov 2005 23:21 GMT > "Well, you (and your government) are welcome to bet against the odds > with your own life. Bon chance, les Canucks." > > This is such a childish response Steve. I fail to see where this is an > issue of my government against your government. But if you want to go > with the paranoia theme... COMMENT:
Sigh. The US government is stockpiling Tamiflu and paying a lot of money to do it (unlike Canada, which isn't). You start a thread with an article which insinuates that a US political appointee is profiteering from said decission, and you post this on "can.politics." THEN, you now call ME "childish" for wondering how this might *possibly* be seen as a "government vs government" issue? Say what?
SBH
fresh~horses - 02 Nov 2005 23:44 GMT > > "Well, you (and your government) are welcome to bet against the odds > > with your own life. Bon chance, les Canucks." [quoted text clipped - 13 lines] > > SBH You want to have that sighing problem looked into. It can be a sign of a heart problem.
Like everyone else I am trying to determine the value of these drugs. To me, and to anyone. Why are we being told, virtually, that we must use them? If I dismissed it out of hand, I wouldn't be asking. Asking involves searching. Searching, for me, involves sharing what I find, especially when it begins to follow a pattern. Why are there such scare tactics being used? I find more and more hype that is typical of how another class of drugs was and is pushed.
**My comments.
Commentary: We need to determine who benefits most from flu treatments Lucy Hansen
Influenza accounts for about 20 000 deaths and 110 000 hospital admissions each year in the United States alone.1 In their meta-analysis of the neuraminidase inhibitors zanamivir and oseltamivir Cooper and colleagues have included the small amount of information available that allows separation of subjects into healthy adults and high risk individuals.
Both zanamivir and oseltamivir reduce the median time to resolution of symptoms by **up to one day** based on intention to treat, with similar results on confirmation of flu positivity.
**No clear difference between the healthy and high risk groups is apparent.**
The prophylactic use of each drug resulted in a more impressive 70-90% risk reduction in both post-exposure prophylaxis and prophylactic treatment during the time of year when flu is most common (seasonal prophylaxis).
**That's RELATIVE risk.**
Subjects were **monitored for only three to four weeks**, however, and a large minority remained symptomatic at the end of this time. This is consistent with my observations that many patients admitted to hospital with complications following a bout of flu have a four to eight week history of symptoms.
No studies have compared the response to treatment in **vaccinated versus non-vaccinated subjects**, but one study of vaccinated, elderly residential patients treated with seasonal prophylaxis reported a 92% **relative** reduction.2
This emphasises the often forgotten fact that **the vaccine is only 70% effective and has only short term benefits.**
Rather than neuraminidase inhibitors being an alternative to vaccination, they might be an additional treatment in high risk groups, particularly during epidemics or local outbreaks.
It is difficult to see what important new information about the treatment of flu this meta-analysis offers. As is often the situation with new drugs, information from new studies is essential before neuraminidase inhibitors will become widely used: characterisation of the type and severity of symptoms and end points such as "return to normal activities" should be automatically included; trials should continue for longer; and data collection should provide more details of the type and severity of complications and admissions to hospital.
Studies concentrating on the different high risk groups may define those who will gain most benefit from treatment and should incorporate information on vaccination status. In addition to comparative studies of the two neuraminidase inhibitors, combination therapy (vaccination, the M2 inhibitors (amantadine and rimantadine), and neuraminidase inhibitors) may prove an effective means of reducing morbidity and mortality in both treatment and prevention of flu. Results of studies to date do not provide adequate evidence of a cost effective treatment for flu,3 but new, more clearly directed research will hopefully clarify which groups will benefit from treatment with neuraminidase inhibitors, alone or in combination with other established treatments.
Competing interests: None declared. 1 Advisory Committee on Immunisation Practices. Prevention and control of influenza: recommendations of the Advisory Committee on Immunisation Practices (ACIP).MMWR 2002;51(No RR 3). 2 Peters PH, Gravenstein S, Norwood P, DeBock V, Van Couter A, Gibbens M, von Planta T,Ward P. Long term use of oseltamivir for the prophylaxis of influenza in a vaccinated frail population. J Am Geriatric Soc 2001;49:1025-31. 3 Appraisal Committee of the National Institute for Clinical Excellence. Full guidance on the use of zanamivir, oseltamivir and amantidine for the treatment of influenza. Report for the National Institute for Clinical Excellence. February 2003. www.nice.org.uk/ Papers University of Edinburgh, Edinburgh EH9 1QH Lucy Hansen consultant physician s0198608@sms. ed.ac.uk BMJ VOLUME 326 7 JUNE 2003 bmj.com page 7 of 7 Downloaded from bmj.com on 20 October 2005
Sbharris[atsign]ix.netcom.com - 03 Nov 2005 00:45 GMT > Like everyone else I am trying to determine the value of these drugs. > To me, and to anyone. Why are we being told, virtually, that we must > use them? COMMENT:
You're not being told that, at present. Not by any competent professional. We are talking about two completely separate cases: 1) ordinary flu season, and 2) a bird flu epidemic with attendent VERY MUCH HIGHER THAN NORMAL mortality profile.
For Case #1, the analysis you post below is entirely reasonable (and in fact contains much of the info I already noted). In normal flu seasons, 90% of the deaths are in people over 65, and most of the rest are in people who are chronically ill, and can be identified as so, beforehand. Tamiflu is useful for those groups and people *in those groups* who are exposed to a known flu case. As for others, probably it's not worth the money, and especially isn't worth using up stockpiles of a drug in short supply, as this one will be for the next couple of years. I wouldn't take my *own* stockpile of Tamiflu for the ordinary kind of flu, if I came down with it. I've been vaccinated, and if I get the flu, then amantidine, aspirin, and the good old hot tub is going to have to do. I might try some ribivirin since I happen to have a lot of it on hand, and know more about the "guts" of why it's not a presently recommended flu drug (bottom line-- this was an FDA screwup, for fully political reasons). But there are things I'd do for myself that I'd never prescribe, and that's one of them.
