The death of an adolescent in a
medical trial last year has federal health officials investigating
whether 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.
"Questions were raised about financial interests of
investigators and whether these interests clouded their judgment in
decisions that were made," said Henney.
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. He
did say of Gelsinger: "We may have activated his immune system
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
Dr. Thomas Bodenheimer, a clinical professor at the University
of California, 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."
Most drug trials, he said, are paid for by drug companies. Other
trials are conducted by researches with a financial interest in the
For instance, said Bodenheimer, an analysis of 70 studies on the
safety of a heart drug found that 96 percent of authors who had
drug company ties found the drugs to be safe, while among experts
with no drug company connections only 37 percent said the drugs
When drug companies pay for research into the effectiveness of
their own pain relievers, said Bodenheimer, 100 percent find their
drug superior to a competitor's.
An analysis of company-funded studies published in peer-reviewed
journals found that results of the studies favored the company's
products 98 percent of the time.
"The take-home message of these studies is that company-funded
trials have a high likelihood of favoring the company's products,"
Among other examples of conflict of interest:
Private physicians may be paid $1,000 to $5,000 for each
patient recruited for a drug trial. This leads to doctors sometimes
enrolling patients who don't belong in the drug trials. Some
doctors have even enrolled patients who don't even have the disease
Up to 75 percent of people enrolled in cancer studies are
younger than 65 because older people respond more poorly to
chemotherapy. Yet, 63 percent of cancer patients in the United
States are over 65. Excluding older people can make it appear that
a drug works better than it really does.
Drug companies own the data from drug trials. Bodenheimer said
in some cases companies release only results that make their drug
look good "and bury data on less favorable" results.
In at least two cases, said Bodenheimer, drug companies
threatened researchers who attempted to publish company-paid
studies that put their drug in a poor light.
Many research studies are written by "ghost" authors, usually
hired by a drug company. The company then pays a prominent
researcher to be named as the author "though they contributed
nothing except their prestige," said Bodenheimer.
And, yet, said Bodenheimer, thousands of doctors rely upon the
results of these studies to make treatment decisions for their
He said the data show "that scientific misconduct does take
place in clinical drug trials, that conflict of interest is a risk
factor for scientific misconduct and that something must be done
Federal officials called the conference to gather information
that may later be used to write new federal regulations controlling
oversight of conflict of interest in medical research.