Dr Barry L. DUNCAN, Psy.D., therapist, director of the Heart and Soul of Change Project, & MarciaBARBACKI, Practicing occupatinal therapist.

Lourdes, May 2010

The number of people using psychiatric drugs in the US increased from 21 million in 1997 to
32.6 million in 2004. More than $24 billion of antidepressants and antipsychotics were dispensed
in 2009. Since 2004, spending for medications for childhood behavior problems
has eclipsed expenditure for any other drug category, including antibiotics. The number of
children taking antipsychotics rose 73% in the four years ending in 2005—over 2.5 million
youth are taking them. There has been a 274% global increase in prescriptions for psychiatric
drugs to youth over the last ten years across more than 50 countries. While psychotropic drug use has risen, community intervention has remained flat or declined. Are these increasing rates of prescription justified by the clinical
trial evidence? Psychiatric drugs, clearly, help some. An examination, however, of clinical trial research
fails to provide the proof of efficacy and safety so often cited. A meta-analysis of all trials
submitted to license four popular SSRIs found no clinically significant differences between
placebo and the drugs, with the exception of the most severely depressed group. Adverse
effects including youth suicidal behavior and birth defects become particularly important in
light of the minimal therapeutic effects over placebo. The CATIE study reaffirms that antipsychotics
present an unacceptable side effect profile, including weight gain, diabetes, and
cardiovascular problems, with minimal efficacy beyond the temporary sedation of psychotic
symptoms. When clinical trials are critically examined—does the study have a true double
blind, are outcome measures clinician or patient-rated, how long did the study last, who
funded the study and what are the authors’ affiliations, and what are the safety ramifications—
it is clear that psychiatric drugs should not be a first line treatment, especially with
children. This conclusion does not eliminate the use of medication. Rather, it frees clinicians
to put other options on the table and engage in risk/benefit discussions to help families choose
treatments in concert with their values and cultural contexts, including Church and community—
thereby enacting the call of evidence based medicine (EBM) to integrate the best
available research with patient preferences. The Catholic Church, in addition to spiritual
leadership, has a rich history of benefiting humanity. The Church holds great international
influence and perhaps may be the only power on earth that can counter the forces of corporate
greed which have no conscience. The Church, via FIAMC and other Catholic organizations,
in conjunction with religious communities, can assist those in need of guidance in
alternatives to medication as well as the risks and benefits of medication use. A place to start
would be an international conference devoted to this topic and how health and pastoral professionals
can be consistent with the Catholic Faith, EBM, and sensitive to cultural diversity…


