Protection Versus Progress: The Challenge of Research on Cannabis Use During Pregnancy
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Protection Versus Progress: The
Challenge of Research on Cannabis Use
During Pregnancy
Katherine E. MacDuffie, PhD,a,b Natalia M. Kleinhans, PhD,c Kaeley Stout, BA,d Benjamin S. Wilfond, MDb,e
A central tension in pediatric research ethics arises from our desire to protect children from abstract
harm while also allowing progress toward discoveries that could improve child health. A
prime example of this tension is research on a controversial yet increasingly common practice:
the use of cannabis by women to treat nausea and vomiting of pregnancy. Studies of cannabis
use in pregnancy face a combination of ethical hurdles because of the inclusion of pregnant
women and involvement of a schedule I controlled substance. Given the growing need for
research on the safety and efficacy of cannabis for nausea and vomiting of pregnancy, we
reflect on the multiple historical contexts that have contributed to the challenge of studying
cannabis use during pregnancy and make a case for the ethical rationale for such research.
Departments of aSpeech and Hearing Sciences, cRadiology, and ePediatrics, School of Medicine, University of Washington, Seattle, Washington; bSeattle Children’s Hospital, Treuman Katz
Center for Pediatric Bioethics, Seattle, Washington; and dScripps College, Claremont, California
Dr MacDuffie conceptualized and drafted the manuscript and revised the manuscript; Dr Kleinhans reviewed and revised the manuscript; Ms Stout participated in the
literature review and reviewed and revised the manuscript; Dr Wilfond participated in conceptualizing the manuscript and reviewed and revised the manuscript; and
all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
DOI: https://doi.org/10.1542/peds.2020-0818R
Accepted for publication May 18, 2020
Address correspondence to Katherine E. MacDuffie, PhD, Department of Speech & Hearing Sciences, University of Washington, 1701 NE Columbia Rd, Box 357920,
Seattle, WA 98195. E-mail: kmacd@uw.edu
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright © 2020 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
FUNDING: Dr MacDuffie is supported by the National Institutes of Mental Health (F32MH118689). Funded by the National Institutes of Health (NIH).
POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.
Downloaded from www.aappublications.org/news by guest on July 4, 2021
PEDIATRICS Volume 146, number s1, August 2020:e20200818R SUPPLEMENT ARTICLEA common trope at the conclusion of nausea and vomiting of pregnancy.6 doxylamine as Bendectin. This
empirical articles is “further studies Within 2 years of its widespread use approval followed numerous
are warranted.” In practice, however, in pregnancy, the first reports epidemiological studies and clinical
practical, ethical, and historical emerged of severe birth defects trials in which researchers showed no
barriers can pose considerable ranging from deformed limbs and evidence of teratogenic effects of this
challenges for researchers attempting organs to premature death.7 An combination treatment.11 Diclegis is
to advance knowledge in maternal estimated 10 000 children were currently the first-line treatment of
and child health. Constraints on impacted before distribution of nausea and vomiting in women who
research with pregnant women, for thalidomide was banned worldwide do not respond to dietary and
example, are designed to protect the in 1962.6 Thalidomide was never sold lifestyle changes.13 However, Diclegis
fetus from unknown harms but have in the United States, in large part is expensive, often not covered by
left knowledge gaps on how to treat because of the work of Frances insurance, and tends to be less
even the most common illnesses of Kelsey, a US Food and Drug effective for severe symptoms than
pregnancy. “Morning sickness,” or Administration (FDA) officer who alternatives.14 The more commonly
nausea and vomiting of pregnancy, is refused to approve thalidomide used alternative is ondansetron,
experienced by an estimated 70% to because of insufficient safety which is currently used by 1 in 4
80% of women and can profoundly evidence (she was subsequently pregnant women despite lacking FDA
impact a woman’s professional, awarded a Presidential Award for approval for use in pregnancy.3 In
physical, and emotional functioning.1 Distinguished Service).8 The narrowly utero exposure to ondansetron has
Although symptoms range in severity, missed thalidomide disaster in the been associated with cleft lip and
50% of women with nausea and United States led to major reform in palate and heart defects in some
vomiting of pregnancy reported the drug approval process in 1962, trials15,16 but not others.17,18
negative impacts on their work which tightened regulations for how According to the American College of
effectiveness and relationships with drugs are approved and marketed, Obstetricians and Gynecologists,
partners, and .55% reported feeling including the requirement to prove “there are insufficient data on fetal
depressed.2 Severe cases can result in both safety and efficacy through safety with ondansetron use and
weight loss, high blood pressure, and controlled clinical trials.9 further studies are warranted.”13
increased risk of preeclampsia and
Public awareness of the teratogenic
hospitalization, with potential
impacts on fetal health.3,4 Long-term
effects of thalidomide led to CANNABIS AS AN ALTERNATIVE
generalized fears about the use of
effects of severe nausea and vomiting Into this frequently changing (and
antiemetics during pregnancy.
