545 e-Letters

published between 2014 and 2017

  • Wilfully misleading or simply negligent?

    In the study you say:

    "Although statins are known to reduce the risk of stroke by as much as 25%,38 benefits are undermined by suboptimal adherence. In a previous examination on patient perspectives around statin therapy, compliance with statins was associated with information provided during the practitioner consultation as well as the beliefs about cholesterol and current health status"

    'As much as 25%'

    The reference you give is to this paper:

    Afilalo J , Duque G , Steele R , et al . Statins for secondary prevention in elderly patients: a hierarchical bayesian meta-analysis. J Am Coll Cardiol 2008;51:37–45.doi:10.1016/j.jacc.2007.06.063 FREE Full TextGoogle Scholar

    The paper very clearly refers to RELATIVE RISK REDUCTION.

    Read this paper: https://www.ncbi.nlm.nih.gov/books/NBK63647/

    In fact the ABSOLUTE RISK REDUCTION is about 1%

    By stating 25% and NOT saying it is RRR you create a scare story for newspapers which creates stress for stroke survivors plus you mislead the public who think that by taking statins their risk of stroke falls by 25% which is simply not true.

    Did you do so wilfully to fit a pharma-dictated criteria or were you just negligent?

  • Re: Risk of death among users of Proton Pump Inhibitors: a longitudinal observational cohort study of United States veterans

    We read with great interest the longitudinal study by Xie et al on the Risk of death among users of Proton Pump Inhibitors (PPI) (1). The study findings suggest that there is an overall increased risk of death among PPI users when compared with histamine H2 receptor antagonists (H2 blockers) users and people who are not on either medication. We also acknowledge the efforts of the authors to statistically eliminate potential bias associated with an observational study design like this. However, we would like to highlight a few points which we believe should be considered when interpreting the results of the study.

    The authors externally adjusted for the use of other therapeutics including anticoagulants, antiplatelet agents, and non-steroidal anti-inflammatory drugs as potential confounders. However, it is not clear if Selective Serotonin Receptor Inhibitors (SSRIs) used in the treatment of Post-Traumatic Stress Disorder (PTSD) were considered and adjusted for. The Veteran population which forms the data set for this study has a higher prevalence of PTSD than the general population and is often prescribed SSRIs (2). The SSRIs are metabolized by the cytochrome P-450 isoenzyme CYP2C19, which is inhibited by the proton pump inhibitors (PPIs) leading to significantly higher levels of SSRIs in the body and potential risk of increased adverse effects (3). Some of the adverse effects of SSRIs including suicide risk could significantly contribute to mortality in the popu...

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  • Letter to the Editor – The INTERMED as a complexity assessment and intervention tool

    Yoshida et al. (1), comparing the PCAM with the INTERMED for the prediction of hospital length of stay (LOS), state (i) that the INTERMED “can be applied only to the secondary care setting” and (ii) is “relatively impractical” due to the length of the interview, and consider (iii) that the PCAM – with its “fewer items and simpler questions” – has “the potential to substitute for INTERMED”.

    First, the INTERMED has been and is utilised in the tertiary (2), secondary (3) and primary care setting (4). Second, assessing case complexity may need some time and a certain number of questions; the questions raised with the INTERMED have been validated by patients as being relevant (5) and the interview as having a positive effect (6). If physicians’ time is the issue: the INTERMED has been demonstrated good inter-rater reliability across medical professions (7) and is utilised in some settings by nurses (3). In addition, a self-assessment version of the INTERMED (the IMSA), reducing the length of the interview, has been validated in a recent multi-centred study (8). Third, when comparing the INTERMED with other instruments assessing case complexity, not only prediction of LOS has to be taken into account. The INTERMED provides a thorough biopsychosocial case complexity assessment (9); it has – unlike the PCAM, as acknowledged by the authors – been proven to be valid across various clinical settings (10) and to predict, in these settings, psychosocial, medical and health care...

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  • Antidepressant use during pregnancy and the risk of major malformations in a cohort of depressed women: Prevalence of major malformations and indication bias.

