Go to any medical educational meeting, and you’ll usually find individuals giving Powerpoint presentations that, when you boil down to it, sell the merits of a drug or device. Such presentations are usually delivered by doctors who are sometimes known as ‘key opinion leaders’ or ‘KOLs’. Being doctors, one might imagine that these doctors give their objective, independent view of the drug or device of which they speak. In reality, though, key opinion leaders are usually paid by pharmaceutical or medical device companies, and might just be viewed as ‘drug reps’ according to one industry insider.
The issue of Key opinion leaders and their payment came to light in this week’s British Medical Journal [1]. Attention to the practice of using key opinion leaders was drawn by Kimberly Elliott who had been a drug company sales rep for almost 20 years. Ms Elliott describes how doctors are initially approached by drug companies and ‘interviewed’ to gauge their opinion and attitude to relevant medical matters and their treatment. Those whose views match the drug company’s own objective are then ‘groomed’ by the company.
This process entails the drug company providing speaking opportunities for these doctors that helps raise their profile and help morph them into key opinion leaders and ‘product champions’. The drug company will often provide the very slides that are used for the basis of the presentations. And doctors tend to be well paid for their efforts too. Ms Elliott, for instance, paid doctors $2500 (�£1280) for a single lecture, and delivering more than one lecture in a day could allow doctors to earn several thousand dollars in a single day.
According to Elliott: These people are paid a lot of money to say what they say. I’m not saying they are bad, but they are salespeople just like the sales representatives are.�
The money paid to key opinion leaders is not for nothing though: the performance of these hired helps is monitored, and if their efforts do not lead to cost-effective increases in sales, they are dropped.
In the BMJ piece Richard Tiner of the Association of the British Pharmaceutical Industry is asked how doctors in the pay of drug companies can retain their independence. His reply referred to the fact that these doctors are free to speak about other drugs and that their presentations are often quite balanced.� His suggested cure for the malady of the sometimes cosy professional and financial relationship between doctors and drug companies is transparency: Doctors should be declaring their potential conflicts of interest whenever they speak.
The articles also cites Harvard University researcher David Blumenthal who has a special interest in the area and whose opinion is that the payment of doctors by drug companies to promote a particular message or product might not be in the best interests of the public, including the patients served by these doctors. He and others have called for the scaling back of influence that drug companies have over doctors and their education.
In the meantime, what are doctors to do? Ms Elliott advises doctors who attend KOL presentations to take them with a grain of salt and go back and do your own research.� However, it’s important to bear in mind that the messages propagated through key opinion leaders gets out into the mainstream too. This means that not just doctors but members of the public too may need to do their own research. My opinion is that the internet now allows unparalleled opportunity for this, and for the uncovering of information that isn’t the usual party line on a some drug or treatment.
References:
1. Moynihan R. Key opinion leaders: Independent expert of drug representatives in disguise? BMJ 2008;336:1402-1403
Come now Dr Briffa and Mr Stone (that sounds rather RL Stevensonesque, no?) you want me to pass on evidence that McDonalds hamburgers cause autism to Prof Baron-Cohen?
Fine, consider it done. I am but a mere amateur compared to you though, Mr Stone, in how to conduct a propaganda onslaught. Can you help? I am sure that the plethora of government bodies, public health organisations, the print and the electronic media will be pleased to know the indefatiguable Mr Stone will be bombarding them with relentless information about burgers rather than vaccines. It will make a nice change for them. Perhaps those with long enough memories can experience the deja vu of CJD.
Ross, the Cochrane authors have admitted it – we might as well admit the game is up.
You see, the design of the various methods by which safety reporting is recorded in many MMR studies is largely inadequate.
Clearly this can only be an unequivocal statement that MMR causes autism.
David
“Come now Dr Briffa and Mr Stone (that sounds rather RL Stevensonesque, no?) you want me to pass on evidence that McDonalds hamburgers cause autism to Prof Baron-Cohen?”
