Pharma Hits On Pregnant Women
By Evelyn Pringle
22 November, 2006
Big Pharma cared one iota about the unborn fetus, at a bare minimum,
it would call off its hired-guns traveling around the country peddling
SSRI antidepressants to pregnant women by convincing doctors to prescribed
the drugs and ignore the studies and FDA warnings that say SSRIs are
associated with serious birth defects.
Less than a month ago, on
October 16, 2006, the first lawsuit in the nation was filed against
GlaxoSmithKline in which an infant charges that his life-threatening
lung disorder was caused by exposure to the SSRI Paxil in the womb during
his mother's pregnancy.
Eric Jackson was born in
Denver, Colorado on October 28, 2004, with persistent pulmonary hypertension
of the newborn (PPHN), a condition in which the infant’s arteries
to the lungs remain constricted after birth and limit the amount of
blood flow to the lungs and oxygen in the bloodstream.
Immediately after birth Eric
had to be placed on a ventilator and eventually had to be placed on
an oscillating ventilator for a month.
In his 2 short years on earth,
Eric has undergone two cardiac catherizations, and another procedure
to combat gastral reflux caused from being on a ventilator for so long.
Since birth, he has remained on oxygen and medications to help him breathe
and he continues to suffer with eating and digestive problems.
With their lawsuit, Eric's
parents hope to recover the medical and other expenses incurred in treating,
and attempting to cure Eric’s condition, as well as the related
illnesses. Some of the related health problems may not even surface
until Eric is a teenager.
A study in the October 3,
2006 Archives of Pediatrics and Adolescent Medicine by Dr Agnes Whitaker,
MD, of Columbia University and the New York State Psychiatric Institute,
and colleagues, reported that low birth weight infants who require mechanical
ventilation, with no obvious disability early on, can have subtle and
cognitive deficits discernable at age 16.
The study sample represented
a cohort of babies who were born at or admitted to one of three hospitals
in New Jersey between September 1, 1984 and June 30, 1987.
The research team said, two
factors, male gender and days of ventilation were predictors of motor
problems. For each additional week of mechanical ventilation, they said,
total and oral motor problem scores were higher by 0.33 and 0.14 points,
Legal analysts predict that
Glaxo will attempt to reach early settlements with the families of infants
born with birth defects because the company in no way wants injured
toddlers paraded in front of a jury.
Karen Barth Menzies is one
of Eric's attorneys. She is a partner at Baum Hedlund, a national pharmaceutical
products liability law firm with offices in Los Angeles, Washington,
DC and Philadelphia, where she heads the Pharmaceutical Antidepressant
Ms Menzies has been waging
legal battles against the SSRI makers on behalf of injured consumers
for more than a decade and she currently represents many other families
in Paxil birth defect cases
Jennifer Liakos is an associate
attorney at Baum Hedlund in Los Angeles, and she is also a member of
the firm's Pharmaceutical Antidepressant Litigation Department, handling
Paxil birth defect cases. She explains that between 10% to 20% of babies
born with PPHN do not survive, even when they receive treatment.
Having been the leader in
the Paxil litigation against Glaxo for years now, and through their
intensive litigation and discovery, Baum Hedlund has evidence that reveals
specifics relating to Paxil and birth defects. Eric's attorneys do not
have to newly learn the inter-workings of Glaxo because they know how
the company operates regarding Paxil and how they analyze or fail to
According to Ms Menzies,
studies have shown that infants who are exposed to selective serotonin
reuptake inhibitor antidepressants (SSRIs), after the 20th week of gestation
are more likely to develop PPHN than infants who were not exposed to
an SSRI during pregnancy.
In addition to Paxil, the
other SSRIs sold in the US include Prozac by Eli Lilly; Zoloft, from
Pfizer; Celexa and Lexapro, from Forest Laboratories; and Luvox, from
Solvay. Wyeth markets Effexor, a serotonin-norepinephrine inhibitor.
Adding to the problem of
curtailing the prescribing of SSRIs to pregnant women, is the fact that
SSRI makers have doctors prescribing the drugs for many other conditions
besides depression, and often for off-label uses, meaning they are not
approved by the FDA.
According to Dr Jay Cohen,
author of, "Over Dose: The Case Against The Drug Companies,"
the "drug companies have marketed SSRI antidepressants vigorously
not only to psychiatrists, who are supposed to have some expertise with
these drugs, but also to family practitioners, pediatricians, gynecologists,
internal medicine specialists, and anyone else who can pen a prescription."
