NAS Bill Is Problematic

Dear Governor Pence:

We hope you will consider the following information before you sign SB 408 into law.

We applaud Indiana legislators for valuing and prioritizing research on maternal, fetal, and child health. We also appreciate SB 408’s focus on gathering information for the purposes of improving health care and treatment for Indiana families. This positive, non-punitive approach is consistent with the universal recommendations of leading medical organizations, including the American Medical Association, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists.

These leading medical and public health organizations agree that punitive responses to drug use “dissuade pregnant women from seeking health care and ultimately undermine the health of pregnant women and their fetuses.”[1] The value of medically informed, non-stigmatizing responses to pregnant women, drug use, and drug treatment, was recently highlighted in the Journal of the American Medical Association article: Confronting the Stigma of Opioid Use Disorder—and Its Treatment.[2]

Because stigma and medical misinformation regarding Neonatal Abstinence Syndrome are pervasive, we address a number of key issues associated with the proposed legislation.

 Neonatal Abstinence Syndrome (“NAS”)

SB 408 states “‘neonatal abstinence syndrome’ and ‘NAS’ refer to the various adverse effects that occur in a newborn infant who was exposed to addictive illegal or prescription drugs while in the mother’s womb.”

NAS is a transitory and treatable set of symptoms that present in some newborns who have been prenatally exposed to certain substances. The legislation, however, mistakenly suggests that NAS occurs only as a consequence of exposure to “addictive” drugs. As the International Classification of Diseases, Clinical Modification (ICD-CM) (see discussion below) makes clear NAS may occur to newborns as a result of prenatal exposure to “drugs of addiction,” as well as from the “therapeutic use” of drugs.

Indeed, NAS may occur in response to non-addictive medications, including medication-assisted treatments for opioid dependence (e.g., methadone, buprenorphine), and to a variety of drugs, including Selective Serotonin Reuptake Inhibitors (SSRIs), a class of compounds typically used to treat depression, and Benzodiazepines, which are typically used to treat insomnia, panic disorders, and epileptic seizures. Exposure to opioids, including heroin and other unprescribed opioids, as well as opioids prescribed for the necessary management of pain, may also result in NAS.

As with most medications—whether they are over the counter medications such as aspirin or prescription medications such as statins—there are potential side effects that may affect newborns. Fortunately, the side effects associated with NAS are diagnosable, treatable, and transitory.

SB 408 uses the language, “born with Neonatal Abstinence Syndrome.” This is incorrect. NAS, if it occurs, is prompted when the umbilical cord is cut and the cessation of the supply of a drug results in a physiologic withdrawal. This typically occurs within the first three days after birth, but may appear up to two weeks after birth.[3] Thus, if symptoms occur, they do so after birth. “Born with” also mistakenly suggests a permanent or lasting condition. NAS, however, has not been associated with any long-term adverse consequences (see discussion below).

 NAS Data Reporting

SB 408 requires hospitals to “use appropriate International Classification of Diseases, Clinical Modification (ICD-CM) codes published by the National Center for Health Statistics for diagnosing NAS.” According to the ICD-10-CM, Neonatal Abstinence Syndrome is coded as “neonatal withdrawal symptoms from maternal use of drugs of addiction” or “withdrawal symptoms from therapeutic use of drugs in newborn,” and the clinical diagnosis is determined by a “constellation of signs and symptoms observable in a neonate.”[4]

For the past 40 years, maternal-fetal health experts have developed and used objective assessments and scoring tools to help health care providers assess the onset and progression of symptoms associated with NAS.[5] If NAS is diagnosed, these tools are also used to determine what, if any, treatment is needed. And if treatment is needed, these tools help to monitor the newborn and determine when the treatment is no longer required.[6] Treatment may include supportive care, such as psychosocial counseling and breastfeeding support, pharmacotherapy in the form of morphine or methadone, or a combination of both.

Because a diagnosis of NAS is not the same as a positive urine drug screen or meconium test, and because drug testing is sometimes used as a substitute for actual diagnosis, SB 408 should unequivocally state that a positive toxicology test is not NAS.