I suggested no such thing. All I asked was for you to provide the evidence on which your assertions regarding McDonald’s hamburgers and autism are based. It seems you cannot. So, it seems you believe you have the power the predict the results of appropriate experiments ahead of time. Which, as I said before, is hardly scientific and suggests bias.
David, from a scientific perspective it seems to me you have been caught with your pants down. No need to get arsey about it, though.
David
You know perfectly well that I didn’t say anything about burgers. Apparently the trend rises when you mention burgers but remains flat if you mention vaccines…
In reply to Ross July 14, 2008 @ 3:22
pm
and David July 14, 2008 @ 12:31
pm
As I have said earlier So endeth these exchanges – what has become a troll’s version of the tennis-elbow-foot game.
I’d much rather spend my time nailing jelly to the ceiling. I’m bored with the David and Ross the troll double act.
Ross claims I rely on one study for a 20% figure s/he quotes. And yet I do not attribute any figure to that paper but cite a substantial body of research instead.
David joins in with the same erroneous claims saying As Ross has pointed out, this refers to the Portuguese study.
I am beginning to think both of you are the nine years old editors of Wikipedia to whom I previously referred – July 12, 2008 @ 11:03
pm.
Both of you now need to identify yourselves and what qualifications you claim to have to comment on any of this. If the answer is you are nine year old editors of Wikipedia claiming to have PhD’s in epidemiology, I will say, you have done very well getting this far and that is not bad for nine year olds.
David
“Ross, the Cochrane authors have admitted it – we might as well admit the game is up.
You see, the design of the various methods by which safety reporting is recorded in many MMR studies is largely inadequate.
Clearly this can only be an unequivocal statement that MMR causes autism.”
Just to be clear (although I have made this point on several occasions), my view is that the science does not vindicate MMR with respect to autism.
You’re right about one thing, though: the game is well and truly up.
Mr Miller, please provide the reference/citation which states that mitochondrial dysfunction acounts for 20% of ASD cases and is triggered by vaccines (as you have claimed)
Dr Briffa – I hoped you would appreciate that when I claimed there was a temporal association between the proliferation of McDonalds and the rise in autism diagnosis that I was being facetious. I did not realise you thought I was seriously implying there was a causative link. (Now if I had mentioned the rise in mobile phone ownership and EMFs that might be a different matter)
Mr Stone, I apologise for misleading you with my burger analogy.
Please do not ascribe things to me which I have not said – where have I ever said that the autism diagnosis rate has remained flat? If you may recall, I was making the point that the diagnosis rates have risen, despite vaccination rates being already near maximum, or actually falling. (remember Fombonne – rate of autism increased by 240% while vaccination rates dipped[or not as the case may be]). This phenomenon is inconsistent with the hypothesis that vaccination accounts for any clinically significant fraction of overall autism cases.
If you wish to take the debate into the area of whether there has indeed been a genuine rise in autism cases, feel free, but that is something not currently under discussion.
David
“Dr Briffa – I hoped you would appreciate that when I claimed there was a temporal association between the proliferation of McDonalds and the rise in autism diagnosis that I was being facetious. I did not realise you thought I was seriously implying there was a causative link.”
I think you’re being somewhat disingenuous here: I was calling for the evidence on which your assertions were based because if you could not provide it (which you could not) then your assertions were:
1. A example of where you appear to feel you have the ability to confidently predict the results of experiments before they are even performed. A neat trick (but hardly scientific).
2. Highly biased.
Rather than attempting to deflect from the point, maybe you should just concede it?
In reply to David July 14, 2008 @ 10:08
pm
No, I will not be answering your questions, as I have already made clear. If you cannot ascertain the answer for yourself, you should not be engaging in this diablog. If you can ascertain the answer for yourself, why are you asking me? I am far too busy with much more important “stuff”, up to my ears in nails and jelly.
If you and Ross identify yourselves and what qualifications you claim to have to comment on any of this then I might answer if I feel like it and then I might not. If the answer is you are nine year old editors of Wikipedia claiming to have PhD’s in epidemiology, I will say, you have done very well getting this far and that is not bad for nine year olds.
