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EVIDENCE-BASED-HEALTH  June 2010

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Subject:

AW: What to do about flu? results of ,survey

From:

"Bastian, Hilda" <[log in to unmask]>

Reply-To:

Bastian, Hilda

Date:

Sun, 13 Jun 2010 20:27:23 +0200

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (298 lines)

Dear Ben

Perhaps the assumptions could first be questioned, rather than jumping to assuming there is an issue about whether people's decision-making is rational? By what basis is the evidence for those medical treatments "lousier" than the evidence for hand-washing? And the hand-washing etc: who wants to (or really will) wash their hands a gazillion times a day and not hug, kiss or shake hands for months? Should the rationality of people who might not want to implement (or rely on) that difficult approach - which in other contexts would be called obsessive-compulsive behaviour - really be called into question?

When any of us fail to convince other people to share our point of view, it does not mean that the other people are operating non-rationally. Although it is always possible of course that they - or we - are being irrational, it is not a necessary pre-condition for a difference of opinion. Interpreting evidence is a subjective, qualitative process, shaped by value judgments (and not only commercial interests, but values - including ideological biases). That people interpret this evidence differently seems to me to be completely normal. I can see no need to question the rationality or motives of everyone who does not agree with one particular point of view.

The EBM-decision making paradigm - to me - accepts that people have different values and will interpret evidence differently - and then apply it in their lives and decisions differently - as Ted's story showed, also in the context of our health beliefs and other complexities. That this means that people come to different decisions and actions, does not challenge the paradigm at all. Nor does it seem to me that every time someone makes money out of something, tht it follows, ipso facto, that the people who agree with those interventions are somehow suspect.

Regards

Hilda

 

-----Ursprüngliche Nachricht-----
Von: Evidence based health (EBH) [mailto:[log in to unmask]] Im Auftrag von Djulbegovic, Benjamin
Gesendet: Sonntag, 13. Juni 2010 18:44
An: [log in to unmask]
Betreff: Re: What to do about flu? results of ,survey

Sorry for keeping this thread alive, but it really deserves further discussion...(I was hoping that someone else will comment first, but let me take the first stab at it)...
Think about for a moment what we have here:

1. Evidence is LOUSY at best
2. Conflict of interest (COI) is HUGE (as it has been discussed repeatedly here and troughout the literature there is strong empirical support to doubt the accuracy of research findings in the setting of COI. Indeed, in this case no one denies that declaration of pandemics by WHO and many other national agencies was a bonanza for pharmaceutical companies, which made an extraordinary profit by selling vaccines and drugs. So, when WHO made guidelines refusing to disclose the names of the panel and their ties with industry, any reasonable observer would doubt motives or even the correctness of recommendations...) 3. Cost to society (-ies) has been ENORMOUS (think about the opportunity costs and how many lives could have been saved if the money spent on stockpiling of vaccines and drugs was used for other pressing societal or health problems...)

and yet,

the majority of people (45%) (all highly knowledgable folks with intricate understanding of all issues discussed here) would pretty much endorse the guidelines made by WHO and other national agencies (such as CDC etc): most of us would recommend double vaccine to others as well to the members of their family, or take double vaccine themselves. Why is this so? What is going on here? I think this case represents a challenge to EBM decision-making paradigm, and truly deserves more discussion.

In my opinion, this case indicates that human processes information both at intuituive (system 1) and deliberative level (system 2), something that Neal Maskrey has pointed out many times in the past. It feels that consequences (regret) of not getting vaccinated are much higher that potential consequences (regret) associated with unnecessary vaccination...
Having said this, a respectable minority (25%) adheres to rational (system 2) decision-making paradigm- outside good medical practice such as hand washing etc they would not endorse using neither vaccine nor drug. I wonder, if one could choose, whom one would like to select as the guidelines panel member? Would society be better off if the experts use system 2 only, or allow human intuition to play a role as well?

