Sense about Science: Follow the Rhetoric

June, 5, 2014 | 30 Comments

Comments

  1. Very interesting indeed Dr. Healy.

    Considering the members of sense about science will likely be reading your blog post- perhaps they would like to inform us if they receive any funding from GSK? If so, how much, over the years? (donations or otherwise). There are reports- easily found on the internet- which claim that sense about science has taken funding from the pharmaceutical industry over the years and continues to do so and also reports that many of its trustees and supporters have close ties t industry in one way or another. Maybe Ben Goldacre, Tracey Brown, or Dick Taverne – from sense about science -would like to offer the public some clarity on these possible conflicts of interest?

    • The issue is not so much do they or anyone – such as RxISK – receive funding from Pharma. Its more a case of by their fruits you shall know them. Has Sense about Science any track record in bringing adverse events to light or do they figure these things are part of the Cowardice of a Pampered Society. From the Sense about Science booklet on Drug Safety you wouldn’t be able to tell.

  2. David,

    Can I try to understand your complaint here and how it fits in with your own company RxISK.

    It is hard to understand your obvious dislike of Sense about Science and Ben Goldacre. They are simply calling for greater transparency and the publication of trial results so that doctors can make better decisions.

    However, I wonder if your company might suffer under such a regime. Please correct me if I am wrong, but your business model is to harvest adverse drug events from patients (they already have the yellow card scheme) and then you package these reports up and sell them to pharmaceutical companies, if they are willing to pay for them.

    This looks like the opposite of transparency and the freedom of such data.

    Would be interested to hear your thoughts.

    • Andy

      It is of course going to be difficult to have a good feel for the issues from the first 2000 words of an 8000 word post. It may be clearer by the end. There is not an obvious dislike of BG or SaS. There are two issues – one is SaS transparent. The second is that even if every one is transparent, and of the best of intentions, are we going the right way. In my opinion, while AllTrials may have done well to help raise awareness of the issues, at present its position is not one that I could sign up to.

      As regards RxISK, exactly these issues come up in a later post and you’ll be better able to judge then But the point has come up in earlier posts also. In some respects RxISK would be better off if there was absolutely no transparency. Its going to make RxISK’s mission more difficult if there is full transparency and even more difficult if there are just the appearances of transparency. The whole transparency debate puts on undue premium on RCTs. If you can’t wait for the next two posts, this was all covered over a year ago in a series of posts starting with Not so Bad Pharma onwards and most recently Welcome to Troy where my personal views confused some others in RxISK as the comments show.

      The business model you talk about for the record is a work in progress and is not a sell data to pharma model. We were intrigued several years ago by the fact that Pharma apparently have a legal obligation to access adverse event reports where they know they exist. They know we have adverse event reports on their drugs. We imagined they might be duty bound to access them. Some generic companies have felt duty bound in response to publications based on these reports but the branded companies haven’t. We will have two reports soon on 93 cases of SSRI induced alcoholism and 120 cases of Persistent post treatment sexual dysfunction. It will be interesting to see if these papers stimulate GSK and Pfizer etc into enquiring whether any of these problems have happened on their drugs. If they do, there will clearly be administrative costs behind retrieving such data. We were interested over a year and half ago in how this might work out and in how the bioethical or average concerned reader might view our “taking” money from Pharma for instance for this purpose. There is as you’ll see extensive debate about this on this blog.

      I suspect that what you’ll glean from this is that we are still quite uncertain about what we are doing which is probably appropriate given the novelty of what we are doing. Around this time we set up a community advisory board to keep us honest. For the record we have not taken a cent from either a pharmaceutical or other company to date.

      I hope these answers keep you going pro temp

      David

  3. It is evident that Sense About Science no longer receives any direct funding from pharma although this was not always the case, and it looks as if this may be a policy decision made in acknowledgement of their former vulnerability to criticism on this matter. In 2007 I posted a BMJ Rapid Response to an earlier article by founder chairman, Lord (Dick) Taverne who was complaining public funding for litigation against the MMR manufacturers and the NHS over Alder Hey. Meanwhile, Taverne had failed to disclose his own conflict as Sense About Science chair. Of course, his goal has by now long been achieved (the Legal Services Commission would not even fund litigation against Merck over Vioxx which had already been successful in the US) and for all effective purposes all medication are now administered entirely the risk of the patient in the UK. Anyhow, my letter records the earlier position (unfortunately the links will no longer work). Clearly they could still receive funding from sources close to the industry which indeed may themselves have received industrial sponsorship.

