BMJ article explores the cosy relationship that drug companies often have with doctors considered ‘key opinion leaders’

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

173 Responses to BMJ article explores the cosy relationship that drug companies often have with doctors considered ‘key opinion leaders’

  1. Paul Anderson 24 June 2008 at 10:49 am #

    As I have become more interested in health related matters I have become more and more aware that the benfits of many drugs have been overplayed, and the adverse side effects are much greater than the drug companies literature suggests.

    It seems to me that many doctors are influenced by financial incentives not just from the pharmaceutical companies, but also for achieving govt targets.

    It often seems that the underlying health and quality of life of the patient is somehow overlooked by a health system that tends to treat symptoms rather than deal with the underlying issues. Arguagly the current obesity epidemic, the massive incidence of metabolic syndrome, and treatment of heart disease, and many other western type diseases, are actually made worse by the current treatment protocols which treat the individual symptoms but ignore the underlying metabolic disturbances.

    The standard mantra of eat less fat, more carbohydrates and exercise a bit more, far from from being helpful actually makes the situation worse for many people. The few that can adhere to such a regime are quite possibly suffering from constant feelings of hunger. For most it results in yo-yo dieting and a gradual worsing of the underlying metabolic disorders.

    Statins – one of the most heavily promoted drugs in history, have no benefit in terms of all cause mortality: with the small reduction in CVD is balanced by an increase in death from other causes. The incidence of side effects anecdotally seems to be much higher than the manufacturers claim. There appears to be no benefit at all for women; yet these drugs are widely prescribed for women.

    Hypertensive medications generally need to be used in triplicate to bring blood pressure anywhere near “normal” levels. Again these drugs can have very significant side effects.

    Many patients would be better off doing the opposite of what their doctors tell them: eating more fat and less carbohydrates (especially wheat based products).

    The NHS in the UK needs a thorough overhaul, and needs to focus on the health and quality of life of the patient (actually the whole population). I have never understood why dental and optical services are dealt with separately. These services have effectively been privatised. A person cannot enjoy optimal health if they have poor oral health (gum disease, tooth decay, etc) or deteriorating and sub-optimal eyesight.

    It was a big mistake to abolish free eyesight tests and dental check ups. I do wonder if the current role of a GP actually makes senses. Surely someone should have an overview the the whole person – including dental health, optical health, feet, and what is currently covered by your GP. Often problems with eyes, or teeth are a window in to the overall health of a patient. A 10 minute appointment span is woefully inadequate for all but the most simple of issues.

    The current specialisms within the health service have led to a culture of treating different syptoms as if they were somehow unrelated as opposed to trying to improve the health and enhance the quality of lire of theindividual. We are currently spending an inordinate amount of money quite possibly making the health and quality of life of he population as a whole worse.

    We should not be seeking to undertake more operations in order to reduce waiting lists; the objective should be to seek to reduce the need for operations by addressing the underlying cuases.

    I know that many in the health service will feel that the very last thing that is needed is yet more reform but I think it is time that the whole ethos of the NHS is re-examined. The current system is unsustainable and will inevitably result in a some form of privatised health care system – along the lines seen in dentistry or for opticians.

    Paul Anderson.

  2. Cybertiger 24 June 2008 at 6:39 pm #

    Miriam Stoppard, one of the nation’s greatest ‘KOLS’ has been preaching rubbish in the ‘Mirror’ recently.

    “Health: why families with autism sufferers need a better deal. 23/06/2008″

    http://www.mirror.co.uk/lifestyle/yourlife/drmiriam/2008/06/23/health-why-families-with-autism-sufferers-need-a-better-deal-89520-20618194/

    and she says,

    “It’s now been proven beyond doubt that the MMR (measles, mumps, rubella) vaccination does NOT cause autism.”

    It’s not that she rather spoils her case by OVERSTATING it … but that underneath that pretty bonnet there may found no end of grimy conflicts and filthy interests. Methinks the lady does not really care for autistic children and their parents … and still less for the true integrity of medical science.

  3. Kelly 25 June 2008 at 8:07 pm #

    Thanks for the information on key opinion leaders. I can’t believe that one man got $2500 for one lecture!

    We recently wrote an article on drug companies relationship with doctors at Brain Blogger. Though the Research Ethics Boards exists to protect research subjects in clinical trials by providing guidelines, sometimes healthcare companies and doctors find a way around them. Is money that big a draw that a doctor could go against his own ethics?

    We would like to read your comments on our article. Thank you.

    Sincerely,
    Kelly

  4. Catherine Collins RD 25 June 2008 at 10:09 pm #

    Sucroguard

    Dr Briffa

    discuss

  5. John Briffa 26 June 2008 at 5:03 am #

    Catherine Collins RD

    How very enigmatic (and devoid of fact).
    Discuss what, exactly?

  6. Dr John Briffa 27 June 2008 at 10:25 am #

    Come on Catherine Collins!

    What are we supposed to be discussing?
    Why so very quiet all of a sudden?

  7. Matty Maccaro 27 June 2008 at 1:36 pm #

    As secretary to a prominent Cardiologist at a major university in North Carolina, I can tell you how it went. The drug companies, Smith Kline, Glaxo, Pfizer etc., all called to book the doctor for a “Symposium”, fancy lingo for sales pitch. Of course the good doctor was never paid, rather he received the standard “Honorarium” which at the time (’85 to ’95) was 3000 US dollars for an hour.
    He was expected to speak for no less than an hour, but of course if his time was short that could be cut to 30 minutes. North Carolina being a rural state, the county doctors were only too happy to have this hot shot come to a local motel to inform them of the newest trends and treatments.
    The doctor often booked 3 Symposiums in a morning and worked it like this. He had the drug Rep give a long & flattering introduction so he could arrive at the last minute, he would then speak, pushing their latest drug for no more than 15 minutes, rapidly going thru the slide show they provided. He then would apologize for having to leave for a conference or surgery, of course as doctors they would understand. He rushed out for the next Symposium while the handhouts were passed around by reps to those country bumpkin doctors who had now learned which medications “really” worked to help their patients.
    Dr. X had it down to a science The locations were often only a 20 minute drive away from each other. He acquired speeding tickets and often (pre-cell phone era) arranged to have someone call him at a given time, providing an excuse for him to leave suddenly for said “emergency”. Arriving late and leaving early made it possible to do three “Symposiums” in just under 3 hours, with a total “Honoraium” of 9000 US dollars. Not bad for a mornings work.
    Multiply that by 2 or 3 days a week and it pumped his already huge salary as Program Director, Clinician, Researcher and Professor at the University.
    Drug companies researched him and knew all his likes and dislikes, his wife’s preferences, how she loved Paris and that they collected wines, their children’s interests etc. Free trips everywhere, all expenses paid. This is very common not some rare and unusual happening.
    Want to hear more? The year the Olympics were in Barcelona drug companies spent millions arranging “Conferences” in Barcelona, for American doctors from Maine to Alaska. Guess what? All expenses paid by pharmaceutical industry. I can assure you these “Conferences” were no more than parties, where reps wined and dined the attendees. This is how they go about recruitment and after that comes the grooming and cultivation stage. How honorable is that?
    People die because they can not afford to pay for life saving medications? How honorable is that?

  8. Cathy 28 June 2008 at 10:27 am #

    …And… Catherine Collins RD… comes in from left field… makes an attempt at a jab to the jaw of Dr Briffa… with an obscure, obtuse and essentially meaningless OT comment… and retires to her crack in the pavement… to pat herself on the back…

  9. superburger 28 June 2008 at 1:16 pm #

    dr briffa/cathy

    i think catherine collins was trying to give dr briffa the oppurtunity to mention his relationship with tablet-makers.

    dr briffa,

    1) Is it true you have helped to formulate a tablet “Sucroguard”? made by the company Biocare – presumably you did not do this for no financial reward?

    2) Did you talk at this £25 medical conference organised by ‘Revital’?

    http://www.revital.co.uk/Overcoming_Tiredness_Dr_John_Briffa

    3) Is it true that by attending this talk one could obtain discounts for drug purchases (including Sucroguard – which you helped to formulate)? (it says so on the above www site)

    “When you attend an event at the Revital Health Education Centre you will be given a name badge. During the day of the event the name badge entitles you to a discount on any items you may wish to purchase in the Revital Health Shop above the Education Centre.”

    because if the above is true – then it might be fair to say that you have a relationship with a pill-making company. You help them formulate tablets. They invite you to talk at a conference (given your status in the field, you could be seen as a “key opinion leader”yourself) .

    Attendees at that conference get a discount on products, including ones you formulate!

    how should one interpret the above in the light of the BMJ article you cite?

    Of course, there’s nothing wrong with the above – you’ve got a living to earn, and you obviously have an interest in nutrition etc.

    Wonder if you could clarify for your readers….

  10. Catherine Collins RD 28 June 2008 at 10:59 pm #

    it would help if submitted comments actually made it onto the website, Cathy…

    But on the offchance this comment is posted and remains so, I am basically asking Dr John Briffa to explain why – having ‘developed’, promoted, presented and is associated with a supplement so clinically irrelevant in the management of diabetes as ‘Dr John Briffa’s Sucroguard with 386.7% RDA vitamin C’ (amongst other nutrients)- he feels the need to attack medics who support or recommend particular drugs.

    He states:
    “As I have become more interested in health related matters I have become more and more aware that the ben(e)fits of many drugs have been overplayed ….. It seems to me that many doctors are influenced by financial incentives”

    I’m just inviting him to comment as to whether he would include himself in such a broad statement – indeed, whether he is actually referring to himself here.

    I assume he must be projecting personal opinion into the more global statements about the conduct of medics given that Sucroguard (TM) is not free, has not been subject to any clinical trials – anecdotal or clinical – and therefore is basically as much (if not more) of a rip-off to vulnerable diabetic patients than those Big Pharma drugs are.

    Hope this clarifies, Dr B and ‘Cathy’
    Of course, if this suddenly disappears then subsequent bile-fuelled rantings won’t make much sense….

  11. Cathy 29 June 2008 at 5:27 am #

    Catherine Collins RD seems to be suggesting I have some control over what does or doesn’t get posted to this blog ” I don’t Catherine, and my name is Cathy ” not ‘Cathy’. I am a private individual who found this blog via another blog only in the last couple of weeks. Get a grip on your conspirational ramblings Catherine ” some Zyprexa might help with that.
    Your comparison between Dr Briffa’s involvement or otherwise with a supplement and the issue of KOLs influencing a whole industry is beyond puerile ” is that really the best you can do?
    You made a remark regarding Sucroguard not having been tested in clinical trials:
    1) All the constituents have been tested ” chromium for instance has been well documented in the literature to reduce insulin resistance and improve insulin sensitivity (very relevant in the management of type 2 diabetes I’d say). All the other vitamins have also been tested and have been demonstrated to be beneficial to health ” and most importantly – SAFE.
    2) When KOLs present at conferences to fellow doctors they are promoting off-label prescribing ” the only legal recourse the drug companies have in expanding a market for a given drug without conducting those troublesome, expensive trials; it is illegal for drug companies to directly promote off-label prescribing to doctors, but they can pay KOLs to do so. Read again Catherine ” NO CLINICAL TRIALS!
    3) It was the off-label prescribing of certain SSRIs to children that led to countless deaths by suicide ” dead children ” but that’s okay in your book isn’t it Catherine? Show me one innocent child or type 2 diabetes sufferer that has been harmed by vitamins and I’ll post a complete capitulation on youtube for all the world to see.
    4) Go and read about the suffering and anguish ” the ruination of people’s lives caused by off-label prescribing of drugs like gabapentin and tell me that what Dr Briffa does is somehow the same thing.

    There’s a world of a difference between recommending a supplement that contains vitamins and minerals (and is available in many other different brands) and representing patented synthetic chemical compounds with unknown long-term effects as “miraculous” and “life-saving”.

    No Sucroguard is not free ” GBP6.30 for one month’s supply, compared with US$200 (GBP100) for one month’s supply of Avandia* ” are you ordering that Lear Jet yet Dr Briffa?

    * Don’t bother telling me that patients in the UK don’t pay that much ” the drug is subsidised by the British taxpayer.

  12. Dr John Briffa 29 June 2008 at 7:29 pm #

    Catherine Collins RD

    For the record, I have never and will never receive any payment for formulating SucroGuard. I did it for free – because of a desire for their to be a product which could be used to help diabetics and others with blood sugar dyresgulation issues.

    There is no conflict of interest here, as you seem to suggest.

    Once again, you have come to this site and ended up looking the idiot.

  13. Dr John Briffa 29 June 2008 at 7:32 pm #

    colmcq

    See comment 12 to Catherine Collins RD.

  14. Catherine Collins RD 29 June 2008 at 7:59 pm #

    Oh, apologies then. I assume you didn’t get paid for the talks, either?

    I’m sure diabetic readers and myself are keen to know why 201mg (348.3%RDA) of Vitamin C and 1.1mg of manganese are the necessary supplements for diabetics?

    Or is this amount of manganese only for non-tea drinking diabetics?

  15. superburger 30 June 2008 at 12:32 am #

    dr briffa,

    There is a value to having one’s name associated with a successful product. As a media doctor (i think that’s a fair description of at least some of your role) you benefit (if not financially) from having your name on products. Increases awareness of your personal brand.

    Companies pay lots of money to have their name appear in association with succesful products, it’s a fairly standard business tactic, wouldn’t you say?

    So, your name appears on a prodcut. You speak, in your capacity as what could be described as a “key opinion leader” at a £25/head conference. Attendess at same conference get a discount on products sold buy company. including product with your name on.

    Don’t think it’s fair to imply catherine collins looks an idiot for suggesting that you too have a relationship with a pill maker.

  16. Dr John Briffa 30 June 2008 at 8:16 am #

    Catherine Collins

    Justification for the inclusion of manganese in Sucroguard comes from studies which show that manganese levels are generally low in diabetics (Biol Trace Elem Res. 2001;79(3):205-19) and that manganese deficiency appears to contribute to glucose intolerance in animals and may be reversed by supplementation (J Nutr 1990;120:1075”9).

    Justification for the inclusion of vitamin C in Sucroguard include studies which shows that vitamin C can inhibit glycosylation (Diabetes 1992;41:167”73) and may improve glucose tolerance in type 2 diabetes (Ann Nutr Metab 1995;39:217”23, J Am Coll Nutr 1995;14:387”92).

    And what’s this got to do with the issue that was the focus of the blog anyway?

    According to you, now the conflict of interest appears to be that members of the public have paid to attend a lecture I delivered (and where my payment was therefore quite transparent, right?). Hold the front page: “People pay to attend lecture delivered by doctor!”

    Your tactics are desperate. As is the situation of those who have suffered at the hands of standard dietetic advice.

  17. Dr John Briffa 30 June 2008 at 8:19 am #

    superburger

    “Don’t think it’s fair to imply catherine collins looks an idiot for suggesting that you too have a relationship with a pill maker.”

    That’s not the only reason Catherine Collins looks an idiot (obviously).

  18. David 30 June 2008 at 2:20 pm #

    Dr Briffa, it seems as though it is you who has lost sight of the focus of this blog, despite the subject being one you raised.

    To remind you, it concerns the ethics of drug companies paying key opinion leaders to give lectures which may have the end result of promoting the use or sale of that company’s products. This is something you clearly disagree with, but it now appears that you have been doing the very same thing. Shame on you.

    So how much did you get from Biocare to deliver your lecture?

  19. colmcq 30 June 2008 at 6:00 pm #

    Hi Dr

    I can’t really afford to splash out all that cash on BioCare Sucroguard pills. Can’t I get the same amount of chromium, Vitamin C and maganese from fruit, meat and veggies?

  20. colmcq 30 June 2008 at 6:00 pm #

    sorry, ‘manganese’

  21. superburger 30 June 2008 at 6:03 pm #

    if you read post 15, for example, i point out that there is a clear commercial advantage to having ones brand associated with a succesful product. It raises brand awareness. Who’d heard of AIG till they started sponsoring Man Utd?

    as a media nutritionist you are a brand. You need to keep brand awareness high.

    You formulate sucroguard – and your name is associated with it. Even if no money changes hand you still receive that advatnage of having your name associated with a product.

    You then speak at a conference organised by the makers of that product.

    People who attend conference can then buy discounted products including the one with your name on it.

    The more people buy or are aware of the product you are associated with the better it is for your own personal brand.

    so – would you say that you have a cosy relationship with a pill-maker? Would you say that you are a “key opinion leade?”

    How should one interpret your relationship with a pill-maker in the light of the BMJ article?

