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Neuropsychiatric side effects.

I have some concerns about the appropriateness of the following sentence and would just like to ping to see if anyone else agrees with me

"A survey conducted in 2009 by the Health Protection Agency and the European Centre for Disease Prevention and Control found that out of 85 children treated with the drug 18% reported a neuropsychiatric side effect (defined as one or more of the following symptoms: poor concentration or unable to think clearly, problems sleeping, feeling dazed or confused, bad dreams or nightmares, behaving strangely"

My concerns are as follows:

• The suggesting that Tamiflu is causing an 18% incidence of AEs seems extraordinary given 1) the drug was approved four use in children on two continents without a label warning for psychiatric events, and 2) the NNH in adults is 94
• Its unclear exactly what the number means in the absence of a control group - how many of these events were drug-related and how many flu-related. "Trouble sleeping", "feeling dazed", "problems with concentration or unable to think clearly" are very reminiscent of my last bout with the flu, and I wasn't taking any Tamiflu.
• We usually require secondary sources for this sort of information, e.g. a review or meta analysis. In this case the source is a "investigative report" by BMJ that is not a peer reviewed scientific publication.

— Preceding unsigned comment added by Formerly 98 (talk • contribs) 13:25, 25 April 2014‎

As you say in your second bullet, before worrying about an 18% incidence of poor concentration, problems sleeping, and other symptoms, you'd have to know what the likelihood of those symptoms are for people who have the flu anyway. I don't think I've ever heard anyone say that they feel like they're mentally at their best when they have the flu. It could well be that 18% is a lower rate of problems than people with untreated influenza, in which case this "harm" is actually a "benefit". WhatamIdoing (talk) 01:51, 8 December 2014 (UTC)

Badly Unbalanced; needs rewrite

At the risk of jumping in on an edit war that has apparently died down, I have put back the "Undue" and "Quality" tags on this article. (I'd originally thought about putting "NPOV" on, but I think "Undue" is a little more accurate here). This is a badly written article. Perhaps it is, indeed, unbiased-- but it reads like a biased article, and should be rewritten to have a more balance. The lede has one sentence about what the drug is and how it works, and then jumps to a long paragraph summarizing studies suggesting it's not effective (without mentioning any studies suggesting the opposite.) This shouldn't even be in the lede-- the lede should simply say "The efficacy of oseltamivir and its overall risk-benefit ratio are controversial." Although that paragraph is inaccurate according to the article: nothing in the article suggests any controversy; the "controversy" is entirely one-sided. The very first sentence--before even discussing the drug itself-- states it doesn't have any benefits. Rewrite desperately needed. Geoffrey.landis (talk) 16:51, 5 December 2014 (UTC)

Evidence for benefit is lacking. The medication; however is still recommended. I am not seeing the issue?

The issue is that this is a badly-written article: poorly balanced in both senses of the word. If it is not in fact biased, then please make at least an attempt to make it read like an article that is not biased. Geoffrey.landis (talk) 17:02, 5 December 2014 (UTC)

Any refs to support your claims? The article appears to have lots. Doc James (talk · contribs · email) 16:56, 5 December 2014 (UTC)

Let look at the VERY FIRST SENTENCE "Oseltamivir marketed under the trade name Tamiflu, is anantiviral licensed to prevent or slow the spread of influenza A and influenza B (flu) virus between cells in the body by stopping the virus from chemically cutting ties with its host cell." Appears Geof is mistaken. Doc James (talk · contribs · email) 17:01, 5 December 2014 (UTC)

My claim was that the lede has a single sentence devoted to what the drug is and how it works. That's the sentence. Your point is? Geoffrey.landis (talk) 17:02, 5 December 2014 (UTC)

You state "The very first sentence--before even discussing the drug itself--" which appears to be wrong. Doc James (talk · contribs · email) 17:03, 5 December 2014 (UTC)

Good lord, you're trying to nit pick-fine details of phraseology on a talk page? Why don't you spend that energy actually writing the article so that it is well written?