For Case #2, all bets are off. Who you use Tamiflu on THEN, depends on who's doing the dying. If it's 1918 again, that might be people age 20. Previously done risk analysis only applies very losely to this situation, except that it's very reasonable to believe that a drug which ameliorates lesser flus, and almost completely prophylaxes against lesser flus, will do so also against a killer bird flu (which we know will use the same mechanisms that this drug works against).
>If I dismissed it out of hand, I wouldn't be asking. Asking > involves searching. Searching, for me, involves sharing what I find, > especially when it begins to follow a pattern. Why are there such scare > tactics being used? I find more and more hype that is typical of how > another class of drugs was and is pushed. Scare tactics in medicine are used mainly on people who don't seem to "get it" any other way. Know any?
SBH
fresh~horses - 03 Nov 2005 01:15 GMT > > Like everyone else I am trying to determine the value of these drugs. > > To me, and to anyone. Why are we being told, virtually, that we must [quoted text clipped - 6 lines] > ordinary flu season, and 2) a bird flu epidemic with attendent VERY > MUCH HIGHER THAN NORMAL mortality profile. Please show me any evidence that TAMIFLU has efficacy against Avian Flu.
> For Case #1, the analysis you post below is entirely reasonable (and in > fact contains much of the info I already noted). You didn't mention your figures were relative, not absolute.
In normal flu seasons,
> 90% of the deaths are in people over 65, and most of the rest are in > people who are chronically ill, and can be identified as so, > beforehand. Tamiflu is useful for those groups and people *in those > groups* who are exposed to a known flu case. That's not what the BMJ articles said.
As for others, probably
> it's not worth the money, and especially isn't worth using up > stockpiles of a drug in short supply, as this one will be for the next [quoted text clipped - 6 lines] > for fully political reasons). But there are things I'd do for myself > that I'd never prescribe, and that's one of them. Thanks you for sharing that with us. It's useful information.
> For Case #2, all bets are off. Who you use Tamiflu on THEN, depends on > who's doing the dying. If it's 1918 again, that might be people age 20. [quoted text clipped - 3 lines] > against lesser flus, will do so also against a killer bird flu (which > we know will use the same mechanisms that this drug works against). I've read American opinion in American publications from American physicians which disagree with you.
> >If I dismissed it out of hand, I wouldn't be asking. Asking > > involves searching. Searching, for me, involves sharing what I find, [quoted text clipped - 4 lines] > Scare tactics in medicine are used mainly on people who don't seem to > "get it" any other way. Considering the scare coverage propagated by the manufacturers of Tamiflu then this must be the majority of the American population.
>Know any? Yes. I have been reading you on this issue.
I was wrong. You're like a mutating virus; you're now able to morph from polymath to protogrunt without mention of Ca-na-da.
> SBH Sbharris[atsign]ix.netcom.com - 03 Nov 2005 02:04 GMT > > > Like everyone else I am trying to determine the value of these drugs. > > > To me, and to anyone. Why are we being told, virtually, that we must [quoted text clipped - 9 lines] > Please show me any evidence that TAMIFLU has efficacy against Avian > Flu. COMMENT:
In people? None exists because there have been too few cases. There has even been a report of a resistant strain isolated from one person. Too few of any of these to do stats with. In mice, the drug works reasonably well. The virus is essentially 100% lethal without it. However, the flu is worse in mice than it is in people. I think that has to do with our respiratory reserve. Humans are runners with lots of reserve, and it takes a more lung problem to kill us than any mammal but the dog.
You can do your own medline searches, you know.
1: J Infect Dis. 2005 Aug 15;192(4):665-72. Epub 2005 Jul 15.
Virulence may determine the necessary duration and dosage of oseltamivir treatment for highly pathogenic A/Vietnam/1203/04 influenza virus in mice.
Yen HL, Monto AS, Webster RG, Govorkova EA.
Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee 38105-2794, USA.
BACKGROUND. Control of highly pathogenic avian H5N1 influenza viruses is a major public-health concern. Antiviral drugs could be the only option early in the pandemic.METHODS. BALB/c mice were given oseltamivir (0.1, 1, or 10 mg/kg/day) twice daily by oral gavage; the first dose was given 4 h before inoculation with H5N1 A/Vietnam/1203/04 (VN1203/04) virus. Five- and 8-day regimens were evaluated.RESULTS. Oseltamivir produced a dose-dependent antiviral effect against VN1203/04 in vivo (P<.01). The 5-day regimen at 10 mg/kg/day protected 50% of mice; deaths in this treatment group were delayed and indicated the replication of residual virus after the completion of treatment. Eight-day regimens improved oseltamivir efficacy, and dosages of 1 and 10 mg/kg/day significantly reduced virus titers in organs and provided 60% and 80% survival rates, respectively (P<.05). Overall, the efficacy of the 5- and 8-day regimens differed significantly (death hazard ratio, 2.658; P<.01). The new H5N1 antigenic variant VN1203/04 was more pathogenic in mice than was A/HK/156/97 virus, and a prolonged and higher-dose oseltamivir regimen may be required for the most beneficial antiviral effect.CONCLUSIONS. Oseltamivir prophylaxis is efficacious against lethal challenge with VN1203/04 virus in mice. Viral virulence may affect the antiviral treatment schedule.
PMID: 16028136 [PubMed - indexed for MEDLINE]
2: Antimicrob Agents Chemother. 2001 Oct;45(10):2723-32.
Comparison of efficacies of RWJ-270201, zanamivir, and oseltamivir against H5N1, H9N2, and other avian influenza viruses.
Govorkova EA, Leneva IA, Goloubeva OG, Bush K, Webster RG.
