A cardiology researcher in Illinois coerced trainees to fake the results of a heart test so that patients would qualify to enter a clinical trial, according to a new finding by the Office of Research Integrity (ORI).
Here’s an excerpt from the ORI’s notice about Parag V. Patel, of Advocate Lutheran General Hospital, in Park Ridge, Illinois:
ORI and Advocate Health Care found that the Respondent engaged in research misconduct by directing or intimidating fellows and others to influence left ventricular ejection fraction (LVEF)scores of ≤ 35% and requesting attending physicians to reassess scores of LVEF to be reported as ≤ 35% for research subjects after being diagnosed with acute myocardial infarction, thereby causing and being responsible for falsification of research records. These falsifications made subjects eligible for enrollment into the “Vest Prevention of Early Sudden Death Trial” (VEST) when they otherwise may not have been eligible.
The LVEF is a measure of how efficiently the heart pumps blood, and a normal range is somewhere between 55% and 70%. The VEST trial “explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-threatening arrhythmias,” according to its entry in ClinicalTrials.gov. It began recruiting 1,900 participants in 2008, and is expected to be complete in 2015.
Patel’s work was supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) grant U01 HL089458.
Patel agreed to having his research supervised for two years, and to not serve on any NIH peer review committees for the same length of time, but he did not confess to any wrongdoing. The ORI report continues:
The Respondent, Advocate Health Care, and the U.S. Department of Health and Human Services (HHS) want to conclude this matter without further expenditure of time or other resources and have entered into a Voluntary Settlement Agreement (Agreement) to resolve this matter. Respondent neither admits nor denies ORI’s and Advocate Health Care’s findings of research misconduct. This settlement does not constitute an admission of liability on the part of the Respondent.
Patel and one of his patients were the stars of a 2011 story in a local paper about an unrelated trial for the AngelMed Guardian cardiac monitoring implant. We found two papers by him in PubMed, neither of which has anything to do with the VEST trial.
Patel, who was born in Kenya, is also chairman and founder of the Foundation for International Cardiac & Children’s Services, which helps “promote sustainable healthcare for poor and needy women and children who are discriminated against and given less opportunities” in his birth country.
We’ve contacted Patel, his hospital, and the VEST trial organizers, and will update with anything we learn.
The ORI has been in the news recently, as its director, David Wright, stepped down in a scathing resignation letter.
Update, 10:20 a.m. Eastern, 3/18/14: Advocate Health, the parent organization for Advocate Lutheran General Hospital, sent us this comment:
Providing the safest and best place for our patients to heal and physicians to practice is our top priority. Because the terms of the settlement agreement prohibit public comment, we are unable to provide any specific details regarding the matter.
Please see an update on this story.
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