This bill also presents an opportunity for the Indiana Department of Health to gather information on drug testing practices and policies. Such data can help to answer a number of important medical, ethical, and economic questions including: whether positive toxicology tests are confused with diagnoses of NAS; whether testing is done in compliance with federal workplace drug testing guidelines;[7] whether testing is done with informed consent; if selective testing is done, whether the criteria used are based on evidence based research;[8] whether low income women and women of color are disproportionately subjected to such testing;[9] and the cost to the State of such testing.

An expert panel convened by the U.S. Department of Health and Human Services to address the issue of pregnant women’s drug use did not endorse the routine drug testing of pregnant women, nor did it endorse any criteria for selective testing.[10] This expert panel did, however, advise health care institutions that conduct such testing to do so in accordance with the standards used in the workplace as proscribed by the federal workplace drug testing guidelines.[11]

This is particularly important because pregnant women, new mothers, and newborns who are patients in a medical facility are typically afforded fewer safeguards regarding the accuracy and fairness of testing than guaranteed to a job applicant at the same health care facility. These safeguards include initial and confirmatory cutoff concentrations to establish a true positive result, a detailed collection procedure in order to prevent contamination, and having the opportunity to challenge results and retest specimens.[12] Such safeguards help prevent false (simply wrong) or innocent (positive for a prescribed drug or over-the-counter medication) positives among pregnant women and newborns.[13]

Scope of Recommendations to the General Assembly

SB 408 requires the NAS data report to include “[r]ecommendations for appropriate education and training to obstetric and gynecological physicians and treatment providers of pregnant women.” To be effective, this legislation should include maternal-fetal health specialists, pediatricians, and neonatal intensive care unit doctors and nurses.

Pediatricians and others who provide care after birth play a major role in the identification and treatment of NAS and should be included in education and training efforts. Indeed, the extent of pharmacological treatment provided to infants diagnosed with NAS has been shown to be less a function of the severity of NAS—a set of symptoms with significant variability[14]—and more to do with local practice by health care providers after the child is born.[15]Two national surveys assessing the management of NAS in NICUs not only highlight the inconsistency of policies that determine the presence of and treatment for NAS, but also explain that approximately only half of all NICUs have written guidelines for the management of NAS.[16]

Including professionals who provide care after a child is born is also important because both the occurrence and severity of NAS are affected by factors that occur after birth. For example, one study demonstrates that when hospitals employ “rooming in”—the practice of caring for mother and newborn together in the same room immediately after birth—newborns have less need for pharmacological treatment of NAS and shorter lengths of hospital stay.[17] Another study found that only 11% of babies who boarded (stayed) with their mothers required treatment of NAS compared to more than four times as many who were placed in a NICU.[18] Thus, as a brochure published by the Substance Abuse and Mental Health Services Administration explains, “Many times a quiet, comfortable environment is enough to provide comfort to your baby.”[19]

Peer-reviewed research has also found that allowing mothers to breastfeed their newborns can reduce the need for and length of treatment for NAS.[20] And notably, “there is no evidence of long term adverse outcomes in children treated with pharmacological agents vs. infants who do not require treatment for NAS.”[21]

Commission on Improving the Status of Children in Indiana

SB 408 charges the Commission on Improving the Status of Children in Indiana with significant duties. The membership of the Commission includes a variety of legislative members and directors of statewide agencies.[22] In order to make, fully informed and medically sound recommendations to the legislature, this legislation should require key individuals, in addition to Commission members, to be part of the body making recommendations. These should include medication-assisted treatment (MAT) providers, pediatricians, and most importantly, women who are directly affected by the bill, including those receiving MAT or taking prescription SSRIs or opioid painkillers.[23]

Below we offer some clarification concerning the Commission’s duties and make suggestions regarding additional study questions to help ensure maternal, fetal, and child health. As written, the legislation directs the Commission to:

(1) Study the prenatal medical treatment services that are available to pregnant women addicted to illegal or prescription drugs.

We reiterate that NAS does not result solely from “pregnant women addicted to illegal or prescription drugs.” NAS may also occur as a result of pregnant women using drugs that are neither illegal nor to which they are addicted, including for the treatment of depression and anxiety disorders, pain management, and medication-assisted treatments, like methadone and buprenorphine.

 (2) Study the addiction treatment services that are available to pregnant women addicted to illegal or prescription drugs.