Department of Virology and Molecular Biology, St. Jude's Children's Research Hospital, 332 N. Lauderdale, Memphis, TN 38105, USA.
The orally administered neuraminidase (NA) inhibitor RWJ-270201 was tested in parallel with zanamivir and oseltamivir against a panel of avian influenza viruses for inhibition of NA activity and replication in tissue culture. The agents were then tested for protection of mice against lethal H5N1 and H9N2 virus infection. In vitro, RWJ-270201 was highly effective against all nine NA subtypes. NA inhibition by RWJ-270201 (50% inhibitory concentration, 0.9 to 4.3 nM) was superior to that by zanamivir and oseltamivir carboxylate. RWJ-270201 inhibited the replication of avian influenza viruses of both Eurasian and American lineages in MDCK cells (50% effective concentration, 0.5 to 11.8 microM). Mice given 10 mg of RWJ-270201 per kg of body weight per day were completely protected against lethal challenge with influenza A/Hong Kong/156/97 (H5N1) and A/quail/Hong Kong/G1/97 (H9N2) viruses. Both RWJ-270201 and oseltamivir significantly reduced virus titers in mouse lungs at daily dosages of 1.0 and 10 mg/kg and prevented the spread of virus to the brain. When treatment began 48 h after exposure to H5N1 virus, 10 mg of RWJ-270201/kg/day protected 50% of mice from death. These results suggest that RWJ-270201 is at least as effective as either zanamivir or oseltamivir against avian influenza viruses and may be of potential clinical use for treatment of emerging influenza viruses that may be transmitted from birds to humans.
PMID: 11557461 [PubMed - indexed for MEDLINE]
3: Antiviral Res. 2000 Nov;48(2):101-15.
The neuraminidase inhibitor GS4104 (oseltamivir phosphate) is efficacious against A/Hong Kong/156/97 (H5N1) and A/Hong Kong/1074/99 (H9N2) influenza viruses.
Leneva IA, Roberts N, Govorkova EA, Goloubeva OG, Webster RG.
Department of Virology and Molecular Biology, St. Jude Children's Research Hospital, PO Box 318, 332 N. Lauderdale, Memphis, TN 38105-2794, USA.
In 1997, an H5N1 avian influenza A/Hong Kong/156/97 virus transmitted directly to humans and killed six of the 18 people infected. In 1999, another avian A/Hong/1074/99 (H9N2) virus caused influenza in two children. In such cases in which vaccines are unavailable, antiviral drugs are crucial for prophylaxis and therapy. Here we demonstrate the efficacy of the neuraminidase inhibitor GS4104 (oseltamivir phosphate) against these H5N1 and H9N2 viruses. GS4071 (the active metabolite of oseltamivir) inhibited viral replication in MDCK cells (EC(50) values, 7.5-12 microM) and neuraminidase activity (IC(50) values, 7.0-15 nM). When orally administered at doses of 1 and 10 mg/kg per day, GS4104 prevented death of mice infected with A/Hong Kong/156/97 (H5N1), mouse-adapted A/Quail/Hong Kong/G1/97 (H9N2), or human A/Hong Kong/1074/99 (H9N2) viruses and reduced virus titers in the lungs and prevented the spread of virus to the brain of mice infected with A/Hong Kong/156/97 (H5N1) and mouse-adapted A/Quail/Hong Kong/G1/97 (H9N2) viruses. When therapy was delayed until 36 h after exposure to the H5N1 virus, GS4104 was still effective and significantly increased the number of survivors as compared with control. Oral administration of GS4104 (0.1 mg/kg per day) in combination with rimantadine (1 mg/kg per day) reduced the number of deaths of mice infected with 100 MLD(50) of H9N2 virus and prevented the deaths of mice infected with 5 MLD(50) of virus. Thus, GS4104 is efficacious in treating infections caused by H5N1 and H9N2 influenza viruses in mice.
PMID: 11114412 [PubMed - indexed for MEDLINE]
fresh~horses - 03 Nov 2005 03:10 GMT > > > > Like everyone else I am trying to determine the value of these drugs. > > > > To me, and to anyone. Why are we being told, virtually, that we must [quoted text clipped - 13 lines] > > In people? None exists because there have been too few cases. It was a rhetorical question.
There
> has even been a report of a resistant strain isolated from one person. > Too few of any of these to do stats with. In mice, the drug works [quoted text clipped - 161 lines] > > PMID: 11114412 [PubMed - indexed for MEDLINE] notritenoteri - 03 Nov 2005 06:05 GMT So what evidence is in existance that Tamiflu is effective against the suspected but as yet undefined bird flu? could the answer be "we don't know"? GIven the recent past fuckups by the pharmacutical industry and its "69-ing" partner, the medical trade, it may be entirely reasonable to suspect the whole lot of having less than sincere motives in promoting a particular product.
> > Like everyone else I am trying to determine the value of these drugs. > > To me, and to anyone. Why are we being told, virtually, that we must [quoted text clipped - 42 lines] > > SBH Skeptic - 03 Nov 2005 19:19 GMT > So what evidence is in existance that Tamiflu is effective against the > suspected but as yet undefined bird flu? could the answer be "we don't > know"? Are you saying that it is not effective or that we need more information? Based on available literature and an understanding of its mechanism of action, it seems there would be no reason it would not have clinical utility.
BTW, Merck won its case today - the jury ruled a man's heart attack was not related to short term Vioxx use. Just for your info.
fresh~horses - 03 Nov 2005 20:03 GMT > > So what evidence is in existance that Tamiflu is effective against the > > suspected but as yet undefined bird flu? could the answer be "we don't > > know"?
> Are you saying that it is not effective or that we need more information? > Based on available literature and an understanding of its mechanism of > action, it seems there would be no reason it would not have clinical > utility. There's a limit to the number of qualifiers you can have in a sentence and expect credibility.
