Dear Paul,

about 2 months ago, you forwarded the message raising a possibility that "seasonal flu shot may raise the risk of catching swine flu" (see below). Ever since I was on look out for the release of the study you quoted, since your post disturbingly affected my own practice. This, I now feel, have been unwise on my part, since the major organizations such as CDC recommend (both) seasonal (and H1N1) vaccine. (http://www.cdc.gov/h1n1flu/vaccination/public/vaccination_qa_pub.htm)

I am CC this e-mail to the group not only because I am interested in further information that you or someone else may know, but also to illustrate the problem of generating and communicating evidence when stakes are high. I consider myself as a fairly experienced person when it comes to the issue of evidence and decision-making, yet unconfirmed rumours have been very succesful in affecting my behavior/practice (probably not only in this case). I have been wondering why is this so. I am not sure, but I believe that this has to do to with some implicit trust to the source and fact that the message has appeared on this discussion group, which has run so succesfully for so many years. So, when should we act on unpublished information rumours, or inadequate information? Should we insist that the press releases are always accompanied with raw data, so that everyone can see for himself/herself where recommendations come from? Is it more important "who" provides guidelines vs. "what" they are based on?

I realized that there is no easy solution here; neverthless, I hope, as always, to read insigtful comments from you and the rest of the EBH folks.

Ben

Ps Paul, this is , of course, not to criticize your post, but rather to use it to highlight the issue, which in different ways is practised on daily basis (as, for example, when an "expert" gives his advice based on "his experience", which likely amount to 2 cases vivibly remembered and many cases not remembered etc)

-----Original Message-----
From: Tom Jefferson [mailto:[log in to unmask]" ymailto="mailto:[log in to unmask]">[log in to unmask]]
Sent: Friday, September 25, 2009 9:56 AM
To: Djulbegovic, Benjamin
Cc: [log in to unmask]" ymailto="mailto:[log in to unmask]">[log in to unmask]
Subject: Re: News release 1 hr ago: In wake of study concerns, Ontario delays seasonal flu shots for all but +65

You see Ben this is where the EBM bandwagon falls down. Evidence says
one thing, experts another, so we do what experts say.....