Sorry for a long message- but I hope it will stimulate some good discussion

ben

-----Original Message-----
From: Djulbegovic, Benjamin
Sent: Saturday, June 12, 2010 3:39 PM
To: [log in to unmask]
Subject: What to do about flu? results of ,survey

Dear all,
at half time of hopefully successful debut of the US soccer time at the World Cup (1:1 against England at the moment), I went ahead and compiled the results related to the flu management survey (prompted by the accusation of the WHO in the way they manage pandemics and developed guidelines for prevention and treatment of seasonal and H1N1 flu). Although a response rate was rather minimal, the results based on selected group of highly knowledgable folks reveal striking variation/uncertainty about the best advice one could offer to the public (see attached).
Personally, this discussion has been one of the most interesting discussion we have had over years- there is still a lot to digest, but in the mean time it would be good to have some comments on the results of the survey

Thanks'

ben



-----Original Message-----
From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Djulbegovic, Benjamin
Sent: 09 June 2010 16:10
To: [log in to unmask]
Subject: Re: WHO and the pandemic flu "conspiracies" ..,survey

Thanks everyone for this fascinating discussion. So, here we have all (typical) potpourri of the issues: conflict of interest, poor quality evidence, trade-offs between potentially good and bad outcomes, difference in the risk attitudes etc However, decisions have to be made HERE & NOW (or, rather in 3 months from now). This discussion group is made of probably most informed people that can debate this (or, any other )health issue.

So, I'd like to ask the members of this group to make the following decisions/ recommendations in 2 situations( pertaining to identical indications discussed in this thread and the WHO documents):

A) imagine that you serve on the WHO panel and is asked whether to recommend


1) seasonal flu vaccine
2) H1N1 vaccine
3) both seasonal and H1N1 vaccine
4) tamiflu for prevention
5) tamiflu for treatment
6) no drug/no vaccine (hand washing, gloves, alcohol)


B) imagine that you personally or members of your family face the same decision as in A). What would you do?
1) get a flu vaccine
2) get H1N1 vaccine
3) get both
4) take tamiflu for prevention
5) take tamiflu for Rx
6) 6) no drug/no vaccine (hand washing, gloves, alcohol)

It would be truly fascinating to see what will be this group' "vote" (all smart and attuned to the issues of evidence and decision-making) May I ask you to send me your responses to this ad hoc survey- I will then collate responses and share (aggregate) data with the group.
Thanks
Ben

Ps this is not a research- if the results are meaningful, they can be send to the WHO or other agencies to help them deliberate how to improve the quality of their decision-making process.

Ben Djulbegovic,MD
Professor of Medicine



On Jun 9, 2010, at 7:30 AM, "Dr. Carlos Cuello" <[log in to unmask]> wrote:



        I guess you already read the WHO response, but here it is anyway.

        <http://www.who.int/mediacentre/news/statements/2010/letter_bmj_20100608/en/index.html> http://www.who.int/mediacentre/news/statements/2010/letter_bmj_20100608/en/index.html





        On Wed, Jun 9, 2010 at 6:16 AM, Bastian, Hilda < <mailto:[log in to unmask]> [log in to unmask]> wrote:


                G'day, Tom!

                Better and more up-to-date information will make me very happy: whether or not more or less fridges get stocked is, I'm happy to say, not my issue - manipulating behaviour change rather than supporting individual informed choice is not (for me) justified here right now. I look forward to communicating whatever people/patients would want to know, as best we can judge what that is (and what our testing/evaluation shows). If that comes down "pro" or "contra" Tamiflu in individual situations is not for me to decide. We don't give recommendations: we try to inform neutrally (a very difficult thing to do!), and we consider and debate very heavily before we ever do otherwise (and that is rare as hen's teeth, and usually relates to immediate very serious danger, when neutrality could be reasonably expected or proven to be actively seriously harmful).

                Symptom-relieving is not what I meant: I mean days of sickness, days off work/school/daycare, and preventing healthy but exposed people in the household getting sick at all, as being outcomes of particular value. Adverse effects of course always important - again, that's a personal trade-off, isn't it? And if they are not so bad that you have to stay home from work, then there will be people willing to trade that off (and others of course who are unwilling).