  22. superburger 30 June 2008 at 8:06 pm #

    i’m obviously not as sharp-witted as you dr briffa, but I still don’t think it makes anyone look particulary good by calling them idiotic.

    anyway, i note that you’ve chosen not to engage with the substance of my posts 15 and 9. That’s your choice of course….

    i think you might be a little misleading when you say

    “that members of the public have paid to attend a lecture I delivered” because the lecture was *also* aimed at profesionals – that’s why CPD points were awarded. Right?

    So, given

    1) you have relationship with a pill-maker (whether you receive direct payment for formulating sucroguard is irrelevant – the brand publicity it generates for yourself has a value)

    2) the fact that you spoke (as a “key opinion leader?”) at conference organised by a company that sells pills that you are involved with.

    3) the fact that attendees at conference got a discount on products – including the pills that you are involved with.

    how should one iterpret your relationship with a pill-maker in the context of the BMJ article (which is the substance of your blog post, irrespective of the merits of sucroguard as a pill)

    hope this comment appears on site – think there’s some interesting debate to be had.

  23. Dr John Briffa 30 June 2008 at 10:04 pm #

    David

    “So how much did you get from Biocare to deliver your lecture?”

    Nothing. Yes, shame on me…

  24. Dr John Briffa 30 June 2008 at 10:04 pm #

    colmcq

    What do you feel you need to take Sucroguard for?

  25. Dr John Briffa 30 June 2008 at 10:09 pm #

    Superburger

    I formulated a product for BioCare for which I did not receive payment. BioCare do not pay me to promote the product (and never have).

    How, in your mind, does this mirror or equate to the activities of KOLs highlighted in the blogpost above?

  26. colmcq 30 June 2008 at 10:18 pm #

    Dr B said:

    “What do you feel you need to take Sucroguard for?”

    I suffer from hypoglycemia. Would BioCare Sucroguard help? But I can’t really afford to splash out all that cash on BioCare Sucroguard pills. Can’t I get the same amount of chromium, Vitamin C and maganese from fruit, meat and veggies?

  27. colmcq 30 June 2008 at 10:19 pm #

    same typo. sorry. Manganese.

  28. superburger 1 July 2008 at 9:14 am #

    dr briffa,

    if you consider posts 21 and 15, I point out that you don’t need to received direct payment in order for you to benefit from association with BioCare and Sucroguard.

    why do you think BioCare invited you to speak at conference, and help them formulate their tablets for them, if not to increase their brand own brand awarness and their bottom line. It is naive to think otherwise. And of course, you benefit too, with increaed exposure for yourself. Symbiosis, if you like.

    It’s not a bad thing, per se, but it is interesting to think about, given the BMJ article you discuss in your blog.

  29. Dr John Briffa 1 July 2008 at 12:11 pm #

    superburger

    You need to get your facts straight:

    1. Biocare did not ask me to speak at the Revital event

    2. It wasn’t a conference (it was just a talk).

    Also, the talk was for the public (though health professionals could come if they wished, obviously). And remember, Biocare have not paid me to formulate or promote Sucroguard.

    Seems to me, superburger, your desperate to give this some sinister undertone when there is one. Truly desperate.

  30. superburger 1 July 2008 at 12:36 pm #

    “2. It wasn’t a conference (it was just a talk).” What would your response be to a physician of the type discussed in the BMJ article be if they used that line?

    Anyway,

    i’ve no particular axe to grind. Just interesting how you point to an article in the BMJ about relationships between key opinion leaders, the talk/lecture/conference circut and pill makers. All good interesting stuff.

    The talk was aimed at public *and* professionals -hence the clear mention of CPD points.

    It looks to me like you too have a relationsip with a pill maker (your name associated with their product) and they, in turn, have a business relationship (they supply goods) with an organisation which invited you to speak at an event they organised.

    Certainly nothing wrong with any of this, per se, and absolutley your choice how you run your business affairs. Like I say, no sinister undertone or desperation on my part.

    how one interprets these facts is entirely subjective, but it’s good that it’s all in the open for people to think about (both excellent BMJ article and this blog post)

  31. ross 1 July 2008 at 6:48 pm #

    Dr B, it seems like you have worked for Biocare Limited in developing, promoting and putting your name on a supplement but have not received financial remuneration for this, although having your name on the pills is likely to increase awareness of the ‘Briffa brand’. As an ex-Director of Biocare Limited, is that the full extent of the relationship?

    (BTW – the Highgate Hospital still hasn’t changed its website to reflect the fact that you aren’t a nutritionist).

  32. David 1 July 2008 at 9:33 pm #

    Cathy, you said:
    “Show me one innocent child or type 2 diabetes sufferer that has been harmed by vitamins and I’ll post a complete capitulation on youtube for all the world to see.”

    A 1 minute internet search turned up this article showing 17.2% of kids developed nausea, headache, fever, or diarrhoea after Vitamin A dosing.
    http://www.ajcn.org/cgi/reprint/52/4/694?ijkey=fad35029cea8b110b14d50605c927b5929f69b12

    The Merck Manual has this to say about vitamin A toxicity:
    “Acute toxicity in children may result from taking large doses (> 100,000 µg or 300,000 IU); it manifests as increased intracranial pressure and vomiting, which may lead to death unless ingestion is discontinued.”
    I myself felt nauseated to read the horror descriptions of what chronic toxicity can do.

    So, when do we get to see your capitulation on Youtube?

  33. Paul Anderson 1 July 2008 at 11:34 pm #

    David,

    I believe the doses of vitamin A you are referring to are in the region of 30 to 90 times the recommended daily intake. If you drank between 150 and 450 litres of water a day I suspect you wouldn’t feel too well either- you would probably be dead. That doesn’t mean water is dangerous, or that exceeding the recommended daily fluid intake is necessarily dangerous – rather that a degree of common sense is applied.

    Perhaps you can quote more appropriate and relevant examples. If you can find any studies showing the levels contained in the sugroguard product are harmlful please quote them. In fact if you can find evidence of any negative side effects whatsover please draw it to our attention.

    Paul.

  34. Paul Anderson 1 July 2008 at 11:36 pm #

    Dr Briffa, you seem to have tocuhed a very raw nerve indeed with this article. Keep up the good work.

    Perhaps you have strayed too close to the truth for some people’s liking.

    Paul.

  35. Cathy 1 July 2008 at 11:52 pm #

    David

    The Merck Manual is describing extremely high (over)dosages ” an overdose of anything can cause death ” even water. As for the other link – it’s generally a good idea to actually read a study if you intend to use it to refute another’s argument.
    The normal RDA for vitamin A for infants is 500mcg. The study gave a dose of 60 mg to children with no documented vitamin A deficiency (such children were excluded) ” that’s 60,000mcg ” a 120-fold higher dose than the RDA. What do you suppose giving a child a 120-fold higher dose of paracetamol would do (or 960 glasses of water per day)?
    Why would a study make kids “sick” with an overdose of vitamin A? The purpose of the study was to assess the use of 6-monthly high-dose vitamin A administration in a population prone to vitamin A deficiency-associated blindness, and other vitamin A deficiency-associated morbidity and mortality. A high dose every 6 months is more practical in a poor resource setting than multiple lower doses, which is why the WHO and UNICEF recommend this regime.
    The WHO and UNICEF also recommend mega-dose vitamin A in children with measles in areas prone to vitamin A deficiency because it has been shown to reduce death and severe complications by 50%.
    “I myself felt nauseated to read the horror descriptions of what chronic toxicity can do” ” really David? You would prefer death or blindness over transient nausea or diarrhoea? Now that’s sickening! I don’t think I’ll be capitulating any time soon but I’ll rephrase for the pedants:
    “Show me one innocent child or type 2 diabetes sufferer that has been harmed by vitamins (within the recommended therapeutic range) and I’ll post a complete capitulation on youtube for all the world to see.”

  36. Cathy 2 July 2008 at 9:00 pm #

    David you are projecting; it is you that has moved the goalposts. I didn’t ask for an example of an overdose and I suspect you well knew that, but that is what you provided nevertheless. You did not provide proof that vitamins when properly used are dangerous and you were either disingenuous in quoting that particular study or are “hard of thinking” yourself.
    According to your reasoning drinking 9600 glasses of water per day proves water is dangerous and should not be given to children.
    I didn’t sidestep ” I addressed the study directly by reading it and comprehending it. Look at your response ” who’s the sidestepping weasel now?

  37. David 2 July 2008 at 10:10 pm #

    Cathy, I expected as much (rapid moving of goalposts).
    No doubt if I were to hit the target again, there will be another side step. Let me see…… You’ll probably say: “remember I said show me one innocent child…. I am afraid a published case report won’t do, I want to have the child stood in front of me where I can see him!” or some such.
    Weaseling, this is called.

  38. David 3 July 2008 at 12:08 am #

    Actually, I have found reports of Vitamin C in repeat doses of 1gm causing intrauterine deaths.

    http://www.stopabductions.com/WeakAlien.htm

  39. Paul Anderson 3 July 2008 at 3:11 pm #

    David, this latest evidence is out of this world!

  40. ross 3 July 2008 at 6:39 pm #

    Dr B, your justification for the inclusion of manganese in Sucroguard “comes from studies which show that manganese levels are generally low in diabetics (Biol Trace Elem Res. 2001;79(3):205-19) and that manganese deficiency appears to contribute to glucose intolerance in animals and may be reversed by supplementation (J Nutr 1990;120:1075”9).”

    Catherine Collins said:

    “Indeed, at risk of alienating your key audience, the ‘UCP-2′ model/ oxidative stress/ manganese etc popularly assumed to contribute to the pathogenesis of diabetes (especially Type 2) has – unfortunately ” been disproven. A couple of years ago. Sorry. http://lib.bioinfo.pl/pmid:17916951. Never mind. I agree that manganese-deficient rats should eat manganese-rich cake. But ‘Dr Briffa’s Sucroguard’ ™ is, well, superfluous to manganese requirements – especially as the above reference again quotes the common finding that human diabetics have twice the blood manganese levels of non-diabetics.”

    Do you agree with the science she quotes and, if so, are you going to re-formulate Sucroguard?

  41. ross 5 July 2008 at 2:32 pm #

    Dr B, I appreciate the constraints on your time but I wondered whether you could clarify whether as an ex-Director of Biocare Limited (and still doing unpaid work for them in developing, promoting and putting your name to one of their products) you receive any other benefit from them other than increased awareness of the ‘Briffa brand’?

  42. Dr John Briffa 6 July 2008 at 3:06 pm #

    ross

    No, I don’t personally receive any other benefit from Biocare.

  43. ross 6 July 2008 at 6:48 pm #

    OK thanks. Do any other members of your family, associates, employees, corporate entities or partnerships that you have an interest in receive any benefit from Biocare Limited (or associated companies) or do you or they, directly or indirectly, hold shares in Biocare Limited (or associated companies) or have they done since your directorship ended?

  44. Dr John Briffa 6 July 2008 at 8:43 pm #

    ross

    No.

    But do please persist with this line of questioning as it does, I think, serve so well to demonstrate how desperate you are to dig something (anything) up that might discredit this me or this blog piece in some way.

    Now, while we’re on the subject of potential conflicts of interest, how about revealing yours? You might start by declaring your identity, profession (if you have one), sources of income and share-holdings.

    Something tells me you’re not going to be quite as transparent with me as I have been with you. But I’d be delighted to be wrong about this.

  45. ross 6 July 2008 at 9:15 pm #

    Hey, you should be thanking me, I’ve just given you the opportunity to distance yourself from potential accusations of hypocrisy! I think we’re all quite clear on where you stand on this issue now and that the only reward you get for working for Biocare is good PR.

    My identity is immaterial and as I’m not the one making claims about nutrition or MMR or Diabetes UK deliberately giving bad dietetic advice, there is no conflict of interest. The questions I’ve asked are reasonable ones.

  46. ross 6 July 2008 at 9:23 pm #

    Any response on the Sucroguard thing? Or the Highgate Hospital thing?

  47. ross 6 July 2008 at 9:31 pm #

    Or the NHS Blog Doctor thing?

    http://nhsblogdoc.blogspot.com/search/label/Dr%20John%20Briffa

    Or the Adam question thing?

    “Would Dr. Briffa like to suggest foods containing carbohydrates that are not disruptive to blood sugar levels?”

    Or the MMR experiment thing?

    “What experimental result of set of results would convince you ‘beyond reasonable doubt’ that there is no reason to link MMR and any form of autism?”

    Or the MMR vaccination thing?

    “In your opinion, and after weighing up the evidence, on the balance of probabilities do you think that the risks associated with the MMR vaccination outweigh the benefits of vaccination? Do you advise parents to vaccinate? Or do you not offer any form of advice?”

  48. Dr John Briffa 6 July 2008 at 9:52 pm #

    ross

    “My identity is immaterial and as I’m not the one making claims about nutrition or MMR or Diabetes UK ”

    The thing is, you are not immune from making claims yourself, ross. See here

    http://www.drbriffa.com/blog/2008/06/02/i-was-going-to-write-about-beta-carotene-and-sunburn-but/ where you state:

    “…there is a lot of good evidence that shows no correlation between MMR and autism.”

    So if making claims should be accompanied by transparency regarding conflicts of interest, then your identity, profession, sources of income and share holdings are not “immaterial”.

    Or is it one rule for me and another for you? I have a sneaking suspicion the answer to this is going to be ‘yes’. But again, I’d be delighted to be wrong on this.

  49. ross 6 July 2008 at 10:22 pm #

    That was a fantastic example of the ‘Briffa Sidestep’ (TM). Are you ever going to answer any of these questions?

    It really is one rule for you and one for me Dr B. You make claims on a blog that allows anonymous comments & don’t censor or delete comments that you don’t agree with. I referred to the fact that there “is a lot of good evidence that shows no correlation between MMR and autism”. If you don’t think the Cochrane review is good evidence then explain why. You could also explain why you think it likely that an anonymous commenter referring to data in the public domain is likely to have a conflict of interest. Or what difference it would make to the argument if I did.

  50. Dr John Briffa 6 July 2008 at 11:22 pm #

    ross

    “If you don’t think the Cochrane review is good evidence then explain why.”

    It doesn’t work like that. You’ve made a claim now it’s up to you to substantiate it (properly, and not just by invoking the word ‘Cochrane’). Please do quote the SPECIFIC studies in the Cochrane review that you regard as ‘good evidence’ that show no correlation between MMR and autism and we’ll take it from there.

    “You could also explain why you think it likely that an anonymous commenter referring to data in the public domain is likely to have a conflict of interest.”

    I didn’t say it was likely, but your identity, profession, sources of income and share holdings are important for the purposes of transparency, which is something you appear to hold in high regard.

    So, it appears that the answer to the question about whether it’s one rule for me and another for you does appear to be ‘yes’ after all. In your mind anyway. It’s just not good enough, ross. Please do declare your identity, profession, sources of income and share holdings. What have you got to hide?

    And I’m hoping that the irony of you accusing me of sidestepping is not lost on you.

  51. ross 7 July 2008 at 10:21 am #

    “So, it appears that the answer to the question about whether it’s one rule for me and another for you does appear to be ‘yes’ after all”

    Yes. As I explained in my post.

    “I didn’t say it was likely, but your identity, profession, sources of income and share holdings are important for the purposes of transparency”

    I’m an anonymous commenter on a blog that allows anonymous comments, who I am and what I do are immaterial. Really, they are. If you don’t like my questions then please feel free to continue ignoring them but please don’t try and put up this ‘reveal your identity first’ smokescreen. If you are going to insist on it then I’ll happily do so if you also require every other person who posts on here to do the same.

    Even if I did have a conflict of interest, what difference it would make? If you are sure of your arguments and the research you base your arguments on then surely you wouldn’t hesitate to put a pharma shill in his place.

    “It doesn’t work like that. You’ve made a claim now it’s up to you to substantiate it (properly, and not just by invoking the word ‘Cochrane’).Please do quote the SPECIFIC studies in the Cochrane review that you regard as ‘good evidence’ that show no correlation between MMR and autism and we’ll take it from there.”

    Like John Stone it’s almost as if you don’t understand what a Cochrane review is. I was quoting the meta-analysis itself as the good evidence, the sum of its parts. It concludes that the current state of the evidence base does not support any correlation between MMR and autism. I agree that that is a fair assessment. As there is no good evidence to support the MMR/autism hypothesis and good evidence that there is no correlation, then I think that the minimal risks associated with the MMR vaccination are vastly outweighed by the benefits. If you don’t then it would be nice if you would say so. And provide the evidence on which you base your opinion.

    So in the meantime, any response on the Sucroguard thing?

    Or the Highgate Hospital thing?

    Or the NHS Blog Doctor thing?

    http://nhsblogdoc.blogspot.com/search/label/Dr%20John%20Briffa

    Or the MMR experiment thing?

    “What experimental result of set of results would convince you ‘beyond reasonable doubt’ that there is no reason to link MMR and any form of autism?”

