SCOTT H. PETERS 1122 LONGWORTH HOUSE OFFICE BUILDING WASHINGTON, DC 20515 52MB DISTRICT, CALIFORNIA [202) 22543508 4350 EXECUTIVE DRIVE, SUITE 105 Congress at the ??niteh ?tatea Barrera/gram ?nalise of Representatives Washington, EM 20515?0552 November 26, 2018 The Honorable David P. Roe, MD. The Honorable Jack Bergman Chairman Chairman, Oversight and Investigations Committee on Veterans? Affairs Committee on Veterans? Affairs U.S. House of Representatives U.S. House of Representatives The Honorable Tim Walz The Honorable Ann McLane Kuster Ranking Member - Ranking Member, Oversight and Committee on Veterans? Affairs Investigations U.S. House of Representatives Committee on Veterans? Affairs U.S. House of Representatives Dear Chairman Roe, Ranking Member Walz, Chairman Bergman, and Ranking Member Kuster: I write with serious concern about a recent report from the Of?ce of Special Counsel (OSC) regarding a whistleblower disclosure from the VA San Diego Healthcare System (VASDHS). Due to severity of these allegations and the unsatisfactory ?ndings, I respectfully request an oversight hearing on this matter. The OSC report (OSC File Nos. DI?l6?l945 and DI-17-1294) outlines a whistleblower disclosure detailing unapproved human research wherein doctors performed transjugular biopsies on nine patients diagnosed with alcoholic hepatitis. This study was initially approved by Institutional Review Board (IRB). However, the doctors disregarded the parameters of the approved study by performing biopsies without appropriately informing patients of the risk involved in these procedures. Additionally, the whistleblowers claim that transjugular biopsies were not considered the standard of care, not necessary for diagnosis, and could result in excessive bleeding and possible death. The VA reviewed the whistleblowers? case and failed to substantiate the whistleblowers? claims that the doctors performed unapproved human research without consent. However, the OSC refutes the ?ndings and outlines the shortcomings of the report. The VA asserts transjugular biopsies were in fact the standard of care, contrary to the ?ndings that no transjugular biopsies occurred until after this study was approved and that experts in the San Diego community agree they are not the standard of care. The OSC ultimately determined the ?ndings to be unreasonable and remain concerned that they failed to acknowledge and solve a variety of the whistleblowers? concerns. I would like the House Veterans? Affairs Committee to conduct congressional oversight of the unapproved human research at VASDHS and handling and ?ndings of the whistleblowers? disclosure. The VA appears to have shrugged off the primary allegations of the whistleblowers, PRINTED ON RECYCLED PAPER or at the very least, seems unaffected by the potential consequences if the standard of care was not apprOpriately determined. I am seriously concerned that the findings will deter future whistleblower disclosures should VA not thoroughly investigate their claims. The committee should also consider whistleblower retaliation, VA medical center management, the IRB approval process, research coordinator training, and HIPAA Violations in its oversight work. As we plan the end of the 115?h Congress and move into the 116?h Congress, I will work with you and new leadership of the committee to address these issues. I am proud of the work the House Veterans? Affairs Committee has done for veterans this Congress, and look forward to working with you to ensure whistleblower disclosures are taken seriously and handled prOperly. Thank you very much for your consideration of this request. Sincerely, SCOTT H. PETERS Member of Congress