Canadian Medical Doctor Exposes Dr. Aryeh Shander's Faulty Bloodless Research

by OrphanCrow 10 Replies latest watchtower medical

  • OrphanCrow

    In the June 2016 issue of CMAJ, Dr. Hebert published an article, Survival Without Transfusion Is Possible but Not Recommended for All, that critiques Dr. Aryeh Shander's research study Outcomes of Protocol-Driven Care of Critically Ill Severely Anemic Patients for Whom Blood Transfusion Is Not an Option, published in Critical Care Medicine 2016.

    Dr. Aryeh Shander is familiar to anyone who follows the blood management and the bloodless surgery industry. Shander is the "face" of blood management worldwide. I have spoke of him many times on this forum and elsewhere.

    But who is Dr. Paul Hebert? What qualifies him to critique Shander's research?

    Dr. Paul C. Hébert is Head of Department of Medicine, a scientist and a Critical Care Physician at The Centre Hospitalier de l’Université de Montreal. He is also Chair of the Canadian Critical Care Trials Group. During his 14 years on Faculty at the University of Ottawa, Dr. Hébert established the Clinical Epidemiology Program at the General Campus of The Ottawa Hospital (1998) and the University of Ottawa Centre for Transfusion Research. Dr. Hébert’s research interests center on the examination of transfusion practice, including the use of alternatives to transfusion, blood conservation, resuscitation fluids, as well as on cardiac resuscitation and trauma research. Dr. Hébert has undertaken more than 30 research projects with a focus on transfusion practice and bleeding control. To date, he has published more than 250 articles and he obtained a large number of peer-reviewed grants (with a combined value in excess of $40 millions).

    Dr.Paul Hebert was also the editor-in-chief of the Canadian Medical Association Journal (CMAJ), Canada’s leading peer-reviewed medical journal from 2007-2011.

    The objective of Shander et al's study was "to compare the outcomes of severely anemic criticallyill patients for whom transfusion is not an option (“bloodless” patients) with transfused patients." To do this, "one hundred seventy-eight bloodless and 441 transfused consecutive severely anemic, critically ill patients, admitted between May 1996 and April 2011", were selected and compared.

    Shander et al concluded this:

    Overall risk of mortality in severely anemic critically ill bloodless patients appeared to be comparable with transfused patients, albeit the latter group had older age and higher Acute Physiology and Chronic Health Evaluation II score. Use of a protocol to manage anemia in these patients in a center with established patient blood management and bloodless medicine and surgery programs is feasible and likely to contribute to improved outcome, whereas more studies are needed to better delineate the impact of such programs.

    Is this a valid conclusion? That "...Overall risk of mortality in severely anemic critically ill bloodless patients appeared to be comparable with transfused patients"? Dr. Hebert disagrees and he discusses the problem with Shander's methodology:

    The authors made a number of inferences regarding outcomes
    from the transfused and untransfused population of
    critically ill patients. Overall, these populations were quite different
    at baseline; they were younger, less severely ill, and more
    often admitted to ICU for postoperative care. So comparing
    rates of death without some form of statistical adjustment
    would not be fruitful. There is, however, no guarantee that any
    form of statistical manipulation will provide an unbiased and
    unconfounded comparison.

    Next, Hebert tells us how Shader et al approached this statistical problem:

    Shander et al (1) opted to use a method of analysis called
    propensity analysis to improve the matching between groups.
    The choice of the many propensity analyses is not created
    equal and may not be superior to other methods in this regard
    (2). Using this approach, they ended up selecting a group of
    patients who did not develop extreme anemia.
    So what did happen with the use of the propensity matching
    technique? The technique invariably removed approximately
    half the deaths. The most severely anemic patients
    were removed from the analysis by design. Therefore, mortality
    rates were drastically decreased in both groups but
    more so in the bloodless group. By doing so, both groups
    ended up looking comparable with average hemoglobin
    concentrations that were not much lower than a standard
    restrictive strategy.

    Dr. Hebert identifies the underlying problem with this type of study:

    At the outset, it is not possible to produce meaningful comparisons
    between a group of patients who will not receive any
    blood products to a group who does. This is because risks
    increase as hemoglobin concentrations drop. Therefore, risks
    of death attributed to anemia in the bloodless group will always
    be higher than in a transfused cohort. There is no ethically
    acceptable manner to allow the transfused group to develop
    extreme anemia prior to being transfused.