    Finally, I also note in relation Taverne’s apparent fabrication about the MMR litigants that any information of this sort should certainly have been confidential.

    ‘Unaccountable
    ’10 December 2007

    ‘Revisiting this article by the (unacknowledged) chairman of Sense About Science [1] I was struck by this remarkable statement:

    ‘”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.”

    ‘On what basis could Taverne claim either that this was a group (some may have known each other, but others not) or that they were “strong believers in homeopathy”. One thing that is fairly certain about all of them is that they had their children vaccinated: that some may have become disaffected with mainstream medicine might perhaps be a factor of their experience, but if he was saying that collectively the litigants were adherents of homeopathy this is without foundantion and the purest nonsense.

    ‘What is disturbing about this article after all this time is the way it targets people rather than provides any scientific argument for its position, and is substantially propagandistic. Sense About Science list as its sponsors:

    ‘”the ABPI, AstraZeneca plc, BBSRC, The Biochemical Society, Blackwell Publishing, BP plc, British Institute of Radiology, Dixons Group plc, Elsevier, Engineering and Physical Sciences Research Council, The Esmee Fairbairn Foundation, Garfield Weston, GE Healthcare, GlaxoSmithKline, Halifax Bank of Scotland, Health and Science Communication Trust, Institute of Physics, Institute of Physics and Engineering in Medicine, John Innes Centre, John Innes Trust, Medical Research Council, NESTA, New Scientist, Oxford GlycoSciences plc, Pfizer plc, The Physiological Society, Royal Academy of Engineering, Royal Astronomical Society, Royal College of Radiology, Royal Pharmaceutical Society of Great Britain, Royal Society of Chemistry, Science Careers.org, Social Issues Research Centre, The Society for Applied Microbiology, The Society for Endocrinology, The Society for General Microbiology, Unilever plc. Help with equipment, facilities and services has been received from: AXA Investment Management, Horticultural Research International, Institute of Biology, The Natural History Museum, Lord Stevenson of Coddenham, and WPP.” [2]

    ‘Now that the ABPI have a code of practice [3] it is also an interesting question whether influencing public perceptions through such lobby organisations fits either within its spirit or its letter.

    ‘[1]http://www.senseaboutscience.org.uk/index.php/site/about/7

    ‘[2] http://www.senseaboutscience.org.uk/index.php/site/other/130/

    ‘[3] http://www.bmj.com/cgi/eletters/335/7618/480#176540

    ‘Competing interests: Autistic son’

    • It has been pointed out to me that a further false aspect of Taverne’s claim was that the first Legal Aid Certificates in the MMR litigation were granted in 1991 and 1992 in respect of the products Pluserix (GSK) and Immravax (Sanofi Pasteur) which had been withdrawn by the manufacturers in 1992 after many reports of adverse reactions (the GSK vaccine had already been withdrawn in Canada in an agreement with the Canadian government in 1988 even before it was introduced in the UK). These were not frivolous suits.

      There were a couple of words left out in my previous comment:

      “Lord (Dick) Taverne who was complaining public funding..”

      should have read:

      “Lord (Dick) Taverne who was complaining about public funding..”

      and

      “..and for all effective purposes all medication are now administered entirely the risk of the patient in the UK.”

      should have read:

      “..and for all effective purposes all medication are now administered entirely at the risk of the patient in the UK.”

      I should also have given the link to my BMJ letter:

      http://www.bmj.com/rapid-response/2011/11/01/unaccountable

  4. About “data” . . . anybody who has conducted empirical research knows that these are the recorded observations of an observer or the recorded responses of a research subject. For analytic purposes, these are “coded” according to rules that are inscribed in a “code book.” Thus, “access to data” requires access to facsimiles of the original recorded observations/responses and the codes and codebook. With these in hand, independent sources can check the original observations/responses against the codes in replicating the original analysis. Edited CSRs are clearly not the original data. CRFs may or may not be . . . depending on whether or not they contain the original uncoded observations/responses. If coded, one still needs to check the codes against the uncoded observations/responses for reliability. In careful research, one typically checks the inter-reliability of coders in coding the original observations/responses and makes known the results as part of any published or unpublished report. I am struck how seldom this essential step is published in clinical trial reports. That said, the AllTrials brouhaha serves to remind how much ignorance surrounds the topic of true scientific transparency that will permit (1) replication of the original analysis and (2) replication of the entire study with full knowledge of intervention ingredients, research subjects, and surrounding conditions. As a consequence, I think we are foundering over competing agendas and rhetoric.