We very much appreciate SB 408’s use of the term addicted, as it acknowledges important differences between use, physiological dependence, and addiction. The Commission’s study, however, should also document to what extent treatment services are informed by evidence-based research, and whether the treatment available has the hallmarks of successful treatment, such as guarantees of provider-patient confidentiality. Typically, confidentiality is denied to those whose treatment is mandated through drug courts, child welfare systems, and probation and parole.

In studying the services available to pregnant women, the Commission is necessarily charged with studying the barriers to appropriate drug treatment as well. Notably, one such barrier to accessing effective and affordable treatment is Indiana’s Medicaid coverage. Indiana is one of the few states that provides only partial Medicaid coverage for individuals receiving methadone treatment—meaning that while Medicaid covers the behavioral and counseling services offered at medication-assisted treatment programs, it does not cover the oral medication itself.[24]

This lack of funding is particularly problematic since nearly 50 years of evidence-based research has confirmed that methadone maintenance treatment (“MMT”) is the optimal course of care for opioid dependence,[25] and that MMT during pregnancy “remains the gold standard” for opioid-dependent women.[26] Specifically, MMT reduces the likelihood of obstetrical complications and produces much better fetal outcomes than are realized by mothers who simply cease the use of opioids entirely during pregnancy.[27] MMT allows for stabilization and management of the levels of opioids in the pregnant woman’s system,[28] eases withdrawal symptoms, and provides the opportunity for women to obtain comprehensive prenatal care and other support services that they might not otherwise seek, all of which advances maternal, fetal, and child health.[29] And as highlighted by a government brochure that urges pregnant women who are opioid dependent to obtain MMT, “babies born to mothers on methadone do as well as other babies.”[30]

For the 2012/2013 fiscal year, the state of Indiana received $6,481,333 for substance abuse treatment from the Substance Abuse and Mental Health Services Administration Block Grant funding. We hope that the study will consider whether future applications for funding could include requests to support low-income, Medicaid eligible pregnant women in receiving the gold standard of care for opioid dependence.

In considering the availability of treatment to pregnant women, we also hope that the role of drug courts and family courts will be considered. A recent nationwide survey explained that although “[v]irtually all drug courts (98%) reported that at least some of their participants were opioid-dependent, . . . [f]ifty percent of drug courts reported that agonist medication was not available to participants with opioid dependence under any circumstances.[31] In addition, Indiana health care providers, pregnant women, and parents in Indiana have reported that they have been threatened with loss of custody of their children if they continue to receive medically recommended and supervised medication-assisted treatment (e.g. methadone or buprenorphine). We hope this legislation will consider these kinds of barriers as well – barriers that not only limit the availability of care and discourage people from seeking effective services, but that also reinforce the stigma associated with opioid dependence and its treatment.

Additionally, we urge that this legislation include direction to do the following:

(1) Study existing education and training programs that will reduce NAS and improve provision of maternal, fetal, and child health care services.

Several model programs and educational resources addressing NAS and improved provision of care could prove useful to the Commission and should be considered. For example, the Vermont Oxford Network (VON), a not-for-profit voluntary collaboration of healthcare professionals dedicated to improving the quality, safety, and value of healthcare for newborn infants and their families, has carefully developed such resources.

In 2012, VON identified the need to focus on the issue of NAS and subsequently developed a network-wide approach to providing care for newborns diagnosed with NAS. VON’s video and facilitator guide—“Nurture the Mother – Nurture the Child”: A Trauma-Informed, Family-Centered Approach to Supporting Women with Substance Use Issues Who Are Pregnant and Newly Parenting—focuses on providing care that is patient- and family-centered, and has thus far been effective. These educational materials may prove useful to the Commission’s research, and most of the materials can be accessed online at: http://www.vtoxford.org/quality/inicq/NasControversies.aspx

We hope that this legislation will direct those gathering information to consider pre-existing research and models that may be useful to the State of Indiana.

(2) Record and document other factors that are affecting maternal fetal and child health in the State of Indiana.

Reports and studies suggest that poverty and lack of access to health care play a greater role in birth outcomes than the use of any prescription or illicit drugs.[32] To fully understand the role and scope of NAS as a factor in maternal, fetal, and child health, those tasked with research through this legislation should be directed to record and document the ways in which social determinants of health are related to birth outcomes.