Tamiflu efficacay is a couple hours, in a study covering a cherry-picked population for a four weeks; about half the average flu course. Read BMJ up-thread.
Sbharris[atsign]ix.netcom.com - 03 Nov 2005 22:06 GMT > > > So what evidence is in existance that Tamiflu is effective against the > > > suspected but as yet undefined bird flu? could the answer be "we don't [quoted text clipped - 11 lines] > cherry-picked population for a four weeks; about half the average flu > course. Read BMJ up-thread. Read the entire literature, not some abstract of a bad BMJ review (remind to tell you what I think of the politics of the BMJ). Tamiflu reduces illness time by 3 to 5 days, and reduces pneumonia in children (a high risk group). It cuts mortality in avian flu infected mice in half. From this, you are required to *make an inference.* Yes, perform logical induction, like a human being. Yes, I know some people aren't up to it. Perhaps including the "cost efficacy" skeptics writing for the BMJ. Not my problem. I can lead you to water. Socialists will have to decide when it's okay for the public "as a whole," to drink. Sheep that they are. That probably won't happen for quite a while, and after a lot of people have died. That's the way of it with herd animals.
1: Med Microbiol Immunol (Berl). 2002 Dec;191(3-4):165-8. Epub 2002 Sep
12.
Early therapy with the neuraminidase inhibitor oseltamivir maximizes its efficacy in influenza treatment.
Gillissen A, Hoffken G.
St. George Medical Center, Robert-Koch-Hospital, Nikolai-Rumjanzew-Str.
100, 04207 Leipzig, Germany. adrian.gillis...@sanktgeorg.de
Influenza illness is an important cause of severe morbidity and mortality in the population. Oseltamivir, the first oral neuraminidase inhibitor, has proven efficacy. In children of 1 year and older (weight-dependent dosing: 30 mg, 45 mg, 60 mg or 75 mg BID for 5 days) and adults (75 mg BID for 5 days), oseltamivir reduces the duration and
severity of acute influenza. Furthermore, it decreases the incidence of
secondary complications such as otitis media, bronchitis, pneumonia and
sinusitis. Oseltamivir has been shown to prevent influenza when given for long-term prophylaxis or for post-exposure prophylaxis. Because oseltamivir blocks the neuraminidase, an enzyme crucial to influenza virion liberation from the host cell, it is only effective during the replication phase. Clinical benefits are only seen, when oseltamivir is
applied within 48 h after onset of symptoms, and clinical efficacy in acute influenza is ighly dependent on the beginning of treatment. Treatment within 12 h after onset of symptoms reduces the duration of illness by an additional 74.6
h, and treatment within 24 hours an additional 53.9 h compared to the benefit seen with an intervention at 48 h. In conclusion, clinical efficacy of oseltamivir can be maximized by early start of treatment. Resistance of influenza virus against oseltamivir has rarely been observed and seems to be of no clinical relevance due to reduced transmissibility and pathogenicity of mutants. Oseltamivir is generally
well tolerated. About 10% of the patients complain of transient upper gastrointestinal events, which resolved within 1-2 days, and which could be reduced when the medication was taken with a light snack.
Publication Types: Review Review, Tutorial
PMID: 12458353 [PubMed - indexed for MEDLINE]
Robert - 03 Nov 2005 22:30 GMT > Read the entire literature, not some abstract of a bad BMJ review > (remind to tell you what I think of the politics of the BMJ). Tamiflu [quoted text clipped - 5 lines] > the BMJ. Not my problem. I can lead you to water. Socialists will have > to decide when it's okay for the public "as a whole," to drink. Sheep
> that they are. Incredible how they complain about for profit companies and yet have that extreme that equally scares the sh.t out of me. Having someone like Zee oversee my healthcare gives me the creeps.
notritenoteri - 03 Nov 2005 22:55 GMT Yah yah. So your trying to say what works for mice is absolutely 1000% transferable to people. I know we have certain genes in common but and its a big but there are differences I know I like cheese and Mice are supposed to too.On the other hand they like raw grain and I just can't seem to get past the cellulose. Do you really think that blind faith is an option? How are you about Jesus talked to him lately? You talk about inference how about this inference? Cars kill large numbers of people so on that basis one should infer that riding in one is a very dangerous activity and should try to avoid it. Do you follow that dictum?
So your advice is listen to the experts say for example the captain of the Titanic or Rumsfeld?
> > > > So what evidence is in existance that Tamiflu is effective against the > > > > suspected but as yet undefined bird flu? could the answer be "we don't [quoted text clipped - 76 lines] > > PMID: 12458353 [PubMed - indexed for MEDLINE] Sbharris[atsign]ix.netcom.com - 04 Nov 2005 05:01 GMT > Yah yah. So your trying to say what works for mice is absolutely 1000% > transferable to people. COMMENT:
That rather depends on the drug. Antimicrobials which work in animal models transfer very well to people, since they aren't really working on the animal at all, but the microbe (which is often the same). In this case, it is.
Occasionally a successful antiomicrobial in animals will get nixed in people due to some special toxicity problem of the drug in people. But Tamiflu's already been though human trials.
Nothing in life's 100%. But then that's true even of drugs what DO work in people. Skeptics always then ask "Yes, but where's the proof they work in my sex? Or my age group? Or my ethnic group? Or my knitting circle? What the proof they work in people with my particular genetics (ie, myself and my twin). Or just me, if I don't have a twin...."
Because there no formal proof of any inductive propostion (rather, just more and more evidence for it), you can deny there exists proof all you like for any one of them, and not technically be wrong. But you will also likely wind up dead.
Besides, it's dishonest. Few people go about refusing to eat new foods unless they have prior proof they won't be deathly allergic to them. Life is about taking reasonable chances.
-- Hume
SBH
notritenoteri - 04 Nov 2005 14:46 GMT You certainly are defensive. You sound like the jarheads that get up on TV and try to tell the world that collateral damage is just ticky-boo as long as the baddies are terminated. Whether or not drugs directly effect the so-called host is largely irrelevant if the host suffers sufficient collateral damage as to kill it.