    Or the MMR vaccination thing?

    “In your opinion, and after weighing up the evidence, on the balance of probabilities do you think that the risks associated with the MMR vaccination outweigh the benefits of vaccination? Do you advise parents to vaccinate? Or do you not offer any form of advice?”

  52. Dr John Briffa 7 July 2008 at 11:21 am #

    ross

    “I’m an anonymous commenter on a blog that allows anonymous comments, who I am and what I do are immaterial. Really, they are. If you don’t like my questions then please feel free to continue ignoring them but please don’t try and put up this ‘reveal your identity first’ smokescreen.”

    You, more than once, have attempted (unsuccessfully) to accuse me of hypocrisy regarding conflict of interest. Whether you have conflicts of interest is not known because you hide your identity. Who you are and what you do is not “immaterial” in this context, is it? You want transparency, so please come to the party with some of your own. Tell us now who you are, what your profession is (if you have one), what your sources of income are, and what share-holdings you have.

    “Even if I did have a conflict of interest, what difference it would make?”

    Well if conflicts of interest don’t matter, ross, why pursue so aggressively what you felt mine might be? Where’s the logic in this? Again, one rule for me, and another one for ‘ross’.

    “Like John Stone it’s almost as if you don’t understand what a Cochrane review is. I was quoting the meta-analysis itself as the good evidence, the sum of its parts.”

    Lame, very lame (see below).

    “It concludes that the current state of the evidence base does not support any correlation between MMR and autism.”

    How is that the same as there being ‘good evidence’ that MMR does not cause autism? Of course, the answer is, it isn’t.

    Quote the specific studies please, ross, that confirm your assertion so I (and others) can have the opportunity to comment on them. Seems like you’ve backed yourself into a corner on this one, but please do come out fighting!

    And do please keep asking me questions about Sucroguard, how the Highgate Hospital describe me, the comments of an anonymous blogger and MMR here, because they are SO relevant to what we’re discussing here, which is (to remind you, because I know how you and some others like to stray off the point) undeclared/unrecognised conflicts of interest.

    I don’t suppose I’ll be the only person to see desperation in your tactics. Now, let’s know who you are and what your potential conflicts of interest might be, so that we call all judge whether it’s not me who is the hypocrite, but you. Come on, ross, what is there to hide?

  53. John Stone 7 July 2008 at 11:59 am #

    Ross

    1) Behind the institutional pieties (not to mention the British government bailing Cochrane’s central admin) the review nevertheless managed to state that the evidence base for safety was “largely inadequate”, so at best they are engaged in double-talk. If that’s what a Cochrane review is about these days, then sadly I will have to concede the point to you. I am inclined to think that that is what you are engaged in as well. Yes, I do not understand the beauty of Big Brother.

  54. Dr John Briffa 7 July 2008 at 12:09 pm #

    John Stone

    Not so hasty!

    Let’s give ross the opportunity to reveal the actual studies on which he (and many others) base their assertions regarding the safety of MMR with regard to autism.

    Perhaps he’ll also reveal his identity and potential conflicts of interest too.

    We live in hope.

  55. John Stone 7 July 2008 at 12:12 pm #

    Sorry point 2 was lost.

    2) It has to be said, you would look incomparably more plausible if you would put your name to your opinions (of which you seem to have many).

  56. John Stone 7 July 2008 at 12:24 pm #

    John B

    The usual strategy is to stoutly maintain that criticisms which plainly invalidate the reviewed studies (if correct) are somehow only marginal. Yes we can see what Ross comes up with this time, though he can’t seem to come up with his own name, when pressed.

  57. Dr John Briffa 7 July 2008 at 1:39 pm #

    John S

    As I said, not so hasty! Let’s see what ross can conjure up (if anything). Something tells me that even repeated asking will not compel ross to engage regarding the specific studies in the Cochrane review. And I think you and I (and many others) know why that may be. I’d be happy to be wrong on this, so that we can again have a full and frank discussion regarding the quality of the evidence ross and others use to suggest that MMR is safe with regard to autism.

    As for the revealing of ross’ identity and potential conflicts of interest, I don’t hold out too much hope for that either. But perhaps he will surprise us!

  58. ross 7 July 2008 at 4:11 pm #

    “You, more than once, have attempted (unsuccessfully) to accuse me of hypocrisy regarding conflict of interest.”

    No, I haven’t. I’ve asked you to declare any potential conflicts of interest. You’ve now made your position crystal clear so thank you.

    “Well if conflicts of interest don’t matter, ross, why pursue so aggressively what you felt mine might be? Where’s the logic in this? Again, one rule for me, and another one for ‘ross’.”

    They do matter. Your blog post concerned these conflicts and it seemed as though you might have a conflict of interest too. Now you have clarified your position then we can move on. Even if I worked full time as a Senior Shill for Evil Pharma Ltd, how can interests be conflicted by asking you some very simple and transparent questions?

    “Who you are and what you do is not “immaterial” in this context, is it?”

    Yes it is. I’m asking reasonable questions on a blog that allows anonymous comments. Once again, I’ll declare my identity if you ensure that everyone else who posts here does. You’ll be incredibly disappointed to learn that I don’t work in the fields of science/healthcare/pharma and have no conflicts of interest whatsoever. I still wouldn’t be comfortable in giving you this information though as your questioning of jdc325 regarding his identity and employer was frankly quite creepy. I happen to think that anonymity on these types of blogs is a positive thing, both for freedom of expression and data protection reasons. You are of course free to disagree, in which case I suggest you amend the comment facility on your blog to make it a level playing field for all.

    “Quote the specific studies please, ross, that confirm your assertion so I (and others) can have the opportunity to comment on them. Seems like you’ve backed yourself into a corner on this one, but please do come out fighting!”

    My assertion was “…there is a lot of good evidence that shows no correlation between MMR and autism.”. The Cochrane meta-analysis is good evidence that there is no correlation between MMR and autism. Don’t you agree? The review summary states:

    Measles, mumps and rubella are three very dangerous infectious diseases which cause a heavy disease, disability and death burden in the developing world. Researchers from the Cochrane Vaccines Field reviewed 139 studies conducted to assess the effects of the live attenuated combined vaccine to prevent measles, mumps and rubella (MMR) in children. MMR protects children against infections of the upper airways but very rarely may cause a benign form of bleeding under the skin and milder forms of measles, mumps and rubella. No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found. No field studies of the vaccine’s effectiveness were found but the impact of mass immunisation on the elimination of the diseases has been demonstrated worldwide.

    Since my assertion is in agreement with that of this summary, the ball is now in your court. If you disagree with the findings of the Cochrane review, please feel free to let me know where they went wrong. Just steer clear of cherry picking quotes, a la John Stone. Or you could do the same with Honda et al, or perhaps you need to give this a bit more thought:

    http://pyjamasinbananas.blogspot.com/2008/06/briffas-devastating-critique.html

    Perhaps you’d also like to take the oportunity to present the peer reviewed evidence that supports the MMR / autism hypothesis. Or give us your view on the evidence base as it stands and your approach to the situation in clinical practice – in your opinion, and after weighing up the evidence, on the balance of probabilities do you think that the risks associated with the MMR vaccination outweigh the benefits of vaccination? Do you advise parents to vaccinate? Or do you not offer any form of advice?

    Very simple questions Dr B, very simple. And yet you’ve evaded answering them on every occasion that I’ve put them to you. Why?

  59. John Stone 7 July 2008 at 5:12 pm #

    I have, may it be noted, previously quoted all six of Cochrane’s comments on the reviewed autism studies, which oddly hover between significant reservations (Smeeth, deStefano, Makela), stating that they had confused the data (Madsen) and blistering contempt (Taylor, Fombonne). I have not been cherry picking, but Ross circles round a single quote, and I ask once again what the absence of this evidence means given what it has said about the quality of the studies either individually, or collectively (“largely inadequate”). Ross and his pals have picked the cherry (something specially prepared for the media) and I have looked at the detail.

    It has to be said that if you examine the mismatch between the rhetoric of the plain language summary and the scientific substance, there is a yawning gap.

  60. Dr John Briffa 7 July 2008 at 5:56 pm #

    John S

    There’s something reminiscent here of an exchange I had here http://www.drbriffa.com/blog/2008/05/23/the-limited-value-of-statistical-significance-in-the-real-world/
    with Anthony Cox (see comments 52 and 55 if you’d like to cut to the chase). After repeated asking, Dr Cox finally coughed up the ‘evidence’ to support his claim that MMR is safe with respect to autism, but on examination it didn’t amount to a hill of beans.

    Do you think that one reason why ross is reluctant to cite actual studies is because he fears ‘doing a Cox’ and looking an idiot?

    No wonder he’s also reluctant to reveal who he is (and what his potential conflicts of interest might be).

  61. John Stone 7 July 2008 at 6:50 pm #

    John B

    I think the speed with which these people retreat behind the plain language summary of Cochrane on MMR – rather in the same way as children cross their fingers to claim immunity in a game of tag – is what strikes me.

  62. John Stone 7 July 2008 at 8:10 pm #

    Ross

    Please, which are the good studies?

  63. ross 7 July 2008 at 11:01 pm #

    Dr B. The specific claim of mine that you quoted (to deftly sidestep answering any of the questions I had posed) was “…there is a lot of good evidence that shows no correlation between MMR and autism.”

    This is what the Cochrane review demonstrates. Once again, the ball is in your court. If you disagree with the findings of the Cochrane review what are the specific problems you have with it?

    I note that you also gave my follow up questions a wide berth, so I’ll repeat them again here:

    Perhaps you’d also like to take the opportunity to present the peer reviewed evidence that supports the MMR / autism hypothesis. Or give us your view on the evidence base as it stands and your approach to the situation in clinical practice – in your opinion, and after weighing up the evidence, on the balance of probabilities do you think that the risks associated with the MMR vaccination outweigh the benefits of vaccination? Do you advise parents to vaccinate? Or do you not offer any form of advice?

    Very simple questions Dr B, very simple. And yet you’ve evaded answering them on every occasion that I’ve put them to you. Why?

  64. David 8 July 2008 at 12:22 am #

    Dr Briffa, there are a number of articles which fail to establish any MMR-autism link. These include the following among others:

    Dales L, Hammer SJ, Smith N. 2001. Time trends in autism and in MMR immunization coverage in California. JAMA 285(9):1183-5.

    DeStefano F, Bhasin TK, Thompson WW, Yeargin-Allsopp M, Boyle C. 2004. Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan Atlanta. Pediatrics 113(2):259-66.

    DeWilde S, Carey IM, Richards N, Hilton SR, Cook DG. 2001. Do children who become autistic consult more often after MMR vaccination? British J Gen Pract. 51(464):226-7.

    Farrington CP, Miller E, Taylor B. 2001. MMR and autism: further evidence against a causal association. Vaccine 19(27):3632-5.

    Fombonne E, Chakrabarti S. 2001. No evidence for a new variant of measles-mumps-rubella-induced autism. Pediatrics 108(4):E58.

    Gillberg C, Heijbel H. 1998. MMR and autism. Autism 2:423-4.

    Kaye JA, del Mar Melero-Montes M, Jick H. 2001. Mumps, measles, and rubella vaccine and the incidence of autism recorded by general practitioners: a time trend analysis. British Med J. 322(7284):460-3.

    Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, Olsen J, Melbye M. 2002. A population-based study of measles, mumps, and rubella vaccination and autism. N Engl J Med 347(19):1477-82.

    Patja A, Davidkin I, Kurki T, Kallio MJ, Valle M, Peltola H. 2000. Serious adverse events after measles-mumps-rubella vaccination during a fourteen-year prospective follow-up. Pediatr Infect Dis J 19(12):1127-34.

    Peltola H, Patja A, Leinikki P, Valle M, Davidkin I, Paunio M. 1998. No evidence for measles, mumps, and rubella vaccine-associated inflammatory bowel disease or autism in a 14-year prospective study [letter]. Lancet 351(9112):1327-8.

    Some of these are controlled observational studies, some are ecological studies, some relate to passive reporting after MMR vaccine studies. Now I am aware that people like John Stone have tried to rubbish these studies for what he percieves as major defects where there are relatively minor problems if any to quibble about. These studies are far more robust than any he tries to use to support his fantasy that MMR and autism are linked (but then he consistently applies different standards of objectivity when reviewing evidence).

    The question is, what do you think about these studies? You can’t avoid answering questions about your own views on the matter for ever, you know. Perhaps you are going to save it all up for your blog expose, but if so, then tell us when we can expect to read your “expert” takedown of the current scientific consensus.

    Can you provide scientific evidence that supports the hypothesis that MMR and autism are linked?

    If these questions are a bit more than you would care to answer just now, perhaps as Ross has already alluded to, you could just answer one simple question:
    Do you feel the benefits of MMR vaccination in children outweighs the risks?
    A simple Yes or No will do.

  65. Dr John Briffa 8 July 2008 at 12:34 am #

    ross

    “Dr B. The specific claim of mine that you quoted (to deftly sidestep answering any of the questions I had posed) was “…there is a lot of good evidence that shows no correlation between MMR and autism.”

    This is what the Cochrane review demonstrates. Once again, the ball is in your court.”

    Once again, ross, you are mistaken. The ball is fairly and squarly in YOUR court. I have repeatedly asked for you to cite the specific studies on which you base your assertions and you have failed to do so.

    Your position on this has been revealed to be a sham unless you can cite the evidence on which your assertions are based. But again and again you seem unwilling or unable to do so.

    You have invoked the Cochrane review but will not engage with the specific studies. Why not? Is it because they are simply not fit for purpose?

    The genie’s out of the bottle now, ross, and no amount of obfuscation or attempts at diversion on your part will put it back in.

    The ball’s in your court, ross, but it doesn’t matter much now as I reckon the game’s up anyway.

  66. ross 8 July 2008 at 9:42 am #

    “Your position on this has been revealed to be a sham unless you can cite the evidence on which your assertions are based. But again and again you seem unwilling or unable to do so.”

    My assertion (singular) is based on Demicheli V, Jefferson T, Rivetti A, Price D. Vaccines for measles, mumps and rubella in children. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD004407. DOI: 10.1002/14651858.CD004407.pub2

    Now, what problems do you have with the evidence that I cite?

    Perhaps you’d also like to take the opportunity to present the peer reviewed evidence that supports the MMR / autism hypothesis. Or give us your view on the evidence base as it stands and your approach to the situation in clinical practice – in your opinion, and after weighing up the evidence, on the balance of probabilities do you think that the risks associated with the MMR vaccination outweigh the benefits of vaccination? Do you advise parents to vaccinate? Or do you not offer any form of advice?

    Very simple questions Dr B, very simple. And yet you’ve evaded answering them on every occasion that I’ve put them to you. Why?

  67. Dr John Briffa 8 July 2008 at 9:58 am #

    ross

    “Now, what problems do you have with the evidence that I cite?”

    Because you have invoked the Cochrane review and selectively quoted from it. I’m interested in the actual studies within it that you view as ‘good evidence’ for your assertions.

    But repeatedly you have failed to provide them to us. Why?
    I think I know the answer. I suspect it’s because you know the evidence to be flawed. Because if not, why not just quote the studies and be done with it?

    You may be a better poker player than Anthony Cox, but you (like he) are seriously hampered by the fact that I have a pretty good idea of what’s in your hand, and that fact that it’s a very weak hand at that.

    Now prove me wrong by showing us your cards.

    And while you’re at it, let’s learn who you are and what your potential conflicts of interest are.

  68. ross 8 July 2008 at 11:02 am #

    “Because you have invoked the Cochrane review and selectively quoted from it.”

    By quoting the whole of the plain language summary? Which sets out, in plain language, the findings of the review? You call that ‘selectively quoted’? Really?

    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:

    Dales L, Hammer SJ, Smith N. 2001. Time trends in autism and in MMR immunization coverage in California. JAMA 285(9):1183-5.

    DeStefano F, Bhasin TK, Thompson WW, Yeargin-Allsopp M, Boyle C. 2004. Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan Atlanta. Pediatrics 113(2):259-66.

    DeWilde S, Carey IM, Richards N, Hilton SR, Cook DG. 2001. Do children who become autistic consult more often after MMR vaccination? British J Gen Pract. 51(464):226-7.

    Farrington CP, Miller E, Taylor B. 2001. MMR and autism: further evidence against a causal association. Vaccine 19(27):3632-5.

    Fombonne E, Chakrabarti S. 2001. No evidence for a new variant of measles-mumps-rubella-induced autism. Pediatrics 108(4):E58.

    Gillberg C, Heijbel H. 1998. MMR and autism. Autism 2:423-4.

    Kaye JA, del Mar Melero-Montes M, Jick H. 2001. Mumps, measles, and rubella vaccine and the incidence of autism recorded by general practitioners: a time trend analysis. British Med J. 322(7284):460-3.

    Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, Olsen J, Melbye M. 2002. A population-based study of measles, mumps, and rubella vaccination and autism. N Engl J Med 347(19):1477-82.

    Patja A, Davidkin I, Kurki T, Kallio MJ, Valle M, Peltola H. 2000. Serious adverse events after measles-mumps-rubella vaccination during a fourteen-year prospective follow-up. Pediatr Infect Dis J 19(12):1127-34.

    Peltola H, Patja A, Leinikki P, Valle M, Davidkin I, Paunio M. 1998. No evidence for measles, mumps, and rubella vaccine-associated inflammatory bowel disease or autism in a 14-year prospective study [letter]. Lancet 351(9112):1327-8.

    And I’ll also chuck this onto the pile:

    Honda et al 2005 J Child Psychol Psychiatry 46(6):572-9 No effect of MMR withdrawal on the incidence of autism: a total population study.

    And remember, my claim was:

    “…there is a lot of good evidence that shows no correlation between MMR and autism.”

    Not:

    ‘as well as the ‘good evidence’ you claim exists which supposedly vindicates MMR with respect to autism’

    as you stated in Post 119 here:

    http://www.drbriffa.com/blog/2008/06/25/why-might-a-leading-diabetes-charity-offer-dietary-advice-that-is-likely-to-increase-the-need-for-medication/

    I don’t want my assertion to be misrepresented, misquoted or otherwise misunderstood.

    “And while you’re at it, let’s learn who you are and what your potential conflicts of interest are.”

    Do you think David should reveal his identity? superburger? colmcq? Is it only people who don’t necessarily agree with you that could be conflicted? How about Cathy? Hilda? Cybertiger? Is John Stone really who he claims to be and not a pharma shill double agent? Introduce a level playing field for all posters. Although I’d still be reticent – as I said previously, your quizzing of jdc325 re. his employer and identity was frankly quite creepy.

    And I’d also like to know, from the questions I have asked on a number of topics, what possible conflict of interest do you think I could have?

  69. John Stone 8 July 2008 at 1:51 pm #

    David

    Minor problems?

    “The study demonstrates the difficulties of drawing inferences in the absence of a non-exposed population or a clearly defined causal hypothesis”.

    “The number and possible impact of biases in this study was so high that interpretation of the results is impossible”.

    “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 the date of diagnosis rather than onset of symptoms of autism”.

    “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”

    I just noticed this:

    “We identified 139 articles possibly satisfying our inclusion criteria and included 31 in the review.”

    There is an interesting ambiguity here. One of the problem is that the studies included do not seem to be good enough to meet their criteria, and this formulation avoids stating that they do.

    You remind me of the line of the Duke in Thurber’s ‘The 13 Clocks”: “We all have our little faults: mine is that I am wicked.”

  70. Cybertiger 8 July 2008 at 11:21 pm #

    David asked of John Briffa,

    “Can you provide scientific evidence that supports the hypothesis that MMR and autism are linked?”

    Dr Briffa knows, as we all know, that Andrew Wakefield was intruding on the comfort zone on this one, just a little too closely.

    And it is very likely that Dr Wakefield will be acquitted of all the charges made against him at the GMC.

    And will the price paid have been worth it?

    But then ‘ross’ is not a doctor (at least not a proper one) – neither is John Stone and ‘David’ has not yet declared himself. As a doctor (a proper one), I think the trial of Andrew Wakefield and his professorial colleagues represents a disgraceful, outrageous waste of scientific resource and medical professional money. What does Dr Briffa think?

    And John Briffa said to ‘ross’,

    “Now prove me wrong by showing us your cards. And while you’re at it, let’s learn who you are and what your potential conflicts of interest are.”

    Let’s see ya! Let’s see the cards of that ‘better poker player’ … face up on the table. ‘ross’, your bluff has been called.

  71. Catherine Collins RD 8 July 2008 at 11:51 pm #

    Ross
    thanks for the most entertaining Dr Briffa blog I’ve read in a long, long time.

    Ready for my insult now, Dr B :)

  72. John Stone 9 July 2008 at 10:03 am #

    Catherine

    If you think being slippery about the shoddy official science surrounding MMR is entertaining, you deserve every insult in the book.

  73. John Stone 9 July 2008 at 10:33 am #

    Catherine

    I paused to take my son to school. The Cochrane review of MMR 2005 states:

    “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”

    Is that alright? Do you think parents ought to be told that, or not?

  74. Dr John Briffa 9 July 2008 at 11:16 am #

    ross

    Like so many before, have invoked the Cochrane review to support your assertions regarding MMR and autism. Let’s start with the basics before we dive into the detail.

    Above you supply the following quote: “Researchers from the Cochrane Vaccines Field reviewed 139 studies conducted to assess the effects of the live attenuated combined vaccine to prevent measles, mumps and rubella (MMR) in children.”

    Yet you neglect to point out that actually only 31 studies were actually analysed for the purposes of the review (this fact is declared even in the abstract of the review).

    Of these, I can find six studies in this review which relate to MMR and autism. These are:

    1. DeStefano F, Bhasin TK, Thompson WW, Yeargin-Allsopp M, Boyle C. Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan Atlanta. Pediatrics 2004;113(2):259-66

    2. Fombonne 2001 {published data only} Fombonne E, Chakrabarti S. No evidence for a new variant of measles-mumps-rubella-induced autism. Pediatrics 2001;108(4):E58

    3. Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, et al.A population-based study of measles, mumps, and rubella vaccination and autism. New England Journal of Medicine 2002;347(19):1477-82

    4. Makela A, Nuorti JP, Peltola H. Neurologic disorders after measles-mumps-rubella vaccination. Pediatrics 2002;110(5):957-63.

    5. Smeeth L, Cook C, Fombonne E, Heavey L, Rodrigues LC, Smith PG, et al.MMR vaccination and pervasive developmental disorders: a case-control study. Lancet 2004;364(9438):963-9

    6. Taylor B, Miller E, Farrington CP, Petropoulos MC, Favot-Mayaud I, Li J, et al.Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association. Lancet 1999;353(9169):2026-9

    Of these studies, you cite only 3 of them (DeStenafo, Fombonne and Madsen). Here are the limitations of these studies according to the Cochrane reviewers.

    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.

    Fombonne: The number and possible impact of biases in this study was so high that interpretation of the results was difficult.

    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.

    And here’s what the Cochrane reviewers wrote regarding the 3 studies you omitted:

    Makela: The study was weakened by the loss of 14% of the original birth cohort and the effects of the rather long time frame of follow up. What the impact of either of these factors was in terms of confounders is open to debate, however the long follow up for autism was due to the lack of a properly constructed causal hypothesis.

    Smeeth: The study appeared carefully conducted and well reported, however, GPRD-based MMR studies had no unexposed (to MMR) representative controls. In this study the approximately 4% to 13% seemed to be unexposed controls regarded by the authors as representative. Such a small number may indicate some bias in the selection of controls.

    Taylor. The study demonstrates the difficulties of drawing inferences in the absence of a non-exposed population or a clearly defined causal hypothesis.

    Here’s some other ‘home truths’ that appear in the review:

    From the abstract:
    “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”

    From the section: “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.”

    And bearing all this in mind, ross, what do we get from you: a misleading and totally unrepresentative quote from the ‘plain language summary’. And then you seem somewhat put out that I suggest you have quoted selectively.

    As for the other studies you cite, all were published (bar one) before the Cochrane review, but none of them are cited in it. So, in effect, you have cited Cochrane, left some of the evidence from this review out, and then brought in other studies that were not even in the Cochrane review.

    Would you care to comment on why the Cochrane reviewers felt this evidence was unfit to include in their review? Perhaps you’d like to tell us why we should be considering evidence that Cochrane rejected?

    As regards the Honda study (which came too late for the Cochrane review), perhaps you’d like to consider this critique of it here:
    I have already referred to this and a critique of it here: http://www.drbriffa.com/blog/2008/05/23/the-limited-value-of-statistical-significance-in-the-real-world/ (comment 55).

    Here’s what I write about it there:
    “It’s important here to remember that Andrew Wakefield’s original work (however discredited) implicated the measles component of the MMR vaccine in bowel disease (and autism). I know you know this Anthony, but not everyone reading this might.

    If what is stated in it is true, this critique’s most salient points, I think, are:

    In Japan, while MMR vaccination was phased out, measles vaccination continued.

    When both MMR and measles vaccination rates are added together (data from another published study), it appears as though total vaccination rates mirror quite closely the rates of autism and autistic spectrum disorder (ASD) in Japan.

    The relationship between vaccination and autism/ASD appears ‘dose-responsive’ i.e. as vaccination rates go up, so do rates of autism/ASD, and as the rates of vaccination go down, so do rates of autism/ASD.

    I have no way of verifying the data presented here, and even if I could, I think you’d have to describe these findings as ‘preliminary’. But they do look suspicious. I personally would recommend very strongly that this data be subjected to formal study, and published if appropriate.”

    To be clear, I am not claiming that MMR can causes autism. I’m claiming that we just don’t one way or the other.

    Your claim is that “there is a lot of good evidence that shows no correlation between MMR and autism.” I suppose you and I (and many others) have very different ideas about what constitutes “good evidence”, ross. I mean, even the Cochrane reviewers describe the quality of science in the area as “largely inadequate.” So please do continue to quote from the plain language summary if you wish. I prefer, myself, to quote from the review itself in the interests of accuracy and transparency.

    Regarding the Cochrane review I think you have presented a gross distortion of the truth. The reason that your declaring your identity is important is because it will help individuals to understand what ideological/commercial/political motivations are behind your assertions (because they don’t appear to be rooted in good science nor a desire to get to the truth, that’s for sure).

  75. David 9 July 2008 at 11:21 am #

    Mr Stone – Thank you for confirming your disposition to quote mining. Is that the only sentence you have ever read from the Cochrane review? Presumably, as it is the only piece you ever cite. Pity you never quote any of the review’s conclusions, and can only ever cite caveats from other studies.

    I am so pleased to know that you presumably feel studies like the Geiers and Wakefields are methodologically perfect and free of any possible criticism. Perhaps they could be held up to the scientific community worldwide as prime examples of scientific excellence and how to produce a paper without conflict of interest.

    Dr Briffa – now you have at least some of the syudies to look at, perhaps you would care to detail your objections to their overall conclusions.

    And while you are at it, can you please tell us: Do you think the benefits of MMR immunisation outweigh its risks?

  76. John Stone 9 July 2008 at 11:37 am #

    I am grateful to John B, but only to add that if parents say MMR causes autism, why are they not listened to? This short-circuits elementary medical and scientific procedures, and calls the good faith of the rest into question.

  77. David 9 July 2008 at 11:37 am #

    There seem to be some problems with where posts appear in this blog. My last post actually predated Dr Briffa’s response. To clarify, it was me who gave some study references for Dr Briffa to look at, not Ross. I did not confine myself to those only in the Cochrane review.

    Dr Briffa – is the most damning statement you can find in the Cochrane review a comment that the quality of reporting of adverse events needs to be improved? Please forgive me for being underwhelmed.This comment somehow is meant to show autism and MMR are linked?

    You comment on what constitutes “good evidence”. No scientific study is ever perfect (except Wakefield’s of course -;)
    Have you had a sudden damascene conversion to what constitutes perfect evidence? If one applied your new-found criteria for “good evidence” to all the studies you usually enthuse about on your blog, I doubt there would be any that could pass muster.

  78. Dr John Briffa 9 July 2008 at 12:52 pm #

    David

    “…is the most damning statement you can find in the Cochrane review a comment that the quality of reporting of adverse events needs to be improved? Please forgive me for being underwhelmed.”

    Just to remind you, the Cochrane reveiwers concluded: “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”

    Regarding the quality of the “good evidence” used to support your and ross’ assertions, do please forgive me and others if we remain a little “underwhelmed”.

  79. ross 9 July 2008 at 3:02 pm #

    “As regards the Honda study (which came too late for the Cochrane review), perhaps you’d like to consider this critique of it here:

    http://www.drbriffa.com/blog/2008/05/23/the-limited-value-of-statistical-significance-in-the-real-world/ (comment 55).”

    I think that’s been dealt with quite effectively here:

    http://pyjamasinbananas.blogspot.com/2008/06/briffas-devastating-critique.html

    Do you want to critique the critique of your critique?

  80. ross 9 July 2008 at 4:10 pm #

    “Above you supply the following quote: “Researchers from the Cochrane Vaccines Field reviewed 139 studies conducted to assess the effects of the live attenuated combined vaccine to prevent measles, mumps and rubella (MMR) in children.””

    Yes. I quoted the whole of the author’s own plain language summary, which summarises, in plain language, the review.

    “Yet you neglect to point out that actually only 31 studies were actually analysed for the purposes of the review (this fact is declared even in the abstract of the review).”

    Why do you consider it neglectful? I quoted the whole of the author’s own plain language summary, which summarises, in plain language, the review.

    “And bearing all this in mind, ross, what do we get from you: a misleading and totally unrepresentative quote from the ‘plain language summary’. ”

    You think that quoting the whole of the author’s own plain language summary is misleading and totally unrepresentative? Don’t you think that you should take this up with the review author’s? Perhaps they were satisified that their own plain language summary was a fair representation of the review?

    I think it’s pretty neglectful to disregard the following statement in the summary: “No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found.”

    It’s also neglectful to disregard this statement in the ‘Main Results’: “Exposure to MMR was unlikely to be associated with Crohn’s disease, ulcerative colitis, autism or aseptic meningitis (mumps) (Jeryl-Lynn strain-containing MMR).”

    “Just to remind you, the Cochrane reveiwers concluded: “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.” ”

    How does that invalidate their other findings? The ‘Author’s conclusions’ for the report state:

    “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.”

    You quote the above as a ‘home truth’. Hmmm, we probably have very different ideas as to what would constitute a home truth. I’d concede your point however if the conclusion did not call for improvments but said something along the following lines:

    “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. The improvements we would like to see in future studies gives us cause for concern regarding the methodology of the studies we have reviewed. For this reason we are unable to state that we have found no credible evidence of an involvement of MMR with either autism or Crohn’s disease, nor are we able to state that exposure to MMR was unlikely to be associated with Crohn’s disease, ulcerative colitis, autism or aseptic meningitis (mumps) (Jeryl-Lynn strain-containing MMR)”

    But it doesn’t.

    “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?

    Perhaps you’d also like to take the opportunity to present the peer reviewed evidence that supports the MMR / autism hypothesis. Or give us your view on the evidence base as it stands and your approach to the situation in clinical practice – in your opinion, and after weighing up the evidence, on the balance of probabilities do you think that the risks associated with the MMR vaccination outweigh the benefits of vaccination? Do you advise parents to vaccinate? Or do you not offer any form of advice?

    Very simple questions Dr B, very simple. And yet you’ve evaded answering them on every occasion that I’ve put them to you. Why?

  81. John Stone 9 July 2008 at 5:52 pm #

    David

    You are playing rhetorical games. Anyone who scratches beneath the surface of the plain language summary of Cochrane on MMR is “quote mining”, yet there is loads to cause disquiet including patently damning remarks about several studies reviewed – if these are the good ones, what are the bad ones like?

  82. Cybertiger 9 July 2008 at 6:29 pm #

    David, loudly and repeatedly, asks,

    “Do you think the benefits of MMR immunisation outweigh its risks?”

    This is a very silly question and one that is impossible to answer with any degree of honesty or credibility. It is the sort of unintelligent, weasely question that Anthony Cox (pharmacovigilant pharmacist for the West Midlands) would have asked if he hadn’t flounced off ” bleeding badly ” several weeks ago.

    Though Andrew Wakefield was starting the probe, the risks of MMR have not been adequately investigated. The science is inadequate, the evidence for safety with respect to autism is inadequate and ‘David’ is plainly inadequate.

  83. David 9 July 2008 at 6:48 pm #

    Dr Briffa:

    Just to remind you, the Cochrane reveiwers concluded: “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”

    This is what it boils down to, doesn’t it? My understanding of what this phrase means obviously differs from yours. I’ll explain what I understand by it, then maybe you can reciprocate.

    The Cochrane Review gives a number of caveats about the inconsistency between studies on what outcomes are measured within the quite numerous different types of study that were analysed. By way of explanation, the Cochrane authors say that the large variety of study designs is a consequence of attempts to devise studies that can answer the safety questions posed without having recourse to large numbers of unvaccinated controls. With several studies with diverse methodology, there is a lack of consistency between them in respect to the design of recording and in the reporting of adverse outcomes.