The Use and Abuse of Psychiatric Drugs in Pregnancy

Barry Duncan and Marcia Barbacki

Rome, September 2011

Denmark, Israel, Germany, and Italy, and there has been a 274% global increase in prescriptions
for psychiatric drugs over the last ten years across more than 50 countries.
Given that the highest incidence of psychiatric disorders occurs at the onset of
childbearing age, it is important to weigh the risks and benefits of all treatment options during
pregnancy. There are no randomized clinical trials (RCT) that address the efficacy and safety of
SSRIs during pregnancy. A risk/benefit analysis, therefore, requires the review of RCTs with
adults and epidemiological studies of the risk of birth defects and complications with SSRI use.
Kirsch et al. (2008) and Fournier et al. (2010) meta-analytically examined available SSRI trials
and found no differences between placebo and SSRIs, for mild, moderate or severe depression
with the exception of the most distressed in the severely depressed group. The negligible
advantage of SSRIs over placebo underlines the importance of their substantial adverse effects,
including the higher risk of suicide for young adults as well as the increased risks on the
developing fetus and newborn. The FDA has established Pregnancy Safety Ratings that
categorize risk:
 Category A—controlled studies show no fetal risks associated with the drug;
 Category B—no evidence of risk in humans, although risks have been noted in animal
 Category C—risk cannot be ruled out;
 Category D—positive evidence of risk; and
 Category X—contraindicated for use in pregnancy.
Depression, mood disorders, and other psychiatric problems have the highest incidence at the onset
of the childbearing years. Across the world, psychiatric drugs have emerged as a first-line
treatment for pregnant women in distress. Thirteen per cent of pregnant women in the US and 4% in
Canada took a Selective Serotonin Reuptake Inhibitor (SSRI) at some time during pregnancy.
Increases have also been reported in Finland,
2 No SSRI has an A or B rating. The FDA and has already issued a warning in 2006 for use of
SSRIs past the 20th week of pregnancy because of the link to a 6-fold increase in risk for
persistent pulmonary hypertension (PPHN) in newborns.
Over the years, there has been substantial inconsistency of results regarding SSRIs and its
effects on the fetus and newborn, and research has been plagued by methodological flaws.
Recent studies, however, are more sophisticated, and many findings of birth
defects/complications have now been replicated. Reported here are only replicated findings
(except one, see below), emerging from the most recent, methodologically sound studies.
Confirming previous investigations, a large study in Finland looking at birth registry data
covering eleven years (Malm, Artama, Gissler, & Annukka, 2011) found a 2-fold increase for
ventricular septal defects associated with fluoxetine use and for paroxetine, a 4-fold increase for
right ventricular outflow tract defects (0.5% for unexposed to .9% for SSRI to 2.1% for 2
In a Denmark study (Lund, Pedersen, & Henriksen, 2009) that controlled for many
confounding factors, including a comparison to women with a history of depression who didn’t
take SSRIs, researchers found that infants of mothers who took SSRIs had twice the risk for
preterm birth over those with no history of depression, and significantly more risk (than controls
or those with a history of depression) for a low 5-minute Apgar score and admission to the
neonatal intensive care unit (NICU). Exposed infants admitted to the NICU experienced
symptoms likely caused by withdrawal from or adverse effects of SSRIs, including jitteriness,
seizures, respiratory problems, infections, and jaundice, or what is often called prenatal
antidepressant exposure syndrome (Gentile, 2011).
Perhaps in the most methodologically rigorous study to date, Nakhai-Pour, Broy, and
Berard (2010) found the use of SSRIs, especially paroxetine and venlafaxine was associated with
a 68% relative increase in the overall risk of spontaneous abortion. Use of more than one class of
antidepressant doubled the risk of spontaneous abortion. Once again, a key feature of this study
was its control for women with a history of depression who did not use SSRIs during pregnancy.
One recent finding, although too new to be replicated, is a relationship between SSRIs and an
increased risk for autism spectrum disorders (ASD; Croen, Grether, Yoshida, Odouli, &
Hendrick, 2011).
3 The diagnosis of autism has increased from 4 to 5 per 10,000 in 1966 to almost 100 per
10,000 today. In this study of more than 1800 children, investigators found an adjusted 2-fold
increased risk for ASD among mothers who used an SSRI during the year before delivery and a
3-fold increased risk when SSRIs were ingested during the first trimester. A compelling aspect
this study, once again, is that it compared rates of autism with women diagnosed with depression
and anxiety who didn’t take SSRIs. There was no increased risk among those mothers who had a
history of mental disorders but did not take SSRIs during pregnancy.
A review of this literature reveals two often repeated responses that serve to minimize the
findings of defects or complications: 1) the risk is low and, 2) the risk of untreated maternal
depression offers greater peril to the fetus and newborn. While the individual risk of the different
defects and complications are low (although any increased risk is disturbing), the cumulative risk