  5. Hi David, in your recent post you wrote:

    “In the UK, the most potent weapon on the lips of the academic puppets sitting on corporate hands ever since has been that Godlee or Jefferson is another Wakefield”.

    I am not sure I understand what you mean. Could you clarify for me?

    Sorry for disturbing you.

    Best wishes,

    Tom [Jefferson].

  6. Apologies Tom, this isn’t as clear as it might be. The point was that rather than engage with you you would be smeared as being a Wakefield – particularly easy in your case being easily cast as anti-treatments for flu.

    As the post goes to make clear this is exactly the kind of slur Rory Collins has attempted to apply to Fiona Godlee.

    This is one of four posts – you keep coming up in the next three so worth keeping your eyes peeled for any more misphrasings

    David

  7. David,
    Thanks for this. Over here in the former colonies, we don’t so much know about the vaccine stories and how that history is part of the current EMA/AllTrials/SaS narrative. Any and all clarity appreciated. Likewise, the distinction between CSRs [Clinical Study Reports] and CRFs [Clinical Record Forms] is vital and can’t be emphasized and clarified too often. Assuming a Clinical Trial has been well executed in a double blind fashion, the trouble starts the day the blind is broken. “Data” is the information that comes available on that day. Any version beyond that is suspect…

  8. Dr. Nardo,

    I’m fairly certain the following is not what you are looking for as the far as the intersection between the EMA, etc. and the vaccine stories. However, if you are interested in the anti-vaccination wars, this is the place to go. The site is almost wholly devoted to pillorying the anti-vaccination crowd, along with alternative medicine, and contains many references to Wakefield. It has a very robust search tool and I recommend using it to search on Wakefield or whatever else sparks your interest. Also, it covers much of what is happening in Britain, but is written by a doctor in the States.

    http://scienceblogs.com/insolence/

    OT: I think the scientists at there are wasting their massive brainpower on the low-hanging fruit of “quack” medicine, and often wish they would dissect mainstream medical research in addition, yet that is not where their interests lie. So, I don’t read the blog very much anymore.

    Arby

  9. I think RB (Arby) is indicative of the mentality of ‘Scienceblogs’ – unfortunately a lot of pillorying and labelling people and little to do with tolerant debate. In commenting here – as someone known for their views on the hazards of vaccines – I wanted to contribute to background knowledge of Sense About Science. I also suggest any assumption that concern about vaccine safety is in a different category from that of other pharmaceutical products would be extremely unwise (and dependant on propaganda): different category medicine but the same issues, only perhaps even worse because of the unscientific and sacrosanct status accorded to them.

  10. “Here and here are EMA’s proposals about how CSRs will be redacted, and here is Ben’s acceptance of this redaction and apparent buying the line that CSRs contain commercially confidential information.”
    I don’t support redaction of CSRs for “commercially confidential” information: I’ve campaigned against it. I don’t accept the EMA’s proposals about CSRs: I’ve campaigned against them. This is another set of entirely false claims from David Healy. I’m saddened to see David continue to post destructively.

    In previous posts and comments he has repeatedly asserted that people hold positions they do not, have done things they have not, and when asked to provide evidence he has failed to do so, retreating instead into ad hominem, changing the topic, and making further wild accusations. I’m reluctant to get further involved. If there is serious disagreement then that is a matter for productive discussion rather than false accusations or assertions about a shadowy conspiracy. If you need to claim someone holds a position that they don’t, to make your argument, then your argument is broken.

    David Healy has posted an email I sent from the top of a mountain on a family holiday from my phone. It was part of a discussion among a wide range of people on how best to respond to the EMA’s deplorable last minute backtracking on transparency (against which I have campaigned and lobbied), and offered up a few bits of context on EMA thinking in case they were helpful.