                Unless you find something really dramatic, I do not imagine I would expect to use the word "toxic" to describe Tamiflu. Many people would picture something almost like what is happening to some of those poor birds in the Gulf of Mexico with the word "toxic". What I want to be able to tell people is: what percentage are going to have diarrhoea or flu-like symptoms or whatever, so they can see what trade-offs they might be making.

                I look forward to reading more data!

                Thanks!

                Hilda



________________________________

                Von: Tom Jefferson [mailto: <mailto:[log in to unmask]> [log in to unmask]]
                Gesendet: Mittwoch, 9. Juni 2010 12:07
                An: Bastian, Hilda
                Cc: <mailto:[log in to unmask]> [log in to unmask]

                Betreff: Re: WHO and the pandemic flu "conspiracies"


                Dear Hilda, the points you make are fair and reasonable. However let me explain that the Tamiflu story is far from over, it is in fact only gathering steam for another version of the review which we hope to be able finish in reasonable time using mainly unpublished data. So far we have found very substantial publication bias, multiple inconsistencies across different versions of the same dataset, discovered the presence of ghost authors in some of the original published trials and at least one instance of guest authorship of a key piece of evidence and none of the non-Roche "authors" had access to their own data.

                So far this does not apply to symptom relieveing properities of Tamiflu (nor of Relenza) but we have not really looked carefully (because of lack of resources). Ths is something we will do in new versions of the review. Before you go stocking any more fridges please remember that the drug is toxic and it has never been tested against other symptom relievers. This is something that should be done as a matter of urgency.

                Best wishes,

                Tom.




                On 9 June 2010 09:17, Bastian, Hilda < <mailto:[log in to unmask]> [log in to unmask]> wrote:


                        G'day!

                        Leaving totally aside the issue of the influence of industry and concerns about process intransparency and undisclosed data, I think it's also important to remember that it is not only reduced mortality rate and so on that matters: patients care about other outcomes too. If you provide the results of Tom Jefferson and his colleagues' review of Tamiflu to patients, neutrally (that is, neither exaggerating them nor dismissing them because of your own value judgments), then many many people will think it is in some circumstances worthwhile. While many people will just want their GP to make a decision for them, many patients would like to think that they are being given unbiased information from their GPs too. But many people would - if they saw the evidence as it is, and without any industry influence - decide that Tamiflu in the back of the fridge was a good idea. If the only outcome was mortality reduction, say, then we could probably all agree. But this is not the only outcome: days off work can be very important to people too (especially depending on the timing). Just following without thinking is of course not the greatest. But there is also a lot of room for thinking, and then coming to a different conclusion. And somehow, it seems to me that far too often, the outcomes that patients care about just get dismissed in debates like this, and people's behaviour is slated when it is in fact totally reasonable. Just because the public behaves in a way that is inconsistent with the value judgments of experts, does not necessarily make them wrong - or even unthinking.

                        Just to declare perhaps - I have never had any Tamiflu in my fridge: could absolutely imagine it, though, if I had kids in the house, some people were sick (and I was certain it was flu), and I absolutely was desperate for some reason in my life at that point not to get the flu. The small effect might not be, according to many people's judgments, important in terms of costs, or public health benefits: but that does not mean that every GP who prescribes Tamiflu has left their brains in neutral. Here an excerpt from the abstract of Tom's review in the BMJ <http://www.bmj.com/cgi/content/abstract/339/dec07_2/b5106?maxtoshow=&hits=10&RESULTFORMAT=1&author1=jefferson&title=neuraminidase&andorexacttitle=and&andorexacttitleabs=and&andorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=date&fdate=1/1/1981&resourcetype=HWCIT> :

                        "The drugs are effective postexposure against laboratory confirmed influenza, but this is a small component of influenza-like illness, so for this outcome neuraminidase inhibitors are not effective."
                        Many people might agree with this - for whatever reason. But just as certainly, many people in a household with people with laboratory-confirmed influenza who saw this review might disagree. They and the doctors who write their prescriptions are not necessarily unthinking - they may just have looked at the evidence that was available to them, and come to a different - and fully legitimate - conclusion. More than one conclusion from the same data can be fully legitimate - it can just depend on the values and perspectives. And the perspective of doctors is often not that of patients - nor does it mean that this means that doctors should always persuade patients to change their minds. When doctors and patients disagree, the doctors are not necessarily right! And either way - it's not their bodies/families, is it?

