Former Stanford employee guilty of illegally accessing, altering breast cancer database
A former employee of Stanford University was found guilty of accessing a clinical research database for a multisite breast cancer study and altering patient records after her authorization was revoked over a decade ago, according to federal prosecutors.
Naheed Mangi, 66, was convicted on Friday following a two-week trial, the U.S. Attorney's Office for the Northern District of California said in a statement Monday.
Mangi was employed as a clinical research coordinator in the Clinical Trials Office at Stanford's National Cancer Institute from September 2012 through August 2013. Prosecutors said she worked with doctors and patients in the clinical research program, reporting patient events, monitoring research, helping with patient appointments, and entering data.
Mangi was reportedly assigned to a Genentech-sponsored study being conducted at Stanford for breast cancer patients that was referred to as the "Velvet Breast Cancer MO27782 Study." The study sought to determine the safety and efficacy of a new, experimental pharmaceutical treatment for patients with metastatic or locally advanced breast cancer.
Prosecutors said Mangi was responsible for reporting any serious adverse events that a patient may experience during the study and entering patient medical data into the database.
On Aug. 19, 2013, Mangi was sacked by Stanford and her supervisor tried to revoke her Stanford-related computer access and privileges. The supervisor emailed Genentech to terminate Mangi's access to the clinical database, but her credentials were not disabled until the following day.
Based on court documents and evidence shown at trial, Mangi logged into the clinical database later that day and altered data in the Velvet Breast Cancer MO27782 Study, replacing patient medical data with erroneous information and insults about her former supervisor.
Prosecutors said that due to her actions, Stanford undertook an internal investigation, reentered all of the data about its participants in the study from source documents into the study database, and reported her to local and federal regulatory authorities, including the U.S. Food and Drug Administration.
The U.S. Attorney's Office said Mangi's actions caused thousands of dollars in financial loss to Stanford University and the Stanford School of Medicine.
"Naheed Mangi intentionally tampered with a breast cancer research database by entering false information and personal insults. Her senseless actions undermined a study into the safety and efficacy of a new treatment for breast cancer patients," Acting United States Attorney Patrick Robbins said in a statement. "The jury's verdict holds the defendant accountable for her crimes."
Mangi was convicted of two counts of intentional damage to a protected computer and one count of accessing a protected computer without authorization.
She will be sentenced on July 21.
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