eLetters

77 e-Letters

  • A shot of light in the dark, but still waiting for the big bang

    I commend the authors for their well balanced and informative review on recent evidence on reduced fetal movement (RFM). Over the years I sadly saw the practice in the NHS being driven by fear and emotions rather than evidence, certainly, some units now offer mothers induction of labour even after a single episode of RFM! Junior doctors are prompted to act on RFM at induction day, and hospitals are adopting the official Care Bundle from the NHS promoting action (http://www.geh.nhs.uk/latest-news/saving-babies-lives-campaign/) yet, where is the evidence that any of this is beneficial?! certainly efforts like the AFFIRM study need wider dissemination and adoption by policymakers. The question remains, what can we offer to worried couples presenting with RFM daily? Still waiting for the game-changer.

  • Industry sponsorship bias in the SGLT2 inhibitor study

    The EBM Verdict by O'Sullivan on the CREDENCE trial of canagliflozin and renal outcomes (1) concluded that "Sodium-glucose cotransporter-2 (SGLT2) inhibitors appear effective to reduce cardiovascular events and deterioration of renal disease in patients with type 2 diabetes and renal impairment." O'Sullivan stated that the study was well-conducted based on conventional assessments of validity (blinding, randomization method, choice of outcomes). However, an important overlooked source of potential bias was not mentioned. The CREDENCE study was sponsored by the pharmaceutical company (Janssen). The analyses of the data was conducted by Janssen, and important conflicts of interest were reported by authors of the paper. A Cochrane review of the relationship of industry sponsorship and research results (2) found significantly more favorable efficacy results in studies by the manufacturing company than sponsorship by other sources, and that the industry bias could not be explained by other "risk of bias" assessments. This important source of bias warrants caution in the interpretation of the results in the absence of independent (non-industry sponsored) data.

    1. Perkovic V. et. al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. CREDENCE Trial Investigators. N Engl J Med 2019;380:2295–2306.
    2. Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database of Systema...

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  • An epidemic of spin in psychiatry

    Psychiatry is, to an extent, a looking glass world, in which the evidence base can be shrunk, expanded, or, the same as Alice, made to descend down a deep, deep hole.

    Joanna Moncrieff for anti- psychotics (1), and Irving Kirsch for anti- depressants, have been suspicious that the drugs concerned may often be not much better than placebo- or that the complexity of the drugs makes comparison with placebo problematic. (Moncrieff cites the impossibility of true double blinding because side effects are, unfortunately, so evident for patients and clinicians alike).

    The problem is money. Big Pharma tends to be avaricious, and how soon greed may make one disregard that silly obstacle known as truth!

    Spin can be the case even if there appears to be statistical significance. A large sample size- as in meta-analysis- will conclude a tiny difference, of no medical worth, is statistically significant. 'Overpowering' is spin too.

    Big Pharma, roaming around its own psychopharmacological 'wonderland', is ensuring, in the most bizarre and baffling ways possible, that everything is 'curiouser and curiouser'.

    References:

    (1) The Bitterest Pills. The Troubling Story of Anti-Psychotics. Joanna Moncrieff. Palgrave Macmillan. 2013.

  • The utility of Medicines Information services in addressing GPs' specific information needs

    Muscat et al1 report on their evidence-based information or ‘literature searching’ service supporting clinicians to answer their clinical questions. They found that treatment-related enquiries were one of the most common categories of clinical questions from a group of General Practitioners (GPs) from five practices in NSW and QLD, Australia. Medications are included in the classification systems used by the group. In particular the taxonomy of generic clinical questions includes at least seven codes specifically incorporating drug-related issues such as timing (code 2.1.1.3), indications (code 2.1.2.1* and 2.1.2.2), safety (code 2.1.3.3), adverse drug reactions (codes 2.1.3.1 and 2.1.3.2) and drug interactions (code 2.1.4.1).
    Medicines Information (MI) services also support clinicians in providing effective patient care and optimising therapeutic strategies in a timely manner. The National Prescribing Service funded Therapeutic Advice and Information Service (TAIS) operated in Australia from 2000 to 20102. It was a telephone-based service provided by a consortium of hospital-based medicines information services and handled over 6 000 enquiries annually from community based healthcare professionals across Australia. One third of enquiries were from GPs. Requests for advice regarding medication safety issues such as adverse drug reactions, drug interactions, dosing or administration and pregnancy or lactation were among the most common, supporting the findings of Musc...

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  • Research Integrity & BJPsych

    Dear Editor,

    We welcome the publication of the Jellinson study (9) which is consistent with the focus on research integrity lead by the BJPsych editorial team (please see our most recent retraction (1) and associated editorial (2)).

    The issue of ‘spin’ is a widespread problem across the whole research community and is not unique to psychiatry as recognised by the authors of this study (3, 4, 5). We note that according to the protocol the authors are carrying out and publishing similar studies in the fields of cardiology, otolaryngology (6), orthopaedic surgery, obesity medicine (7), anaesthesiology (8) and emergency medicine.

    It is unclear from the article or protocol why this subset of journals was chosen for evaluation. We would be interested to know why the number of journals was limited to 6 and what were the parameters for a journal to be considered ‘influential’. It is also interesting to note that none of the journals chosen exclusively publish psychology research (2 publish psychiatry and psychology research and the remaining 4 journals solely publish psychiatric research). Do the authors infer that the problem is more prevalent in influential psychiatry journals? The authors also acknowledge that identifying spin is subjective, highlighting the difficulties faced by journal editors and reviewers who are also trying to identify instances of spin.