Medical Misinformation Regarding Infant Mortality

Finally, although funding for a grant program was not included in the final bill, much of the discussion concerning such funding focused on reducing infant mortality. According to Representative Gail Riecken, a cosponsor of the bill, the legislation “requires the Commission on Improving the Status of Children in Indiana and the state Department of Health to develop and administer a grant program to fund community-based efforts to reduce infant mortality.”

While reducing infant mortality is a laudable goal, there is in fact no connection between scientific and medical research on NAS and lethality. NAS, when it occurs, is diagnosable and treatable, and has not been associated with fetal demise or long-term adverse consequences.[33] Therefore, referring to research on NAS as a method by which to reduce infant mortality is medically inaccurate and misdirects attention away from those factors that do increase the risk of infant mortality.

Suggesting that there is a clear causal link between a pregnant woman’s medical treatment or prescription drug use and infant mortality when there is not also fuels health related stigma. And this stigma has the potential to adversely affect pregnant women, mothers, and their families, as they experience considerable public scrutiny.[34]

As research demonstrates, and as research collected from SB 408 will undoubtedly confirm, providing pregnant women with comprehensive healthcare, social support, and medically proven treatment options improves pregnancy, birth, and child development outcomes.

Conclusion

We hope that you will consider these issues and send SB408 back to the state legislature in order to more fully develop the legislation.

 

Sincerely.

Indiana Religious Coalition for Reproductive Justice and Indy Feminists – Indiana’s Feminist Collective

 


[1] American College of Obstetricians and Gynecologists, Committee on Ethics, Committee Opinion 321 Maternal Decision Making, Ethics and the Law, 106 Obstetrics & Gynecology 1127 (2005). See also, American College of Obstetricians and Gynecologists, Committee on Ethics, Committee Opinion 473 Substance Abuse Reporting and Pregnancy: The Role of the Obstetrician-Gynecologist, 117 Obstetrics & Gynecology 200 (2011) (“Seeking obstetric–gynecologic care should not expose a woman to criminal or civil penalties, such as incarceration, involuntary commitment, loss of custody of her children, or loss of housing. These approaches treat addiction as a moral failing. Addiction is a chronic, relapsing biological and behavioral disorder with genetic components. The disease of substance addiction is subject to medical and behavioral management in the same fashion as hypertension and diabetes.”).

[2] Yngvild Olsen & Joshua M. Sharfstein, Confronting the Stigma of Opioid Use Disorder—and Its Treatment, JAMA (Feb. 26, 2014), available at http://jama.jamanetwork.com/article.aspx?articleid=1838170&resultClick=3.

[3] Loretta Finnegan, Licit and Illicit Drug Use During Pregnancy: Maternal, Neonatal and Early Child Consequences, 44 (2013), available at http://www.ccsa.ca/2013%20CCSA%20Documents/CCSA-Drug-Use-during-Pregnancy-Report-2013-en.pdf.

[4] ICD-10-CM P96.1; ICD-10-CM P96.2, available at http://apps.who.int/classifications/icd10/browse/2010/en.

[5] Lauren M. Jansson, et al., The Opioid Exposed Newborn: Assessment and Pharmacologic Management, 5 J. Opioid Manag. 47, 48 (2009).

[6] Id.

[7] Substance Abuse & Mental Health Serv. Admin., U.S. Dep’t of Health & Human Servs., Mandatory Guidelines for Federal Workplace Drug Testing Programs, 73 F.R. 71858-01 (Nov. 25, 2008).

[8] Marylou Behnke, et al., Multiple Risk Factors Do Not Identify Cocaine Use in Rural Obstetrical Patients, 16 Neurotoxicology & Teratology 479 (1993) (finding that criteria established by a hospital for testing certain women were not effective in predicting which women were more likely to have used an illegal drug).

[9] See Ira Chasnoff, et al., The Prevalence of Illicit-Drug or Alcohol Use During Pregnancy and Discrepancies in Mandatory Reporting in Pinellas County, Florida, 322 New England J. Med. 1202 (1990) (comparing results of universal testing with the number of cases reported to child welfare authorities, the study concluded that “a significantly higher proportion of black women than white women were reported, even though we found that the rates of substance use during pregnancy were similar.”); See also Brenda Warner Rotzoll, Black Newborns Likelier to be Drug-Tested: Study, Chicago Sun-Times (March 16, 2001) (noting that “Black babies are more likely than white babies to be tested for cocaine and to be taken away from their mothers if the drug is present, according to the March issue of the Chicago Reporter.”); Troy Anderson, Race Tilt in Foster Care Hit; Hospital Staff More Likely to Screen Minority Mothers, L.A. Daily News (June 30, 2008).