    The Cochrane authors have asked in respect to future research in this area that there should be an improvement in the design of safety outcome recording and reporting, and that “standardised definitions of adverse events should be adopted”. This is little more than an appeal for better design in methods of recording adverse outcomes and greater consistency in reporting and so that cross-comparisons can be more easily made between studies and that the studies are more readily conformable to metanalysis.

    The way that you go on about this, it seems as though you are totally misinterpreting the Cochrane review as concluding “These vaccine safety studies are inadequate”, which is quite obviously not the case. Cochrane reviews are exceedingly strict with their assessment of studies – have you ever seen any others?- and criticism of aspects of study methodologies is their norm.

    I have several requests for you Dr Briffa (i.e. not for John Stone):
    (1) Please tell us your own interpretation of the sentence: “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.” Explain what you think this actually means.

    (2) Please can you say which parts of the “Plain Summary” part of the Cochrane review you disagree with, if any.

    (3) For the 4th time of asking, please can you tell us if you think the benefits of MMR vaccination outweigh the risks?

  84. Dr John Briffa 9 July 2008 at 7:52 pm #

    ross

    “You think that quoting the whole of the author’s own plain language summary is misleading and totally unrepresentative? Don’t you think that you should take this up with the review author’s? Perhaps they were satisified that their own plain language summary was a fair representation of the review?”

    They may appear satisfied, you may be too. But I’m not. And neither are lots of other people. There is a serious ‘disconnect’ I think between the plain language summary, the actual studies in the review and even some parts of the abstract.

    “I think it’s pretty neglectful to disregard the following statement in the summary: “No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found.””

    Do you now? Because I think if the studies on which this statement are based are flawed and even not fit for purpose, then this statement is, to all intents and purposes, meaningless.

  85. David 9 July 2008 at 7:54 pm #

    I would also say that Cochrane is not the only source of systematic review of this question. I would urge Dr Brifa to review the IOM review, and I would be interested in his view of this paper and its conclusions:

    Association of Autistic Spectrum Disorder and the Measles, Mumps, and Rubella Vaccine A Systematic Review of Current Epidemiological Evidence.
    Kumanan Wilson, MD, MSc, FRCP(C); Ed Mills, DPH; Cory Ross, MSc, DPH, CHE; Jessie McGowan, BMus, MLIS; Alex Jadad, MD, DPhil, FRCP(C)
    Arch Pediatr Adolesc Med. 2003;157:628-634.

  86. Dr John Briffa 9 July 2008 at 7:59 pm #

    David

    ” Please tell us your own interpretation of the sentence: “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.” Explain what you think this actually means.”

    Would you also like to explain what is meant by “The cat sat on the mat”?

  87. Clifford G. Miller 9 July 2008 at 8:19 pm #

    In response to Ross July 9, 2008 @ 4:10 pm

    Regarding Cochrane, the statement “No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found.” Appears nowhere in the discussion or conclusions in the Cochrane MMR review. That statement appears to have been added after the event to the abstract for the puirposes of inclusion in worldwide press releases.

    The Cochrane MMR review itself has been associated, in the very words of one of its own authors, with fraudulent research practices as you can read here:-

    http://www.jpands.org/vol11no4/millerc.pdf

    In fact, the word “credible” appears only once in the body of the Cochrane paper but not in the context of autism or Crohn’s disease. In short, that was not one of the authors’ conclusions.

    And even if it was, authors’ discussion and conclusions must be disregarded as opinion which is prone to bias. All that can be taken into account is the data and the results. Where a expert giving expert opinion evidence cites the opinion of the authors of a paper, the English Court rules of evidence requires the witness to make that clear.

  88. John Stone 9 July 2008 at 9:12 pm #

    David

    I think you did not want to hear from me, which is perhaps one reason for posting:

    “Do you feel the benefits of MMR vaccination outweigh its risk?”

    Interesting phraseology – at least on the basis of Cochrane no one could possibly know, but feeling does not come into it. But there is another problem, which is that there is the absence of any attempt (and Cochrane is excellent evidence of this) to ensure the vaccine is as safe as possible. And what is absolutely certain is that almost no one in the medical profession or government will want to listen to you if it does go wrong, which makes it an unacceptable risk.

    This is why Wakefield is a lot more credible than you (and at least we know who he is).

  89. DT 9 July 2008 at 9:56 pm #

    Dr Briffa said:

    Would you also like to explain what is meant by “The cat sat on the mat”?

    Fine – as you wish. Your unwillingness (inability?) to debate the relevant issues has been noted, and on your own blog, what’s more.

    I had assumed your previous unwillingness to clarify your position on the issue stemmed from your inability to grasp the underlying science. That would have been OK – it’s alright to admit you don’t know something.

    However, it is clear now that it stems not from ignorance, but from cowardice. You can always prove me wrong by answering the question (5th time now):
    Do you feel the benefits of MMR vaccination outweigh its risk?

  90. david 9 July 2008 at 9:59 pm #

    PS: DT=David
    (I’m not pretending to be someone else – just put in my initials rather than name in error)

  91. ross 9 July 2008 at 11:16 pm #

    CM – “Regarding Cochrane, the statement “No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found.” Appears nowhere in the discussion or conclusions in the Cochrane MMR review. ”

    I know. It’s in the plain language summary here:

    http://www.cochrane.org/reviews/en/ab004407.html

    “That statement appears to have been added after the event to the abstract for the puirposes of inclusion in worldwide press releases.”

    a) Your evidence?
    b) Even if it was, what’s your point?
    c) Presumably the authors are happy that it’s a fair reflection of their findings since they wrote it, why do you disagree and are you going to take up this issue with them or have you done so?

    “The Cochrane MMR review itself has been associated, in the very words of one of its own authors, with fraudulent research practices as you can read here”

    Could you please provide the quote. I read your paper and it’s not clear what you are referring to. For future reference it’s courteous to quote information of that sort so people don’t have to spend time wading through papers to try and locate it.

    Dr B “They may appear satisfied, you may be too. But I’m not. And neither are lots of other people. There is a serious ‘disconnect’ I think between the plain language summary, the actual studies in the review and even some parts of the abstract.”

    OK. Let’s hear them then. It would be helpful if you started by telling us your interpretation of “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”

    Clearly it’s not as simple as “The cat sat on the mat” because there is a fundamental disagreement between posters as to the merit of the review that seems to hinge on this statement. Indeed, it seems to be the trump card for some of you.

    “I think if the studies on which this statement are based are flawed and even not fit for purpose, then this statement is, to all intents and purposes, meaningless.”

    OK. So do you want to explain why you think these studies are flawed by providing answers to the questions I asked re. DeStefano, Fombonne and Madsen?

    It’s clear you don’t think that there is good evidence to support the view that there is no correlation between MMR and autism. However, you must think that there is some good evidence to support the MMR / autism hypothesis. What is it? How reliable is it? How does it stack up against the ‘no correlation’ studies? What is your view of the evidence base as it stands? What do you think the implications should be for public health policy? Do you agree with the other Cochrane conculsion:

    “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.”

    How do you approach this in clinical practice- in your opinion, and after weighing up the evidence, on the balance of probabilities do you think that the risks associated with the MMR vaccination outweigh the benefits of vaccination? Do you advise parents to vaccinate? Or do you not offer any form of advice?

  92. Dr John Briffa 10 July 2008 at 12:15 am #

    David

    “However, it is clear now that it stems not from ignorance, but from cowardice.”

    Yeah, that’s right – I, who declares openly my identity, am a coward. But you, who hides behind anonymity, are a much more courageous breast, obviously.

    “Do you feel the benefits of MMR vaccination outweigh its risk?”

    That’s not the question here, so stop trying to divert from the real issue. The question is “Can MMR cause autism?” The answer, in my opinion, is we don’t know.

    And I won’t be bullied or belittled into silence either (despite being a coward…).

  93. David 10 July 2008 at 11:35 am #

    Dr Briffa,
    I see you don’t wish to debate the Cochrane Review and other evidence, or answer simple questions about MMR’s risk/benefit ratio;

    “Do you feel the benefits of MMR vaccination outweigh its risk?” That’s not the question here.

    That’s fine, don’t answer,it’s your blog. What I do find strange are your reasons for not doing so ” you maintain this is not because of any cowardice on your part, but that you rather perversely feel it is me who is “hiding” because I have remained “anonymous” and not declared any possible conflicts of interest, therefore you don’t need to answer any questions I pose.

    This is a bizarre position to take, and nothing but an inverse form of the ad hominem fallacy. This is not how science operates. It assesses evidence, not what is the name of the person who is trying to discuss that evidence. Conflicts of interest operate when a person is generating data, and therefore may produce potentially biased “evidence” (Wakefield is an excellent example), and not when someone merely tries to debate peer reviewed papers and evidence already in the public domain. How would any possible conflict of interest I have affect the evidence presented in the Cochrane review? It could only affect my objectivity in interpretation of the evidence (rather in the way that John Stone’s , and as we have seen, very few people on this blog

    OK, I’ll admit it – I am a Merck pharma shill*, paid by the hour to post on the internet. Now can we get on and discuss the evidence please? Feel free to take what I say with a pinch of salt, but let’s discuss things in a pleasant co-operative manner rather that resort to trite insults like yours (“Would you like to explain what “the cat sat on the mat” means?”).
    *I am joking.

    The question is “Can MMR cause autism?”

    I am overjoyed with this redefinition ” it indicates you now want to address the science, not play silly word games or try and persuade people to disprove a negative. So in the light of your new-found mission statement for this debate, please can someone (even you will do) present evidence to show that MMR can cause autism?

  94. Dr John Briffa 10 July 2008 at 12:39 pm #

    David

    The reason for not answering the question regarding the risks/benefits of vaccination is partly because it’s not the question that is the focus of this discussion. It has nothing to do with your hiding behind anonymity, so please do not insinuate this. My comments regarding your anonymity were (very obviously) a reference to your claim that I am cowardly.

    “but let’s discuss things in a pleasant co-operative manner rather that resort to trite insults like yours (“Would you like to explain what “the cat sat on the mat” means?”)”

    The point is you’ve asked me to explain my understanding of a phrase the meaning of which is, I believe, patently clear to anyone with even the most basic grasp of the English language. But we know you have a good grasp of the language. So, it looks to me like you are doing what you can to distort the meaning of the sentence: “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.” Why’s this insulting to you? It certainly looks to me like an accurate reflection of the truth.

    “The question is “Can MMR cause autism?” I am overjoyed with this redefinition ” it indicates you now want to address the science, not play silly word games or try and persuade people to disprove a negative. So in the light of your new-found mission statement for this debate, please can someone (even you will do) present evidence to show that MMR can cause autism?”

    David, tell me where it seems to you that I have been interested in anything but the question of whether MMR can cause autism? And please do show me where it seems I seem to have stated that MMR can cause autism? Because if you can’t, then you’re asking me to provide evidence for claims I have not made. Which would be silly, wouldn’t it?

  95. ross 10 July 2008 at 3:58 pm #

    “The point is you’ve asked me to explain my understanding of a phrase the meaning of which is, I believe, patently clear to anyone with even the most basic grasp of the English language”

    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?

  96. David 10 July 2008 at 4:43 pm #

    Dr Briffa, regarding the question of whether MMR can cause autism, I accept that your position is that you “don’t know”.

    However, the general focus of the MMR/autism threads on your blog have been towards disproof of the negative – i.e. that proponents of vaccination have been asked to show that there is no association between MMR and autism, and if I mistakenly have assumed this was your fallback position I apologise – but little you have posted has indicated otherwise. You certainly have indicated that you disagree with the conclusions of studies which suggest there is no credible scientific evidence for a link.

    If the question is “Can MMR cause autism?”, which you agree is the topic now under consideration, all I am doing is appealing for people to provide evidence in support of the claim that MMR can cause autism, which seems quite a reasonable thing to do. The onus is really upon those who believe there is a causative link to provide valid scientific evidence to support this claim.

  97. Dr John Briffa 10 July 2008 at 5:27 pm #

    david

    Thank you for your last reponse (96)

    “However, the general focus of the MMR/autism threads on your blog have been towards disproof of the negative – i.e. that proponents of vaccination have been asked to show that there is no association between MMR and autism,”

    I actually think the thrust has been more the expression of the opinion that the current state of evidence is inadequate to conclude, beyond reasonable doubt, that MMR does not cause autism. This is obviously a view I share, and I think it’s reasonable for me and others to express it.

    I also think, and no doubt you are aware of this, that the area is steeped in a culture of fear and bullying. I think parents of children who feel their children may be vaccine-damaged have been dismissed and treated inhumanely and uncaringly in the main. I, personally, have been deeply saddened by this.

    The Wilson review you quote above makes some interesting points, I think. Here are the conclusions from it in full:

    Our review finds no evidence of the emergence of an epidemic of ASD related to the MMR vaccine. It also finds no evidence of an association between a variant form of autism and the MMR vaccine although recognizing that relatively few studies have examined this specific question. The characterization of a variant form of autism remains the focus of considerable debate. Given the current evidence, if a variant form of ASD exists that is associated with the MMR vaccine, it is sufficiently rare so as not to be identified by the current epidemiological studies.

    While the risk of autism from MMR remains theoretical, the consequences of not vaccinating are real with several studies demonstrating the health effect of reducing vaccination coverage. Based on this evidence public health officials should continue to advocate vaccination with MMR while continuing to recognize public concerns. The potential association of ASD and the MMR vaccine occupies a particularly high-risk space among the general population by being both unknown and potentially catastrophic. Risks of this type can cause substantial concern amongst the public that may appear irrational to public health officials. The public may require more studies ruling out an association between the risk factor and disease for these types of risks than other types. If future studies are conducted to examine this question, we recommend that they focus on identifying an association between the MMR vaccine and a specific phenotype of ASD rather than between the MMR vaccine and all forms of ASD.

    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.

  98. John Stone 10 July 2008 at 6:06 pm #

    John B

    Surely, any kind medical or scientific procedure is being abandoned if parents are being ruthlessly sidelined, so this is not proper or objective science.

    As to Cochrane, it is such a palimpsest of contrary opinions, re-writes, slippery language that on grounds of simple literary criticism it should impossible to derive any confident belief in the vaccine’s safety from it.

  99. David 10 July 2008 at 7:12 pm #

    Thank you Dr B for your comments on the Wilson review.

    For the record, I maintain that it is feasible that a small subset of vulnerable children might be disposed towards ASD from external triggers (which could include vaccines although the evidence to suggest a plausible causal mechanism is currently lacking). Whatever the impact of vaccines on the incidence of autism, it is likely to contribute at most to a tiny proportion of cases. It is clear from ecological/epidemiological studies in my opinion that the contribution of toxins/mercury/combined MMR/whatever is largely inapparent, meaning that any clinically significant impact on ASD rates is very small.

    I am against what has been termed the “Nirvana fallacy” – the concept that if one cannot do something that is proven to be 100% safe, then it is better to do nothing. Many antivaccine campaigners apply this irrational principle to the issue of vaccination. Vaccination may not be completely risk free, but the alternative of no vaccination is far more likely to lead to death, disability or other harm.

  100. ross 10 July 2008 at 11:37 pm #

    “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 presumably you would 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’) you would also 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?

  101. John Stone 11 July 2008 at 8:47 am #

    “I am against what has been termed the “Nirvana fallacy” – the concept that if one cannot do something that is proven to be 100% safe, then it is better to do nothing. Many antivaccine campaigners apply this irrational principle to the issue of vaccination. Vaccination may not be completely risk free, but the alternative of no vaccination is far more likely to lead to death, disability or other harm.”

    This does not represent the situation at all. Most “anti-vaccine” campaigners are vaccine safety campaigners, who accepted the proposition of the lesser risk when they vaccinated. The trouble is that it is difficult to see what the basis of the risk-benefit equation is, when their cases are subject to aggressive dismissal, non-investigation, professional persecution of anyone who shows concern for the problem – all of which are (a) sources of bias (b) means that if it does go wrong, so far from being supported you will be subject to huge amounts of personal unpleasantness if you speak out of turn.

    One thing I deduce from the weak evidence base for MMR safety, is that most studies were desperately evading detecting a likely effect. In the case of the Madsen and Honda studies the problems have been mentioned, and the aggressive dismissal does not suggest that Ross, David & co really mind what happens providing a negative relation is found. That is bias.

    The most bizarre case was when Prof Fombonne (involved in so many of these studies) produced a study in which the PDD rate in a district of Montreal was comparen not with the MMR vaccination rate for the province of Quebec in which Montreal is situated, but with the vaccination rate in Quebec City 265km away. All Ross and David will do is pretend I am weird for pointing it out.

    http://www.vaproject.org/yazbak/tale-of-two-cities-20070307.htm

    That is how much they care for the conduct of science in reality.