    I don’t support redaction of CSRs for “commercially confidential” information (nothing in my email says that I do). I don’t think CSRs contain this kind of information to any credible degree, as I’ve said on innumerable occasions, and it is a disappointing waste of time to have to deal with yet more of David Healy’s false claims. I was simply pointing out, from a mountain top, in case it was of use, that the EMA have produced a useful summary of where individual patient information (and stuff that companies argue is commercially sensitive) will appear in CSRs, in case it was helpful for people thinking through the broader issues around how to manage and monitor occasional necessary redactions; in case it was helpful for people thinking through how necessary redactions for personal confidential information on patients can be done cost effectively before public release of these documents where necessary; and in case it was useful to people thinking through how to monitor redactions in different sections of CSRs to ensure that inappropriate or dishonest redactions are not made.

    To be absolutely clear (I don’t support redaction of CSRs for commercially confidential information) companies in the past thought CSRs were just between them and the regulator, so in certain bits of the report they might discuss other commercial plans for the drug, new marketing authorisations for different uses that they might apply for in the future, and so on. Companies certainly won’t be doing that now, because they know we’ve moved culture forward and CSRs are plainly going to be public in future; and I don’t think companies can argue that previous commercial plans, for a CSR from, say, 2004, or 1998, are going to be relevant to their current commercial plans. So I don’t support redaction of CSRs for commercially confidential information. I don’t think there’s much commercially confidential information in CSRs, if any. And I’ve repeatedly criticised organisations claiming otherwise.

    Just to reiterate: I don’t support redaction of CSRs for commercially confidential information. I’ve never said I do. I’ve frequently said: I don’t support redaction of CSRs for commercially confidential information. I don’t support the EMA proposals, I’ve campaigned against them. David Healy is repeatedly fabricating positions and ascribing them to other people.

    To be absolutely clear: I *do* believe that *publicly* available CSRs should be redacted to remove confidential information about individual patient’s medical histories; and I *do* believe this individual patient information *must* be made available to researchers on application, with clear safeguards against inappropriate redaction, and with transparency around the application and adjudication process. The cost of this redaction is generally low and so cost is no significant barrier, despite what industry has claimed when he have taken them to task over this issue through AllTrials. When I have raised the need for researchers having access to confidential patient material redacted from publicly posted CSRs, some from industry have tried to argue that any gatekeeping role – to ensure researchers can get hold of it, while, say, malicious actors are excluded – represents an insurmountable administrative nightmare. This is plainly false. My suggestion on how to manage applications is covered in the long AllTrials document linked previously: essentially, I suggested that in the first instance it can be handled in the same way that the raw text of Yellow Card forms is handled, with applications through ISAC, since much of this information is the same thing, simply adverse event reports in free text.

    There are lots of models on how to manage access to confidential patient information, whether the descriptions of adverse events in CSRs, or huge rich computerised datasets of individual patient data in a trial, or collections of patients’ electronic medical records. It’s an important job that needs to be done: we cannot simply post rich individual patient data openly online, but at the same time, we need to ensure that it is not inappropriately withheld from researchers. This is extremely topical, and goes way beyond the issue of clinical trials.

    http://www.theguardian.com/society/2014/feb/21/nhs-plan-share-medical-data-save-lives
    http://www.theguardian.com/commentisfree/2014/feb/28/care-data-is-in-chaos

    The solutions are complex, and need to be hammered out in the open for a number of different areas. If you think no gatekeeping role is necessary, that this stuff should be freely and publicly posted on the internet, then you’ve probably not thought the patient confidentiality issues through. If you accept some kind of gatekeeper is necessary, then the discussion on what that will look like is just beginning, and it will involve heavy lifting. Innuendo, denunciations, and absurd false assertions about other peoples’ positions are not a productive contribution to that discussion.

    So there we go. My position on all of this is already extremely well known to all sensible people interested in the topic. I’ve written on it extensively in Bad Pharma, AllTrials, badscience.net, the BMJ, academic journal articles, submissions to select committees, lectures, newspaper articles and evidence sessions, and so on. There really is no need to create any peculiar new beliefs for me, I write very directly, my positions are clear, and if anyone has any genuine doubt on my view about these issues, they can just ask me.

    To return to David Healy’s latest false claims: once again, I don’t support redaction of CSRs for “commercially confidential” information, I campaign against it; and I don’t support the EMA latest backtracking, I’ve campaigned against it. I also don’t trebly sense check every email to guard against wishful misinterpretation, not least when those emails are sent from my phone on holiday to large email discussion lists of people I naively regard as fellow travellers on the road to greater transparency.