On 25/09/2009, Djulbegovic, Benjamin <[log in to unmask]" ymailto="mailto:[log in to unmask]">[log in to unmask]> wrote:
> Paul, this is really awful...I am not sure what was motivation of the
> Ontario officials, but this reminds me of crying the "fire" in a crowded
> theater... or of a manipulation of uncertainties, which was so successfully
> exploited by the tobacco industry in the past and now being increasingly
> done by big pharma [The lack of "definitive" scientific proof that smoking
> is harmful to one's health resulted in postponement of tobacco legislation
> for decades, with the unfortunate consequences of much avoidable disease;
> see Michaels D. Doubt is their product, Sci Am 292 (6):96-101, 2005.
> Michaels D. Manufactured uncertainty: protecting public health in the age of
> contested science and product defense, Ann N Y Acad Sci 1076:149-162, 2005.]
>
> An increasing number of patients have asked me whether it is safe to have
> both a seasonal flu and swine flu shots. We all know that the evidence is
> not there, but decisions/recommendations have to be made. This is where
> experts/expertise (the second part of the famous EBM definition) come into
> play. Our local experts concluded that it is OK to give both vaccines (the
> swine flu is not available yet, but I told my patients that when it becomes
> available it is OK to have it). Now, if the evidence speaks to foolishness
> of this advice, this has to be worked out promptly...Why the findings could
> not be posted or released for everyone to see them instead of releasing the
> news that creates further confusion? I realize that the Ontario officials
> may have worried that they will be accused of hiding data, and this does
> raise an important question when and which evidence should be shared with
> the public. Only reliable evidence? Everything and anything, even if it
> later turns out the be false?
>
> ben
>
> Benjamin Djulbegovic, MD, PhD
> Professor of Medicine and Oncology
> University of South Florida & H. Lee Moffitt Cancer Center & Research
> Institute
> Co-Director of USF Clinical Translation Science Institute
> Director of USF Center for Evidence-based Medicine and Health Outcomes
> Research
>
>
> Mailing Address:
> USF Health Clinical Research
> 12901 Bruce B. Downs Boulevard, MDC02
> Tampa, FL 33612
>
> Phone # 813-396-9178
> Fax # 813-974-5411
>
> e-mail: [log in to unmask]" ymailto="mailto:[log in to unmask]">[log in to unmask]<mailto:[log in to unmask]" ymailto="mailto:[log in to unmask]">[log in to unmask]>
>
>
> ______________________
>
> Campus Address: MDC02
>
> Office Address :
> 13101 Bruce B. Downs Boulevard,
> CMS3057
> Tampa, FL 33612
>
>
> From: Evidence based health (EBH)
> [mailto:[log in to unmask]" ymailto="mailto:[log in to unmask]">[log in to unmask]] On Behalf Of Paul Elias
> Sent: Thursday, September 24, 2009 8:48 PM
> To: [log in to unmask]" ymailto="mailto:[log in to unmask]">[log in to unmask]
> Subject: News release 1 hr ago: In wake of study concerns, Ontario delays
> seasonal flu shots for all but +65
>
>
> I share....
>
> TORONTO - Faced with puzzling but unconfirmed evidence that suggests a
> seasonal flu shot may raise the risk of catching swine flu, Ontario
> announced Thursday it is rescheduling its seasonal flu vaccine program to
> delay most of it until after pandemic vaccine has been administered.
> At a news conference in Toronto, Dr. Arlene King, the province's chief
> medical officer of health, said the seasonal and pandemic vaccines will be
> delivered in three waves, starting in October.
> People 65 and older, who have been largely spared by swine flu but who are
> at greater risk from seasonal flu, will be offered seasonal shots then. All
> residents of long-term care facilities will be included in that group.
> When the pandemic vaccine becomes available in November, all in Ontario who
> want to be vaccinated will be given access to those shots.
> Once the pandemic vaccination effort is completed, Ontario plans to resume
> the seasonal flu shot program, which offers free vaccination to anyone who
> wants it. By then, said Dr. Vivek Goel, president of the Ontario Agency for
> Health Protection and Promotion, the questions about a possible link between
> seasonal shots and swine flu infection may have been answered.
> Drawn from a series of studies from British Columbia, Quebec and Ontario,
> the findings appear to suggest that people who got a seasonal flu shot last
> year are about twice as likely to catch swine flu as people who didn't. The
> findings haven't yet been published and few people have actually seen them.
> But they have been looming like a spectre over decisions about vaccine
> delivery timing in Canada and are a source of consternation internationally.
> "This has been a very difficult decision," King said in an interview. "This
> has been difficult for everyone across the country."
> The head of the World Health Organization's vaccine research initiative, Dr.
> Marie-Paule Kieny, said Thursday that researchers in the U.S., Britain and
> Australia have looked for the same effect and have not observed it.
> People who have seen the unpublished scientific paper say the elevated risk
> - if it exists - is only that people who've had flu shots catch swine flu.
> It does not suggest they get more severe disease.
> King admitted adjustments had been made, both to deal with the concerns
> raised by the unpublished study and the worries that there may be a double
> pronged flu season, with swine flu hitting children and adults under 60 or
> so and seasonal flu viruses targeting people over 65.
> "Is it typical that we adjust our program? No it isn't typical. But we are
> not dealing with a typical flu season this year," King said.
> Influenza expert Dr. Allison McGeer said the compromise makes sense.
> "It's a reasonable balance," said McGeer, who is head of infection control
> at Toronto's Mount Sinai Hospital. "(But) it has some obvious logistical
> challenges."
> McGeer acknowledged there was discussion about whether giving seasonal shots
> to seniors in October might actually spark more infections in that age
> group, if the effect seen in the unpublished paper is valid. But she said on
> balance it was thought that the risk seasonal flu viruses pose to this group
> outweighed the theoretical risk the studies showed.
> And King noted that in the troubling data, the effect was not seen in people
> 65 and older.
> Earlier in the week when it first emerged that some provinces were thinking
> of delaying their seasonal flu shot delivery efforts, a number of provinces
> expressed hope a pan-Canadian approach could be adopted.
> King said that would have been desirable, if it were possible, but it became
> apparent that different jurisdictions were weighing factors differently and
> a one-size-fits-all solution seemed out of reach.
>
>
>
> Best,
>
> Paul
>
>
> --- On Thu, 9/24/09, Piersante Sestini <[log in to unmask]" ymailto="mailto:[log in to unmask]">[log in to unmask]> wrote:
>
> From: Piersante Sestini <[log in to unmask]" ymailto="mailto:[log in to unmask]">[log in to unmask]>
> Subject: Re: Do the antivirals reduce mortality in flu?
> To: [log in to unmask]" ymailto="mailto:[log in to unmask]">[log in to unmask]
> Received: Thursday, September 24, 2009, 11:41 PM
> At 18.07 24/09/2009 +0100, Owen Dempsey wrote:
>
>> Thus: The idea that all views on e.g. use of Tamiflu; [i.e. the competing
>> views that either everybody should have Tamiflu (as under the criteria of
>> the guidelines) versus the decision/choice that Tamiflu is too risky for a
>> given healthy individual and shouldn t be prescribed or taken] are of
>> equal moral status, is flawed.
>
> I don't see the them as the only options available. In fact, the options
> could be just the opposite: on the community perspective, it would be better
> *not* to use antiviral drugs to prevent the emergence of resistance
> (possibly at the cost of a few casualities) and of side effects, while
> individuals could prefer to have it to reduce the small risk of serious
> disease, despite the risks of side effects and of inducing resistance.
>
>> This liberal all views are fine by me stance assumes that everybody has
>> equal access to and understanding of the real state of affairs when it
>> comes to the risk benefit ratio of this intervention. This is akin to
>> pretending that we live in a real democracy (which is of course an
>> impossible fiction to attain) instead of an organised democracy where the
>> outcomes e.g. of elections are preordained and the people misinformed.
>
> It is the doctor's responsibility to get the best information available and
> to pass it to individual patients in a way that they can understand and
> decide. And, by the way, this is just what EBM is all about. It is not in
> the possibilities of EBM to make politicians or patients to behave
> rationally, although it might help to make the choices more explicit.
>
>
>>
>>
>> With Tamiflu, the government, health spokesmen and the drug industry with
>> the help of the corporate media conspire to mislead the public by
>> over-egging the dangers of e.g. Mexican/Swine Flu and overstating (even if
>> it is by implication i.e. simply by recommending its use) the benefits of
>> Tamiflu.
>
>
> Politicians (and public health managers are often just that) probably just
> anticipate what they expect to be "typical" reaction of the laymen: as Ben
> explained, omitting of doing something that could possibly prevent a serious
> bad event is often considered more undesirable that having a side effect, no
> matter how little is the chance of getting a benefit.
> I agree with you that this behavior (of politicians) is incorrect (in fact,
> most of the business of "EB-recommendations", as far as it fails to
> integrate individual circumstances, is flawed), but I maintain with Neal
> that is the patient, the owner of the problem, that has to be informed of
> the possible consequences (and uncertainty) of different choices and then
> assisted unjudgementally in thinking and deciding which stance to assume.
>
> In this context, both choices are acceptable.
>
> regards,
> Piersante Sestini
>
>
> ________________________________
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--
Dr Tom Jefferson
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Italy
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