"But this doesn't mean,”
he says, “that they possess in-depth knowledge of SSRIs or their
actions and toxicities.”
A study from the University
of Georgia in the June 2006, Journal of Clinical Psychiatry, found that
75% of the people prescribed antidepressants received them for a reason
not approved by the FDA.
Little Eric's lawsuit contends
that when allowing Paxil to be prescribed to pregnant women, Glaxo has
an ongoing duty of pharmacovigilance. The FDA describes the term pharmacovigilance
to mean "all scientific and data gathering activities relating
to the detection, assessment, and understanding of adverse events."
This includes, the agency
notes, the use of pharmacoepidemiologic studies and activities "undertaken
with the goal of identifying adverse events and understanding, to the
extent possible, their nature, frequency, and potential risk factors."
"During the entire time
Paxil has been on the market in the US," Ms Menzies says, "FDA
regulations have required Glaxo to issue stronger warnings whenever
there existed reasonable evidence of an association between a serious
risk and Paxil."
"FDA regulations specifically
state," she explains, "that a causal link need not have been
proven before a new warning is issued and they explicitly allow Glaxo
to issue a new warning without prior FDA approval."
Ms Menzies reports that research
as far back as October 3, 1996 in the New England Journal of Medicine,
by Dr Christina Chambers and colleagues, of the Department of Pediatrics,
Division of Dysmorphology and Teratology, at the University of California–San
Diego, indicated a risk of PPHN in babies born to mothers taking SSRIs.
For this study, the researchers
identified 228 pregnant women taking Prozac between 1989 through 1995,
and compared the outcomes of their pregnancies with those of 254 women
who were not taking Prozac.
The study found that babies
exposed to the Prozac, during the third trimester of pregnancy, had
significantly higher rates of premature delivery, respiratory difficulties,
admissions to special care nurseries, jitteriness, and poor neonatal
adaptation including cyanosis on feeding.
There have also been studies
specific to the use of Paxil during pregnancy that have shown respiratory
problems in exposed infants upon delivery. For instance, in 2003, researchers
at the Motherisk Program at the University of Toronto, reported that
exposure to Paxil in late pregnancy was associated with a significantly
higher rate of neonatal complications among 55 exposed newborns, when
compared to infants exposed to Paxil in early pregnancy or to newborns
with no exposure, and respiratory distress was the most commonly reported
In June 2004, the journal,
Prescrire International, reported that newborns exposed to SSRIs toward
the end of pregnancy had breathing and suction problems and showed signs
of agitation, and altered muscle tone. The study estimated that 20%
to 30% of infants were effected and warned that doctors should be aware
of the risks when considering treatment during pregnancy with Paxil,
Celexa, Prozac, Zoloft, and Lexapro.
The following month, on July
9, 2004, WebMd reported that over the past decade the FDA had received
"hundreds" of reports of adverse effects with infants born
to mothers taking SSRIs.
That same month, the FDA
changed the labeling for all SSRIs, warning that upon delivery, some
infants exposed to SSRIs required respiratory support, tube feeding
and prolonged hospitalizations.
In May 2005, a University
of Pittsburgh study in the Journal of American Medical Association,
combined the previous research and found that women who took SSRIs late
in pregnancy had a three times higher risk of giving birth to infants
suffering from serious respiratory problems, jitteriness, and irritability
in the first couple of weeks after birth.
The drugs involved in this
study also included the serotonin norepinephrine reuptake inhibitor
Effexor. The researchers estimated that in any given year in the US,
at least 80,000 pregnant women are prescribed the drugs. According to
psychiatrist, Dr Eydie Moses-Kolko, the lead author of the study, serious
respiratory problems develop in about one out of 100 infants born to
As a follow-up to her findings
of breathing problems in the previous Prozac study in 1996, Dr Chambers,
now an assistant professor of pediatrics at the University of California,
San Diego, and colleagues, performed a case control study of women on
SSRIs who gave birth between 1998 and 2003, to determine whether PPHN
was associated with exposure to SSRIs in late pregnancy.
The results of the study
published in the February 9, 2006, New England Journal of Medicine,
reported that mothers who took SSRIs in the second half of their pregnancies
were 6 times more likely to give birth to babies with PPHN.