[10] Center for Substance Abuse Treatment, Substance Abuse & Mental Health Serv. Admin., U.S. Dep’t of Health & Human Servs., Pregnant, Substance-Using Women, Treatment Improvement Protocol (TIP) Series 2, Guideline 15, DHHS Publication No. (SMA) 95-3056 (1993), available at http://www.taadas.org/publications/prodimages/TIP%202.pdf.

[11] Id. at 48

[12] Substance Abuse & Mental Health Serv. Admin., U.S. Dep’t of Health & Human Servs., Mandatory Guidelines for Federal Workplace Drug Testing Programs, 73 F.R. 71858-01 (Nov. 25, 2008).

[13] See e.g., Troy Anderson, False Positives Are Common in Drug Tests on New Moms, L.A. Daily News (June 28, 2008).

[14] Lauren M. Jansson, et al., The Opioid Exposed Newborn: Assessment and Pharmacologic Management, 5 J. Opioid Manag. 47 (2009).

[15] For example, “to babies whose mothers received methadone [during pregnancy,] the total morphine dose administered to control neonatal abstinence syndrome averaged 4.93 mg in rural American sites, 5.04 mg in Vienna, and 34.17 mg in urban U.S. sites; the number of days of medication averaged 4.92, 9.26 and 17.91, respectively.”  Robert Newman & Susan Gevertz, The Complex Factors Determining Neonatal Abstinence Syndrome and Its Management, 18 Eur. Addict. Res. 322 (2012) (citing data in a publication by A. Baewert, et al., 18 Eur. Addict. Res. 130 (2012)).

[16] Aakriti Mehta, et al., Neonatal Abstinence Syndrome Management From Prenatal Counseling to Postdischarge Follow-up Care: Results of a National Survey, 3, 4 Hospital Peds. 317 (Oct. 2013); Subrata Sarkar & Steven M. Donn, Management of Neonatal Abstinence Syndrome in Neonatal Intensive Care Units: a National Survey, 26 J. of Perinatology 15 (2006).

[17] Ronald R. Abrahams, et al., An Evaluation of Rooming-In Among Substance-exposed Newborns in British Columbia, 32 J. Obstet. Gynaecol. Can. 866 (2010).

[18] Tolulope Saiki, et al., Neonatal Abstinence Syndrome–Postnatal Ward Versus Neonatal Unit Management, 169 Eur. J. Peds. 95 (2010).

[19] Id.

[20] Gabrielle K. Welle-Strand, et al., Breastfeeding Reduces the Need for Withdrawal Treatment in Opioid-Exposed Infants, 102 Foundation Acta Paediatrica 1060 (2013).

[21] Walter K. Kraft & John N. van den Anker, Pharmacologic Management of the Opioid Neonatal Abstinence Syndrome, 59 Ped. Clinics of N. Am. 1147 (2012).

[22] Pursuant to IC 2-5-36-4, the membership of the commission consists of eighteen members ranging from four appointed “legislative member[s],” to the “the executive director of the prosecuting attorneys council of Indiana,” to the executive director of the division of state court administration.”

[23] Ctrs. for Disease Control & Prevention, Introduction to Program Evaluation for Public Health Programs: A Self-Study Guide (May 11, 2012) (explaining the importance of engaging stakeholders in the evaluation of public health programs, including those who are directly affected by an issue), available at http://www.cdc.gov/eval/guide/step1/index.htm.

[24] The Am, Soc’y of Addiction Med., Advancing Access to Addiction Medications: Implications for Opioid Addiction Treatment, 2013 Report Series, available at http://www.asam.org/docs/advocacy/Implications-for-Opioid-Addiction-Treatment.