Let me explain some terminology in Misplaced Pages. The lede is the stuff at the beginning of the article. It is, basically, a precis of what will be found in the article. Following the lede is the contents. Following the contents is the body of the article. The sentence you quote-- of which I said "the lede has a single sentence devoted to what the drug is and how it works" is in the lede. The first sentence of the body of the article is the one of which I stated "The very first sentence--before even discussing the drug itself-- states it doesn't have any benefits". Geoffrey.landis (talk) 17:13, 5 December 2014 (UTC)

Good point. Fixed that section. Doc James (talk · contribs · email) 17:41, 5 December 2014 (UTC)

Feedback please

According to the Tamiflu website, "Tamiflu is a prescription medicine used to treat the flu (influenza) in people 2 weeks of age and older who have had flu symptoms for no more than 2 days. Tamiflu can also reduce the chance of getting the flu in people 1 year and older." Is there an objection to adding this information to the article even though our article states, "There is low to moderate evidence that it decreases the risk of getting symptomatic influenza by 1% to 12% in those exposed."? Gandydancer (talk) 17:40, 5 December 2014 (UTC)'

By the Tamiflu website you mean this one It is not a reliable source per WP:MEDRS. Doc James (talk · contribs · email) 17:42, 5 December 2014 (UTC)

Yes, that's it - they have been running that ad in the US. Thanks Doc. Gandydancer (talk) 17:44, 5 December 2014 (UTC)

Yes that is how the ad people re interpret the evidence. Doc James (talk · contribs · email) 17:49, 5 December 2014 (UTC)

Mass changes to lede without discussion

I disagree with the changes to the lede. The lede can summarise the body. If there is text in the lede that is not in the body it may also be included in the body. I do see any reason for the tags. The change to the lede also restored the tags. The tags were added to the body instead of the lede this time. QuackGuru (talk) 18:58, 5 December 2014 (UTC)

Thanks, yes a very controversial topic. And this user feels they should be able to edit war in changes. Doc James (talk · contribs · email) 19:04, 5 December 2014 (UTC)

To the contrary, it was not "without discussion." The discussion-- which User:Doc James participated in, and hence presumably knows about-- had the following statement: "The lede has one sentence about what the drug is and how it works, and then jumps to a long paragraph summarizing studies suggesting it's not effective (without mentioning any studies suggesting the opposite.) This shouldn't even be in the lede-- the lede should simply say "The efficacy of oseltamivir and its overall risk-benefit ratio are controversial.""

There were no comments nor objections made to this proposed change. Moving the material (note: not deleting it, just moving it to the appropriate section) goes a long way toward dealing with the (undue) and (quality) problems with the article that User:Doc James believes should not be mentioned. Geoffrey.landis (talk) 19:43, 5 December 2014 (UTC)

Should have been obvious but to clarify I oppose. Doc James (talk · contribs · email) 19:51, 5 December 2014 (UTC)

A few more items to tidy up

I'd say the lede is too long. I support reducing it in an NPOV way.

I'll preface my other remarks by noting that I've gone back and forth with Doc James for quite a while on this article. He has generally been very open to my concerns, but I still think the article somewhat over-emphasizes the Cochrane-BMJ PR juggernaut over the opinions of just about every other medical organization that has commented on the data. Cochrane had a huge COI here, in that they had made Tamiflu the poster child for their AllTrials campaign. If successful, that campaign sets up Cochrane as a "shadow FDA" with extraordinary influence over public policy. The AllTrials campaign would be strengthened in direct proportion to the extent that Cochrane's meta analysis "proved" that Roche had used data secrecy to perpetuate a huge fraud upon the public.

A couple of suggested aspects of the article that I think need to be further tweaked.

