Drug
Companies Want Women Of Childbearing Years
By Evelyn Pringle
05 April, 2007
Countercurrents.org
Drug makers are hell-bent on
recovering the antidepressant customer base represented by women of
childbearing years. With doctors now reluctant to prescribe the drugs
to pregnant women, a new recruitment scheme has cropped up. Screening
programs are being set up all over the country to screen every pregnant
woman for mental disorders.
The name-brand selective
serotonin reuptake inhibitor antidepressants, or SSRIs, with a stake
in this controversy, include Paxil, by GlaxoSmithKline; Zoloft, from
Pfizer; Prozac by Eli Lilly; Celexa and Lexapro, from Forest Laboratories;
and Luvox, from Solvay.
According to one of the world's
leading experts on SSRIs, Dr David Healy, a professor at the University
of Wales College of Medicine, "there is quite a movement at the
moment to say all pregnant women are depressed."
Every pregnant woman, he
explains, can have depressive symptoms such as fatigue, disturbed sleep,
and anxiety at times, along with loss of interest in sex. "But,"
he says, "having depressive symptoms and being depressed are two
different things."
"When people get the
flu," he points out, "they have a full house of depressive
symptoms but doctors would not prescribe antidepressants to people with
the flu."
The Advocate Good Samaritan
Hospital in Downers Grove, Illinois continues to recommend that SSRIs
be used to treat pregnant women even despite recent warnings concerning
birth defects and other life-threatening disorders in children born
to mothers who took antidepressants during pregnancy. "Any woman,"
the Hospital warns, "who is thinking about becoming pregnant, is
pregnant, or had a baby within the past year can be affected by depression
or other mood disorders."
Good Samaritan screens all
new mothers, according to a March 1, 2007 Naperville Sun article, and
universal screening may soon become state law in Illinois through legislation
called the, Postpartum Mood Disorders Prevention Act, that was introduced
in February 2007. Similar legislation has been adopted or introduced
in several other states.
According to the Sun, if
the new legislation introduced in Illinois becomes law, it will require
health care professionals to:
"Assess women for mood
disorders at least four times: at a prenatal checkup in the third trimester
of pregnancy, prior to discharge from the place where they give birth,
at the initial postnatal checkup and at every postnatal checkup until
the child's first birthday."
And the new potential customer
base for SSRIs is no longer limited to postpartum depression, it has
now been expanded to include, "mood disorders."
The Good Samaritan Hospital
website also instructs women to "check your symptoms for a variety
of postpartum mood disorders."
"They are trying to
talk women into believing they have a mental illness, says Karen Barth
Menzies of Baum, Hedlund, Aristei, Goldman & Menzies, one of the
attorneys leading the charge against the antidepressant manufacturers
for failing to warn about birth defects. "But the symptoms they
are being told to check for are no different than what any person may
feel on a bad day or when they are under the weather. By their definition,
everyone is mentally ill and should pop a psychotropic pill, continued
Menzies.
Talk about market expansion,
even in the best of cases, the odds are fairly good that a new mother
may be in a bad mood on at least one of those 4 days, leading to a label
of "mental illness requiring medication.
For its article, the Sun
interviewed a first-time mom named, Jami. Shortly after she gave birth
at Good Samaritan, a nurse psychotherapist had Jami fill out a 15-question
test. And surprise, surprise, Jami flunked the test, started seeing
a shrink and is now on an SSRI.
"I learned I had anxiety
before," she told the Sun. "(People like me are) overachievers,
our resumes look like we're 40 or 50, but when we have a baby, it can
come out very intense."
So Jami agreed to take Lexapro
for 6 months for anxiety, something she did not originally want to do,
according to the Sun.
The old line that there,s
no difference between taking insulin for diabetes and taking SSRIs for
whatever, has apparently been replaced with an equally overly simplistic
line as Jami explained, "People get glasses, people get braces,
and now there's something for anxiety."
Some experts view it differently.
"Drug makers have been trying to get a better deal with pregnant
women for ages," Dr Healy says, "by saying they are under
a lot more stress than most people realize, so this is now the easiest
of marketing for drug companies."
"The trouble is,"
Dr Healy points out, "it,s almost too easy for drug companies here
because lots of people are cooperative."
But it gets worse. The SSRI
pushers in Illinois, have convinced Jami to start taking an SSRI the
moment she even thinks of becoming pregnant again. "My psychiatrist
said when my husband and I want to have another baby," she told
the Sun, "it might not be a bad idea to get on something low-dosage
before we even start trying."
"And I'm OK with that,"
says Jami. Apparently Jami,s psychiatrist didn,t tell her that she could
be placing her unborn child at risk for birth defects, persistent pulmonary
hypertension (PPHN), neonatal withdrawal syndrome and other potential
life threatening defects and disorders.