The study found 14 infants
with PPHN in the group who had been exposed to an SSRI, compared to
6 infants with the disorder in the group who were not exposed to the
The FDA found the study so
alarming that it prompted the agency to hold a press conference. “This
appears to be a very well-conducted study and we find the results to
be very concerning,” said Dr Sandra Kweder, deputy director of
the office of new drugs at the FDA.
She also told reporters that
women of reproductive age are the "biggest users of antidepressant
Instead of immediately taking
action to warn doctors and consumers of this development, the pharmaceutical
industry went into all-out damage control to protect SSRI profits by
encouraging pregnant women to keep taking SSRIs.
A corresponding study in
the February 2006, Journal of the American Medical Association, warned
that pregnant women who stopped taking the drugs could greatly increase
their risk of a relapse of depression. The authors of the study predicted
that their findings would prompt some women to stay on SSRIs throughout
The JAMA study got much more
media attention than Dr Chambers, and included headlines warning about
the dangers of relapse in pregnant women going off SSRIs. Many local
television news broadcasts even ran an unedited video provided by JAMA,
featuring a study author and one of his patients.
However, 5 months later,
on July 11, 2006, the Wall Street Journal published an expose on the
researchers involved in the study who were encouraging pregnant women
to keep taking SSRIs. "But the study," it reported, "and
resulting television and newspaper reports of the research failed to
note that most of the 13 authors are paid as consultants or lecturers
by the makers of antidepressants."
Most of the authors, the
WSJ noted, were leading psychiatrists at Massachusetts General Hospital,
the University of California Los Angeles, and Emory University
The lead researcher, Dr Lee
Cohen, a professor at Harvard Medical School, it reported, "is
a longtime consultant to three antidepressant makers, a paid speaker
for seven of them and has his research work funded by four drug makers."
Among the most significant
of the missing financial disclosures, the Journal said, were those of
study author, Lori Altshuler, director of the Mood Disorders Research
Program at UCLA, who was a speaker or consultant for at least 5 antidepressant
Vivien Burt and Victoria
Hendrick were also authors who did not report financial relationships
with SSRI makers, and Dr Viguera, another author, did not disclose her
paid speaking relationship with Glaxo.
All total, the Journal said,
"the authors failed to disclose more than 60 different financial
relationships with drug companies."
“The work of these
academic researchers,” the article wrote, “highlights the
role of "opinion" or "thought" leaders coveted by
drug companies because of their ability to influence not only the practice
of doctors, but popular opinion as well.”
In the case of SSRI use by
pregnant women, the WJS said, the industry-paid opinion leaders have
become dominant authorities in the field and stated:
“They help establish
clinical guidelines, sit on editorial boards of medical journals, advise
government agencies evaluating antidepressants and teach courses on
the subject to other doctors. In some cases, the financial ties between
industry and these leading researchers are not disclosed.”
According to the WSJ, as
soon as their study was published, Dr Cohen and some the other authors
went out on the lecture circuit, telling doctors about their findings
and pointing out flaws in the studies that found an increased risks
of birth defects with infants exposed to SSRIs.
For instance, the panel of
experts who criticized the Chambers study during the May 17, 2006, continuing
medical education lecture, "Psychotropic Drug Use During Pregnancy,"
sponsored by the Massachusetts General Hospital Psychiatry Academy,
was comprised entirely of psychiatrists with financial ties to drug
During the lecture, the panelists
were also critical of the FDA for adding new warnings about birth defects
to Paxil’s label. On December 8, 2005, the FDA issued a Public
Health Advisory after US and Swedish studies showing that exposure to
Paxil in the first trimester of pregnancy to be associated with an increased
risk of heart birth defects.
With the warning, the agency
for the first time placed an SSRI in the D category, its second highest
for the risk of birth defects. Category D means that either controlled
or observational studies of pregnant women "have demonstrated a
risk to the fetus."
The agency did not ban Paxil
from use with by pregnant women, but it did go so far as to say, "FDA
is advising patients that this drug should usually not be taken during
At the May 17 conference,
panelist, Zachary Stowe, from the women's mental health center at Emory
University, described the FDA’s decision to change the label as
"driven by a single set of data that is unpublished, non-peer reviewed,
and somehow this trumps the very nicely done prospective investigations
that have really failed to find this risk."
However, here once again,
according to the WSJ, Dr Stowe has served as an paid adviser and speaker
for several SSRI makers.
In July 2006, corresponding
with the WSJ’s expose about the undisclosed financial relationships
of the Cohen study authors with SSRI makers, JAMA published a correction
to announce that 7 of the authors of the February 2006, study had failed
to reveal their financial ties with drug companies.