  102. ross 11 July 2008 at 10:29 am #

    No, you are not weird for pointing out Yazbak’s criticisms. But it’s worth considering evaluating the criticism as well as the study:

    “When he was in France, Dr. Fombonne was a well known psychiatrist who published articles on psychiatric topics. He was still a psychiatrist when he moved to England …until Andrew Wakefield suggested that the link between MMR vaccination and autism should be further investigated and suddenly… Dr. Fombonne became a “psychiatrist / epidemiologist” and a consultant to the UK medical authorities on MMR vaccination and autism.”

    THe following studies were done pre Wakefield (1998):

    Fombonne, E. (1996). Is the prevalence of autism increasing? Journal of Autism and Developmental Disorders
    Fombonne, E. (1997). The prevalence of autism and other pervasive developmental disorders in the UK. Autism, 1,

    For what it’s worth, there’s a good summary of the shortcomings of the study and the critique here:
    http://leftbrainrightbrain.co.uk/?p=515

  103. John Stone 11 July 2008 at 11:17 am #

    I don’t have those early Fombonne studies to hand but the prevalence rates in them for autism were much lower (going on memory) than latterly.

    Also, by the mid-90s the rising trend in autism was already becoming a bureaucratic embarrassment.

    Yazbak’s error is not comparable with the deliberate manipulation and apparent mis-representation of data.

  104. John Stone 11 July 2008 at 2:11 pm #

    I would just add that my personal doubts about Fombonne go back to before my acquaintance with many of the people in this debate, to when I was sent a copy of his latest article by the DH: ‘Is there an epidemic of autism?’ (February 2001):

    http://pediatrics.aappublications.org/cgi/content/full/107/2/411

    The fallacy of his position, as it struck me at the time, was that while you might conclude that there were still insufficient controls on the California data to prove that autism was rising, there was certainly no grounds for assuming that it was not. If this was his view, then it denoted bias.

    Also, it was quite clear with my dealing with DH at the time, that while I was only raising the issue of the more than apparent increase in autism they seemed to be backed into a corner over MMR, which I had not brought up. But the projects of denying autism increase and denying vaccine damage always seemed to go hand in hand.

  105. John Stone 11 July 2008 at 2:16 pm #

    PS Yes, I do recall reading the comments of Jonathan Semetko and Kevin Leitch at the time of Ed Yazbak’s publication. They were certainly forced to concede much more than usual.

  106. Cybertiger 11 July 2008 at 4:27 pm #

    David said,

    “For the record, I maintain that it is feasible that a small subset of vulnerable children might be disposed towards ASD from external triggers (which could include vaccines although the evidence to suggest a plausible causal mechanism is currently lacking).”

    You’ve conceded that a subset, albeit tiny, of children, could be vulnerable to ASDs through vaccination. Considering the devastating nature of ASDs, do you not think this matter merits serious investigation? As a scientist, are you not a tiny bit curious? Is playing Russian-roulette any longer acceptable?

  107. David 11 July 2008 at 4:54 pm #

    Mr Stone – no you are not weird for pointing it out. What is weird is your baseless prediction that I would label your comment as weird and that this would enable you to jump to the nonsensical conclusion that I do not care about the realities of science. I care very much about the scientific method and how science operates, thank you. Are we to conduct this debate on the basis of speculative accusations of others regarding their possible theoretical future actions?

    The phrase I used when talking about the Nirvana fallacy was that many antivaccine campaigners use it. I don’t see how you can disagree with the statement that “many” antivaccine campaigners, who are by definition against vaccines, would fulfil this definition. I could have said “all” and still been technically correct. It is true that there are those who campaign for safer vaccines or an altered vaccination schedule, and I agree these individuals would not necessarily argue against all vaccination. There are in fact some vaccines that even I think should not be routine (but that is another story). However, those who campaign against all vaccines have sneakily jumped onto the bandwagon of vaccine “safety”. One only needs to look at the “Green our vaccines” movement in the States to appreciate this. Supposedly, the concept is that they only want safer vaccines. This is such a reasonable plea that no-one could disagree with it. But in fact, if you look at what the campaigners actually say, it is clear that nothing less than a total removal of all vaccines form the routine childhood schedule is their underlying aim.

    Regarding the Fombonne data, the basic underlying fact remains that PDD rates increased at a time when MMR rates were not correspondingly increasing. In Quebec MMR rates have always been high, so even if you dismiss Fombonne’s use of MMR rates from elsewhere in Quebec province than montreal to use in his analysis there is a problem for you. Let us hypothetically assume MMR rates actually increased from 96% to 100% in the period under study – a 4% rise. In the same period, PDD rates rose from 45 to 107 – a 240% rise.

    Can you provide a rational explanation for this? What is it about MMR that when administered to 96% of children it produces autism only in a certain percent, but that is so strange that when given to an extra 4% of children it suddenly makes the autism rate more than double? If the base MMR vaccination rate was, say 40%, and an increase to 90% correlated to a more than doubling of autism rates then you might have a point.

    The conclusions of Fombonne appear quite logical – MMR and autism do not appear to be linked. Pointing out some methodological or selection bias problems in studies like his does not negate the underlying findings which remain consistent. The inescapable conclusion is that virtually all cases of autism must be due to something other than MMR, and even if there are any cases where MMR could trigger autism, these cases must make up a tiny fraction of the overall numbers.

  108. John Stone 11 July 2008 at 8:27 pm #

    David

    I do not accept you reading of the vaccine safety movement. Almost everyone had their children vaccinated – it does not have naturopath ideology though this would not in itself be dishonourable. This is the kind of propaganda we have to deal with – an article by Lorde Taverne, Chairman of Sense About Science:

    “The first was a claim against manufacturers of the MMR (measles, mumps, and rubella) vaccine. As long ago as 1994 legal aid was granted to a group of parents who were opposed to immunisation (and who were strong believers in homoeopathy), for an action claiming that MMR causes brain damage, epilepsy, arthritis, and autoimmune disease.”

    http://www.bmj.com/cgi/content/full/329/7459/239

    You have to ask what Taverne could possibly have known about the beliefs of the litigants except that they all had their children vaccinated. I bet there were many nuanced opinions on the ‘Green our Vaccines’ rally, but I am sure the basic message was people wanted the authorities to be a great deal more careful.

    The other point is that you are using the usual straw argument. No one is saying that MMR is the sole cause of autism, or even that vaccines are, but the vaccine schedule certainly represents a cumulative challenge and even if people had not witnessed the immediate adverse events with their children – sometimes very scary particularly with an indifferent GP telling you everything is alright – there should still be great concern. And every time you add another vaccine with other adjuvants or excipients you are adding further confounders which make the problem harder to investigate.

    It really also will not do to announce that the conclusions of a study were fine despite the mis-matching of data. I note that Fombonne also participated in the data analysis not only of the heavily criticised study with Chakrabarti, but also Smeeth. A lot of routes lead to Eric.

  109. Clifford G. Miller 11 July 2008 at 11:47 pm #

    In response to Ross on July 9, 2008 @ 11:16 pm.

    Ross is regrettably trolling. S/he thinks that by providing any form or aggressive response is an adequate answer to the other person.

    The statement “No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found” appears nowhere in the discussion or conclusions in the Cochrane MMR review.

    So Ross can produce as many “plain language” summaries as he likes. They are not the authors’ paper nor are they the data or results which are all that count. Conclusions or discussions of authors or papers are opinion and irrelevant. Here Ross refers to a statement which is no part of the body of the paper or the discussiion or conclusions. Even if Ross claim this is a statement in an abstract, that is also not the body of the paper and is to be disregarded.

    Ross again is trolling here when s/he says asks for the showingn that tThe Cochrane MMR review itself has been associated, in the very words of one of its own authors, with fraudulent research practices. Ross and everyone else can read about it here in:-

    “Questions on the Independence and Reliability of Cochrane Reviews, with a Focus on Measles-Mumps-Rubella Vaccine”
    http://www.jpands.org/vol11no4/millerc.pdf

    As to the question “Can MMR cause autism”, that question is beginning to be answered in the affirmative in the USA. I have put some details on my website here:-
    Explaining Vaccines Autism & Mitochondrial Disorder
    http://homepage.ntlworld.com/clifford.g.miller/Mitochondrial.html

  110. ross 12 July 2008 at 12:22 am #

    CM, I note that you haven’t addressed any of the questions I put to you but have accused me of ‘trolling’, providing an ‘aggressive’ response and repeated that:

    “The statement ‘No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found’ appears nowhere in the discussion or conclusions in the Cochrane MMR review.”

    So I will repeat that I know. It’s in the plain language summary here:

    http://www.cochrane.org/reviews/en/ab004407.html

    “So Ross can produce as many “plain language” summaries as he likes.”

    I think one is suffiecient.

    “They are not the authors’ paper nor are they the data or results which are all that count.”

    Presumably the plain language summary was written by the authors and they are happy that it reflects their findings. Do you have any evidence to the contrary?

    Do you know of any other studies where the conclusions and plain language summaries were not written by the authors and do not reflect their findings?

    “Conclusions or discussions of authors or papers are opinion and irrelevant. Here Ross refers to a statement which is no part of the body of the paper or the discussiion or conclusions. Even if Ross claim this is a statement in an abstract, that is also not the body of the paper and is to be disregarded.”

    CM, can you please explain why the conclusions the authors draw and the plain language summary they provide are to be ignored?

    I’d also like you to address these points:

    “The statement appears to have been added after the event to the abstract for the puirposes of inclusion in worldwide press releases.”

    a) Your evidence?
    b) Even if it was, what’s your point?
    c) Presumably the authors are happy that it’s a fair reflection of their findings since they wrote it, why do you disagree and are you going to take up this issue with them or have you done so?

  111. Hilary Butler 12 July 2008 at 6:34 am #

    David, you say:

    >>>“ Let us hypothetically assume MMR rates actually increased from 96% to 100% in the period under study – a 4% rise. In the same period, PDD rates rose from 45 to 107 – a 240% rise.

    Can you provide a rational explanation for this? What is it about MMR that when administered to 96% of children it produces autism only in a certain percent, but that is so strange that when given to an extra 4% of children it suddenly makes the autism rate more than double? If the base MMR vaccination rate was, say 40%, and an increase to 90% correlated to a more than doubling of autism rates then you might have a point.”<<<

    So the rate in the 40% of children vaccinated was X percent.

    You are assuming that the rate of autism in the 50% increase (40 + 50 = 90%) to be inherently identical to the first 40%. Why?

    When a parent has a really robustly healthy child, they don’t consider that anything could go wrong. After all their babies are “strong enough to take what comes their way”. Though illogically, this doesn’t extend to a belief that their ultra healthy babies might survive disease, but medical conditioning is an interesting subject of study. But it is notable to me that parents of healthy children give little thought to the possible consequences of vaccines. They just want to avail themselves of any opportunity to keep their children healthy.

    But what say that the second 50%, were parents who were initially reluctant to vaccinate their babies? What say these reluctant parents didn’t vaccinate because their children were low birth weight. Maybe some had initial failure to thrive. Perhaps some had repeated urinary tract infections, or ear infections, or whatever circumstance, which made the parents hesitate to stick needles into them.

    When your children don’t look as tough as an ox, you think twice about vaccines.

    Then along comes the doctor to push you and say, “But can’t you see, that because your child is not a strong child, they are much more likely to have complications to the disease, or die? (Implant fear here) Can’t you see that the safer of two options is to vaccinate?”

    And so you vaccinate.

    But here’s where the logic stops. When your “not so strong child” suddenly keels over after the vaccine, the doctor says their complaint is coincidental: “the vaccinee effect”, because we all know that the these things happen in those not given the MMR (which isn’t what the studies say, but never mind).

    And we all know where the original vaccinee effect “fallacy” theory comes from too, don’t we David? That unscientific study (PMID 2871241) done with the placebo that wasn’t, but which is then extrapolated by you doctors to mean illnesses which happen to everyone out there in the community who hasn’t had a needle of any sort stuck in them for years!

    The reason why there might be a higher rate in the 50% of children vaccinated after the first 40%, just might come under the heading of “vaccinomics”, and might be because there are a much larger percentage of fragile children in that 50%.

    AND I venture to suggest that if Canada made sure the FINAL 10% of “errant parents” had their babies vaccinated regardless of their state of health, and studied them they might find an even higher percentage of resultant developmental disorders in them as well.

    That wouldn’t mean that the vaccine had nothing to do with it David. It just might be that the first 40% were “self selected” because they were children whose parents thought them to be ultra healthy and therefore never considered the effect of any vaccine to be an issue.

    It just might be an unstudied confounder, which you’ve not taken into account. It could well be argued that the 240% increase could reflected a real increase in the percentage of fragile children whose should have vaccines, and, whose parents (if you knew who that “small subgroup” was) would be advised to skip vaccine altogether.

    It does not mean, as you allege, that vaccines have nothing to do with the developmental disorders these children have.

  112. Hilary Butler 12 July 2008 at 6:38 am #

    That second to last paragraph should read:

    It could well be argued that the 240% increase could reflected a real increase in the percentage of fragile children whose should NOT have vaccines, and, whose parents (if you knew who that “small subgroup” was) would be advised to skip vaccine altogether.

  113. Clifford G. Miller 12 July 2008 at 7:13 am #

    Reply to Ross July 12, 2008 @ 12:22 am.

    I see Ross has no answer to the evidence showing a causal mechanism between vaccines and autism some of which I put on my website here:-
    Explaining Vaccines Autism & Mitochondrial Disorder
    http://homepage.ntlworld.com/clifford.g.miller/Mitochondrial.html.

    Ross demands evidence of the obvious is trolling behaviour. The statement ‘No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found’ was obviously written after the event. It and nothing like it is in the paper itself, and as Ross describes it a summary, it must have been written after the event. Not too smart eh, Ross?

    And as the papers the Cochrane MMR review commented on were themselves were so poor, they were not credible evidence. So we can all agree with Ross’ “plain language” summary on that.

    Ross also tries to supplant an entire formally published paper with what Ross calls a “Plain language” summary. Only data and results of formally published papers are relevant. Either you cite the formal literature or you do not. Ross does not.

    The “no credible evidence” claim is an interesting statement in itself for authors who are meant to be so expert.

    Epidemiology deals with “associations”, not “involvements” so it is strange for them to use the word “involvement”. “Involvement” means MMR is the cause or part of it. Epidemiology does not prove cause or lack of it but only whether there might be an association.

    Non epidemiological evidence is required to assess causation, and the standard guide is the Bradford Hill criteria. So the statement is completely irrelevant.

    If the authors claimed in their paper (but did not) to have found no evidence of “involvement”, that would be unsurprising, if reviewing epidemiology. If the statement said “no credible evidence of an involvement of MMR in icecream consumption was found” it would be equally valuable. The papers being studied were not looking for that either. So all in all, Ross’ point again suggests trolling.

    Ergo, Ross is a troll, Ross employs common troll tactics like demanding others answer irrelevant questions and raising spurious points as if important. Responding by demanding evidence for irrelevancies when Ross has no other answer to sound points is typical troll behaviour.

    Thanks Ross for the opportunity to clarify these points.

    This message is posted at approx 0620 BST 12 July.

  114. Clifford G Miller 12 July 2008 at 12:26 pm #

    In reply to David July 11, 2008 @ 4:54
    pm

    David says “the basic underlying fact remains that PDD rates increased at a time when MMR rates were not correspondingly increasing.

    Fombonne showed that autism Englsh incidence in 8 years during the 1990s was a steady uniform rate [1]. And we know that during that time MMR vaccination uptake was a steady uniform rate too.

    Fombonne’s study found that autism prevalence had increased in the 15 years since 1990.

    That is evidence the increase in autism is a new phenomenon affecting the child population.

    It is also evidence of a temporal association with the introduction of tthe 1988 MMR and 1990 accelerated DTP vaccination programmes.

    Where incidence is uniform over many years, that is evidence there is no “better diagnosis” or “greater awareness”. The rates were uniform as Fombonne showed.

    [1] Chakrabarti S, Fombonne E. Pervasive Developmental Disorders in Preschool Children:Confirmation of High Prevalence. Am J Psychiatry 2005;162:1133”1141

  115. John Stone 12 July 2008 at 1:05 pm #

    Hilary

    Several very interesting points.

    Mind you, I think David gave the game away when he congratulated Fombonne for coming up with the right result, even though he had compared and matched data from different locations to get it.

  116. ross 12 July 2008 at 1:24 pm #

    “I see Ross has no answer to the evidence showing a causal mechanism between vaccines and autism some of which I put on my website here”

    I haven’t read it yet. But I read your paper:

    http://www.jpands.org/vol11no4/millerc.pdf

    Please point out the part where one of the authors of the Cochrane MMR review states, in his or her own words, that the “review itself has been associated…with fraudulent research practices”

    “Ross demands evidence of the obvious is trolling behaviour.”