Attorney Karen Barth Menzies,
who represents more than fifty mothers who were taking Paxil and whose
babies were born with birth defects, commented, "I wish Jami could
talk to any mother who has watched her infant undergo open-heart surgery
and then decide if she is willing to take that risk.
According to psychiatrist,
Dr Grace Jackson, author of, "Rethinking Psychiatric Drugs: A Guide
for Informed Consent," prescribing SSRIs as a preventative measure
during pregnancy is a terrible idea. The major reason why preventive
use is so dangerous, she says, is that there is research suggesting
that the SSRIs exert a direct effect upon the early embryo.
For example, she notes, researchers
in France published a paper in 2005 that suggests that serotonin exerts
an impact on developmental processes of the embryo much earlier than
previously believed. "It was already known in the 1980s and 1990s,"
Dr Jackson says, "that the administration of SSRIs to embryonic
cultures of rats and mice leads to craniofacial and cardiac defects."
Experts critical of SSRI
use during pregnancy, all agree that in the absence of any proven effectiveness
of treatment with SSRIs, no potential harm to the fetus can be justified.
"Even if women are depressed
or anxious during pregnancy," Dr Healy says, "there is no
good reason to prescribe antidepressants, because only 1 out of 10 people
are likely to respond to the drugs rather than to attention and support."
"So in essence,"
he notes, "nine out of 10 pregnant women will be subject to the
risks of the SSRIs for the one person who might benefit."
Other experts agree. The
July 2005, British Medical Journal, published a report on a review of
SSRI data by Moncrieff & Kirsch, that said, SSRIs have no clinically
meaningful advantage over a placebo and considering the risks, recommendations
for prescribing the drugs should be reconsidered.
It's worth noting that there
is not a single word in the Sun article that would indicate that Jami
is aware of any of the serious birth defects now known to be associated
with SSRI use during pregnancy. This concerns Harvard trained psychiatrist,
Dr Stefan Kruszewski. "Informed consent," he says, "requires
full disclosure."
"In every case in which
a doctor writes a prescription for a drug," he explains, "the
person receiving the prescription must be fully and understandably provided
a statement of the risks associated with treatment."
"This is never more
serious," he warns, "than when two lives are potentially at
risk, such as the pregnant mom and her fetus.
"Those risks for the
pregnant mom," Dr Kruszewski warns, "may include antidepressant
withdrawal, akathisia or rapid mood swings."
"For the fetus,"
he says, "the overwhelming worry is congenital malformations, resulting
in complications for both mother and child.
SSRI makers have known about
the fetal harm of SSRIs for over a decade. As far back as 1996, the
New England Journal of Medicine reported a study that showed higher
rates of premature delivery, low birth weight, admissions to intensive
care units, and poor neonatal adaptation, including respiratory and
feeding difficulties, and jitteriness, in children born to women who
took Prozac during pregnancy.
In 2004, the FDA revised
SSRI labels to warn that some infants had developed problems requiring
prolonged hospitalization, respiratory support, and tube feeding. Three
FDA advisories have been issued on Paxil since December 2005, and the
drug's pregnancy category has been raised from C to D, meaning there
is positive evidence of fetal harm.
In February 2006, the Archives
of Pediatrics & Adolescent Medicine, reported that roughly one-third
of infants exposed to SSRIs showed signs of withdrawal such as high-pitched
crying, tremors, gastrointestinal problems and disturbed sleep, with
13% severe.
The April 2006, American
Journal of Obstetrics and Gynecology, reported that taking SSRIs doubled
the mother's risk of delivering a stillborn infant and increased the
risk of premature delivery, underweight babies, and seizures.
In July 2006, the FDA issued
an advisory warning that infants exposed to SSRIs were six times more
likely to develop the often fatal lung disorder, persistent pulmonary
hypertension (PPH), than infants who were not exposed.
The October 2006 edition
of Epidemiology reported that women who took SSRIs during the second
or third month of pregnancy had nearly two times the risk of having
babies with congenital malformations, with the most common being cardiovascular
malformations in 29%, muscle and bone malformations in 31%, and 14%
had digestive malformations.
Meanwhile, the Sun reports
that Good Samaritan screened 1,262 patients in 2006, and found 18% at
risk for postpartum depression. Not a bad catch for SSRI makers and
it can only get better when the plan for "universal screening"
kicks in.
One of the latest recruitment
scams involves expanding the postpartum depression market by 10% simply
by including the husbands. According to an August 2006 study in Pediatrics,
about 10% of fathers suffer from moderate or severe postpartum depression.
"Postpartum depression
in fathers was strikingly high and more than twice as common than in
the general adult male population in the U.S.," say researchers
including Dr James Paulson, of the Center for Pediatric Research at
the Eastern Virginia Medical School.
As a result, the authors
advise, pediatricians must make a greater effort to screen moms and
dads for postpartum depression.