Critics of Big Pharma‘s
influence over studies published in medical journals were quick to respond
to the disclosure. On July 11, 2006, Merrill Goozner, director of the
Center for Science in the Public Interest, issued a statement saying:
“It’s clear that the Journal of the American Medical Association
does not evaluate conflict of interest disclosures when articles are
“As a result,”
Mr Goozner said, “some authors with blatant conflicts of interest
apparently feel they can ignore the journal’s policy with impunity.”
“The only solution,”
he added, “is for journals to adopt strong penalties for authors
who fail to disclose – a three-year ban from publishing in the
pages in the journal.”
A month later in August 2006,
another study in the Archives of General Psychiatry, by Canadian researchers
at the University of British Columbia, found babies born to women who
took SSRIs during pregnancy to be at an increased risk of having respiratory
distress and low birth weight.
Lead investigator, Dr Tim
Oberlander, told Reuters Health on August 25, 2006, that "our study
was undertaken to distinguish the effects of maternal mental illness
-- pregnancy-related depression -- from its treatment -- SSRIs -- on
The researcher reviewed health
records for almost 120,000 live births between 1998 and 2001 and determined
that 14% of the mothers were diagnosed with depression. They then compared
the outcomes of infants born to women treated with SSRIs to those born
to depressed women who were not treated with SSRIs and found a significantly
higher incidence of respiratory distress in infants exposed to SSRIs
by a ratio of 13.9% to 7.8%.
The study reported longer
hospitalizations for infants born to mothers on SSRIs, and found birth
weight and gestational age were also significantly less in SSRI exposed
"These findings are
contrary to an expectation that treating depressed mothers with SSRIs
during pregnancy would be associated with lessening of the adverse neonatal
consequences associated with maternal depression," Dr Oberlander
In October, 2006, the journal,
Pediatrics, reported that CDC researchers cited preterm birth as the
leading cause of infant mortality in the US, accounting for at least
one-third of all infant deaths in 2002.
The contribution of prematurity
to infant mortality may be twice as high as originally estimated, reported
Dr William Callaghan, MD, MPH, and colleagues.
The research team looked
at the top 20 causes of infant deaths in 2002, and found that 34% occurred
in preterm infants, 95% of whom were born before 32 weeks gestational
age of 32 weeks and weighed less than 3.3 pounds.
"The extreme prematurity
of most of the infants and their short survival indicate that reducing
infant mortality rates requires a comprehensive agenda to identify,
to test, and to implement effective strategies for the prevention of
preterm birth," the authors wrote in Pediatrics.
There are also studies showing
infants born with symptoms of neurological damage associated with SSRI
exposure in the womb. In February 2004 a study in the American Journal
of Pediatrics reported abnormal sleeping patterns, heart rhythms and
levels of alertness linked to SSRIs.
Dr Philip Zeskind, a developmental
psychologist and research professor at the University of North Carolina,
Chapel Hill, led the investigation and on February 22, 2006, told the
Sunday Telegraph, "What we've found is that SSRIs disrupt the neurological
systems of children, and that this is more than just a possibility,
and we're talking about hundreds of thousands of babies being exposed
to these drugs during pregnancy."
In reaching their results,
the team of researchers compared 17 babies born to mothers who took
the Prozac, Paxil, Zoloft or Celexa throughout their pregnancy, with
17 babies born to mothers who had never taken SSRIs.
According to Dr Zeskind,
"These babies are bathed in serotonin during a key period of their
development and we really don't know what it's doing to them or what
the long-term effects might be."
"It could be that they
go `cold turkey' when they are born,” he explained in the Telegraph,
“or the serotonin could be having an effect on their brains, or
it could be a bit of both."
“We're not saying that
pregnant women should not take the drugs, because depression is itself
a big problem,” he said. “But these drugs are being given
away like smarties, and this is a big problem,” Dr Zeskind warned.
Legal analysts predict that
this first PPHN lawsuit is just the tip of the proverbial iceberg because
there are tens of thousands of infants exposed to SSRIs in the womb
After the results of her
PPHN study were made public, Dr. Chambers says she heard from women
all across the country who took SSRIs during pregnancy and had babies
born with PPHN.
The fact that Glaxo has not
ordered its hired-guns to stop promoting the sale of Paxil to pregnant
women, proves that the company plans to go on sacrificing the lives
of babies in the name of profits and that should be a fairly easy point
to get across to a jury.
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