• "Randomized clinical trials have failed to find a benefit of treatment among people seeking care for flu-like symptoms, that treatment does not change the risk of hospitalization in the elderly or other high risk populations, and that it is unclear if it affects rates of death." Here we present Cochrane's conclusions in Misplaced Pages's voice, in spite of the fact that the design of the Cochrane review has been contested by important healthcare groups

• According to Public Health England, "The Cochrane review has been reported as suggesting that antivirals are not effective for influenza. This is not the case because of the following aspects of the review... ", "It has limitations in understanding hospitalisations, complications, and the prevention of complications occurring in cases of severe infection, and mortality", and "There is good evidence that antivirals can reduce the risk of death in patients hospitalised with influenza".
• According to the ECDC, "They do not give reasons for changing the current approach to public health use of antivirals, including prophylaxis, pandemic preparedness, stockpiling or use in outbreaks. While their publication represents a ‘signal event’ we clearly have a long way to go in this field."
• The IDSA refers to the Cochrane review as "causing confusion", and states " the Cochrane analysis included both influenza virus-infected and non-infected persons with influenza-like illness. Given the specific antiviral activity against influenza viruses of NAIs, this analytic approach underestimates NAI treatment efficacy."
• And so on. There are too many disputes of the Cochrane methodology and conclusions for us to state Cochrane's conclusions in Misplaced Pages's voice. Doing so implies the existence of a scientific consensus that has not yet been reached.

• We further state that "A survey conducted in 2009 by the Health Protection Agency and the European Centre for Disease Prevention and Control found that out of 85 children treated with the drug 18% reported a neuropsychiatric side effect (defined as one or more of the following symptoms: poor concentration or unable to think clearly, problems sleeping, feeling dazed or confused, bad dreams or nightmares, behaving strangely." The source is a news article written by BMJ staff, and given BMJ's advocacy role in this affair, this should be deleted or supported by a MEDRS-compliant, WP:THIRDPARTY source.
• "Rare ADRs include: liver inflammation and elevated liver enzymes, rash, allergic reactions including anaphylaxis, and Stevens–Johnson syndrome. Various other ADRs have been reported in postmarketing surveillance, including: toxic epidermal necrolysis, cardiac arrhythmia, seizure, confusion, aggravation of diabetes, and haemorrhagic colitis." - According to the cited source, these are not ADRs but AEs, "causation has not been established".
• "Regulatory reports examining harms in the prophylaxis trials, were analysed while participants were receiving treatment only and not after they stopped taking it, although this information was available in the full clinical study reports." - The source is not MEDRS compliant, and the statement itself seems dubious. Formerly 98 (talk) 10:24, 7 December 2014 (UTC)
• "From about 2004 there were concerns that oseltamivir caused dangerous psychological, neuropsychiatric side-effects including self-harm in some users. These dangerous side-effects occurred more commonly in children than in adults." - this provocative language indirectly references the package insert, which says "the contribution of TAMIFLU to these events has not been established." We have 5 paragraphs on this AE of unestablished causation, reminscent of the sort of endless discussion of the "history" of FDA commentary on rare AEs of unknown causation in the FQ articles of several years ago. Formerly 98 (talk) 13:15, 7 December 2014 (UTC)

Ah "their AllTrials campaign" It is not their campaign. Yes they are involved with it but other supportive organizations include NICE, the Medical Research Council and Wellcome Trust.

That this represents a meaningful COI I do not agree.

Agree this "A survey conducted in 2009 by" is poor and trimmed

Change the heading to "side effects". We can discuss both confirmed and potential side effects in this section. The section heading does not need to fully describe the sectionDoc James (talk · contribs · email) 18:34, 7 December 2014 (UTC)

The Cochrane reviews are typically the most authoritative sources to be used on Misplaced Pages. They usually represent the scientific consensus. Some of the wording can be tightened or reworded. Current wording "A 2012 Cochrane review maintained that...". I would change it to "A 2012 Cochrane review stated that...". QuackGuru (talk) 20:05, 7 December 2014 (UTC)

There was no consensus to delete Cochrane review from the lede. QuackGuru (talk) 20:47, 7 December 2014 (UTC)

