http://www.lawyersandsettlements.com/articles/orthoe
vra.html
Ortho-McNeil knew Ortho Evra Patch was Lethal
April 19, 2006. By Evelyn Pringle*
Documents have surfaced in litigation that show Ortho-McNeil
has been
analyzing the FDA's death and injury reports on women using
the Ortho
Evra birth-control patch, and has charts that show a higher
rate of
blood clots and deaths in women on the patch when compared
to women
who take birth-control pills.
In addition, according to a November 11, 2005, article by
the
Associated Press, an internal company memo shows that in
2003, the
company refused to fund a study comparing the Ortho patch to
the
company's Ortho-Cyclen pill because there was "too
high a chance that
study may not produce a positive result for Evra" and
a "risk that
Ortho Evra may be the same or worse than
Ortho-Cyclen."
A number of doctors and health-care providers no longer
prescribe the
patch, saying they do not want to take any chances. In
Memphis, TN,
obstetrician and gynecologist, Henry Sullivant, told the
Wall Street
Journal, that he has stopped writing new prescriptions and
suggests
that his roughly 2 dozen users try other forms of birth
control, such
as the pill or vaginal ring.
Pennsylvania State University, which provides health
services for
42,000 students, is also no longer issuing prescriptions,
and
according to the Journal, is considering contacting all
students who
have been given prescriptions, even if they are no longer at
the
university.
Since obtaining FDA approval in 2002, the Ortho patch has
become a
very popular product. In 2004, according to the industry
monitoring
firm, IMS Health, doctors wrote more than 9.4 million
prescriptions
for the patch and sales topping $411 million. That is 21%
more than
the top-selling brand of birth-control pill, IMS Health
says.
The patch is about the size of a matchbook and the biggest
draw is
that it eliminates the need to remember to take a pill every
day. The
patch is applied to the lower abdomen, buttocks, upper arm
or upper
body and worn for 7 days, and then replaced with another
patch, for 3
consecutive weeks, followed by a week without a patch.
The system delivers hormones through the skin into the
bloodstream and
contains progestin and estrogen, the same hormones found in
birth-control pills. Although the estrogen levels are
similar in the
pill and the patch, before entering the blood stream the
hormones in
the pill are processed through the digestive tract, while
hormones in
the patch go straight to the bloodstream.
Both products work the same by: (1) preventing ovulation; an
egg is
not released by the ovaries for fertilization; (2)
thickening cervical
mucus so sperm are less likely to enter the uterus; and (3)
causing
changes in the endometrium to reduce egg implantation.
In the case of adverse reactions, blood clots usually form
in the
legs, and become serious problems if they travel to the
heart, lungs
or brain. Symptoms include pain in the calf, shortness of
breath,
chest pain, or coughing up blood.
When the patch was up for approval in 2000, it is now known
that
doctors warned the FDA that clots could be a problem if the
patch was
approved.
When conducting the review of more than 3000 women, doctors
discovered
that two women had been treated for clots in the lungs.
Ortho argued
that one case should not be counted as an adverse event
because the
woman had undergone surgery. However, in report, a reviewing
doctor
argued against that claim in capital letters.
"THE REVIEWER DOES NOT AGREE WITH THE SPONSOR'S ABOVE
CONCLUSIONS," he
wrote.
"The two cases of pulmonary embolus, a serious and
potentially fatal
condition, must be counted as two cases ...," the
report said. "The
incidence rates quoted by the sponsor may be
misleading."
The doctor also said, "the label should clearly
reflect this
reviewer's safety concern about a potential increased
risk."
In addition, the reviewer expressed concern that 211 women
had gained
10 or more pounds during the trial and said the
effectiveness of the
patch was reduced in women weighing over 198 pounds.
And although the report said it would be important to
continue to
study problems with the patch once it was approved, there
were no
requirements for follow-up studies other than the routine
review of
reports filed by consumers, doctors and manufacturers.
In July 2005, the Associated Press conducted an
investigation that
tracked adverse reactions in women using the patch since it
came on
the market. In response to a FOIA request, the FDA provided
the AP
with a database that contained roughly 16,000 adverse
reaction reports.