    Since December 2017 (the end of data extraction in the study), the BJPsych has proactively t...

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  • Game keepers, poachers, thin ice and disease definition

    The fine paper by Moynihan et al moves the goal posts in terms of how changes in disease definitions are made.1 They identify many of the problems involved, including financial conflicts of interest. Their proposal fails to address two issues. First, only the most problematic vested interests are dealt with and second, they fail to acknowledge and address the necessarily flawed evidence base they must work out of.
    The authors find that the present financial arrangements in industry almost inevitably introduce unacceptable biases to its advocacy positions. Interests, so compromised, must be excluded from panels determining disease definitions. On the other hand, Moynihan et al. allow for participation by medical specialists deeply in the related fields. Such groups can have compelling financial and/or professional interests, particularly where private practice or turf battles prevail. This situation, though noted in passing, is inadequately challenged, and it is at least arguable, that the professions are too influential. The biases of many professional groups identified (and others not mentioned) can be just as problematic as those of the industry.
    The paper favours an evidential approach without noting the endemic medical evidence crisis of the last decade.2 This must be part of any serious discourse in which the wider public is, inevitably, included. Among the problems, in no particular order are poor choice of question; biases and poor quality in study desig...

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  • Yes, bias is pervasive . .

    I find this discussion unbalanced. Yes, bias is pervasive, and - unfortunately - primary care organizations are not exempt. Like, "the public" can be mislead - about chlorinated water and measles vaccination. But most importantly, put simply, expanding disease definitions usually means more patients to treat, and more cost to account for - this can be a negative incentive in health systems. I have witnessed on several occasions - including WHO BP treatment panels - a strong, explicit bias by primary care organizations to resist the evidence of benefit to treatment at lower levels of BP because it would increase patient loads. Historically the call to "not over-treat" goes back to the '60's, when many argued that "high BP was just like a fever - a symptom not a cause", and every step of progress has been to adopt lower targets. In my view, like it or not, pills are a new era in public health - much like vaccination. And, yes, wide use of safe, effective pills is being resisted for many of the same reasons. But progress cannot be denied, BP goals have declined from "never treat" to SBP of 120, with 80-90% decline in CVD - esp stroke. The US may have the bias toward more treatment (some doctors get patient for more visits . . ) but stroke rates are much lower than in Europe, and many dozens of US health systems have achieved the goal of 80% of treated patients with BP < 140, with excellent results. It shoul...

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  • Expanding the scope – pursuing a fully integrated discourse on health

    Expanding the scope – pursuing a fully integrated discourse on health

    Thank you for starting a long overdue discussion about the largely “insidious vested interest driven” activity of disease redefinition. Clearly this is causing high risks to the health and well-being of people and communities [1]. However, I think, there is a need to expand the emerging discourse on three front right at the beginning, especially the complex adaptive epistemology of health, a clear elaboration of the limitation of statistics as a means to “prove the truth”, and more fundamentally, the consideration of “biological plausibility”, i.e. the need to focus on integrated network physiology, in considering what are healthy “normal” indicators across the lifespan.

    (1) The paper tangentially alludes to the epistemic issues of defining health, illness, dis-ease and disease. Putting it in this way infers as a presupposition that health, illness, dis-ease and disease are distinctively “different things” – essentially a reflection of the reductionist tradition of thought of the past 350 yrs. In the first instance health in all it’s forms is subjective in nature [2], and must be distinguished from the objective features of pathology we use to define disease. As most generalist health professionals know at the end of a consultation patients fall into one of four principle clusters:
    • Subjectively healthy with no identifiable pathology
    • Subjectively health with well-defined path...

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  • Evidence maps: a tool to guide research agenda setting

    This is Cancun Lu, is a master from the Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, China. Here, I thought the 17th citation in the references of this paper with a mistake. And it should be——Schulz KF, Altman DG, Moher D, et al. CONSORT statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;2010:c332.
    Conflicts of interest
    I declare that I have no conflicts of interest.

  • Re: Defamation: no evidence required

    Sergey Tarasov responded to our article “Drug discovery today: no molecules required” with claims of mistakes in our analysis. We are sure that we did not conceal anything of relevance or make any mistakes. This is a response to the claims by Sergey Tarasov.

    1. Tarasov claims that one of us has an undeclared conflict of interest: “However, one of the authors of the article, Khromov-Borisov NN, is a defendant in a defamation lawsuit brought by Materia Medica (June 28, 2018). Materia Medica has sued Khromov-Borisov NN <…> this therefore raises serious doubts over the objectivity and impartiality of one of the authors of the article, who also carried out the data analysis presented in supplementary letter 1”. However, the analysis provided by Khromov-Borisov NN was sent to the editor of International Journal of Diabetes Research on Dec 13, 2017 (Supplementary Letter 1). Then editors of Drug Discovery Today (Feb 5, 2018, Supplementary Letter 5), BMJ (Apr 2, 2018), and BMJ EBM assessed the article including analysis mentioned above. Thus Tarasov presented the chronology completely wrong. First we have submitted our criticism of release-activity (RA) to scientific journals and only then Materia Medica sued one of our co-authors.

    2. We don’t see how any of our previous criticisms of RA drugs and homeopathy creates a conflict of interest or are relevant to the reception of our article.

    3. We have stated that RA drugs contain no active substance. Simple...

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