    Dear Editor,

    We thank Drs Burt, Rasminsky, Andrade, and Barros for their letters on our study published in BMJ Open in January 2017.1 We agree with them that our baseline prevalence of major malformations in the Quebec Pregnancy Cohort (QPC) is higher than the reported 3-5%. Bérard et Sheehy2 have described the QPC, and have presented baseline statistics showing that the baseline prevalence of major malformations in Quebec was 9.3%. We have disclosed that already in our Discussion section – ‘Our major congenital malformation population prevalence may seem somewhat higher than the routinely reported 3-5%, but in fact our rate is consistent with what is expected in the province of Quebec, due to high concentration of genetic risk factors stemming from the ‘founding’ French ancestors.’1,3 It is true that we are referencing another of our studies to highlight the Founders’ effect. Indeed, Zhao et al.3 have shown that the prevalence of major malformations in the province of Quebec vary by geographical regions, and are higher in the regions where the founding French ancestors first inhabited. This is a well know fact and is representative of specific genetic traits of those founding fathers. Again, this was well discussed and represented in Zhao et al.,3 and it is why we are referencing this study in Bérard et al.1 Bérard et al.1 further showed that the prevalence of major malformations among those with depression during pregnancy was even higher (greater than 11%). Howev...

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  • New onset diabetes and statins – real risk not so trivial

    We have read the article by Ooba N et al with interest. The authors have conducted a retrospective cohort study to assess the risk of new-onset diabetes associated with lipid-lowering drugs in Japanese population.

    Authors have excluded patients with diabetes characterized by HbA1c ≥6.5% or fasting blood glucose ≥126 mg/dL. However, in Table 1 (Baseline characteristics), patients are not categorized based on their HbA1c or blood sugar fasting levels as pre-diabetic (HbA1C between 5.7 to 6.4) or normoglycemic. It is important to note that the risk of new-onset diabetes among lipid-lowering users is particularly high in pre-diabetic patients (1) and hence, authors should have categorized the patients as either pre-diabetic or normoglycemic. Looking at the mean HbA1c not more than 5.2% in various groups (Table 1), it appears that the number of patients with pre-diabetes were not high. This finding of normoglycemics converting rapidly into diabetes in a mean duration of 4 to 5 months of statin use points to the gravity of the problem of statin associated diabetes which will have huge implication in clinical practice, wherein a short exposure to statins (4 to 5 months) can have the risk of shifting glucose homeostasis towards diabetes. Unlike other previous studies, wherein pitavastatin use was not associated with adverse effects on glycemic control (2, 3, 4), in this study, the risk of new-onset diabetes was highest with pitavastatin (HR-3.11). Authors should comment o...

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  • Reply to the comment "A sandwich won’t sway a doctor"

    We acknowledge of course that the pharmaceutical industry produces many medicines that are an important part of healthcare. However, inappropriate use and overuse of medicines is detrimental to health, and use of an unnecessarily expensive medicine that is no better than a cheaper alternative represents wasteful health care spending.

    Although Mr. Catelin states “It’s ludicrous to suggest that a sandwich and a soda water would sway the opinions of medical practitioners”, the evidence shows otherwise. Among the studies that have examined the relationship between exposure to pharmaceutical industry information or payments and the quality, quantity and cost of prescribing, there is an overwhelming finding of no benefit. (1-4) Pharmaceutical industry payments, even small payments such as a meal, are associated with increased prescriptions of the promoted drug. One US study found a “dose-response effect” on prescribing of cholesterol-lowering drugs, blood pressure drugs and antidepressants, starting with even a single meal costing less than US $20: the more free meals a doctor ate, the more likely they were to prescribe the promoted drug. (2) Another study found that the more payments a doctor received from the industry, the more likely they were to prescribe expensive brand-name drugs rather than less expensive generic equivalents. (4)

    The aim of our study was neither to undermine patients’ confidence nor to call health professionals into disrepute. The aim was...

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  • Epistemonikos: A database not to be missed while searching systematic reviews

    We have read the article, “Systematic review of systematic reviews of non-pharmacological interventions to treat behavioral disturbances in older patients with dementia. The SENATOR-OnTop series” by Abraha et al. published in BMJ Open in March 2017 with a lot of interest. This systematic review study presents very important findings on the use of non-pharmacological interventions to treat behavioral disturbances in elderly dementia population.