However, this appears to
be a case of the dueling researchers in medical journals because in
December 2006, a Danish study in the Journal of American Medical Association,
found that first-time mothers were at an increased risk for mental disorders
but fathers were not.
This 32-year stdy included
more than 2.3 million people, and roughly one out of 1,000 first-time
mothers were admitted to a hospital with a mental illness within one
year, and most were admitted within the first three months after birth.
But among fathers, only 0.37 of 1,000 births resulted in a mental disorder,
which the authors noted, was comparable to men without children or men
with an older infant.
"This may indicate that
the causes of postpartum mental disorders are more strongly linked to
an altered physiological process related to pregnancy and childbirth
than psychosocial aspects of motherhood," said study author Trine
Munk-Olsen of the University of Aarhus, Denmark.
This is indeed the case,
according to Dr Jackson. "The third trimester," she says,
"is a wild time for the mother, in terms of hormonal changes that
occur within her system largely because of the hormones that are produced
in the placenta."
In general, she notes, the
mother,s hypothalamus-pituitary-adrenal axis is in a state of over-drive,
and "the brain itself gets in on the act in terms of Steroids that
are made inside the brain."
She says, researchers were
very excited in the late 1990s to discover that Prozac, for example,
increased levels of the neurosteroid called allopregnanolone.
Neurosteroids, Dr Jackson
explains, are made in the brain itself and allopregnanolone is a chemical
which acts to modulate mood and anxiety and may account for why most
mothers forget the intense pain of labor. "Nature," Dr Jackson
says, "has created a way to remove the memory of the most intensely
painful experience which a woman can encounter during her lifetime."
Some researchers report that
it takes about 90 days for the steroid levels to re-equilibrate. "Although
all women experience these hormonal changes," Dr Jackson explains,
"some may be more sensitive than others to the fluctuations which
occur in the immediate post-partum period - a 90 day phase of steroid,
withdrawal."
Giving SSRIs may help relieve
this "withdrawal period by boosting the allopregnanolone artificially,
she says, but many women will become addicted to the SSRIs, for a hormonal
change that would have ended naturally on its own within 90 days.
Then there is the little
matter of prescribing SSRIs to nursing mothers. "No one yet knows,"
Dr Jackson warns, "because no one has studied the long term consequences
of administering SSRIs to infants via breast milk."
"It has never been proven,"
she notes, "that there is no effect, of giving infants these drugs
during the first months or years of post-uterine existence."
Furthermore, she says, no
one understands how the in utero exposure to SSRIs changes the wiring
of the newborn's brain.
In regard to the overall
scheme of screening all women before, during and after pregnancy and
putting them on SSRIs, Dr Jackson says, "in sum, there could not
be a more foolhardy public health practice than this one."
A better use for a post-pregnancy
screening survey, may be to screen women who were conned into taking
SSRIs during pregnancy whose babies died or were born with birth defects,
to see how many of those mothers are depressed for reasons that no pill
can cure.
A good place to start would
be West Virginia, with the mother of twin daughters who were born with
heart birth defects, after she took Paxil during pregnancy. Only one
infant survived and the other died at 20-months-old.
Another infant with Paxil
related heart defects was born to a mother in Omaha, Nebraska, and the
baby lived only 24 days after enduring four surgeries in an attempt
to save his life.
A screening should also be
conducted on the Toledo, Ohio mother who took Paxil and had a baby born
with heart defects who lived only 17 days after undergoing several surgeries.
Another infant was born with
Paxil related heart birth defects to a mother in Westerville, Ohio,
and the baby required two surgeries in the first nine months after birth
and will have to undergo more in the future.
A Texas mother on Paxil also
gave birth to an infant with heart birth defects who required multiple
open-heart surgeries and had to have a pacemaker implanted.
The Los Angeles-based Baum
Hedlund law firm has the longest track-record handling SSRI litigation
in the country. The firm currently represents families in dozens of
SSRI-related birth defect cases, including Paxil, and has seven attorneys
assigned specifically to SSRI litigation.
Attorney, Karen Barth Menzies,
has been handling SSRI cases for more than a decade involving Prozac,
Paxil and Zoloft and now leads the team, along with Baum Hedlund attorney
Jennifer Liakos, representing families in Paxil birth defect cases.
In addition to birth defects,
SSRIs have been linked to suicidality, violence and homicide, abnormal
gastrointestinal and uterine bleeding, a decrease in bone density, fertility
problems, sexual dysfunction, and a severe withdrawal syndrome.
However, almost without exception,
every time the FDA issues a warning about a new adverse event associated
with SSRIs, the drug companies send out their paid shills to present
industry-funded studies to downplay the seriousness of the warning.
Families seeking justice
for infants born with Paxil related birth defects can contact Baum,
Hedlund, Aristei, Goldman & Menzies at: (800) 827-0087.
Evelyn Pringle
is an investigative reporter. She can be reached at: [email protected]
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