> > Yah yah. So your trying to say what works for mice is absolutely 1000% > > transferable to people. [quoted text clipped - 29 lines] > > SBH (PeteCresswell) - 04 Nov 2005 16:42 GMT Per notritenoteri:
>You certainly are defensive. You sound like the jarheads that... YYMV, but to me, he is, by far, the most credible-sounding participant in the group.
 Signature PeteCresswell
notritenoteri - 04 Nov 2005 19:31 GMT fraid I'm not that impressed. I got papers too that don't make me an expert.
> Per notritenoteri: > >You certainly are defensive. You sound like the jarheads that... [quoted text clipped - 3 lines] > -- > PeteCresswell fresh~horses - 03 Nov 2005 23:35 GMT > > > > So what evidence is in existance that Tamiflu is effective against the > > > > suspected but as yet undefined bird flu? could the answer be "we don't [quoted text clipped - 76 lines] > > PMID: 12458353 [PubMed - indexed for MEDLINE] I read the pdf of the study article.
Skeptic - 03 Nov 2005 22:19 GMT I believe you are referring to an editorial - an opinion. I could be wrong. The only data I recall seeing on tamiflu was that it reduced the duration of the flu. There is no magic bullet for a viral illness. But, with this type of medication, if given promptly - and I personally think that will be the biggest obstacle ... both a delay in starting it on those who need it and jumping the gun when it isn't really necessary - it can be effective. I don't know if there is much/any data on its use in the avian flu. I'm a surgeon not an infectious disease specialist. But I do know that the bird and human flu work sufficiently similar that that would lead me to believe it would be about as effective with each.
For what it's worth, I think this has been overhyped - both the disease and the tamiflu thing. I don't have any in my house. I am currently sick - thus home posting and not working - and I'm not running in for tamiflu. But... should this explode as it quite obviously has the potential to - to NOT use a medication like tamiflu in the young, the old, the weak, the immunosuppressed, etc. would be, well, it would be wrong.
>> > So what evidence is in existance that Tamiflu is effective against the >> > suspected but as yet undefined bird flu? could the answer be "we don't [quoted text clipped - 11 lines] > cherry-picked population for a four weeks; about half the average flu > course. Read BMJ up-thread. notritenoteri - 03 Nov 2005 23:03 GMT You know I agree with you. I have had a little experience in having to make hard choices when the sh.t hits the fan so to speak. If Tamiflu is all that I have then I will go for it. The odds are pretty good the side effects won't kill me. If they do lets hope its quick. On the other hand it is very highly probable that Tamiflu will contribute to the mortality of some. I feel sorry for the people that have expectations that there are magic bullets. My partner worked in a rehab unit where stroke victims were given physio and one of the hardest thing to deal with was the expectations of relatives that the patient would be "the same".
I like to pull Robert's and Dr. whoever's chain. Call it a weakness.
> I believe you are referring to an editorial - an opinion. I could be wrong. > The only data I recall seeing on tamiflu was that it reduced the duration of [quoted text clipped - 29 lines] > > cherry-picked population for a four weeks; about half the average flu > > course. Read BMJ up-thread. Skeptic - 03 Nov 2005 23:07 GMT fair enough
> You know I agree with you. I have had a little experience in having to > make [quoted text clipped - 54 lines] >> > cherry-picked population for a four weeks; about half the average flu >> > course. Read BMJ up-thread. fresh~horses - 04 Nov 2005 01:56 GMT > I believe you are referring to an editorial - an opinion. I could be wrong. > The only data I recall seeing on tamiflu was that it reduced the duration of [quoted text clipped - 13 lines] > NOT use a medication like tamiflu in the young, the old, the weak, the > immunosuppressed, etc. would be, well, it would be wrong. Here you go Dr. Skeptic:
ttp://bmj.bmjjournals.com/cgi/content/full/331/7524/1041?ehom
"I would like to know what evidence there is that Tamiflu actually alters mortality," {Joe Collier, professor of medicines policy at St George's Hospital Medical School, London, and former editor of the Drug and Therapeutics Bulletin} said.
"And if it doesn't then what are we doing? What it certainly does is shorten the illness by a day, but the question is-does that matter?"
On the other side of the Atlantic Canada's federal health minister, Ujjal Dosanjh, told listeners to an interview on a Canadian Broadcasting Corporation radio programme ("The Current," 27 Oct) that oseltamivir did not prevent infection with the flu virus and that at best it would reduce the severity of the illness.
`````````````````````````````
The full article on TAMIFLU in BMJ: http://bmj.bmjjournals.com/cgi/content/full/326/7401/1235
"The results of our systematic review show that treating otherwise healthy adults and children with zanamivir and oseltamivir reduces the duration of symptoms in the intention to treat population by between 0.4 and 1.0 days and provides 29% to 43% relative reduction in the odds of complications requiring antibiotics when these are given within 48 hours of onset of symptoms. The results were less conclusive in the high risk population (as defined in the methods) though these were based on fewer patients. Caution is required when comparing the results because the definition of symptoms assessed for alleviation in the treatment trials varied among trials of the two compounds, and between adults and children for each compound. Moreover, the time to event outcomes were measured on different scales (days and hours). Also, the rates of flu positive (=49%) individuals who were enrolled in the trials may be higher than the rates identified routinely in clinical practice. Thus, the treatment effects estimated for the ITT trial populations may not be achievable in routine practice.
The data on complications reported above were not ideal because they relied primarily on pooled marginal analyses and thus did not take into account any heterogeneity between trials.19 20 It is not clear how well complications requiring antibiotics correlate with the incidence of more serious complications of flu. Little evidence exists either on serious complications requiring admission to hospital or causing death or on adverse events. Both of these are evidently rare (at least in otherwise healthy individuals) but are potentially important in the evaluation of treatments; the trials were underpowered in terms of such outcomes. Insufficient data are available from clinical trials to assess adequately the risk of emergence of resistance to neuraminidase inhibitors.