    If the evidence were obvious then there would be no need to ask you to clarify it. And on the contrary, I think that making statements without the evidence to back them up is a more obvious behaviour trait of a troll.

    “The statement ‘No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found’ was obviously written after the event. It and nothing like it is in the paper itself, and as Ross describes it a summary, it must have been written after the event. Not too smart eh, Ross?”

    Hmmm, well I wouldn’t have expected them to write the summary before the research was concluded. But you said “That statement appears to have been added after the event to the abstract for the puirposes of inclusion in worldwide press releases.”

    Appears to? For the purposes of inclusion in worldwide press releases? Where’s your evidence for this? Even if it was, what’s your point? Presumably the authors are happy that it’s a fair reflection of their findings since they wrote it, why do you disagree and are you going to take up this issue with them or have you done so?

    “Ross also tries to supplant an entire formally published paper with what Ross calls a “Plain language” summary.”

    I point to the what the authors call a “Plain Language Summary”. It was written by the review authors and can be found here:

    http://www.cochrane.org/reviews/en/ab004407.html

    “Only data and results of formally published papers are relevant. Either you cite the formal literature or you do not. Ross does not.”

    I cite: V Demicheli, T Jefferson, A Rivetti, D Price, Vaccines for measles, mumps and rubella in children, Cochrane Database of Systematic Reviews 2008 Issue 2

    I also cite the ‘Main Results’ where it states that “Exposure to MMR was unlikely to be associated with Crohn’s disease, ulcerative colitis, autism or aseptic meningitis (mumps) (Jeryl-Lynn strain-containing MMR).”

    “The “no credible evidence” claim is an interesting statement in itself for authors who are meant to be so expert.”

    Perhaps you could point to the ‘data and results of formally published papers’ to demonstrate the credible evidence? After all, you have stated that only this is relevant.

    “Conclusions or discussions of authors or papers are opinion and irrelevant.”

    Please explain why.

    “Even if Ross claim this is a statement in an abstract, that is also not the body of the paper and is to be disregarded.”

    So the statement “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate” from the ‘Authors’ conclusions’ section of the abstract can be disregarded as an argument for supposedly demonstrating t that the other review findings in the same study have been undermined?

    Are you using this statement as evidence for your argument that “as the papers the Cochrane MMR review commented on were themselves were so poor, they were not credible evidence” or do you have more substantial criticisms of the science?

    In any event, I think it makes more sense to read that statement in the context of the main body of the report:

    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.

    CM, can you please provide a good explanation as to why the conclusions the authors draw and the plain language summary they provide are to be ignored?

    (Can’t we try and keep this civil? If I’m quoting from the published review and you call me a troll for doing so then we’ll never get anywhere. Likewise stating that ‘I see Ross has no answer for…’ if I haven’t given an immediate response is playground behaviour and no way to conduct a reasoned debate.)

  117. David 12 July 2008 at 2:43 pm #

    Mr Miller, I think your slip is showing:

    “Fombonne’s study found that autism prevalence had increased in the 15 years since 1990.
    That is evidence the increase in autism is a new phenomenon affecting the child population.
    It is also evidence of a temporal association with the introduction of tthe 1988 MMR and 1990 accelerated DTP vaccination programmes.

    So, let’s get this straight. You feel it is fine to ignore conclusions and summaries that authors have written concerning their own data (simply because you disagree with them), and now you think it is fine to use data from studies (Fombonne’s) to derive your own ridiculous conclusions (which we are meant to believe merely because you say so).

    Sorry, but I’d rather believe the opinions and conclusions of international experts in pediatrics and child health, infectious diseases, epidemiology, public health, immunology and vaccination than I would a lawyer who has a vested interest in vaccine damage cases.

    PS: There is also a “temporal association” between autism trends and the sale of McDonald’s hamburgers. Want to make something of it?

  118. Dr John Briffa 12 July 2008 at 3:00 pm #

    David

    “There is also a “temporal association” between autism trends and the sale of McDonald’s hamburgers. Want to make something of it?”

    This is an honest question: do you have any evidence which shows that McDonald’s hamburgers don’t/can’t cause autism?

  119. ross 12 July 2008 at 3:17 pm #

    “This is an honest question: do you have any evidence which shows that McDonald’s hamburgers don’t/can’t cause autism?”

    I thought we had got past this?

    You said “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 presumably you would 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’) you would also 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?

  120. ross 12 July 2008 at 4:10 pm #

    Oh and CM, well done for getting published in such a prestigious journal as JPANDS (formerly the Medical Sentinel). Was that your first choice or did you submit elsewhere? Perhaps to a journal that is listed on MEDLINE/PubMed? Or one that hasn’t been described as the “house magazine of a right-wing American fringe group [AAPS]” and “is barely credible as an independent forum.”

    There’s a nice summary of the kind of journal it is here:

    http://en.wikipedia.org/wiki/Association_of_American_Physicians_and_Surgeons

    They’ve published some interesting papers haven’t they? Amongst the AIDS denialist ones there’s a peach of a paper arguing that
    that “humanists” have conspired to replace the “creation religion of Jehovah” with evolution. (Conspiracy — Part III, by Curtis W. Caine, MD. Published in Medical Sentinel, 1999;4(6):224)

    All good scientific stuff no doubt, so presumably you would disagree with the Quackwatch assessment of JPANDS as ‘fundamentally flawed’ and its listing here as a “Non-recommended Periodical”:
    http://www.quackwatch.org/04ConsumerEducation/nonrecperiodicals.html

  121. John Stone 12 July 2008 at 4:28 pm #

    David

    One of the most nauseating aspects of this matter is that we are all expected to kowtow to experts even when they are caught with their trousers down. I have already pointed to your ludicrous and pompous endorsement of Fombonne over the Montreal data – never mind the data you say, just look at the conclusions. And we also have the way that British health officials recorded a more than doubling of the autism rate in N London temporally associated with the introduction of the accelerated DPT in their MMR studies but failed to note it as confounder. I don’t see why we should trust or defer to people who do that, particularly as they were investigating their own policies.

    Frankly, it is the biggest try-on in history, and all this rank-pulling is just bluff.

  122. Clifford G. Miller 12 July 2008 at 4:35 pm #

    In response to Ross July 12, 2008 @ 1:24
    pm

    Ross is trolling.

    Ross – deal with the important point – do you agree or disagree that there are plausible biological mechanisms for how vaccines cause autism. I see Ross still has no answer to the evidence showing a causal mechanism between vaccines and autism some of which I put on my website here:-
    Explaining
    Vaccines Autism & Mitochondrial Disorder

    That is key to the discussion here. Ross instead ignores that and goes off on a tangential troll regarding the fraud issue relating to Cochrane.

    As Ross has read my paper Questions on the Independence and Reliability of Cochrane Reviews, with a Focus on Measles-Mumps-Rubella Vaccine

    s/he can see the matter is fully and clearly set out in the paper and anyone else reading this can see for themselves the Cochrane MMR review itself has been associated, in the very words of one of its own authors, with fraudulent research practices. Ross chooses to disagree.

    Ross makes many claims without evidence. What Ross calls a “plain language summary” is not part of the body of the paper. Ross now has difficulty contesting the plain language summary was quite obviously written after the event.

    The particular sentence Ross claims to rely on is not supported by the data and the results of the paper. It was given prominence in the worldwide publicity someone paid to obtain for this paper and was specifically included in the press release but does not appear in the body of the paper itself.

    I cannot help Ross when Ross seeks to contest that discussion and conlusions of the authors of papers are to be ignored as opinion and interpretation and the data and results preferred. That is well known and accepted. Obviously not by Ross, but then, Ross is a troll, so Ross will not accept anything if Ross can keep on arguing about anything. That is what trolls do.

  123. Dr John Briffa 12 July 2008 at 4:38 pm #

    ross re comment 119

    Who said anything about MMR and autism (in my comment 118)?

    As I said, it was an honest question (no need to be quite so defensive…)

  124. ross 12 July 2008 at 5:04 pm #

    OK Clifford, just started to read your webpage for “the evidence showing a causal mechanism between vaccines and autism” bearing in mind that “only data and results of formally published papers are relevant. Either you cite the formal literature or you do not.”

    http://homepage.ntlworld.com/clifford.g.miller/Mitochondrial.html

    I got as a far as the 2nd paragraph when I came across:

    “The clinical “vaccines-to-autism” case of Hannah Poling appears to be just one example of what is shown by the recent research to be caused by a biological mechanism.”

    Now apart from the fact that the statement is unclear and ungrammatical, please cite the evidence that the Poling case was ‘vaccine to autism’. I think you should define what you mean by ‘a biological mechanism’. Inheritance of genetic traits is a biological mechanism but I don’t think that is what you mean.

    Paragraph 2 then goes on to say:

    “That mechanism is indicated by current research to account for 20% of cases of autistic spectrum disorders (ASDs) and be triggered by vaccines. ”

    The study you reference is here:

    http://adventuresinautism.com/images/VivaPortugal.pdf

    It states quite clearly that:

    “The global prevalence of ASD per 10 000 was 9.2 in
    mainland, and 15.6 in the Azores, with intriguing regional
    differences. A diversity of associated medical conditions was
    documented in 20%, with an unexpectedly high rate of
    mitochondrial respiratory chain disorders.”

    You even underlined the last sentence!

    What led you to conclude that the ‘biological mechanism’ you refer to could “account for 20% of cases of autistic spectrum disorders (ASDs) and be triggered by vaccines.”?

  125. ross 12 July 2008 at 5:06 pm #

    Dr B, not defensive, guess I was just a little bit eager for an answer to the following:

    You said “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 presumably you would 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’) you would also 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?

  126. ross 12 July 2008 at 5:35 pm #

    CM “Ross – deal with the important point – do you agree or disagree that there are plausible biological mechanisms for how vaccines cause autism.”

    I haven’t seen any good evidence but I’m willing to be persuaded. Show me some evidence.

    CM – “I see Ross still has no answer to the evidence showing a causal mechanism between vaccines and autism some of which I put on my website ”

    I’ve got as far as para 2, see above.

    CM “That is key to the discussion here. Ross instead ignores that and goes off on a tangential troll regarding the fraud issue relating to Cochrane.”

    We’ve been discussing the Cochrane MMR review for most of this post. It’s very much part of the discussion. You raised the fraud issue, not me, I just asked you to provide evidence to back up yor claim. I will do so once again:

    Please provide a quote of one of the authors of the Cochrane MMR review stating, in his or her own words, that the “review itself has been associated…with fraudulent research practices”.

    That was your original claim (“The Cochrane MMR review itself has been associated, in the very words of one of its own authors, with fraudulent research practices”) so please provide the quote, not a reference to the paper.

    “What Ross calls a “plain language summary” is not part of the body of the paper. ”

    Again, I’ll point out that the authors call it a ‘plain language summary’,

    “Ross now has difficulty contesting the plain language summary was quite obviously written after the event.”

    I don’t. I said “Hmmm, well I wouldn’t have expected them to write the summary before the research was concluded.”

    But you said: “That statement appears to have been added after the event to the abstract for the puirposes of inclusion in worldwide press releases.”

    Appears to? For the purposes of inclusion in worldwide press releases? Where’s your evidence for this? Even if it was, what’s your point? Presumably the authors are happy that it’s a fair reflection of their findings since they wrote it, why do you disagree and are you going to take up this issue with them or have you done so?

    “The particular sentence Ross claims to rely on is not supported by the data and the results of the paper. ”

    I don’t claim to rely on that particular sentence. And please explain why the review summary is not supported by the data and the results of the paper and why the review authors have made an error in their summary.

  127. Cybertiger 12 July 2008 at 7:48 pm #

    ross said,

    “Oh and CM, well done for getting published in such a prestigious journal as JPANDS (formerly the Medical Sentinel). Was that your first choice or did you submit elsewhere? Perhaps to a journal that is listed on MEDLINE/PubMed? Or one that hasn’t been described as the “house magazine of a right-wing American fringe group [AAPS]” and “is barely credible as an independent forum.””

    In some of my more pointless travels into the outer reaches of the blogosphere, I recall a cranky creature with an obsessive antipathy to JPANDS. The alien blogoterritory onto which I inadvertently alighted (!) was occupied by a certain Anthony R Cox PhD, an evil pharmacovigilant insurgencyshill from the far-out planet MHRA.

    http://www.blacktriangle.org/blog/?p=1798

    (Home territory is currently a very arid and bleak place to land)

    Dr Cox, blacktriangulist, said,

    “The anti-vaccine movement feeds off a steady stream of poor quality research that either appears in posters at conferences not subjected to sufficient scientific scrutiny, in gray literature, or in dubious journals. The Journal of American Physicians and Surgeons (JPANDS) is the house journal of The Association of American Physicians and Surgeons (AAPS). The AAPS are a right wing fringe medical organisation in the US described by the New York Times as “ultra-right-wing… political-economic rather than medical” group. Their journal carries material denying that HIV is linked AIDS, that gay lifestyles shorten life by 20 years, and is pro-creationist.”

    We know that ‘ross’ has never worked full time as a ‘Senior Shill for Evil Pharma Ltd’, so any similarity with the views of Anthony R Cox must surely be entirely coincidental.

  128. Clifford G. Miller 12 July 2008 at 7:57 pm #

    In reply to David July 12, 2008 @ 2:43
    pm

    You really must tell us who you are and what you do. You are demonstrating a comprehensive lack of knowledge. It is impossible to have a reasoned debate with those unencumbered by the facts.

    It is essential to ignore the conclusions and summaries authors have written concerning their own data and to assess the data and results independently.

    That is a fundamental and a given. David is unaware of this.

    If the conclusions of authors of a paper diverge from their own data and results, it is not a question of whether anyone disagrees but a question of what the data and results show rather than what the authors claim and opine or would like them to show as stated in their discussions and conclusions, influenced by author bias.

    If David wants to think the data lead to “ridiculous conclusions” he is welcome to do so. It is a free world. And he really does not have to believe “merely because” I “say so” but by assessing the data and results, if he is able, which regrettably appears not to be the case.

    David’s difficulty is that he is wrong and cannot admit it and because, like his double act with Ross, he appears to be trolling.

  129. ross 12 July 2008 at 10:31 pm #

    You said “do you agree or disagree that there are plausible biological mechanisms for how vaccines cause autism.”

    Then you said “What you need to do is to answer the question, either “yes” or “no”.”

    No I don’t. I need to answer the question. Which I did.

    Then you say “Ross cites Wikipedia as a peer reviewed authority. Wikipedia is not a reliable source.”

    I didn’t ‘cite Wikipedia as a peer reviewed authority’. If you think I did then please quote my actual words.

    Instead of making strawman arguments like the ones above, perhaps you’d like to deal with the substance of the questions I’ve asked.

  130. John Stone 12 July 2008 at 10:31 pm #

    Clifford

    I have noted above that trolling or not, the strategy of certain posters in this blog and related ones has been to hide behind the “plain language summary” of Cochrane, and accuse others who go to the main text of such crimes as “quote mining”. This was the case, for instance, when I collected Cochrane’s remarks on all six autism studies:

    http://www.drbriffa.com/blog/2008/06/13/fda-acknowledges-that-the-jury-is-still-out-on-whether-mercury-amalgam-fillings-can-be-hazardous-to-health/#comment-97631

    Quoting the main text of Cochrane is evidently a great heresy, it is the “plain language summary” in which official truth lies. It should be said once and for all that the “plain language summary” is not – in plain language – a summary at all: it has the character of an official statement for popular consumption tacked on to the main text, and is deliberately misleading – this is true, whoever authored it.

    I think it is fascinating to watch these apparently seasoned professionals like Ross and David, who really want to tell you that anything which lies below the public front “of the plain language summary” and the press release are mere details.

  131. ross 12 July 2008 at 10:41 pm #

    CM, – are you happy to be published in a ‘scientific’ journal that sees fit to publish ‘scientific’ studies such as “Conspiracy ” Part III, by Curtis W. Caine, MD. 1999;4(6):224″ that concludes that “‘humanists’ have conspired to replace the “creation religion of Jehovah” with evolution”? Was this your first choice? Second? Third?

  132. ross 12 July 2008 at 10:53 pm #

    CM, you said “Ross – deal with the important point – do you agree or disagree that there are plausible biological mechanisms for how vaccines cause autism.”

    I said “I haven’t seen any good evidence but I’m willing to be persuaded. Show me some evidence.”

    Could you please explain why this isn’t an acceptable answer and why only:

    “I agree that there are plausible biological mechanisms for how vaccines cause autism”

    or

    “I disagree that there are plausible biological mechanisms for how vaccines cause autism”

    would suffice. Please bear in mind that we are working in the shadow of the wisdom of the famous “Briffa Blue Ball/Red Ball Thought Experiment (TM):

    http://www.drbriffa.com/blog/2008/06/02/i-was-going-to-write-about-beta-carotene-and-sunburn-but/

  133. Clifford G Miller 12 July 2008 at 11:03 pm #

    In response to “Ross” July 12, 2008 @ 5:04
    pm

    The question for you is whether you agree or disagree that there are plausible biological mechanisms for how vaccines cause autism.