Otherwise, this diablog is ended.
As a footnote it is very curious that Prof Fombonne – after spending a decade trying to peruade everyone that autism incidence is static, should simply concede that it is rising, without commenting on his revisionism, Presumably, the earlier studies were wrong. The Montreal study is , nevertheless, on its own a quagmire.
http://www.vaproject.org/yazbak/tale-of-two-cities-20070307.htm
http://www.nationalautismassociation.org/press030707.php
http://pediatrics.aappublications.org/cgi/eletters/118/1/e139#2315
How very appropriate that David should espouse it.
Dr B, now I see- you want the “evidence” for my saying McDonalds was “temporally associated” with a rise in autism diagnoses?
Of all the fascinating topics that could be looked into on this thread, you wish me to continue to wax apocryphal? Are you hoping I will accuse McDonalds of causing autism, so Mr Miller can take up their case of libel against me? Perhaps he should be warned – they don’t usually do too well in court cases of libel/slander.
What depth of evidence for the “association” do you wish to see? Will a simple comparison of the rise in number of restaurants from the mid seventies to the current number in the UK today suffice, if I couple it with a tale of how autism diagnosis rates have been steadily rising?
This strength of evidence is usually sufficient for people to cry “MMR causes autism” when the vaccine/autism data are compared – something you seem to have no problem accepting without challenge, so I guess that’s all you want. Or perhaps you would like something a bit more devious, rather like the “Miller massage” of the Honda data?
Mr Miller, I see you like to play the “appeal to authority” card as and when it suits you.
On the one hand, we have systematic reviews conducted by international experts in their fields, and you are happy to reject their own findings and conclusions in order to insert your own corrupted interpretation. Yet you have, apart from having done litigation in this area, no relevant medical background. So that’s OK I guess.
On the other hand, when Ross and I ask for a citation concerning claims you have made here and on your own web site, you feel free to dismiss us unless we explain what qualifications we have to allow us to comment on the issue. Strange you do not ask anyone else for their qualifications to comment, only those who threaten to expose your own inadequacies in assessing the data.
Dr B, you said:
“I agree with the Cochrane review authors when they state (in their own words) that ““The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.””
Why don’t we look at this statement in context in the actual study:
Authors’ conclusions
Implications for practice
Existing evidence on the safety and effectiveness of MMR vaccine supports current policies of mass immunisation aimed at global measles eradication in order to reduce morbidity and mortality associated with mumps and rubella.
Implications for research
The design and reporting of safety outcomes in MMR vaccine studies, both pre and postmarketing, need to be improved and standardised definitions of adverse events should be adopted.
Do you think that this phrase is:
a) calling for studies to be better designed in future
or
b) stating that the methodology of the reviewed studies was so poor that the other findings of the review are undermined(from the ‘Main results: “MMR was unlikely to be associated with Crohn’s disease, ulcerative colitis, autism or aseptic meningitis (mumps) (Jeryl-Lynn strain-containing MMR)” and from the Plain Language Summary: “No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found”).
or c) something else?
Dr B, do you agree with my assertion that “there does not seem to be any good evidence to show a causal link between MMR and autism”?
Given that you believe that the Wilson review offers a ‘generally reasonable set of conclusions’ (including as it does the statement ‘Our review finds no evidence of the emergence of an epidemic of ASD related to the MMR vaccine’) do you also agree that “…there is a lot of good evidence that shows no correlation between MMR and autism” or, at the very least, that there is “some good evidence that shows no correlation between MMR and autism”?
This is a bit more grmane to the issue than the McDonald’s analogy so rather than attempting to deflect from the point, maybe you should just concede it?
CM – “So endeth these exchanges – what has become a troll’s version of the tennis-elbow-foot game.”
That’s a shame because they never really got started. I guess I’ll never know what the ‘tennis-elbow-foot game’ is, nor will you explain to me your autism/MMR hypothesis or provide the evidence for this claim of yours:
“That mechanism is indicated by current research to account for 20% of cases of autistic spectrum disorders (ASDs) and be triggered by vaccines.”