    Dr. Hebert discusses the one redeeming feature of Shander's study: it shows how risk of death increases dramatically once a certain level of hemoglobin deficiency is reached:

    ...mortality rates with hemoglobin
    concentrations below 3 g/dL is over 55% and drop precipitously
    to somewhere around 28% when hemoglobin concentrations
    are between 3.1 and 4 g/dL. Anemia in the bloodless group was
    thought to be the primary cause of death in 36% of all deaths.

    Dr. Hebert then goes on to identify what information was left out in Shander's study, that could have been useful to include:

    Additional information would have been useful to readers. A
    figure of all patients divided by transfused and not transfused
    would have also been very useful. Also, it would have been interesting
    to examine whether such severe anemia also increases
    other risks: for example, functional outcomes from prolonged
    ICU stays.

    And why would this information be useful?

    These rates, albeit from a single center with extensive
    experience with extreme anemia, provide some information to
    provide families of critically ill patients who refuse blood.

    In conclusion, Dr. Hebert addresses the impact of this failed study on the families who are faced with making decisions about the care of a patient with severe anemia:

    In summary, these observations demonstrate that acute
    severe anemia is lethal. It directly contributes to the death
    when hemoglobin concentrations fall below 3 g/dL. Furthermore,
    from the data provided, we would be unable to
    provide meaningful comparisons of risks of death comparing
    transfused with nontransfused patients to families when
    lowest measured hemoglobin concentrations were between
    3 and 7 g/dL.

    Far too often, JW patients approach medical problems with erroneous and incomplete information that has been fed to them by the WT. Doctors are then left with the task of trying to give those patients reliable and accurate information - a task that is often insurmountable.

    Dr. Paul Hebert has shown why Dr. Aryeh Shader's research is shoddy and incomplete. Shander's study fails the sniff test and the reader is left wondering why and how research like this comes about. Sponsorship is the very first place that a person can get some clues.

    Dr. Hebert's article has this attached to it:

    The author has disclosed that he does not have any potential conflicts of

    Aryeh Shander's study has this attached to it:

    Dr. Shander received funding from Bayer, Luitpold, and Masimo; has been
    a consultant or speaker with honorarium for or received research support
    from Bayer, Luitpold, Masimo, Novartis, Novo Nordisk, OrthoBiotech,
    Pfizer, Masimo, and Zymogenetics; and is a founding member of the Society
    for the Advancement of Blood Management (SABM).

    Aryeh Shander - a founding member of the Society for the Advancement of Blood Management. The society that sets the standards for blood management. The society that was founded along with members of the Hospital Liaison Committees of the Watchtower Society.

    Dr. Shander - the "face" of blood management. The hero of bloodless surgery. The co-author of the seminal textbook used to educate blood management professionals - co-authored with a German JW doctor - Dr. Petra Seeber.

    Dr. Shander - the spokesperson for STORMACT.

    Dr. Shander - the doctor who went to Russia to promote blood management with Sherri Ozawa, the JW blood management 'specialist'.

    Dr. Shander - a researcher who manipulates data to get the results he needs in order to promote bloodless procedures

    It will be interesting to see if Shander's latest published research get presented at upcoming professional seminars and cited in support of bloodless procedures. I wonder how many citations Shander's shoddy research will get within the blood management world.

    Much thanks goes out to Dr. Paul Hebert who has taken the time to expose researchers like Aryeh Shander who manipulate data to get the results they want.

    *note - if anyone is having trouble accessing Dr. Hebert's article and Shander's research study...I am pretty sure Wifibandit will be able to help you out

  • Simon

    Great write-up, very informative - thanks!

  • OrphanCrow

    Thanks for the feedback Simon

    What struck me, and impressed me, about Dr. Hebert's article, was his concern for the families of those who refuse blood. He is saying, "What do I tell the families of my patients who are about to die? What do I tell them when their loved one is approaching that critical threshold point? How do I deal with their protestations that the bloodless research says such and such when I know that this research is faulty? How do I do my job?"

