Teen’s Death Prompts U.S. Look at Big Research Deals
Prompted by the death of a teenager in a medical trial last year, federal health officials are investigating whether lush financial rewards earned by some researchers may affect patient safety and public health.
In a conference at the National Institutes of Health, officials said Tuesday that a new era of biotechnology economics, in which researchers may earn millions through stock deals with drug companies, has raised serious questions about scientific integrity and threatens public confidence in medical research.
“If a crisis in confidence develops, if research subjects no longer feel safe, then medical research will grind to a halt,” said Jane Henney, commissioner of the Food and Drug Administration.
She said the death last September of 18-year-old Jesse Gelsinger, a test subject in a gene therapy trial, caused the government and research institutions to take a close look at the highly profitable arrangements that some researchers have with companies that are financing their research.
Gelsinger died in an experiment at the University of Pennsylvania’s gene therapy program led by Dr. James Wilson. It later was learned that a company founded by Wilson funded part of the Penn research. The company, Genovo Inc., later was sold to a bigger company and Wilson got a reported $13.5 million in stock.
Penn’s gene therapy research has been suspended by the FDA, in part because the agency found that researchers did not report two other serious reactions from it.
Wilson has not commented publicly on violations cited by FDA but will have an opportunity to challenge the agency’s findings.
Tests showed that there was a swift rise of immune system proteins, just as there were with other patients who had been involved in the therapy. But for Gelsinger, the proteins never receded.
Dr. Thomas Bodenheimer, a clinical professor at UC San Francisco, said financial conflict of interest among researchers risks scientific misconduct that can “impact the practice of tens of thousands of physicians” who are guided by the research in treating millions of patients.
“Investigators who allow bias or error to infect their work are practicing scientific misconduct,” he said.
Bodenheimer said such bias includes reporting only good results in a drug trial, making claims not justified by the evidence and “outright fraud with fabrication of evidence.”
For instance, said Bodenheimer, an analysis of 70 studies on the safety of a heart drug found that 96% of authors who had drug company ties found the drugs to be safe, while among experts with no drug company connections only 37% said the drugs were safe.