I hope you manage to catch up on the ‘important stuff’ you’re up to your ears in, perhaps then you’ll have the time to take part in the discussion.
David
“Of all the fascinating topics that could be looked into on this thread, you wish me to continue to wax apocryphal?”
No, not at all. Again, you’re being disingenuous. I’d just like you to accept what seems apparent: that you appear to be able to predict the results of experiments before they have been done which suggests a certain (biased) mindset. That’s all.
As I said, instead of deflecting from the point, why not just concede it? I mean, you don’t even need any balls for it (seeing as you hide behind anonymity).
ross
Have a trawl through the comments here and you’ll see I’ve made my views on the Wilson and Cochrane reviews abundantly clear.
Please reflect on how I have quoted the text from the actual reviews in support of these views.
Note how I have not quoted from the ‘plain language summary’ of the Cochrane review which might also be called the ‘Summary for Idiots’ (not because people are generally idiots, mind, but because they have clearly been taken for such by you and others).
You started by suggesting you did not make claims but it turns out you do. And when asked for the evidence that supports your claim then you refuse but simply invoke the Cochrane review. By the authors’ own admission the specific studies in this review turn out to be ‘largely inadequate’ and analysis of the specific studies shows fundamental flaws.
Like so many before you have invoked the Cochrane review. And, what a thorn in the side it turned out to be for you.
As I said, the game’s well and truly up.
when asked for the evidence that supports your claim then you refuse but simply invoke the Cochrane review.
I cited the Cochrane review but then I said:
I find it strange that you don’t seem to regard the findings of a meta-analysis as evidence. That’s odd. Here (comment 51) you state that you don’t need to critique the evidence as it’s already been done.
http://www.drbriffa.com/blog/2008/05/23/the-limited-value-of-statistical-significance-in-the-real-world/
By, erm, the Cochrane review. So I suspect that providing references to the individual studies wouldn’t get us very far. But I’m an optimist so here are the references David posted:
And in addition to those references I cited Honda et al. You said you had critiqued Honda. I referred you to criticism of your critique and asked if you would like to address this criticism. You chose not respond.
I then addressed the criticisms you made of DeStefano, Fombonne and Madsen.
“DeStefano: The conclusion, however, implied bias in the enrollment of cases which may not be representative of the rest of the autistic population of the city of Atlanta, USA where the study was set.”
The risk of (selection) bias is classified by Cochrane as ‘moderate’. Does this invalidate the study or the conclusions drawn in the review? If so, why?
“Fombonne: The number and possible impact of biases in this study was so high that interpretation of the results was difficult.”
The risk of (selection) bias is classified by Cochrane as ‘high’. Did this make interpretation of the results impossible? Or difficult? Does this invalidate the study or the conclusions drawn in the review? If so, why?
Madsen: The interpretation of the study by Madsen was made difficult by the unequal length of follow up for younger cohort members as well as the use of date of diagnosis rather than onset of symptoms for autism.
The risk of (detection) bias is classified by Cochrane as ‘moderate’. Does this, or the inequality of length of follow ups make interpretation of the results impossible? Or difficult? Does this invalidate the study or the conclusions drawn in the review? If so, why?
You chose not to respond, which still leaves us wondering why you think these studies are not ‘fit for purpose’. However, you seem to think that this is what the authors think:
By the authors’ own admission the specific studies in this review turn out to be ‘largely inadequate’ and analysis of the specific studies shows fundamental flaws.
But then you go on to say:
Note how I have not quoted from the ‘plain language summary’ of the Cochrane review
No, you haven’t. You’ve quoted from the abstract, which reads: “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.“
If you look at the conclusions in the context of the study they are:
Authors’ conclusions
Implications for practice
Existing evidence on the safety and effectiveness of MMR vaccine supports current policies of mass immunisation aimed at global measles eradication in order to reduce morbidity and mortality associated with mumps and rubella.