have been reported even after potentially confusing) treatment
Bendectin (doxylamine and
pregnancy, including increased landscape for nausea and vomiting of
pyridoxine) was taken by ∼25% of
posttraumatic stress in mothers and pregnancy now enters cannabis,
pregnant women from the mid 1950s
reduced insulin sensitivity in which was initially approved for
to 1980.10 However, reports in the
children.5,6 Despite the prevalence medical uses, including treatment of
medical literature and popular media
and impact of these symptoms on nausea for patients undergoing
began to suggest that Bendectin was
maternal and child health, there chemotherapy, in 1996.19 Cannabis
also associated with birth defects.11
remain limited safety and efficacy appears to be an effective antiemetic
After lawsuits were brought against
data on currently used antiemetics during pregnancy, and its use during
the manufacturer, the drug was
during pregnancy.7 pregnancy is rising. Researchers in
voluntarily taken off the market 1983,
a recent Canadian study found that
not because of evidence of
92% of respondents reported that
THE TROUBLED HISTORY OF teratogenesis but rather because of
cannabis was effective for treating
TREATMENTS FOR NAUSEA AND its lack of profitability with the
their nausea and vomiting of
VOMITING OF PREGNANCY manufacturer’s increasing insurance
pregnancy,20 and women with
costs.11 A 30-year period followed in
A prime contributor to our lack of more severe nausea and vomiting
which no new antiemetics drugs were
knowledge about antinausea symptoms report higher rates of
approved for use in pregnancy, and
medications in pregnancy is the cannabis use.21 Whether taken for
the number of hospitalizations of
lingering legacy of thalidomide. antiemetic, stress-relieving, or
pregnant women for nausea and
Thalidomide began to be sold as recreational purposes, cannabis use
vomiting more than doubled.12
sedative in Germany in the late during pregnancy has doubled over
1950s. When its antiemetic effects In 2013 the FDA approved a “new” the past 2 decades, outpacing the
were noted, it was marketed as drug, Diclegis, which contains the trend in nonpregnant women; studies
a “safe and effective” treatment of same combination of pyridoxine and have reported an estimated 12% to
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S94 MACDUFFIE et al34% of pregnant women tested pregnancy is safe.31 The absence of providers. For example, one study
positive or reported taking cannabis data is felt by both pregnant women found that only 36% of pregnant
during their first trimester.22,23 and their providers; both groups have patients who tested positive for
Prenatal cannabis exposure may be expressed a desire for more cannabis disclosed use to providers.39
increasing even faster in states where information to guide decision-making Fear of consequences may lead
recreational use is legalized; in about cannabis use during women who are using substances
a study from Colorado, researchers pregnancy.32,34,35 As they say, further during pregnancy to avoid prenatal
reported a 69% increase in studies are warranted. care entirely.40 Indeed, at the state
tetrahydrocannabinol concentration level, more punitive responses to
A barrier, however, to conducting
in meconium specimens since prenatal substance use are associated
research on cannabis is its legal
legalization.24 with an increase in low birth weight
status. Although medical cannabis is
and preterm births, suggesting that
Similar to the case with prescription currently legal in 33 states (and
such policies have the unintended
antiemetics, there is uncertainty recreational use is legal in 11), the US
effect of worsening birth outcomes.41
about the safety of cannabis use government still classifies cannabis as
during pregnancy. There have been a schedule I controlled substance. Research on cannabis use during
few epidemiological studies to date, Researchers seeking to understand pregnancy is still in its early stages
with the most consistent finding an the mechanisms of action of schedule and has the potential to follow a path
association with preterm birth and/ I drugs face multiple regulatory and similar to that taken by prenatal
or low birth weight.25,26 However, financial hurdles that have cocaine exposure research. In the
existing studies are confounded by significantly impacted research 1980s, a small amount of initial data
concurrent use of other known progress.36 In addition, research suggesting possible teratogenic
teratogenic substances during involving pregnant women is subject effects of cocaine became amplified
pregnancy, such as tobacco and to an increased degree of legal, and publicized, and the resultant fear
alcohol.27 Despite these limited data, ethical, and regulatory scrutiny dating of “crack babies” was used to enforce
official medical guidance is back to the days of thalidomide.37 racially-biased criminalization of
unambiguous: the Centers for Disease Together, these two factors can make substance use among pregnant
Control and Prevention,28 American conducting even observational women.27 A recent suggestion to
Academy of Pediatrics,29 and research on prenatal cannabis define a “fetal cannabis spectrum
American College of Obstetricians and exposure difficult (as discussed disorder”42 suggests a similar
Gynecologists30 have all below) and randomized trials inclination among present-day
recommended against any cannabis impossible.27 scholars to prematurely label and
use while pregnant or breastfeeding. segment a cohort of children born to
The legal status of cannabis also has
primarily low-income, minority
Despite these official real consequences for pregnant
mothers. Particular care is warranted
recommendations, women continue women. Women who test positive for
to avoid the same stigmatization from
to use cannabis during pregnancy, cannabis during pregnancy or at time
cannabis that resulted from early
and many perceive it as safe.31 of delivery risk involvement of child
research on prenatal cocaine
Compared with the known risks of protective services and even law
exposure.