    Building towards culture shift and policy change involves people giving up their time for nothing, and going against the grain. It’s a shame to have to waste time on friendly fire. Past experience suggests that David Healy will now set out a new position that I don’t hold, fail to give any evidence, and revert into distraction when asked to do so. I also accept, with some disappointment, that it seems likely he will descend into further ad hominem attacks now that I have dared to stand up and reply to his false claims. I’ve chosen not to engage with his previous ad hominem attacks.

    There is one concerning issue that I’m loathe to raise, but equally loathe to leave unaddressed. David Healy has asserted on the previous thread that RxISK is a better approach than AllTrials. I am very concerned, like Andy Lewis, to find that RxISK is a private profit making company owned by David Healy, with six figure accounts, set up to harvest individual patient reports of adverse events, and then hold that potentially important data behind a paywall, with David Healy demanding that regulators or public health bodies pay him cash to have access to this information. I don’t believe that this is a productive contribution to side effects monitoring, or trials transparency, or our understanding of the relative benefits of treatments. I don’t see how it’s better than AllTrials, or even similar. It’s fine to make money doing your job, but it is odd to set up a business aiming to harvest and then keep important pharmacovigilance data secret, and very weird to launch repeated and unreasonable attacks on other people while trying to promote your own private profit-making business as superior. I’m also concerned that Tracey Brown making an allusion to concerns about this business model on the previous discussion thread seems to have been followed by an announcement of four long posts from David Healy denouncing her and others campaigning for transparency.

    David Healy has still failed to give any evidence to support the bizarre claims he made on the previous thread about positions I don’t hold. I suspect this will continue ad infinitum. Perhaps David will now announce a plan to write another four posts denouncing me: I hope he doesn’t want to waste everyone’s time more. If people are going to explain the importance of transparency anywhere, and discuss different approaches, I don’t think the website of a man making false claims, in amongst his keen followers from the anti-vaccination conspiracy theory movement, is the best place to spend time and energy. I trust that anyone sensible reading this will view any further new false assertions from David Healy, about my positions on these important matters, in the context of his previous repeated false claims and innuendo.

    • Well are we all on the same page? Its important to have an answer. For my money having worked with the GSK proposal for data access ending up with it would be a disaster.

      Let me do two bits of translation. Commercially confidential information is almost inconceivable in a CSR – any more than in the average academic article. It just doesn’t happen.

      Patient confidential material means adverse events. I can see why companies might want to hide this – but its got nothing to do with protecting the interests of patients and its exactly the kind of data that many people who have supported AllTrials would want to see in the public domain. Read on through the next few posts for more on this if its still not clear.

      Re RxISK – its good to see scrutiny of what RxISK is doing. For the record, all the money in RxISK comes from me and friends. When it began we had no real idea what we are doing because its never been done before. We have put the ambiguities involved out there in a series of posts and positively invited comment. We still aren’t sure what we’re doing but given the issues involved this is perhaps a good thing.

      RxISK has kept going as long as it has primarily because its powered by people who have lost loved ones through adverse events and because people with no expertise but lots of motivation have got stuck into the issues and solved problems that the experts couldn’t or wouldn’t.

      To repeat an earlier answer. RxISK hasn’t made a cent and at the moment seems unlikely to do so. There is a small trickle of donations and the kind of response from people that opens up the possibility that it would work best as a co-operative or people’s movement. We’ll see. The private element is primarily so a small group of people none of whose identities are hidden can react speedily to events and ensure that wherever it ends up if anywhere it doesn’t end up somewhere at odds with what the initial hopes were- which is to empower the average person visiting a doctor and the average doctor who is increasingly finding it hard to practice Good Medicine by which they mean something closer to the original vision of Evidence Based Medicine than what we seem to have now. RxISK is the brainchild of Data Based Medicine.

      David

  11. We all know Glaxosmithkline unleashed Seroxat/Paxil on an unsuspecting public with dirty data going back such a long time and it is corporate criminality not to allow anyone to gain access.

    Especially, as the Seroxat/Paxil deaths are ongoing and will never stop unless this data is revealed.

    What is it that people do not understand about corporate manslaughter?

    There is the success of US litigation, Serious Fraud Office investigation here and billions in fines – but legal action for personal injury in the UK is blocked.

    The worry for some of us is that Alltrials could potentially sabotage legal action against GlaxoSmithKline in this country.

