Letter to the Editor: Bronchiolitis Guidelines, tPA Supported by Science : Emergency Medicine News

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Letter to the Editor

Letter to the Editor

Bronchiolitis Guidelines, tPA Supported by Science

doi: 10.1097/01.EEM.0000898276.23877.c9


    I am concerned by what Larry Mellick, MD, and Ravi Garg, MD, wrote about the bronchiolitis guidelines and thrombolytic therapy for cerebrovascular accident, respectively. (“The Nihilistic AAP Bronchiolitis Guidelines.” EMN. 2022;44[9]:22; https://bityl.co/ESoJ; “Well Past Time to Stop Giving tPA for Stroke.” EMN. 2022;44[9]:27; https://bityl.co/ESoN.)

    They are obviously not following the science that has been long established by multiple peer-reviewed studies.

    Can Dr. Mellick be so bold that he believes that he knows better than well-established guidelines based on good-quality evidence that resulted in strong recommendations from the American Academy of Pediatrics? The four concluding points in his article come dangerously close to denying the science.

    And Dr. Garg implying that Genentech is participating in scientific malfeasance? He appears to be accusing the drug sponsor of manipulating the data to favor tPA use in CVA. If we can't trust the pharmaceutical companies to be honest and transparent with their data, then how can we take seriously dissident physicians asking such questions whose answers have already been settled by the science?

    Dr. Garg goes on to imply that the FDA was aware of said data manipulation in 1996, the year they approved tPA for CVA. What possible motivation could the FDA and the pharmaceutical industry have to approve a drug whose “most certain finding...is excess hazards in the form of intracerebral hemorrhage and mortality?”

    I fully support a free exchange of ideas, but questioning such longstanding peer-reviewed literature is reckless and anti-science, especially in this current climate of conspiracy theory and misinformation. Dr. Garg closes his article with a timely question: “Where else in medicine do we accept such biased evidence as justification for a potentially harmful treatment of patients?”

    Kevin Schierling, MD

    Topeka, KS

    Dr. Mellick responds: I am grateful to Dr. Schierling for his genuine concern. I totally understand; it is never comfortable holding a minority opinion. It is even more uncomfortable when those whose work you are critiquing far outnumber you and are exceptionally bright and well intentioned. I have researched this disease process for years. To avoid the risk of personal bias (and embarrassment), I asked a senior researcher working with the University of South Alabama to review for quality the scores of research articles on which I based my opinions. The outcome of that independent review only made me more confident. I was also emboldened because I practice pediatric emergency medicine and see bronchiolitis syndrome patients respond to the forbidden therapies every single shift.

    I am currently working on an exciting paper with a seasoned bronchiolitis researcher and pediatric emergency physician that, among other key things, will provide robust evidence that the guidelines' de-implementation recommendations for albuterol, epinephrine, and hypertonic saline are wrong. The AAP and international writers of the bronchiolitis guidelines had laudable intentions and based their opinions and recommendations on the evidence available when the guidelines were written. Unfortunately, combining multiple small, low-quality studies into a systematic review and meta-analysis does not produce high-quality information and certainly doesn't support a strong recommendation.

    Nevertheless, let me share with you some evidence-based references that support my criticisms. Below are four valuable references for each of the easy ones (hypertonic saline and racemic epinephrine). Based on these and other large meta-analyses published since 2014, hypertonic saline and racemic epinephrine de-implementation should be immediately rescinded by the guideline writers.

    References for hypertonic saline: Pediatr Neonatol. 2014;55(6):431; J Pediatr Pharmacol Ther. 2016;21(1):7; Cochrane Database Syst Rev. 2017;12(12):CD006458; and Pediatr Pulmonol. 2018;53(8):1089.

    References for racemic epinephrine: Cochrane Database Syst Rev. 2011;(6):CD003123; Evid Based Med. 2012;17(1):12; N Engl J Med. 2009;360(20):2079; and Pediatrics. 2021;147(5):e2020040816.

    Albuterol is more complex and clouded by low-quality studies, and it requires further explanation that easily supports doing a trial of albuterol therapy. These two references provide arguments and evidence for rescinding the total de-implementation of albuterol: West J Emerg Med. 2015;16(1):85 and Acad Emerg Med. 2008;15(4):305.

    We are hoping in the near future to have a much more detailed and in-depth publication that might just end up being the coup de grâce for the 2014 AAP bronchiolitis guidelines.

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