Healthy Skepticism Library item: 2756
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Warning issued about birth-control patch
Associated Press ( in CNN online) 2005 Nov 10
http://www.cnn.com/2005/HEALTH/11/10/patch.warning.ap.ap/?eref=yahoo
Keywords:
oestrogen OCP Ortho Evra
Notes:
Ralph Faggotter’s Comments:
This story shows why it is not wise to rely entirely on the reasearch performed by the manufacturers of a particular phrmaceutical.
In this case the company was worried that a camparative study would show its oestrogen patch to increase the risk of clots c.f. normal birth-control pills- so it avoided doing the study!
Several young women using the patch have subsequently died from strokes.
Burying your head in the sand will not make the problem go away, and will probablly cost the company more in the long-run — but that’s corporate culture for you!
Full text:
From CNN online:
Warning issued about birth-control patch
Thursday, November 10, 2005; Posted: 10:28 p.m. EST (03:28 GMT)
More than 4 million women have used the birth-control patch since it
first went on sale in 2002.
The warning from Johnson and Johnson subsidiary Ortho McNeil, makers of
Ortho Evra, says women using the patch will be exposed to about 60
percent more estrogen than those using typical birth-control pills
because hormones from patches get into the bloodstream and are removed
from the body differently than those from pills.
Thursday’s warning comes four months after reports that patch users die
and suffer blood clots at a rate three times higher than women taking
the pill.
Citing federal death and injury reports, The Associated Press found that
about a dozen women, most in their late teens and early 20s, died in
2004 from blood clots believed to be related to the birth-control patch,
and dozens more survived strokes and other clot-related problems.
Ortho McNeil spokeswoman Bonnie Jacobs said Thursday that the warning
speaks for itself and that the company has been cooperating with the
Food and Drug Administration, which distributed the new warning to
health care providers.
More than 4 million women have used the patch since it went on sale in
2002. Several lawsuits have been filed by families of women who died or
suffered blood clots while using the patch, and lawyers said more are
planned.
Documents released to attorneys as a result of that litigation show
Ortho McNeil has been analyzing the FDA’s death and injury reports,
creating its own charts that document a higher rate of blood clots and
deaths in association with the patch than with the pill.
In addition, an internal Ortho McNeil memo shows that the company
refused, in 2003, to fund a study comparing its Ortho Evra patch to its
Ortho-Cyclen pill because of concerns there was “too high a chance that
study may not produce a positive result for Evra” and there was a “risk
that Ortho Evra may be the same or worse than Ortho-Cyclen.”
Last week, in response to questions about the Ortho McNeil memo, company
spokesman Michael Beckerich said in a written statement that “decisions
to fund studies are based upon scientific merit.”
Beckerich said Ortho McNeil is conducting its own epidemiological study
“designed with input from the FDA and similar to those previously
conducted with the Pill.”
Although the patch and most birth-control pills contain the same amounts
of estrogen, new published studies show that women using the patch
absorb about 50 percent more estrogen than with the pill, said Dr.
Leslie Miller, an associate professor of obstetrics and gynecology at
the University of Washington.
When women take the pill, the medication is absorbed into the
bloodstream through the digestive tract. In the process, about half of
the estrogen dose is lost.
Hormone levels in women on the pill are highest one or two hours after
taking it, Miller said. Twelve hours later, estrogen levels are quite
low, meaning the body is not exposed to high levels of estrogen 24 hours
a day.
But the patch causes higher estrogen levels since delivery of medication
continues all day. Those elevated levels may be high enough to increase
some women’s risk of blood clots, Miller said.
“If the patch is delivering too much estrogen, then it may need to be
redesigned,” Miller said. “Women should not just take off their patch;
they risk pregnancy. If they are worried and want to change off the
patch, they can wait to get something else.”
Jennifer Cowperthwaite, 26, of Broad Brook, Connecticut, still suffers
breathing problems after a blood clot reached her lungs two years ago
while using the patch. She said the warnings were long overdue.
“I wish I had known,” she said. “It’s quite likely I would never have
used it.”
Erika Klein’s sister Kathleen Thoren died a year ago from blood clots in
her brain that the coroner said were brought on by Ortho Evra. She said
women deserve to be informed when making birth-control decisions.
“Women have a right to know the true risks and make their decisions
based on that information,” she said. “No one should have to go through
what my sister went through.”
Copyright 2005 The Associated Press. All rights reserved.This material
may not be published, broadcast, rewritten, or redistributed.