    I haven’t read Fid’s post yet, I wanted to put down my own response first.
    But, it seems we are all asking the same question.
    Let’s talk about GlaxoSmithKline………….

  12. It seems to me that some people have wider concerns about an Alltrials/GSK ‘partnership’ – which go beyond the subtle nuances of clinical trial CSR’s, differences in opinions between Healy and Goldace etc etc. Many of us are concerned that GSK are merely using Alltrials in order to use the credibility and popularity of the Transparency movement in general. It seems – so far – that GSK have gained a lot from their association with Alltrials and the ideology of data transparency itself. They have gained this without actually implementing authentic and genuine Transparency and in fact it seems that researchers trying to work with the GSK remote desktop system have found it more of an obstacle to attaining information than anything else.

    Ben has yet to engage in dialogue with myself , Bon Fiddaman or the myriad of other ‘stakeholders’ with an interest in this debate….

    His comments so far are far from re-assuring…

  13. John Stone,

    I am not sure how you came to the conclusion that I am indicative of the mentality of ‘Scienceblogs’. You appear to agree with my assessment of the site as a place where they are pillorying the anti-vaccine crowd. Did you get the impression I agreed with that? And, hasn’t there been vitriol on both sides of this debate?

    If you knew more about me, you would know that I stood up to them. Not as an anti-vaccine proponent (which I am not), but as someone who suffers adverse reactions from them; every single time I get a shot. I had no intellectual arguments to dispute them with as my intellect goes about as far as a crayon in a gunfight. I simply asked why these reactions go unacknowledged. In the end they backed down because they couldn’t argue with me that it didn’t happen (because it did) and they could find no unreasonable fear of vaccines in me (which I don’t have).

    Anyway, where I was going with my previous comment about their brainpower and “quack” medicine, is that there isn’t a lot of science to pick apart in those arguments. I would rather they put their combined intelligence behind any science that is sketchy, whether vaccines, statins, psychotropics, or whatever. I am fascinated when those there go over a research study and reveal it to be flawed because of x, y and z. But, they seem to be pretty accepting of science as it is currently practiced and don’t have much interest in looking at anything other than vaccines and alternative medicine debacles.

    I agree with you that the vaccine issue is the same issue as all the other ones regarding pharmaceuticals. It is a massive subject though, and I am not convinced that everyone here has an interest in it like you and they do.
    Personally. I have no skin in the vaccine wars either way, but to know the truth.

  14. Dr. Goldacre,

    As a former drug study participant, I am very uncomfortable with the idea of study data being freely available to the public. However, I don’t understand the huge issues around vetting those in the public that wish to be investigators and giving them access to data scrubbed of all patient information. From what I signed off on to enroll, it appears drug companies were already coding data so that it was not patient specific at the time they ran their trials. See quote below. Btw, I found no confidently clause in the agreement for me, and the agreement itself doesn’t state it is confidential, so here you go.

    “Other Information:

    All information and test results will be kept strictly confidential to the extent allowed by law. Your records and your laboratory samples will be identified by a code. All records with identifying information will be available only to the investigators and a restricted number of representatives of the Institutional Review Board (IRB), the U.S. Food and Drug Administration (FDA) and Abbott Laboratories (the makers of ABT-229) or their representatives. The medical records utilized in this study will be entered into a centralized computer data base but only code numbers will be utilized. No publication of public discussion of the results of the research will contain information that could identify you.”

    Therefore, would you explain the patient confidently risks that everyone mentions only in passing? Is it because of the coding issue mentioned above, the fact that in some trials personal elements are the data, the fact that the demand is for raw data, not coded or is it something else?

  15. RB

    Sorry, I completely misunderstood what you were saying but I also think that what you call “the anti-vaccine crowd” are mostly people like you who vaccinated and now know that vaccines are not the unalloyed benefit that health officials and industry apologists would have us believe – case in point being the fantasy of Lord (Dick) Taverne QC, founder chairman of Sense About Science, who claimed the original MMR litigants were all people who were opposed to immunisation. Odd that.