alcohol and tobacco during enforcement.32,35 Depending on the
pregnancy, women report less state, evidence of substance use
awareness about the risks of during pregnancy can be reported as THE SOCIAL CONSEQUENCES OF
cannabis, and some perceive cannabis child abuse and result in loss of PRENATAL CANNABIS EXPOSURE
to be safer than prescription custody, jail time, or forced substance RESEARCH
medications.32 Use of cannabis may treatment.38 Structural inequities in Research on illicit substances and
be recommended to pregnant women how testing and reporting laws are research with pregnant women each
by dispensary employees,33 and applied (ie, only to women on face their own regulatory hurdles
studies have revealed that health care Medicaid) and systematic bias in and, together, create an area of
providers tend not to discuss rates of reporting to child protective research that is not only more
potential clinical risks of cannabis services mean that in many states the challenging to conduct but also more
when counseling their pregnant impact of punitive policies is felt most likely to raise ideological hackles.43
patients.32,34,35 Providers are hesitant strongly by pregnant women of color Many research topics in pediatrics fit
to discuss clinical risks because of and those from disadvantaged into this category, given the strong
inadequate data,34 and some women backgrounds.38 The fear of punitive reactions that perceived harm or
have interpreted this reticence as consequences is assumed to result in mistreatment of children can
evidence that cannabis during significant underreporting to engender. Parents do not always act
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PEDIATRICS Volume 146, number s1, August 2020 S95in their child’s best interest; NIDA and the IRB led to an in-depth during pregnancy to permit the
therefore, a key tenant in pediatric re-review of the study that involved creation of social policies and
ethics is to restrict parents from soliciting input on protocol and informed health care decisions for
making decisions that could cause design from external experts in women and children that are based
unnecessary harm.44,45 However, the teratology and obstetrics and on evidence rather than opinion.
premise that children should be gynecology. Two minor changes to the
protected from research that poses protocol were requested: clarifying ACKNOWLEDGMENTS
any risk would preclude discovery of that continued cannabis use was not
new treatments for pediatric illness. required and providing a fact sheet on The authors are grateful to Anna
As Laventhal and colleagues stated, cannabis and pregnancy. Both NIDA Mastrioanni, Jenny Kingsley, Kimberly
“The tension between these two goals and the IRB also confirmed the social Sawyer, Douglas Diekema, and Aaron
—protection and progress—is value of this research. However, the Wightman for their helpful comments
inevitable.”45 Pediatric research that research continues to be targeted by on earlier versions.
stirs up public controversy (for activists who have explored
example, a public health study of numerous avenues in their attempt to
children exposed to lead-based paint disrupt or halt the study, including ABBREVIATIONS
in low-rent housing in Baltimore) can threatening to expose participants FDA: US Food and Drug
shift the priority of courts and other and make reports to child protective Administration
regulatory bodies toward protection services. IRB: institutional review board
and away from progress.46 NIDA: National Institute on Drug
As this experience makes clear, Abuse
The personal experience of one of us research on cannabis use in
(N.M.K.) illustrates this tension in the pregnancy is impacted by the same
context of prenatal marijuana complex social and historical factors
exposure research. Our study is that affect individual pregnant
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S98 MACDUFFIE et alProtection Versus Progress: The Challenge of Research on Cannabis Use During
Pregnancy
Katherine E. MacDuffie, Natalia M. Kleinhans, Kaeley Stout and Benjamin S.
Wilfond
Pediatrics 2020;146;S93
DOI: 10.1542/peds.2020-0818R
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Downloaded from www.aappublications.org/news by guest on July 4, 2021Protection Versus Progress: The Challenge of Research on Cannabis Use During
Pregnancy
Katherine E. MacDuffie, Natalia M. Kleinhans, Kaeley Stout and Benjamin S.
Wilfond
Pediatrics 2020;146;S93
DOI: 10.1542/peds.2020-0818R
The online version of this article, along with updated information and services, is
located on the World Wide Web at:
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