While Cochrane often represents the medical consensus, this is one case where it does not (see the other guidelines by WHO, IDSA, CDC, etc). It's conclusions are controversial and I would not place their conclusion in the lead, especially without the caveats that their conclusions have been largely rejected by the wider medical community. Yobol (talk) 20:51, 7 December 2014 (UTC)

It is not just Cochrane

• 2013 PLoS One "The combination of diagnostic uncertainty, the risk for virus strain resistance, possible side effects and financial cost outweigh the small benefits of oseltamivir or zanamivir for the prophylaxis and treatment of healthy individuals. No relevant benefits of these NIs on complications in at-risk individuals have been established."
• 2013 Family Practice "There is no evidence that oseltamivir reduces the likelihood of hospitalization, pneumonia or the combined outcome of pneumonia, otitis media and sinusitis in the ITT population."
• 2014 Cochrane "The balance between benefits and harms should be considered when making decisions about use of both NIs for either the prophylaxis or treatment of influenza."
• 2014 BMJ "The trade-off between benefits and harms should be borne in mind when making decisions to use oseltamivir for treatment, prophylaxis, or stockpiling."

Doc James (talk · contribs · email) 21:22, 7 December 2014 (UTC)

revision of article - was overly WP:TECHNICAL and clear product of battles among editors

I just took a shot at revising and simplifying this. It was written by smarty pants for smarty pants and had completely lost track of our mission to give people straightforward information per WP:MEDMOS.

I moved a ton of detail that was only in the lead into the body and condensed the lead. I put advice of major medical bodies first (consensus of the field about how to actually use the drug), followed by evidence expressed in reviews, per discussions at WT:MEDRS on consensus vs evidence (again, we are not here to WP:ADVOCATE for evidence-based medicine) I renamed cochrane2014 & coch2012 & CDC refs to make them easier to find. I also removed a bunch of the blow-blow as time unfolded from the Efficacy subsection. We just need to provide the current understanding, not the geeked-out history of how we got here. Jytdog (talk) 20:01, 7 December 2014 (UTC)

Doc James please provide a citation for the organization or individuals who actually say they are contesting the recommendations of the world's major medical bodies on use of this drug. Thanks. Jytdog (talk) 20:30, 7 December 2014 (UTC)

For what article content are you wanting a ref? Doc James (talk · contribs · email) 20:34, 7 December 2014 (UTC)

thanks for talking. it is very clear that you see a controversy. I am asking for a source that says there is a controversy. Also, what major medical body opposes the CDC, ECDC, IDSA, etc etc? What justifies giving cochrane WP:WEIGHT over all these major medical bodies? Jytdog (talk) 20:52, 7 December 2014 (UTC)

You are requesting evidence that their is a controversy? We have this review that states "Oseltamivir is now on the list of World Health Organization essential drugs,4 5 but we could not clarify on what basis WHO or the Centers for Disease Control and Prevention recommend its use" published in the BMJ

We have news sources from 2014 that state "Researchers, regulators and Roche row over stockpiled drug Tamiflu

And a news report in nature Doc James (talk · contribs · email) 21:05, 7 December 2014 (UTC)

I appreciate everyone's work on this today (and especially that my edits were not all reverted :>)). But I'd have to agree withh what I think Doc is saying, the material in the text provides prima facie evidence of a controversy. No ref needed. There are a number of articles out there that support the Cochrane position, and they are not all from BMJ. But I don't think this is something we need to document. Formerly 98 (talk) 21:18, 7 December 2014 (UTC)

Yup thanks Formerly. Documentation can be provided that it is controversial as lot of press describes the controversy. Have provided three systematic reviews and one systematic review of systematic reviews from the last two years above. A reuters states their is a disagreement between regulators and researchers. Doc James (talk · contribs · email) 21:25, 7 December 2014 (UTC)