[25] Ctrs. for Disease Control & Prevention, Nat’l Center for HIV, STD, and TB Prevention, Methadone Maintenance Treatment (Feb. 2002) (stating that the benefits of methadone include “improved family stability and employment potential”) at 1, available at

http://www.cdc.gov/idu/facts/methadonefin.pdf; Nat’l Insts. of Health Consensus Statement, Effective Medical Treatment of Opiate Addiction (1997) (stating that MMT is effective in enhancing social productivity), available at http://consensus.nih.gov/1997/1998TreatOpiateAddiction108PDF.pdd; Michael Scimeca, et al., Treatment of Pain in Methadone-Maintained Patients, 67 Mt. Sinai J. Med. 412, 414 (2000) (stating that MMT “permits the user to focus on life activities unrelated to obtaining and using drugs, resulting in gradual return to normal function and a productive lifestyle”).

[26] Stacy Seikel, Methadone Treatment in Pregnancy . . . That Can’t Be Right, Can It?, 63 N.E. Fla. Med. 28, 29 (2012).

[27] Id. at 28; John J. McCarthy, et al., High Dose Methadone Maintenance in Pregnancy: Maternal and Neonatal Outcomes, 193 Am. J. Obstet. Gynecol. 606 (2005).  See also Stephen R. Kandall, et al., The Methadone-Maintained Pregnancy, 26 Clinics Perinatol. 173, 180 (1999).

[28] John Drozdick III, et al., Methadone Trough Levels in Pregnancy, 187 Am. J. Obstet. Gynecol. 1184 (2002); Loretta Finnegan, Licit and Illicit Drug Use During Pregnancy: Maternal, Neonatal and Early Child Consequences, 80-81 (2013), available at http://www.ccsa.ca/2013%20CCSA%20Documents/CCSA-Drug-Use-during-Pregnancy-Report-2013-en.pdf.

[29] Stephen R. Kandall, et al., The Methadone-Maintained Pregnancy, 26 Clinics Perinatol. 173, 180 (1999). See also Substance Abuse & Mental Health Services Admin., U.S. Dep’t of Health & Human Servs., Pub. No. [SMA] 06-4124, Methadone Treatment for Pregnant Women (2006) (citing Vincenzo Berghella, et al., Maternal Methadone Dose and Neonatal Withdrawal, 189 Am. J. Obstet. Gynecol. 312 (2003)), available at http://www.atforum.com/addiction-resources/documents/SAMHSAbrochurePregnantWomen2006.080904-39-5315-04-44.pdf. See also Lena M. Lundgren, et al., Medication Assisted Drug Treatment and Child Well-Being, 29 Children and Youth Servs. Rev. 1051 (2007)(addressing the value of methadone treatment services as part of child welfare programs and concluding that “[n]ow is the time to recognize that MM is an underused resource that could better the lives of opiate-dependent parents and their children”).

[30] Walter K. Kraft & John N. van den Anker, Pharmacologic Management of the Opioid Neonatal Abstinence Syndrome, 59 Ped. Clinics of N. Am. 1147 (2012).

[31] See Harlan Matusow et al., Medication assisted treatment in US drug courts: Results from a nationwide survey of availability, barriers and attitudes, 43 J. Substance Abuse Treatment 15 (2012).

[32] Laura M. Betancourt, et al., Adolescents with and without Gestational Cocaine Exposure: Longitudinal Analysis of Inhibitory Control, Memory and Receptive Language, 33:1 Neurotoxicol. Teratol. 36 (Jan. 2011) (stating that data shows the “overall effects of poverty” are more salient to cognitive development than prenatal exposure to drugs).

[33] See Walter K. Kraft & John N. van den Anker, Pharmacological Management of the Opioid Neonatal Abstinence Syndrome, 59;5 Pediatric Clinics of North America 1147 (2012) (concluding that “there is no evidence of long term adverse outcomes in children treated with pharmacological agents vs. infants who do not require treatment for NAS . . . .”); Stacy Seikel, Methadone Treatment in Pregnancy . . . That Can’t Be Right, Can It?, 63;1 N.E. Fla. Med. 28, 29 (2012) (stating that research shows “minimal to no long-term negative sequelae on babies born to mothers who are on stable doses of methadone, engaged in psychosocial services, and in a stable living environment.”).

[34] Jamie Livingston, et al., The effectiveness of interventions for reducing stigma related to substance use disorders: A systematic review, 107 Addiction, 107, 39-50 (2011); Natalie Skinner, et al., Stigma and discrimination in health care provision to drug users: The role of values, affect, and deservingness judgments, 37:1 J. of Applied Social Psychology, 163-186 (2007).

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