The FDA's Adverse Event Reporting System (AERS) is a
computerized
database designed to handle the agency's post-marketing
safety
surveillance program for approved drugs. AERS receives
reports from
manufacturers as required by law, and health care providers
and
consumers send reports voluntarily through the MedWatch
program. The
reports then become part of the AERS database.
Since the FDA estimates that it only receives reports on
between 1%
and 10% of the adverse events that actually occur, the death
and
injury rate for products is known to be significantly higher
that
indicated in the database.
Within the group of 16,000 adverse reaction reports, the AP
determined
that there were 23 deaths. Doctors who reviewed the 23
deaths said
about 17 appeared to be clot-related.
According to the AP, about a dozen women, mostly in their
late teens
and early 20s, died from clots in 2004, and dozens more
experienced
strokes and other clot-related problems.
In November 2005, the FDA warned that women using the patch
were found
to have as much as 60% more estrogen in their blood steam
than women
on the pill, putting them at a higher risk for potentially
fatal side
effects.
Greater exposure to estrogen, the FDA said, may increase the
risk of
blood clots. Experts say that clots are a known risk with
hormonal
birth control because estrogen promotes blood coagulation.
On November 10, 2005, the FDA revised the labeling for the
Ortho patch
to include a new, bolded warning to alert health care
providers that
the amount of estrogen delivered through the patch produces
a higher
level of estrogen exposure than birth control pills.
Johnson and Johnson has consistently denied knowledge of any
problems
with the patch. However, according to a story by CBS News,
documents
have surfaced in a lawsuit that show the company's own
records reveal
that it received some 500 reports of serious problems
associated with
the patch between April 2002 and December 2004.
Apparently, Johnson and Johnson has decided it's time to
spring into
damage control. On April 9, 2006, the New York Post reported
that
women "who suffered life-threatening blood clots and
strokes on the
Ortho-Evra birth-control patch are receiving cash
settlements from the
manufacturer, which allegedly failed to warn customers about
the known
risks."
"Ortho-McNeil Pharmaceutical of Raritan, N.J., a
subsidiary of Johnson
& Johnson," the Post said, "has settled a
dozen lawsuits for millions
of dollars in the last few months, and more than 100 other
suits are
pending."
The settled cases include a lawsuit filed by Philomena
Ugochukwa, a
37-year-old woman, who remains totally paralyzed after
suffering a
massive stroke and brain damage while wearing the patch for
less than
2 weeks.
The other 11 plaintiffs who settled out of court include
women between
the ages 18 to 47, who suffered blood clots in the lung,
leg, and brain.
One case involved 18-year-old Zakiya Kennedy, who died after
collapsing in a subway station, in which the medical
examiner
determined the death was caused by a clot brought on by use
of the
Evra patch
More lawsuits are being filed all across the country.
In November 2005, a federal lawsuit was filed in Madison,
Wisconsin,
by the parents of the youngest patch victim, Alycia Brown, a
14-year-old eighth-grader, who died on May 7, 2004, after
using the
patch for 8 weeks, when blood clots developed in her lower
pelvis. The
medical examiner listed the patch as a likely contributing
factor in
her death.
In another case, twenty-five-year-old, Sasha Webber, a
Baychester, NY
mother of two, died of a heart attack in March 2004, after 6
weeks on
the patch.
In many instances it is difficult to determine with any
degree of
certainty that a specific product did in fact cause a death
or an
injury. Such is not the case with the Ortho patch, experts
say,
because the injuries and deaths are occurring in young women
of
child-bearing age, who in most cases have no prior history
of health
problems.
Evelyn Pringle* is a member of our group. Vince
--~--~---------~--~----~------------~-------~--~----~
You received this message because you are subscribed to the
Google Groups "MedicalConspiracies" group.
To post to this group, send email to MedicalConspiracies googlegroups.com
To unsubscribe from this group, send email to
MedicalConspiracies-unsubscribegooglegroups.com
For more options, visit this group at ht
tp://groups.google.com/group/MedicalConspiracies
-~----------~----~----~----~------~----~------~--~---
|