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September 16, 2013 Professor EN Barton Editor-in-Chief West Indian Medical Journal (WIMJ) Faculty of Medical Sciences The

University of the West Indies Mona, Kingston 7 Jamaica, W.I. Dear Professor Barton: From Utilization of the Heimlich Manoeuvre as an adjunct in the management of asthma in paediatric patients: a prospective study, S Feanny, MA St John, P Howard, Department of Paediatrics, Queen Elizabeth Hospital, Barbados, published in the West Indian Medical Journal, 2005; 54 (Suppl. 2): 45 (emphasis added). Objective: The objective of the present study was to determine the usefulness of a modified Heimlich Manoeuvre for treatment of asthma in Barbados. Materials and Methods: Subjects were randomly selected from the Accident and Emergency database and studied prospectively between August 2002 and July 2003. Written consent was obtained from parents for participation of parents. Screening included history, present condition, and fulfilling inclusion/exclusion criteria, with physical examination and lung function tests according to the study protocol. Results: The study population consisted of 67 patients aged 6-16 years with a control group of 34 patients and a study group of 33 patients. Spirometry values for the study group showed progressive improvement in FEV (17.85%) and PEFR (30.8%), which was statistically significant. Changes in the control group readings of 6.75% and 13% respectively were not statistically significant. All symptoms scores improved: 75% for exercise tolerance and 28% for quality of life scores in the study group was (statistically significant) contrasting with total asthma scores of 37% and 0% changes in the quality of life scores in the control group. Improved spirometry and symptom scores were consistent for the study group but fluctuated in the control group. No adverse effects were reported. Conclusion: This study has provided data to support the potential benefits of the modified Heimlich Manoeuvre as adjunctive therapy for asthma, with a consistent improvement in objective parameters of spirometry, subjective symptom scores and quality of life assessment. Per documents I obtained from the University of Cincinnati Medical Library, after being rejected by an Institutional Review Board (IRB) at Deaconess Hospital (Cincinnati, Ohio), the Barbados study was funded by the Rotary Foundation of Cincinnati and Cincinnati's Heimlich Institute. According to the documents, the study was overseen by an (unidentified) IRB (p. 72) and needed to obtain the approval of the Barbados Ministry of Health's ethics review board (p. 64). For almost a year, I've attempted to obtain the following information from Queen Elizabeth Hospital (QEH): 1) Did an Institutional Review Board (IRB) approve, monitor, and review the study? If so, what's the name of the IRB and what's the name of the individual who was responsible for directing the IRB? 2) Was the study approved by the Barbados Ministry of Health's Ethics Committee? If so, what's the name of the individual who was in charge of that committee? In response, I received a November 26, 2012 e-mail from a QEH employee informing me that I' would be receiving a response within a week. I never received any further communications, so I recently re-submitted to my questions via e-mail to Dr. Dexter James, the hospital's Chief Executive Officer. (You'll recall that I courtesy-copied you on that correspondence. )

I received confirmations of receipt from Dr. James, but no reply, therefore I'm respectfully requesting that you contact the authors of the study, ask them to provide you with the answers to my two questions, and that you provide me with their responses. Further, according to an August 7, 2013 Barbados Today article: The Ministry of Health is officially probing the existence of a controversial asthma study purportedly done in Barbados and involving a famous American physician. But amid continued external queries about whether the research “followed legal and ethical guidelines”, Acting Permanent Secretary Tennyson Springer said initial investigations had found no evidence of its existence. ...Last month Springer responded on the Ministry of Health’s behalf and told (Peter) Heimlich that there was no knowledge of the study which was said to have involved 67 minors. ...“(I) wish to acknowledged receipt of your correspondence and inform you that the matter is being investigated,” Springer said in his July 10 letter. “So far, there has been no institutional memory or documentation of this research. However, the Ministry of Health will continue to probe into this alleged project." Given these concerns, this is to request that the editorial board of the WIMJ conduct a review of the study (including but not limited to patient records, parental consent forms, and funding records) in order to determine if the research was conducted in compliance with Barbados and international laws; if the study meets the standards of the WIMJ; and to make public the results of the journal's findings. You may also wish to review this page on my website that includes further information and links to media reports about the study. You may also wish to to review this page on my website that includes links to 2003 media reports about the Heimlich Institute's history of violative, unsupervised media research using human subjects (NY Times, LA Times, CNN/Reuters. ABC News, etc.) and recent reports published by the Associated Press and other news outlets. Thank you for your consideration and I look forward to your reply. Sincerely,

Peter M. Heimlich 3630 River Hollow Run Duluth, Georgia USA 30096 ph: (208)474-7283 e-mail: website: blog: cc: Tennyson Springer, Permanent Secretary, Barbados Ministry of Health Cheryl Cox Macpherson, PhD, President, Bioethics Society of the English-Speaking Carribean Elizabeth Woeckner, Citizens For Responsible Care and Research, Inc. (CIRCARE)