is not. Consider the documented risks, all replicated except the risk for autism:
1. 2 times the rate of cardiovascular malformations;
2. 6 times the rate of persistent pulmonary hypertension (and other withdrawal
3. 68% higher rate of spontaneous abortion;
4. Significantly more preterm births, lower Apgar scores, and intensive care
5. 2 times the rate of gestational hypertension;
6. 2-3 times the rate of autism.
When considering the cumulative risks together with the lack of efficacy and general adverse
effect profile, a risk/benefit analysis suggests that SSRIs not be used as first line intervention
during pregnancy.
The Evidence Warrants A Serious Look & Changes in Prescribing Practices
 We warn about alcohol & cigarettes, but how much evidence do we need to warn about psychiatric
The repeated admonition regarding the “deleterious effects of untreated maternal
depression” to the fetus and newborn is curious given the now overwhelming and much replicated
evidenced that SSRI “treated” depression yields very limited results, differing with placebo with
only the most severe of the severely depressed. Moreover, three of the studies reported above
4 (Croen et al., 2011; Lund et al., 2009; Nakhai-Pour et al., 2010) either controlled for maternal
depression without SSRI exposure or compared it directly and found no effects of “untreated
depression” on the fetus or newborn.
A recent meta-analysis (Grote et al., 2010) examined depression and the risk of preterm
birth, low birth weight, and intrauterine growth restriction. Although the study is often touted as
a rationale for treating depression with SSRIs because of the increased risk associated with
“untreated” maternal depression, a closer inspection reveals the opposite conclusion. First,
among the 29 studies included in the analysis, no consistent diagnosis or measurement of
depression was used. Second, and far more damaging to the credibility of the conclusions, is that
two thirds of the studies included did not control for SSRI use—a major confound. Finally, and
perhaps the finding that tells the true story, when poverty level was controlled, there was no
difference in risk between women diagnosed with depression and those who were not. In other
words, depressed women from the US middle class and above and women who lived in countries
defined as social democracies did not have birth defects/complications; only depressed women
from impoverished countries and the depressed poor in the US had increased risk. This is a much
stronger argument for the deleterious effects of poverty than untreated depression.
Psychotherapy Outperforms Medication in the Long Run
 Alternatives should be discussed: Stress reduction techniques, support groups,
psychotherapy, reducing work hours, familial, Church, &
community support.  Many women express concerns about medication during pregnancy & physicians
must offer alternatives For example, in the case of depression, contrary to conventional wisdom, psychological
treatments have been shown to be as effective as medication treatments in the short run with
more durable benefits in the long run, especially when patient rated measures are considered,
even if the depression is severe (DeRubeis et al., 2005; Hollon et al., 2005) Although combined
treatments are often touted as the best alternative, they have not consistently fared better than
psychological treatments alone over the long term but they have tended to have better results
than medication treatment alone (Blom et al., 2007; Dimidjian et al., 2006).
A risk/benefit analysis suggests that psychotherapy be considered first, depending on patient
preferences. Patients, therefore, have a right to be treated by physicians who recognize psychosocial
options as viable first line, stand alone treatments (including psychotherapy, exercise and nutrition,
problem solving, community, Church, and peer options) for emotional and behavioral problems.
5 Conclusion
A risk-benefit conversation is essential between physicians as well as other health care
professionals and their patients to ensure informed consent. Evidence based medicine suggests:
Pope Benedict XVI, Nov., 2006 “Scientific predictability also raises the question of the scientists’ ethical
responsibilities. His conclusions must be guided by respect for the truth & honest acknowledgement of both the accuracy &
the inevitable limitations of the scientific method. Certainly this means avoiding
needlessly alarming predictions when these are not supported by sufficient data
or exceeds science’s actual ability to predict. But it also means avoiding
the opposite, namely a silence born of fear, in the face of genuine problems. The influence of scientists in
shaping public opinion is too important to be undermined by undue haste or the pursuit of superficial publicity.”
 Patient rated measures of outcome should be used in both research and practice.
 Pharmaceutical company influence should be separated from science and practice.
 A data base of the risks and benefits of psychotropics, independent of industry influence,
should be available to prescribers and patients.
 Psychosocial options, including psychotherapy, Church and community alternatives should
be tried first consistent with patient preference;
 Practices that are not empirically supported—off label prescribing, polypharmacy, dosages outside
recommended ranges, and lifetime regimens—should be
limited and include full patient consent as well as close monitoring;
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