Both the Nature news article and Reuters article are the typical kind of science news that comes out when articles are published. The reuters source is decent for saying that Carl Heneghan is arguing with pretty much every major medical body on the planet - and makes it clear that the EMA thinks he is just dead wrong on this. And Nature News says "But a dozen experts contacted by Nature’s News team said that the clinical-study reports, although they allow more detailed analyses, offer no substantial fresh findings." So the "controversy" appears to be all hype - which you and I assiduously avoid when we edit. Jytdog (talk) 21:24, 7 December 2014 (UTC)

While I guess we disagree that the controversy is all hype. BMJ, Cochrane and PLoS One do not just publish hype. Doc James (talk · contribs · email) 21:26, 7 December 2014 (UTC)

I am OK with either of those as a source for the "controversy" per se - although I see that Everymorning jumped in with a ref (thanks for that!). But this is a side show. The thing I am really looking for and that we should discuss if there is not agreement to let the article stand as it is, is -- what is the basis in policy or guideline for giving EBM/Cochrane more WEIGHT than the views of pretty much every major infectious disease body on the planet? Doc James please do reply to that, if you don't agree with the current state of the article. If you agree, we can just let this go. thx. Jytdog (talk) 21:32, 7 December 2014 (UTC)

This sort of preface should not occur "The world's leading medical bodies for infectious disease." We do not state "published by the prestigious Cochrane Collaboration" or leading medical journal PLoS One. Doc James (talk · contribs · email) 21:43, 7 December 2014 (UTC)

As much as Doc and I have disagreed about this article, we're on the same page today. Agree "leading" does not belong here. Overkill. Formerly 98 (talk)`

• Cochrane is not the only reputable publication objecting to Oseltamivir recommendations. A1candidate (talk) 21:45, 7 December 2014 (UTC)

ok i admit that was my own bullshit piece of WP:ADVOCACY - WP:POINT-y even, over against the kooky elevation of Cochrane that was going on here. Removing it. Jytdog (talk) 21:57, 7 December 2014 (UTC)

Edits of Dec 27 2014

As someone with a long history of carping about this article, I think this version https://en.wikipedia.org/search/?title=Oseltamivir&oldid=637069978 looks pretty good, and would like to express my appreciation to everyone who worked on it today. Formerly 98 (talk) 21:07, 7 December 2014 (UTC)

Agree that it is much similar and to the point. Doc James (talk · contribs · email) 21:47, 7 December 2014 (UTC)

I think we changed it from "fraudulent drug known to be worthless", or something leaning heavily that way, to "controversial in part because the developer did an irresponsible job of designing and performing the clinical trials". I think the latter is probably a fair characterization. Formerly 98 (talk) 22:00, 7 December 2014 (UTC)

actual recommendations

• CDC recommends use of tamiflu to "treat influenza or to prevent influenza" - no restrictions.
• IDSA recommends for treatment of anyone (doesn't mention prevention). notes that its recommendation goes beyond the label
• APA recommends for treatment and prevention in kids.
• ECDC recommends use to treat and prevent in observed risk groups (old, young, sick, pregnant, etc)

Curent text says "recommend the use of oseltamavir for people at high risk for complications and those at lower risk who present within 48 hours of first symptoms of infection" which is not accurate. Fixing. Jytdog (talk) 21:47, 7 December 2014 (UTC)

Ah. Slow down User:Jytdog Doc James (talk · contribs · email) 21:53, 7 December 2014 (UTC)

what's wrong? Jytdog (talk) 21:54, 7 December 2014 (UTC)

While you agreed to discuss and are not. Doc James (talk · contribs · email) 21:55, 7 December 2014 (UTC)

I self-reverted. here is the change i made. what is wrong with it? thx. Jytdog (talk) 21:56, 7 December 2014 (UTC)

Lets look at the CDC "Antiviral treatment is recommended for any patient with confirmed or suspected influenza who: is hospitalized; has severe, complicated, or progressive illness; or is at higher risk for influenza complications. Persons at higher risk for influenza complications"

This could be summarized as "any one who has or is at high risk for complications"

"Antiviral treatment also can be considered for any previously healthy, symptomatic outpatient not at high risk with confirmed or suspected influenza on the basis of clinical judgment, if treatment can be initiated within 48 hours of illness onset"