    What you need to do is to answer the question, either “yes” or “no”. If it is “no” then you need to tell us all who you are and what you believe your credentials are for forming a view.

    Ross cites Wikipedia as a peer reviewed authority. Wikipedia is not a reliable source. It is edited by nine year olds, anonymous people some of whom pretend to have advanced academic qualifications they sadly lack and others some of whom sadly appear to spend their lives on in a zealotic zeal to ensure only what they agree with is published.

    The Journal of American Physicians and Surgeons and the 4000+ members of the Association of American Physicians and Surgeons, the journal takes no drug company advertising. It is very unpopular with those who are fond of the drug companies and who take all the freebies. It is very common for people like Ross and Anthony Cox to attack it in very personal terms, as well as the wikipedia zealots. However, it continues to challenge and its mission statement is “publishing scholarly articles related to the practice of medicine and to promoting open debate and scientific integrity.”

  134. ross 12 July 2008 at 11:04 pm #

    But before you deal with the myriad questions I’ve asked of you so far (that you haven’t taken the trouble to answer as of yet) could could you please explain how you got from:

    “The global prevalence of ASD per 10 000 was 9.2 in mainland, and 15.6 in the Azores, with intriguing regional differences. A diversity of associated medical conditions was documented in 20%, with an unexpectedly high rate of mitochondrial respiratory chain disorders.”

    to:

    how the ‘biological mechanism’ you refer to could “account for 20% of cases of autistic spectrum disorders (ASDs) and be triggered by vaccines.”?

  135. Clifford G Miller 13 July 2008 at 12:36 pm #

    In reply to Ross July 12, 2008 @ 11:04
    pm

    All you have to do Ross is say whether or not you agree there are plausible biological mechanisms for vaccines causing autism. Is it “yes” or is it “no” or are you saying “maybe”? If it is “maybe” then surely that is “yes” because the question is asking for “plausible” mechanisms. I will not require that you provide proof. I will be happy to provide proof once you have pinned your colours to the mast and you also need to tell us who you are and what background you have to debate these matters. As previously noted, it is difficult to engage in a meaningful dialogue with those unencumbered by the facts.

    Is that OK, Ross?

  136. John Stone 13 July 2008 at 2:29 pm #

    Ross

    Could you be specific about which facts in Clifford Miller’s JPandS article about Cochrane you are disputing?

  137. Ross 13 July 2008 at 7:57 pm #

    “All you have to do Ross is say whether or not you agree there are plausible biological mechanisms for vaccines causing autism. Is it “yes” or is it “no” or are you saying “maybe”? If it is “maybe” then surely that is “yes” because the question is asking for “plausible” mechanisms.”

    There may be plausible biological mechanisms for vaccines causing autism but I haven’t seen any good evidence that there are. Which was my original answer. Do you have any good evidence?

    “Could you be specific about which facts in Clifford Miller’s JPandS article about Cochrane you are disputing?”

    JS – where have I disputed anything? CM said:

    “The Cochrane MMR review itself has been associated, in the very words of one of its own authors, with fraudulent research practices”

    I merely asked him to provide a quote of one of the authors of the Cochrane MMR review stating, in his or her own words, that the “review itself has been associated…with fraudulent research practices”.

    So CM, I’ve answered your question. Are you going to answer any of mine? Apart from asking you to provide the quote, they are as follows:

    Presumably the plain language summary was written by the authors and they are happy that it reflects their findings. Do you have any evidence to the contrary?

    Do you know of any other studies where the conclusions and plain language summaries were not written by the authors and do not reflect their findings?

    Can you please provide a good explanation as to why the conclusions the authors draw and the plain language summary they provide are to be ignored?

    “That statement appears to have been added after the event to the abstract for the puirposes of inclusion in worldwide press releases.” Appears to? For the purposes of inclusion in worldwide press releases? Where’s your evidence for this? Even if it was, what’s your point? Presumably the authors are happy that it’s a fair reflection of their findings since they wrote it, why do you disagree and are you going to take up this issue with them or have you done so?

    The “no credible evidence” claim is an interesting statement in itself for authors who are meant to be so expert.” Perhaps you could point to the ‘data and results of formally published papers’ to demonstrate the credible evidence? After all, you have stated that only this is relevant.

    “Conclusions or discussions of authors or papers are opinion and irrelevant.” Please explain why.

    “Even if Ross claim this is a statement in an abstract, that is also not the body of the paper and is to be disregarded.” So the statement “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate” from the ‘Authors’ conclusions’ section of the abstract can be disregarded as an argument for supposedly demonstrating that the other review findings in the same study have been undermined? Are you using this statement as evidence for your argument that “as the papers the Cochrane MMR review commented on were themselves were so poor, they were not credible evidence” or do you have more substantial criticisms of the science?

    “The clinical “vaccines-to-autism” case of Hannah Poling appears to be just one example of what is shown by the recent research to be caused by a biological mechanism.”
    Now apart from the fact that the statement is unclear and ungrammatical, please cite the evidence that the Poling case was ‘vaccine to autism’.

    “That mechanism is indicated by current research to account for 20% of cases of autistic spectrum disorders (ASDs) and be triggered by vaccines. ” The study you reference(…)states quite clearly that: “The global prevalence of ASD per 10 000 was 9.2 in mainland, and 15.6 in the Azores, with intriguing regional differences. A diversity of associated medical conditions was documented in 20%, with an unexpectedly high rate of
    mitochondrial respiratory chain disorders.” What led you to conclude that the ‘biological mechanism’ you refer to could “account for 20% of cases of autistic spectrum disorders (ASDs) and be triggered by vaccines.”?

    Are you happy to be published in a ‘scientific’ journal that sees fit to publish ‘scientific’ studies such as “Conspiracy ” Part III, by Curtis W. Caine, MD. 1999;4(6):224″ that concludes that “‘humanists’ have conspired to replace the “creation religion of Jehovah” with evolution”? Was this your first choice? Second?

    I appreciate that there’s some crossover between these questions but perhaps if you take them one by one from the beginning you can just point out the duplicates.

    (It would be good as well if you could avoid the strawman ‘Ross cites Wikipedia as a peer reviewed authority’ type of argument, the ignoring my previous answer‘Ross has difficulty contesting the summary was written after the event’ type of argument, the ad hom‘Ross is a troll’ type of argument, the ascribing somebody else’s words to me ‘What Ross calls a “plain language summary” ‘ type of argument and, my personal favourite, the ask a question and assume because you don’t get an immediate answer then the respondent has been won over by the force of your ‘evidence’ “I see Ross still has no answer to the evidence” type of argument).

  138. Clifford G Miller 13 July 2008 at 10:29 pm #

    In response to Ross July 13, 2008 @ 7:57
    pm

    Ross says There may be plausible biological mechanisms for vaccines causing autism but I haven’t seen any good evidence that there are.

    Is that a “yes” or a “no”, Ross? What is your position? Are you here to contest that vaccines cause autism or what? At the moment it looks like you are here to waste people’s time or to quote you “the myriad questions I’ve asked of you so far” look very much to me like trolling.

    Pin your colours to the mast. What are you here for? And you really must tell us who you are and what background you have to debate these matters. As previously noted, it is difficult to engage in a meaningful dialogue with those who appear to be unencumbered by the facts.

  139. Ross 13 July 2008 at 10:45 pm #

    “Wikipedia is not a reliable source. It is edited by nine year olds, anonymous people some of whom pretend to have advanced academic qualifications they sadly lack and others some of whom sadly appear to spend their lives on in a zealotic zeal to ensure only what they agree with is published.”

    CM, one more for the pile. You obviously don’t have a high opinion of Wikipedia (I’m also wary of those who refuse to accept other points of view and revel in ‘zealotic zeal’) but are there any inaccuracies in this article?

    http://en.wikipedia.org/wiki/Association_of_American_Physicians_and_Surgeons

  140. Clifford G. Miller 14 July 2008 at 10:15 am #

    In response to Ross
    July 13, 2008 @ 10:45
    pm

    As all can see, instead of coming clean, Ross has gone off on a troll to Wikipedialand, ducking and diving as trolls do. So endeth these exchanges – what has become a troll’s version of the tennis-elbow-foot game.

  141. David 14 July 2008 at 12:31 pm #

    Mr Miller, I can agree with you in some things.

    I see from your website that you are trying to find papers that might support a link to autism and vaccination and which explore possible biological mechanisms. That is commendable, but you must remain objective, and examine all the evidence, not just cherry-picking papers that can be used in anyway possible to confirm your preconceptions. That is not how science works.

    Secondly I can agree that it is the data which are important. You are vitriolic in your criticism of ross and myself for considering what the authors conclude about their own studies. OK, let’s play the game by your rules. Where, in the peer-reviewed publication of the case of Hannah Poling is there any evidence or data to indicate vaccination triggered her “autism”? There is none, of course. It is others who have subsequently drawn this conclusion. And we all know how much you dislike people drawing “conclusions”. Even statements from Hannah’s father do not count, as these are clearly “made after the event with an eye to promoting a certain viewpoint for public consumption” – a form of “plain language summary”, as it were. (And don’t forget that there is the added conflict of interest in seeking compensation for vaccine damage to be considered). This being the case, by your own criteria, all these statements about vaccines, mito dysfunction and autism can be immediately disregarded. Delightful irony, don’t you agree?

    So what about mitochondrial dysfunction? Is it a plausible mechanism for triggering autism? Well, possibly, and I look forward to more studies. But remember that according to the biological hypothesis put forward, virtually anything could “trigger” the metabolic cascade, including fevers and infections. This is important, as children suffer from dozens of mainly viral infections in their infancy, many of which may be inapparent. An attack of genuine natural measles, for instance, would certainly be a potential trigger since it causes several days of febrile illness with high spikes of fever. As I have mentioned in other blogs, there may be justification in vaccinating children to expressly prevent this possible outcome.

    You have mentioned on your website that:

    “The clinical “vaccines-to-autism” case of Hannah Poling appears to be just one example of what is shown by the recent research to be caused by a biological mechanism. That mechanism is indicated by current research to account for 20% of cases of autistic spectrum disorders (ASDs) and be triggered by vaccines.

    As ross has pointed out, this refers to the Portuguese study
    http://adventuresinautism.com/images/VivaPortugal.pdf

    Now I believe you did a science degree at University. Can you explain how you derive from the data in this paper, the conclusion that 20% of autism cases can be triggered by vaccination in someone with underlying mitochondrial dysfunction?

    You are quite right to warn us about people drawing incorrect “conclusions” from data – that is precisely what you have done here, since the data show nothing of the sort. The study showed several things (one of which was that autism rates are 1:1000 in Portugal – some way off the 1:50 or whatever it is that you guys are claiming this week.)
    They looked for possible medical explanation for autism. Having identified a group to analyse (120 cases) they immediately dismissed 15% which had obvious causal genetic disorders. In the remaining 102 cases, they did further studies. In 69, they checked for lab markers that might indicate mitochondrial disorders. The initial screening test for this was a serum lactate level – found to be abnormal in 14 (20%) of the 69 cases (Is this where your “20%” figure comes from?). Of these 14 cases, 11 had muscle biopsies, and mitochondrial dysfunction was definitively confirmed in 6 of them.

    By my own calculations, the only conclusions that can be drawn from this are that 8.7% (6 of 69) cases of unexplained autism in those where genetic disorders have already been excluded have underlying mitochondrial disorder. The authors (Figure 1.) put mitochondrial dysfunction at 4% of the total. It takes some bizarre mental gymnastics to conclude, as you do, that 20% of cases of autism have mitochondrial dysfunction triggered by vaccination.

    Now Mito dysfunction might be a problem, but do you know how prevalent it is in children without autism? In children with autism who have been vaccinated versus those who haven’t?

    I see why you are so fixated about “looking at the data” and ignoring conclusions. It is so you can cherrypick your own data from papers, use a bit of smoke and mirrors, and hey presto! – You can now present your own interpretation and conclusions – ones that conform to your preformed, biased opinion.

  142. Dr John Briffa 14 July 2008 at 1:27 pm #

    David

    Talking of potentially “preformed, biased” opionions, would you mind answering my question to you (comment 118) about the evidence (which may or may not exist) which shows that McDonald’s hamburgers don’t/can’t cause autism?

  143. David 14 July 2008 at 1:56 pm #

    Let’s see – First what is the evidence there may be a link? Plenty of anecdotal evidence where mothers recall visiting a McDonald’s within 3 months of their child being diagnosed as autistic. Plenty of “temporally associated” evidence – just look at the autism rates rising as the numbers of McDonalds outlets rise. Open and shut case I would have thought, wearing my “vaccine-autism hat”.

    So, evidence they are not closely linked? Studies showing that 90% of mothers already ate at McDonalds outlets even before the autism rates began to double. Evidence that when outlets have closed, autism rates still continue to rise. Scanty scientific evidence for a biologically plausible mechanism to relate the two events causally. Studies showing autism is also correlated to mothers eating at M&S. Studies examining children of mothers who ate at McDonalds and who did not develop autism at a rate higher than background. Evidence that the supposed indicator of autism in these children (PCR burger positivity) were all false positives. Population based studies showing no increase in autism rates with the opening of new McDonalds outlets. etc.

    However, despite all this “evidence” one could not reject the null hypothesis and conclude McDonalds never causes autism, because one can never prove a negative.

  144. John Stone 14 July 2008 at 3:15 pm #

    Grateful for David’s acknowledgement that “autism rates began to double”. At least we have stopped pretending they are flat. Perhaps David could communicate his sensible view to Prof Baron-Cohen, Ben Goldacre (IoP), Prof Sir Michael Rutter, Prof Eric Fombonne etc.

  145. ross 14 July 2008 at 3:22 pm #

    “As all can see, instead of coming clean, Ross has gone off on a troll to Wikipedialand, ducking and diving as trolls do. So endeth these exchanges – what has become a troll’s version of the tennis-elbow-foot game.”

    I answered your question Clifford. Are you going to answer any of mine?

  146. ross 14 July 2008 at 3:26 pm #

    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”?

  147. John Stone 14 July 2008 at 3:31 pm #

    I should also have mentioned Prof Brent Taylor, Prof Elizabeth Miller, Prof Gillberg….

  148. John Stone 14 July 2008 at 3:33 pm #

    You might call them the “flat-earthists” of the autism epidemic.

  149. Dr John Briffa 14 July 2008 at 4:55 pm #

    David

    You cite no actual evidence. Can you provide it please? Because if can’t, then what this looks like is an example of someone confidently predicting the outcome of an experiment before the experiment has even been done: Not exactly what you’d call ‘scientific’.

    This suggests a certain sort of mindset, I think. ‘Bias’ would be one way of describing it.

  150. Dr John Briffa 14 July 2008 at 5:34 pm #

    ross

    “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”?”

    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.”

  151. David 14 July 2008 at 6:06 pm #

    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.

  152. David 14 July 2008 at 6:16 pm #

    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.

  153. Dr John Briffa 14 July 2008 at 6:30 pm #

    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.

  154. John Stone 14 July 2008 at 6:43 pm #

    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…

  155. Clifford G Miller 14 July 2008 at 7:35 pm #

    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.

  156. Dr John Briffa 14 July 2008 at 9:55 pm #

    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.

  157. David 14 July 2008 at 10:08 pm #

    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.

  158. Dr John Briffa 14 July 2008 at 11:12 pm #

    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?

  159. Clifford G Miller 14 July 2008 at 11:38 pm #

    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.

  160. John Stone 14 July 2008 at 11:54 pm #

    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.

  161. David 15 July 2008 at 9:29 am #

    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?

  162. David 15 July 2008 at 9:40 am #

    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.

  163. ross 15 July 2008 at 4:25 pm #

    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?

  164. ross 15 July 2008 at 4:39 pm #

    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.

  165. Dr John Briffa 15 July 2008 at 5:49 pm #

    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).

  166. Dr John Briffa 15 July 2008 at 6:11 pm #

    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.

  167. Ross 15 July 2008 at 8:59 pm #

    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.

  168. David 16 July 2008 at 11:35 am #

    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:

    “Please reflect on how I have quoted the text from the actual reviews in support of these views.”

    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:

    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.

    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.

  169. John Stone 16 July 2008 at 1:45 pm #

    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.

  170. Ross 22 July 2008 at 11:42 pm #

    Dr B – any response to 167 & 168?

  171. Dr John Briffa 23 July 2008 at 1:03 pm #

    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.

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