A lack of evidence exists for use of neuraminidase inhibitors for preventing flu in children and in frail elderly people in residential care. We found that neuraminidase inhibitors given for flu prevention led to a relative reduction of 70% to 90% in the odds of developing flu, depending on the strategy adopted and the population studied.
In conclusion, although evidence from randomised controlled trials consistently supports the clinical effectiveness of both oseltamivir and zanamivir for the treatment and prevention of flu, evidence is limited for the treatment of high risk populations and for all prevention strategies. Research is needed into the comparative effectiveness of neuraminidase inhibitors with one another and the potential "added value" of these drugs compared with or in combination with flu vaccine."
~~~~~~~~~
Sbharris[atsign]ix.netcom.com - 04 Nov 2005 05:26 GMT > Here you go Dr. Skeptic: > [quoted text clipped - 7 lines] > "And if it doesn't then what are we doing? What it certainly does is > shorten the illness by a day, but the question is-does that matter?" Talking here about ordinary flu strains. Not talking about a killer strain. And not talking about prophylaxis, since obvious a flu case prevented, is a flu case which won't have a chance to kill you. Limited drug is available for this purpose, but one group there is enough for is paramedics, hospital workers, and other people who will have to deal directly with people who have the flu, in an epidemic.
Tamiflu does matter in animals infected with the killer strain. If it didn't matter in humans infected with the same killer strain, it would be a remarkable thing indeed, given how the drug works. We've been over this.
> On the other side of the Atlantic Canada's federal health minister, > Ujjal Dosanjh, told listeners to an interview on a Canadian > Broadcasting Corporation radio programme ("The Current," 27 Oct) that > oseltamivir did not prevent infection with the flu virus.... It certainly prevents the clinical disease, if used before infection.
> The full article on TAMIFLU in BMJ: > http://bmj.bmjjournals.com/cgi/content/full/326/7401/1235 [quoted text clipped - 21 lines] > complications requiring antibiotics correlate with the incidence of > more serious complications of flu. COMMENT:
It may not be "clear." but it's a good assumption there's a high correlation, since secondary bacterial infection (including bacterial pneumonia) is a major cause of flu-related mortality.
The kind of medical skepticism you see here falls into the category of "bloody minded." Following this logic, we should considering withholding antibacterials from flu victims with secondary bacterial pneumonia, as well. For while these have been proven to decrease mortality in primary pneumonia, nobody has ever proven them to decrease mortality in secondary bacterial pneumonia FROM THE FLU. Same exact argument, QED.
But methinks the writer would be shocked at that suggestion, because he takes as given that these things are "required." Basically, he's just a reactionary, trying to figure out ways to keep from using a new and expensive drug. It was the same when antibiotics themselves came out.
SBH
notritenoteri - 03 Nov 2005 21:23 GMT There have been very few cases of so-called bird flu, something less than 100 documented I believe. Some might make the claim that given the current number they know for "certain" that there must be thousands more unreported. That is pure speculation and bullshit of the first magnitude. I have not seen any public available information that extensive clinical trials or the type necessary to prove efficacy have been conducted. Putting those two facts together suggests to me that here is a fair probability that tamilfu may not be the wonder drug it is supposed to be. I'm certainly open to counter claims. Yah I heard about the Vioxx thing on the news. I'm not surprised. Every drug is a crapshoot, some people win with a specific one some people lose. The trouble is that advertising hype tends to gloss over the losers.
> > So what evidence is in existance that Tamiflu is effective against the > > suspected but as yet undefined bird flu? could the answer be "we don't [quoted text clipped - 7 lines] > BTW, Merck won its case today - the jury ruled a man's heart attack was not > related to short term Vioxx use. Just for your info. (PeteCresswell) - 04 Nov 2005 01:44 GMT Per notritenoteri:
>There have been very few cases of so-called bird flu, something less than >100 documented I believe. Some might make the claim that given the current >number they know for "certain" that there must be thousands more unreported. >That is pure speculation and bullshit of the first magnitude. Wrong disease.
The disease people are worried about hasn't arisen yet. It will, but nobody knows when....
 Signature PeteCresswell
(PeteCresswell) - 03 Nov 2005 01:11 GMT Per Sbharris[atsign]ix.netcom.com:
>The US government is stockpiling Tamiflu Last I heard they were aiming for 20 million doses.
Think about that. ---------------------------------------------------------- For type A influenza, the recommended course is 10 doses: 2 per day for five days. But with H5N1 they tried that on mice and all the mice died. Then they tried it again for eight instead of five days and got a 90% survival rate (i.e. "only" 10% of the animals died).
Ok, 16 doses.
Assume a US population of 300 million people.
16 * 300 million = 4,800,000,000 doses required to see the U.S. population through the first wave.
20,000,000/4,800,000,000 = .004167.
i.e. "Twenty million doses" gives coverage for .42 percent of the U.S. population for the first wave. ----------------------------------------------------------
Run the numbers another way: ---------------------------------------------------------- Health care workers, presidential entourage, congressmen, and various fat cats will need a prophylactic dose through the course of at least the first wave.
The first wave will last how long? Lets's say four months.
120 days * two doses/day = 180 doses per person.
20,000,000/180 = 83,333.
So: about 83 thousand people out of a population of 300 million would be covered - assuming nothing for anybody else.
I have no clue as to how many family doctors and hospital nurses there are in the country - but I'm guessing it's a lot more than only one worker per 3,614 people. (20,000,000/83,333 = 3,614) ----------------------------------------------------------
So, either way, 20 million doses doesn't sound even remotely adequate - in fact it sounds laughable.