  16. I wonder how many people have actually read the infamous Wakefield paper or The Lancet retraction of it? I suspect most people rely on widespread media assertions that it was completely fraudulent and thoroughly debunked. The Lancet retracted the paper for two main reasons: “the claims in the original paper that children were ‘consecutively referred’ and that investigations were ‘approved’ by the local ethics committee have been proven to be false.” While these are serious ethical issues, they do not nullify the findings of the paper itself, which were straightforward: “We describe a pattern of colitis and ileal-lymphoid- nodular hyperplasia in children with developmental disorders.” At no point did Wakefield et al. assert that the MMR vaccine caused either the gastrointestinal problems or the developmental disorders (including autism). In fact, they explicitly stated, “We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described.” They concluded, “Further investigations are needed to examine this syndrome and its possible relation to this vaccine.”

    How this paper came to be so heavily cited, despite being retracted, and was raised as a banner by the autism parents community against the MMR vaccine in particular and vaccination in general is a whole book in itself. But the episode illustrates several points: rightly or wrongly, vaccination has become the sacred cow of science and medicine. Unlike subjects such as GMOs and climate change, it can hardly be debated without drawing the ire of the likes of Paul Offit, Orac and most of the mainstream, especially the liberal, media. Assertions about the safety or efficacy of vaccines have reached the state of dogma, and to question them is heresy. Researchers who do question them are vilified, like Wakefield is, and marginalized. Studies researching a possible association between vaccines and autism have been conducted, and they can be divided into two groups: those that found no association and are touted as supporting the safety of vaccines, and those that do find an association and are promptly denounced. Recently a CDC researcher admitted that an association between the MMR vaccine and autism in African-American boys was deliberately omitted from the study results, but once again the mainstream either denounced the revelation or ignored it.

    We’re at a point where, if there is cause for concern with vaccines, we will never find out until it’s too late because no one has the courage to honestly study the question, for fear the answer might spook the herd. And oh, by the way, the problems with vaccines regarding clinical trial results and adverse events are no different from those with pharmaceutical drugs.

  17. Keith

    That’s right and the US is now being gripped by measles frenzy stoked by a media which refused to report about the CDC Whistleblower, William Thompson. The model looks like the phoney campaign we had in the UK two years ago over the alleged Swansea epidemic, led by a health official who ignored the normal rule (which perhaps did not apply in Wales) that you don’t announce reported cases as confirmed (as mostly they are not). Media screaming everywhere to tighten the mandates just as we had a hue and cry in the UK – led by the BBC in conjunction with Offit – to make the vaccines compulsory.

    As to the Wakefield paper you are completely right, but only to add a couple of points. The issue of referral and a lot of other matters like unauthorised investigations were dismissed by Judge Mitting in the English High Court in 2012 in the appeal of Wakefield’s senior colleague, Prof John Walker-Smith. Also, there was nothing wrong with the statement about ethical approval:

    “Ethical approval and consent

    “Investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust, and parents gave informed consent.”

    The investigations had ethical approval: the paper did not and did not need it because it was a review of patient data.

    The point of course was to make a public example of anyone who listened to parents about adverse reactions to vaccines. And it was very effective.

  18. We can also add that at no point was any of defence reported by the mainstream media. If you were an alleged international terrorist or a genocidal politician the media would probably report your defence, but not if you are before the GMC. I guess that tells you how effective Dense About Science and Science Media Centre have been in their war on the public.

  19. A recent letter in the Los Angeles Times, commenting on the “measles frenzy”, hit close to the truth…while not dismissing the need for the shot, the writer stated that medicine (and, gosh, this includes Pharma) has brought it upon itself. Too many doctors flacking for too many destructive and fatal medicines, too many pushing dangerous medical devices and unnecessary surgery, and so on. Compounding this whole sad scenario includes what Americans see on their televisions each night – foolish commercials touting unneeded and quite often very dangerous prescription drugs – the dangers attempting to be papered over as when they are read out (in a low and fast tone of voice) the visuals attempt to be distracting.

    When will our doctors/pushers wake up to the fact that they have sold themselves down the river to the pharmaceutical/medical device/etc. industries and have broken the pledge that they all took in medical school to first do no harm?

    • Jana, I wholeheartedly agree with your assessment. Public awareness has been long time coming of the rampant conflicts of interest among physicians and other health-related professionals and, in general, of the take-over by Pharma of everybody in sight–most especially the facilitating politicians. So, why should we leap to obey our exploiters? The genie of lost trust is out of the bottle and cannot be put back. “Let the buyer beware” is the best advice for consumers of everything–used cars and medical advice and products included. Confronted with this reality, Diogenes would likely have given up long ago his quest for an honest man (or physician).

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