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Now
If 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, respectively.
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 Litigation Department.
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 analyze data.
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 CaliforniaSan 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 adverse reaction.
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 these women.
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 drugs.
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
drugs."
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 pregnancy.
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 makers.
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 companies.
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 pregnancy."
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 Pharmas 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 submitted.
"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 neonatal outcomes."
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
infants.
"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 told Reuters.
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 each year.
After the results of her 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.
Families seeking justice for
infants born with Paxil related birth defects can contact the
Baum Hedlund Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/
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