    However, we have a specific concern about the database searched and relevant articles included in this systematic review of systematic reviews study. An important omission we found in this study was the systematic review by Kong et al.1 published in Aging & Mental Health Journal in July 2009. This systematic review and meta-analysis assessed the effectiveness of the nonpharmacological interventions for agitation in the older adults with dementia. It qualifies all the criteria for inclusion in the present study since it is published within the range of search duration (2009-2015 March) used in the present study. Furthermore, the present study has included the systematic reviews by Yu et al.2 published in March 2009 along with other systematic reviews such as Kverno et al.3 and Lai et al.4 published in the same year.

    Also, the systematic review by Kong et al.1 assessed the effect on agitation (a type of behavioral disturbance) not assessed by many of the other systematic reviews included in the present study hence m...

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  • Authors response to comments by Tom Boyles

    Dear Tom,

    Thank you for your comments.

    Your first point addresses the poor negative predictive value of a TB symptom screening test. We agree that the symptom screen that is currently called for in South Africa’s national guidelines, as well as WHO’s guidelines, is inadequate in terms of both negative and positive predictive value. We do not have, and you do not propose, however, an easily-available alternative. We consulted a number of TB experts in designing the algorithm and concluded that at the time of study initiation, there was no readily available clinical prediction rule or point-of-care instrument that we could expect to be adopted at a national scale if the trial’s results are compelling. We also designed the study to adhere as closely as possible to existing national guidelines, with the main difference being the timing of the initiation process rather than its content. Our goal is an algorithm that can be incorporated into routine practice as simply as possible, in the hope of benefiting patients at a large scale.

    We also observe that initiating ART in the presence of undiagnosed TB poses the risk of delayed TB treatment (which would have been delayed anyhow, due to the patient not having symptoms) or IRIS (which, while clinically occasionally challenging, is rarely fatal, especially in this group of ambulatory and largely healthy patients). We hypothesize that the well-characterized loss to follow-up and subsequent morbidity and mortal...

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  • A sandwich won’t sway a doctor

    A sandwich won’t sway a doctor.
    Milton Catelin
    Chief Executive, Medicines Australia

    Pharmaceutical companies and medical professionals collaborate on clinical research, share knowledge and support education to ensure that medicines are constantly improving and are used safely and appropriately by health care professionals and their patients.

    Our members are proud of the work that we do to ensure that the public can continue to have confidence in our local medicines industry. We consider transparency to be a key component of the bond of trust with the Australian public.

    Engagement with pharmaceutical companies is an important and legitimate part of a medical practitioner’s ongoing education; foremost, because patients want to be sure that their doctors know how to use the medicines they’re being prescribed.

    The developers of these medicines are the highest authority on how a medicine works, its interactions with other compounds, its efficacy and other information. It stands to reason that a medical practitioner would consider information from the maker of the medicine when making an informed decision about prescribing a medicine. It’s not however, the only source. Medical practitioners do their own research, network with their peers, consult with other clinical experts, read independent medical journals and receive information from independent bodies such as NPS MedicineWise.

    It’s ludicrous to suggest that a sandwich and a so...

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  • Response to comment by Prof. Hughes

    Dr Hughes raises an important point that we also address in discussing limitations of the study. We did not take meta-analyses into consideration that had combined studies with inactive treatments and treatment as usual (TAU) as control interventions. We based this decision primarily on methodological reasons. TAU varies widely across patients and settings and can include antidepressant or behavioral treatments. Therefore, equating TAU with placebo treatment or waiting list seemed problematic for us.

    Nevertheless, Dr. Hughes’ point is well taken. TAU is an important reference standard, particularly in pragmatic studies because it reflects real-world conditions. In a meta-analysis, however, TAU is difficult to handle especially when the components of TAU across individual trials are not well documented. Using TAU in a meta-analysis often comes down to combining apples and oranges without being able to tell which treatments are the apples and which are the oranges.

    Dr. Hughes also argues that patients on waiting lists cannot be prevented from getting some form of treatment. We agree but view this as a general issue of contamination that is almost impossible to control, particularly in pragmatic studies. The fact that, in our study, patients on active treatments had substantially larger treatment effects than those on waiting lists makes us think that contamination issues probably did not have much impact.