Implications for research
The design and reporting of safety outcomes in MMR vaccine studies, both pre and postmarketing, need to be improved and standardised definitions of adverse events should be adopted.
Do you think that this supports your assertion that “By the authors’ own admission the specific studies in this review turn out to be ‘largely inadequate’”?
As I said, the game’s well and truly up.
I thought we were in agreement on the fundamentals!
You said re. Wilson “My interpretation of this is that there is currently no evidence of a link between MMR and autism, though one may exist (in, say, a small subset of a population). Public concerns about this need to taken seriously. There is also what appears to be call for future research (i.e. this matter is not necessarily a closed book). These seem like a generally reasonable set of conclusions to me.”
So you agree with the first part of my assertion which was “there does not seem to be any good evidence to show a causal link between MMR and autism”
And given that you believe that the Wilson review offers a ‘generally reasonable set of conclusions’ (including as it does the statement ‘Our review finds no evidence of the emergence of an epidemic of ASD related to the MMR vaccine’) then you seem to agree with the second part of my assertion which was “…there is a lot of good evidence that shows no correlation between MMR and autism”?
Or at the very least that there is some good evidence that shows no correlation between MMR and autism.
Dr B, you are running a blog which enables people to post comments anonymously. You are happy with this, and do not accuse people of hiding behind their anonymity – unless it happens to be posters who ask uncomfortable questions. I notice you do not refuse to answer the questions of other anonymous posters on your blog. So why just Ross and me? Is it that you have backed yourself into a corner and are trying to use a get out of jail free card?
Let’s see what has happened so far. Regarding the Cochrane study, you have been provided with a breakdown of the individual studies used in the review, and some others besides. You have also been pointed to other systematic reviews such as Wilson and the IOM review.
You seem to be fixated on Cochrane, because it was (fairly and objectively) critical of some aspects of some of the studies and detailed a number of caveats. You and Mr Stone are clinging onto these caveats for dear life, trying to imply they negate the entire validity of all the studies. As I explained earlier, and as Cochrane also points out, there are numerous difficulties in trying to assess MMR/autism studies, not least the problem of not being able to have a clean, unvaccinated control group. So studies have varied in their methodology, and obviously there is little consistency in what some researchers will do in respect to others.
You have stated above:
I have reflected, and find only evidence of selective misquoting on your part. You seem to have great difficulty in accepting the overall conclusions of Cochrane, choosing to hide behind the single phrase: “the design and reporting of safety outcomes……..are largely inadequate”. You consistently misinterpret this sentence (and have been rude to me when I asked what you understood by it – remember you asking me to interpret “the cat sat on the mat” by way of response?). You clearly do not know what this sentence means, since you have said it means the studies themselves are “inadequate”. I think it is you who needs to go back to primary school and start with some basic comprehension lessons actually.
Regarding Cochrane, you have failed to respond to Ross’ request that you consider their conclusions:
Ross has even made it easy for you – when asking you what you think these statements mean he has given you multiple choice answers to pick from. Could you respond please?
If you don’t want to, just say so directly, and everyone will know where you stand.
Just to note the silly season continues. In regard to Fombonne “difficult” is from the main text, but “impossible” is what it says in the notes.
It is one thing if Cochrane detects a “moderate risk of bias” internal to the study – a warning if nothing else not to put too much weight on it – but it turns into a much greater problem if the authors are investigating their own policy.
Presumably, no weight should be placed on a study with a “high risk of bias”.
With Madsen the data was simply biased, reducing the number of autism cases in the vaccinated group. Cochrane should have been clearer about this.
Dr B – any response to 167 & 168?
ross
Just to remind you, the Wilson authors called for more work to be done on a possible link between MMR and a sub-group of autistic spectrum disorder, and the Cocharne reviewers themselves pointed to the manifold deficiencies in the studies that formed part of their review, and go on to describe the evidence in the area as “largely inadequate.”
In light of this, David’s suggestion that it’s me who is backed into a corner over this seems quite ironic.