Can be summarized as "and those at lower risk who present within 48 hours of first symptoms of infection" Thus there was nothing wrong with waht was there fore. Doc James (talk · contribs · email) 21:58, 7 December 2014 (UTC)

doc james that bit you quote is prefaced by as early as possible (bolding from the original) - you are applying an urgent warning for a special case, to the overall use of the drug. That is even POINTier than my use of "world's leading medical bodies for infectious disease".  :) The very first bullet in the bottom section is the general one: "Clinical trials and observational data show that early antiviral treatment can shorten the duration of fever and illness symptoms, and may reduce the risk of complications from influenza" and per the table above it, this applies to everybody. hence my suggested content: "recommends for treatment and prevention (as a second line, after vaccination) of influenza" Jytdog (talk) 22:07, 7 December 2014 (UTC)

you've got your big Efficacy section clearly explaining the Cochrane perspective. You must allow the voice of the major medical bodies to speak clearly. Thanks. Jytdog (talk) 22:14, 7 December 2014 (UTC)

The CDC does not recommend it for everyone. They recommend it for those with complications or at high risk of complications. They do not recommend it in those who are otherwise healthy, have no complications and are not at high risk. It can be considered for some in that group but it is not recommended "Antiviral treatment also can be considered for any previously healthy, symptomatic outpatient not at high risk with confirmed or suspected influenza on the basis of clinical judgment, if treatment can be initiated within 48 hours of illness onset." Doc James (talk · contribs · email) 22:21, 7 December 2014 (UTC)

I see what you mean. I will let the current language stand. Jytdog (talk) 22:32, 7 December 2014 (UTC)

I hesitate to suggest any further changes at this point, as the article basically looks good and the discussion seems to be close to consensus. But didn't this article formerly contain reference to a meta analysis of observational studies in hospitalized patients that many of the aforementioned medical groups refer to in defending their treatment guidelines? These obviously are not RCTs, but given the crappy job that Roche did on looking at these issues in their clinical development program, and the reference to them by the groups above, they seem to be a significant contributor to the overall evidence base. Or at least many view them that way. Formerly 98 (talk) 22:46, 7 December 2014 (UTC)

do you mean this PMID 12885681? Jytdog (talk) 03:31, 8 December 2014 (UTC)

it would be bad to counter more recent reviews with an older one, tho...Jytdog (talk) 03:31, 8 December 2014 (UTC)

Science-based medicine

OK, just came across this. What shall we do with this? Mark Crislip for Science-based Medicine. May 2, 2014 Cochrane Reviews: The Food Babe of Medicine? Quote: "There was a lot of good information in the article, but the bias and FUD rendered it, like much of the Cochrane influenza reviews, more infomercial than a nuanced discussion of a complicated topic. And while I didn’t go through all the supplementary material, I did not see that they suggested oseltamivir is used in the manufacture of yoga mats. But not for a lack of trying." There are many WP articles where we rely on this blog. Note. that article also says, "Not only is the press not bothering to read the article with more critical thinking than Food Babe, the Misplaced Pages editors fell for it hook, line and stinker." Jytdog (talk) 03:51, 8 December 2014 (UTC)

Some changes by JT are poor

Will look at it further tomorrow. But here you removed the plain language summary? Why. And you changed the refs? Also why? Doc James (talk · contribs · email) 03:55, 8 December 2014 (UTC)

With regard to this edit by Doc James. Per WP:LEAD, nothing should be in the lead that is not in the body. Also, one of the refs was for a different drug and the other ref was a general description of what the Australian pregancy categories are; neither was a source for the information about this drug. I made this edit, where i moved the content to the body and provided proper sourcing, and Doc James gave me an edit warring warning. Unclear to me what the problem is. Do we generally put pregnancy categorization only in the lead, or even usually put it in the lead? Please explain! Please don't tell me that providing actual sources is a problem.... :) Thanks. Jytdog (talk) 04:18, 8 December 2014 (UTC)

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