Have I made some unrealistic assumption? Have I slipped a decimal point somewhere?
Somebody point out the flaw(s) to me, and I'll feel a *lot* better.
 Signature PeteCresswell
fresh~horses - 03 Nov 2005 01:28 GMT > Per Sbharris[atsign]ix.netcom.com: > >The US government is stockpiling Tamiflu [quoted text clipped - 48 lines] > > Somebody point out the flaw(s) to me, and I'll feel a *lot* better. How much will that cost?
Sbharris[atsign]ix.netcom.com - 03 Nov 2005 01:35 GMT > So, either way, 20 million doses doesn't sound even remotely adequate - in fact > it sounds laughable. [quoted text clipped - 5 lines] > -- > PeteCresswell No, your math is good. Obviously 20 million doses is not enough for the population for prophylaxis. And is only enough to treat the 1 million sickest people who get the flu-- or may twice that (we don't know if people behave like mice). If you can figure out who those are. The problem is the stuff only works when given early, and in the early stages, people aren't yet ill enough to tell if they're "the sickest." Thus, you end up giving the drug to all high-risk people in early stages. And we have roughly 30 million people over 65 or at special risk, in this country. If a third of them get the flu and need Tamiflu for 10 days we end up with need for 200 million doses. Or 100 million for 5 days. Which is indeed 5 times our supply.
But you do what you can. I don't think there are 200 million doses in the world right now.
SBH
fresh~horses - 03 Nov 2005 01:49 GMT > > So, either way, 20 million doses doesn't sound even remotely adequate - in fact > > it sounds laughable. [quoted text clipped - 22 lines] > > SBH Do not let facts get in your way Steve. Prophylaxis occurs before someone already has the flu. By definition.
Your argument makes me wonder what stake you have in this? You did say your lab tests pharmaceuticals. Does that include flu vaccine?
Sbharris[atsign]ix.netcom.com - 03 Nov 2005 02:17 GMT > > > So, either way, 20 million doses doesn't sound even remotely adequate - in fact > > > it sounds laughable. [quoted text clipped - 25 lines] > Do not let facts get in your way Steve. Prophylaxis occurs before > someone already has the flu. By definition. COMMENT:
Yes. So? The question of whether the drug is useful for prophylaxis is entirely separate from the question of whether we have enough of it for the purpose at this time. Clearly we don't. At least, not for everyone who might need it, in the worst case. Or even a bad case. We need to make more, if we do want it for this use, and various routes to doing so, are being explored. The issue changes as I type. So?
It's a complicated issue, even when it comes to drugs. There are three other drugs which should work on H5N1, one of which (Relenza) has been proven to work in animals, and the other (ribavirin) which works on most A and B flu strains, and should also work here (looking at mechanism of action). Also the classic amantidine may work in some cases, since not 100% of bird viruses are yet resistant to it (just many of them, due to discussed Chinese use of the drug in chickenfeed--- idiots).
> Your argument makes me wonder what stake you have in this? What statement??
>You did say your lab tests pharmaceuticals. Does that include flu vaccine? My, paranoia attack again? No, we do no vaccine or antimicrobial work. We're interested mostly in lipid soluble drug delivery. Recent projects have been general anesthetics and nutritional supplements.
SBH
fresh~horses - 03 Nov 2005 02:23 GMT > > > > So, either way, 20 million doses doesn't sound even remotely adequate - in fact > > > > it sounds laughable. [quoted text clipped - 34 lines] > need to make more, if we do want it for this use, and various routes to > doing so, are being explored. The issue changes as I type. So? Seems I was wrong Steve. My apologies. Mea Culpa and all that. This isn't going to be another greed grab again after all. Roche is going to give it away. Aren't they? Ya know...that great American tradition?
Here's the latest.
http://www.fortune.com/fortune/articles/0,15114,1118699,00.html For Bird Flu, Good PR Equals Bad Medicine Giving away Tamiflu could turn out to be a prescription for disaster. By David Stipp
Big pharma is suffering its worst-ever PR crisis, and the planet is worrying about a potentially catastrophic flu pandemic. Now one company-Switzerland's Roche Holding-has a chance to make a dramatic move. Roche is being asked to allow production of a generic version of its flu-fighting drug Tamiflu for the developing world. .... (subscribers only)
> It's a complicated issue, even when it comes to drugs. There are three > other drugs which should work on H5N1, one of which (Relenza) has been [quoted text clipped - 16 lines] > > SBH Sbharris[atsign]ix.netcom.com - 03 Nov 2005 02:32 GMT > > > > > So, either way, 20 million doses doesn't sound even remotely adequate - in fact > > > > > it sounds laughable. [quoted text clipped - 52 lines] > its flu-fighting drug Tamiflu for the developing world. .... > (subscribers only) COMMENT:
You've got to stop reading FORTUNE. Roche will probably license it out. As Canada did with insulin.
http://www.webmd.com/content/Article/114/111087.htm
fresh~horses - 03 Nov 2005 02:44 GMT > > > > > > So, either way, 20 million doses doesn't sound even remotely adequate - in fact > > > > > > it sounds laughable. [quoted text clipped - 59 lines] > > http://www.webmd.com/content/Article/114/111087.htm Hmmm. 14 days and counting and Roche still hasn't come across. I'll bet you a book of your choice, through Amazon, if I'm right and they refuse, or even waffle.
Deal?
I liked this part best:
"Tamiflu is not a cure for the flu, but it can lessen the flu's severity or cut the chances of spreading the disease if taken before symptoms develop.
Even still, despite the rush to stockpile the drug, some experts warn that uncertainty remains around how effective it will be in a real-world bird flu pandemic.
H5N1 infects more quickly and enters a broader range of lung cells than do other more common flu strains, Michael Osterholm, MD, an infectious disease expert and Department of Homeland Security official, cautioned earlier this week. The infection causes the body to release a rush chemicals that attack the immune system, and there is little evidence showing how well Tamiflu can stop or lessen the release, he told reporters.