    Dr. Hebert's article reveals his compassion. I like that. He is the kind of doctor I would want and the kind that everyone should be so lucky to have - not a doctor who publishes biased research.

  • Vidiot

    Once again, for the newbies, lurkers, and trolls...

    ...if you have to cheat to defend your beliefs, your beliefs don't deserve to be defended.

  • EdenOne

    Thank you for this great piece of information, OC.

    Once again, the stench of something rotten can't be avoided when someone notices the alliance between the WT and the "bloodless surgery" industry. I wonder who's using who.

  • Lee Elder
    Lee Elder

    Was not aware of this. I suppose it really should not come as a surprise. Thanks.

  • steve2

    OrphanCrow - many thanks for keeping us right up to date .So pleased a respected figure in the field has spoken up about the flawed research supporting bloodless surgery .

  • Reazon22
    Will do some research.
  • OrphanCrow

    Thanks for bumping this thread, Reazon.

    Shander's study that is discussed in this thread has been on my mind lately because I wanted to expand on the flaws that have been pointed out already.

    Where this study's flaws become apparent is in the selection of groups. Shander et al was comparing a group of non-transfused surgical patients (all JWs) to a group of patients who received transfusions and made the conclusion that

    Overall risk of mortality in severely anemic critically
    ill bloodless patients appeared to be comparable with transfused
    patients, albeit the latter group had older age and higher Acute
    Physiology and Chronic Health Evaluation II score.

    What Shander is referring to in his conclusion is that the "bloodless" group - the JWs - were generally in better health and younger than the group that was transfused. The reason for this is simple - bloodless methods cannot be done on severely ill patients or those who are too elderly.

    Shander has pointed out that difference in groups but he fails to take into account a couple of other factors that would have skewed the results in favor of the non-transfused group.

    This is how the groups were selected:

    The main eligibility criterion was severe anemia at ICU
    admission defined as at least one hemoglobin level less
    than or equal to 8 g/dL from a blood sample taken within
    24 hours of ICU admission. Exclusion criteria were age less
    than 18 years old; death within 24 hours of admission; treatment
    with artificial hemoglobin-based oxygen carriers;
    admission with diagnosis of traumatic brain injury or acute
    myocardial infarction; and status postcardiac surgery and
    pregnancy. For patients with multiple hospital admissions,
    only the first admission leading to ICU admission was considered.

    Patients were grouped into two cohorts: bloodless
    patients who did not receive any allogeneic blood transfusions;
    and transfused patients, who received allogeneic RBC
    transfusions during ICU stay.

    So, Shander excluded those patients who died during the first 24 hours, and we know that the bloodless group would have more deaths than the transfused group - that 24 hour window is when emergency transfusions would be required and that is something that none of the bloodless group would have received.

    Shander's solution to that data problem is to just exclude it. Don't include it in the study at all.

    And he also left out another high risk group within the bloodless group. And that is the bloodless patients who required a second surgery. Note that only the first admission was considered and this criteria would pertain primarily to the "bloodless" group. One of the ways that "bloodless" surgery deals with a non-transfused person who requires a complicated or lengthy surgical procedure is to do it in two steps rather than one. This is either scheduled in advance for surgeries that anticipate a large blood loss or, sometimes a surgery is cut short when unexpected complications arise. In a conventional surgery, the patient would be given blood and the surgery completed. But, in a non-transfused JW patient, the patient is closed, taken to recovery, and the surgery completed later once the patient is stable enough.

    So what ends up happening through this selection process, is that the JWs most likely to die from bloodless surgery have been excluded from the study's data. And the ones who don't make it as far as the operating theater are excluded.

    This is a common feature of many of the studies that the bloodless industry has promoted. When you hear this: "Jehovah's Witnesses do better than those who use blood", be very suspicious. Shander has just illustrated quite simply how the data can be manipulated before the study even starts. Just leave out the high risk ends of the time line. The ones who have the most risk of dying.

  • Finkelstein

    The JW leaders are known to use and extrapolate only the information that supports their own inherent no whole blood ban.

    What they don't honestly reveal is the many instances where whole blood was transfused to a person which resulted in saving their life.

    One might describe this as selective propaganda or simple self facing biased corruption.

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