                        We cannot make our decisions on information we do not have: and we are always making decisions with imperfect information. For something that cost the community so much money, we should have had better information. That's one thing we can all agree on! But there will often be a difference with what makes economic sense, and what individual people and patients value and choose - those choices should be understood and respected. (Of course, if the community decides not to pay, that has to be understood too - that is not the point I am trying to make here.) I just don't think that everyone who prescribed Tamiflu or who got some to put in the back of their fridge, should be judged harshly or dismissed.

                        Regards

                        Hilda Bastian

                        Ressortleiterin Gesundheitsinformation / Head of Health Information Department

                        ------------------------------------------------------------------------------------

                        Tel:  +49 (0)221/ 35685-401

                        Fax: +49 (0)221/ 35685-81

                        E-mail:  <mailto:[log in to unmask]> [log in to unmask]

                        ------------------------------------------------------------------------------------

                        Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen/

                        Institute for Quality and Efficiency in Health Care (IQWiG)

                        Dillenburger Strasse 27

                        51105 Köln

                        Germany

                        -------------------------------------------------------------------------------------

                        Institutsleitung / Director: Prof. Dr. Peter T. Sawicki

                        -------------------------------------------------------------------------------------

                        Internet: www.iqwig.de <http://www.iqwig.de/>

                        Patienteninformation: <http://www.gesundheitsinformation.de/> www.gesundheitsinformation.de / <http://www.informedhealthonline.org> www.informedhealthonline.org






                        -----Ursprüngliche Nachricht-----
                        Von: Evidence based health (EBH) [ <mailto:[log in to unmask]> mailto:[log in to unmask]] Im Auftrag von OWEN DEMPSEY
                        Gesendet: Mittwoch, 9. Juni 2010 01:56
                        An: <mailto:[log in to unmask]> [log in to unmask]
                        Betreff: Re: WHO and the pandemic flu "conspiracies"




                        Hi Paul,

                        Whilst I am also interested in the investigation into the potential collusion between WHO and the drug industry, which I have no doubt will eventually fizzle out, I am, as a GP interested in a phenomenon you could call 'zoning out' by GPs.  This is where GPs switch off whatever critical faculty they may ever have had, and unthinkingly, do what they are told: to enact policy.

                        I am thinking of the guidelines about  swine flu vaccines and prescribing Tamiflu.  A very easy and quick search, in 2009 by me, revealed that Tamiflu is of uncertain benefit (there may be equipoise on this point for some) as demonstrated by Carl Henegan's rapid response to the BMJ, reporting his journal clubs conclusions on the issue.

                        For the 'interested' there is plenty of disturbing evidence suggesting that Tamiflu could cause more harm than do good.  Yes, it is sad, that the government via the CMO decided to go for a "better to be safe than be sorry" policy, sorry of course meaning sorry that you might be blamed for causing harm, rather than sorry that you caused more harm than good, (knowing that even if we inadvertently do more harm than good  then this, luckily, could never be proved anyway).

                        It is even sadder that GPs and the RCGP just went along with it.  I could, as a GP accept a situation, whereby a 'policy of healthcare'
                        might save lives even though it put large numbers at risk of small harm.  I do this all the time by supporting childhood immunisations to increase herd immunity. But I draw the line at completely unproven treatment strategies aimed at populations, targetting the young and the pregnant, for whom benefit is completely unproven. Where were you, the RCGP, when primary health care needed you?? Where were you, you completely trained to be unquestionng GP?? What does this say about medical education? Ethics for the birds? Numeracy highly valued - as long as you arrive at the right answer? Where was the global movement for evidence based medicine? Nowhere.

