Skip to main content
Premium Trial:

Request an Annual Quote

Falsified Data

Two employees of contract research organization the Lee Research Institute admitted to falsifying study data, reports Pharmalot's Ed Silverman. Registered nurse Lisa Sharp and 73-year-old doctor Wayne Spencer pleaded guilty to conspiracy to defraud Schering Plough, which paid the CRO to conduct a clinical trial for a tablet to treat allergies, Silverman says. Sharp and Spencer also pleaded guilty for not maintaining FDA records. "They could face up to five years in prison and fines up to $250,000 each for the conspiracy charge, and up to three years and a $10,000 fine for failing to maintain records in a clinical trial," Silverman says. "The study was to have enrolled patients at least 50 years old who suffer from ragweed-induced allergy symptoms. Employees at the CRO, which is based in Lenexa, Kansas, were not supposed to participate, but two subjects were Lee Research employees and both were younger than 50." Schering Plough, which is now owned by Merck, paid Lee Research more than $30,000 for its work. Sentencing for Sharp and Spencer has been scheduled for January, Silverman adds, and prosecutors have recommended probation.

The Scan

Expanded Genetic Testing Uncovers Hereditary Cancer Risk in Significant Subset of Cancer Patients

In Genome Medicine, researchers found pathogenic or likely pathogenic hereditary cancer risk variants in close to 17 percent of the 17,523 patients profiled with expanded germline genetic testing.

Mitochondrial Replacement Therapy Embryos Appear Largely Normal in Single-Cell 'Omics Analyses

Embryos produced with spindle transfer-based mitochondrial replacement had delayed demethylation, but typical aneuploidy and transcriptome features in a PLOS Biology study.

Cancer Patients Report Quality of Life Benefits for Immune Checkpoint Inhibitors

Immune checkpoint inhibitor immunotherapy was linked in JAMA Network Open to enhanced quality of life compared to other treatment types in cancer patients.

Researchers Compare WGS, Exome Sequencing-Based Mendelian Disease Diagnosis

Investigators find a diagnostic edge for whole-genome sequencing, while highlighting the cost advantages and improving diagnostic rate of exome sequencing in EJHG.