"Frankly we just don't know," Osterholm said.
Sbharris[atsign]ix.netcom.com - 03 Nov 2005 03:08 GMT >> Hmmm. 14 days and counting and Roche still hasn't come across. I'll bet > you a book of your choice, through Amazon, if I'm right and they > refuse, or even waffle. > > Deal? Deal if the terms are that they do (or don't) license it out to at least two other companies, by end of next year (2006). That's 13 months.
Naturally there's going to be some very heavy bargaining here. The generic guys know they have Roche by the cojones, due to public sentiment and the chance of other countries bolting. There's even precident for the US breaking US patents in the name of public safety. Against this, consider that it's a difficult drug to make, and Roche no doubt has considerable "black art" experience which isn't IN the patents. Which it doesn't have to give up if it doesn't want to. Nobody can force an expert to be a full expert; that takes heart. The best you can do is force an expert to ACT like a full expert. Not the same.
> I liked this part best: > [quoted text clipped - 15 lines] > > "Frankly we just don't know," Osterholm said. COMMENT:
You never know how the human trials are going to come out, till they come out. But there's a world of difference between "We don't know" and "We have no clue." Don't watch what Feds SAY, watch what they DO. That's what they guess and more or less believe.
SBH
fresh~horses - 03 Nov 2005 03:38 GMT > >> Hmmm. 14 days and counting and Roche still hasn't come across. I'll bet > > you a book of your choice, through Amazon, if I'm right and they [quoted text clipped - 15 lines] > can force an expert to be a full expert; that takes heart. The best you > can do is force an expert to ACT like a full expert. Not the same. And we also can assume Rumsfield's going to lean heavy on his pharma buddies to roll over because if they don't his career is going to tank.
> > I liked this part best: > > [quoted text clipped - 24 lines] > > SBH Sbharris[atsign]ix.netcom.com - 03 Nov 2005 07:32 GMT > And we also can assume Rumsfield's going to lean heavy on his pharma > buddies to roll over because if they don't his career is going to tank. And why should they care about Rumsfeld's (note spelling) career as Secretary of Defense? Roche has a business to run and stockholders to please. Rumsfield isn't one of them. He owns stock in Gilead, but Gilead has no say in what Roche does with Tamiflu. They just earn license fees.
And BTW, even Gilead is a $22 billion dollar market cap company. Do you really think they give a crap about the measly $22 million or whatever in stock that Rumsfeld owns? Please.
SBH
(PeteCresswell) - 03 Nov 2005 02:58 GMT Per Sbharris[atsign]ix.netcom.com:
> Roche will probably license it >out. Seems like it could logical on a financial basis: they don't have anywhere near the capacity to meet demand and if they license it out - depending on the license royalties and the diff between their capacity and demand they could conceivably get more money by licensing it - at least until they ramp up production. Volume vs margin and all that....
 Signature PeteCresswell
Carey Gregory - 03 Nov 2005 05:47 GMT >Tamiflu being pushed with little evidence it mitigates flu for more >than a few hours, and that only in certain populations and at great >cost; and who profits from this scam should just be kept quiet. Is that >what you're saying Carey? No, what I'm saying is get a clue how usenet works.
And that's not what your thread was about, so don't give me this conspiracy theory crap. Look at your post. Look at the subject matter. It's purely political. This is sci.med, not sci.sorta.but-mainly-political.and-if-I-feel-like-posting-I-will.so-there
fresh~horses - 03 Nov 2005 05:52 GMT > >Tamiflu being pushed with little evidence it mitigates flu for more > >than a few hours, and that only in certain populations and at great [quoted text clipped - 7 lines] > political. This is sci.med, not > sci.sorta.but-mainly-political.and-if-I-feel-like-posting-I-will.so-there So nice to see you posting again Carey.
Carey Gregory - 03 Nov 2005 07:52 GMT >So nice to see you posting again Carey. Hey, I knew you would enjoy a brief respite from losing your war with Harris. I'm thoughtful like that.
fresh~horses - 03 Nov 2005 07:59 GMT > >So nice to see you posting again Carey. > > Hey, I knew you would enjoy a brief respite from losing your war with > Harris. I'm thoughtful like that. Are you working?
Carey Gregory - 04 Nov 2005 09:22 GMT >> >So nice to see you posting again Carey. >> >> Hey, I knew you would enjoy a brief respite from losing your war with >> Harris. I'm thoughtful like that. > >Are you working? I doubt if my employer would think so.
Are you?
notritenoteri - 02 Nov 2005 13:00 GMT So you never heard the adage about power corrupting? Funny I though it was an American truism!
> >I don't know. If Rumsfeld were the president, or the head of the FDA, > >there'd be a problem. But since he is secretary of defense, I fail to [quoted text clipped - 16 lines] > And what the hell does this have to do with sci.med or can.politics, anyway? > Cross-posted to three newsgroups, only one of which is appropriate. Sbharris[atsign]ix.netcom.com - 02 Nov 2005 23:08 GMT > So you never heard the adage about power corrupting? Funny I though it was > an American truism! COMMENT:
An English one, actually (Lord Acton). Rumsfeld indeed might be doing his present job for the sake of the power it gives, but that power has no relationship to Tamiflu. If Rumsfeld was a major shareholder in (say) Haliburton which does do military-related stuff, we'd have something. But Rumsfeld has nothing to do with Haliburton. That's the vice president---- who isn't in the chain of command on military matters. Ohhhh, so close to a conspiracy, and yet so far....
SBH
notritenoteri - 02 Nov 2005 23:24 GMT THanks for the research. I wasn't referring to tamiflu but maybe it corrupts too?
> > So you never heard the adage about power corrupting? Funny I though it was > > an American truism! [quoted text clipped - 10 lines] > > SBH |
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