                        Owen
                        Owen Dempsey, GP.


                        > Date published: 04/06/2010 16:12
                        >
                        >
                        >
                        > This joint investigation by the BMJ and the Bureau of Investigative Journalism has found that the World Health Organisation's (WHO) key decisions during the H1N1 influenza pandemic may not have been free from commercial influence. The investigation questions the lack of transparency involved and found that scientists advising the WHO on pandemic flu planning did paid work for pharmaceutical companies who stood to gain from the guidance the scientists were developing. The WHO did not publicly disclose these conflicts of interest and has dismissed inquiries into its handling of the A/H1N1 pandemic as "conspiracy theories."
                        >
                        >
                        >
                        > The authors ask:
                        >
                        > * Was it appropriate for WHO to take advice from experts who had declarable financial and research ties with pharmaceutical companies producing antivirals and influenza vaccines?
                        > * Why was key WHO guidance authored by an influenza expert who had received payment for other work from Roche, manufacturers of oseltamivir, and GlaxoSmithKline, manufacturers of zanamivir?
                        > * Why does the composition of the emergency committee from which Chan (Director General of the WHO) sought guidance remain a secret known only to those within the WHO?
                        >
                        >
                        >
                        > They discuss the issues in details and write, "The number of victims of H1N1 fell far short of even the more conservative predictions by the WHO. It could, of course, have been far worse. Planning for the worst while hoping for the best remains a sensible approach. But our investigation has revealed damaging issues. If these are not addressed, H1N1 may yet claim its biggest victim - the credibility of the WHO and the trust in the global public health system."
                        >
                        >
                        >
                        > In a related editorial, the BMJ Editor in Chief calls on the WHO to publish its own report on the issue "without delay or defensive comment, [and] make public the membership and conflicts of interest of its emergency committee." She suggests that the WHO must act now to restore its credibility, and Europe should legislate. The editorialist notes, "Countries like France and the United Kingdom who have stockpiled drugs and vaccines are now busy unpicking vaccine contracts, selling unused vaccine to other countries, and sitting on huge piles of unused oseltamivir. Meanwhile drug companies have banked vast profits - $7bn (Ł4.8bn) to $10bn from vaccines alone according to investment bank JP Morgan. Given the scale of public cost and private profit, it would seem important to know that WHO's key decisions were free from commercial influence".
                        >
                        >
                        >
                        > The editorial also calls on the WHO to develop and commit to stricter rules of engagement with industry that keep commercial influence away from its decision making.
                        >
                        >
                        > Extract
                        > Editorial
                        > BBC News story
                        >
                        >
                        > Ash
                        > Dr Ash Paul
                        > Medical Director
                        > NHS Bedfordshire
                        > 21 Kimbolton Road
                        > Bedford
                        > MK40 2AW
                        > Tel no: 01234897224
                        > Email: <mailto:[log in to unmask]> [log in to unmask]
                        >
                        >









                --
                Dr Tom Jefferson
                Scientific Editor PLoS ONE
                Reviewer, Cochrane Acute Respiratory Infections Group
                tel 0039 3292025051






        --
        Carlos A. Cuello-García, MD
        Director, Centre for Evidence-Based Practice-Tecnologico de Monterrey
        Cochrane-ITESM coordinator. Professor of Paediatrics and Clinical Research
        Avda. Morones Prieto 3000 pte. Col. Doctores. CITES 3er. piso,Monterrey NL, México. CP64710
        Phone. +52(81)88882154 & 2141. Fax: +52(81)88882148
        <http://www.cmbe.net> www.cmbe.net
        <http://twitter.com/CharlieNeck> http://twitter.com/CharlieNeck

        The content of this data transmission must not be considered an offer, proposal, understanding or agreement unless it is confirmed in a document signed by a legal representative of ITESM. The content of this data transmission is confidential and is intended to be delivered only to the addressees. Therefore, it shall not be distributed and/or disclosed through any means without the authorization of the original sender. If you are not the addressee, you are forbidden from using it, either totally or partially, for any purpose

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