Recent News about the Ortho-Evra Contraceptive Patch
Contra-Deception
New York Post -SUSAN EDELMAN
05/08/05
- New questions about the safety of a trendy contraceptive patch have
been raised with revelations that the maker's chief researcher faked data
in previous scientific studies.
In the mid-1990s,
Dr. Andrew Friedman admitted fabricating 80 percent of patient data and
altering files in three studies of hormonal drugs for women.
He was banned
for three years from government-funded research for "scientific misconduct,"
resigned from his post at a Harvard University-affiliated women's hospital
and lost his medical license in Massachusetts for a year.
Today, Friedman
is senior director of clinical research at Ortho-McNeil Pharmaceutical
in New Jersey, a subsidiary of Johnson & Johnson, which makes the
Ortho-Evra birth-control patch.
The company
hired Friedman in January 2000, after he disclosed his history, a company
spokesman said.
"We
made the decision to hire Dr. Friedman based on his performance as a consultant
and overall reputation in the medical community, which was excellent,"
spokesman Michael Beckerich said.
Friedman
was not involved in clinical trials for the patch but is now part of a
team doing further research on the device and the dangerous blood clots
it might cause, said Beckerich.
Patch users'
lawyers say Friedman's role casts doubt over Ortho-Evra's safety claims.
"It
raises questions about the company's credibility, its women's health division
and any new product coming out," said Ray Chester, a Texas personal-injury
attorney who is suing Ortho-McNeil.
Chester
raises Friedman's record in a lawsuit filed last month in Pittsburgh on
behalf of two women, ages 21 and 43, who suffered debilitating blood clots
while wearing the patch.
He filed
another suit in Austin, Texas, last October for a 37-year-old mother of
two left paralyzed after a massive stroke.
In the first
fatality publicly linked to the patch, a Manhattan student and aspiring
model, Zakiya Kennedy, 18, collapsed in a subway station in April 2004.
The medical examiner ruled her death a side effect of the birth-control
device.
Worn on
the shoulder, buttocks or hip, the patch delivers pregnancy-blocking hormones
into the bloodstream.
Ortho-McNeil
has used supermodels, Olympic athletes and sexy ads to promote the device,
touted as more convenient than the daily pill.
Chester's suits call the patch "defective" and "unreasonably dangerous" — more so than oral contraceptives, which also can cause clots and heart attacks.