英文在美国和巴基斯坦儿童抗抑郁药方面文化政府和法律的影响SSRN-id1341786

Electronic copy available at: http://ssrn.com/abstract=1341786 Analyzing the Laws, Regulations, and Policies Affecting FDA-Regulated Products FDLI FOOD AND DRUG LAW JOURNAL VOLUME 63 NUMBER 3 2008 S af et y in a n E ra o f G lo ba liz at io n Roseann B. Termini Christine A. Kelly-Miller The Infl uence of Culture, Government and the Law on the Use of Antidepressants for Children in the United States and Pakistan Electronic copy available at: http://ssrn.com/abstract=1341786 2008 713ANTIDEPRESSANTS FOR CHILDREN IN THE U.S. AND PAKISTAN The Infl uence of Culture, Government and the Law on the Use of Antidepressants for Children in the United States and Pakistan ROSEANN B. TERMINI* CHRISTINE A. KELLY-MILLER** Depression in children is a controversial topic in the United States.1 It is an even more contentious subject when one looks at mental healthcare for children in devel- oping nations, such as Pakistan. The diagnosis and treatment of childhood depres- sion has become more complicated as additional antidepressants become available on the market and their efficacy, as well as their potential for serious side effects, is fiercely debated. American parents struggle with what, if any, medicinal interven- tion to provide to their children, given the information available regarding potential side effects. The Food and Drug Administration (FDA) provides such information as it is analyzed for validity.2 FDA has been criticized as falling short of meeting the governmental entity’s responsibilities.3 Failure to disclose has also been at the heart of multiple lawsuits regarding antidepressant usage in children.4 Despite the lack of agreement on what information should have been disclosed, those in the United States can consider themselves fortunate that they have outlets for receiving and disputing such information. Those who suffer from depression in developing nations not only lack information from the government and from drug manufacturers, they also have centuries of cultural issues that preclude even considering medication as a potential source of helping children with mental health ailments. Culture, governmental involvement and legal ramifications all play roles in the treatment of childhood mental health ailments no matter what country is studied. Pakistan, for example, is a stark contrast to the United States in terms of economy, religion and government. Pakistan’s total population is approximately 160,943,000, compared to the total population of the United States, which is estimated at 302,841,000.5 The probability of dying under the age of five in Pakistan is 97 per 1,000 births.6 In the United States that same probability declines to 8 per 1,000 births.7 The total expenditure on health per capita in Pakistan is forty-nine dollars ($49.00), whereas in the United States, the amount soars to $6,350 per capita.8 Pakistani laws are still derived from the Islamic belief system and 97 percent of Paki- stanis are Muslims.9 In the United States, Christianity is the predominant religion * Ms. Termini is a food and drug Lawyer and Professor of food and drug law courses online, and authored Life Sciences Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements and Statutory CD 3rd, ed. (2007) www.fortipublications.com. ** Ms. Kelly-Miller JD candidate, Dec. 2008 Widener Univ. School of Law. 1 Hope from a Pill, THE ECONOMIST, (Feb. 28, 2008), available at http://www.economist.com/sci- ence/PrinterFriendly.cfm?story_id=10765331 (last visited June 22, 2008). 2 Manual of Policies and Procedures, Center for Drug Evaluation and Research (CDER) (MAPP 4151.3) (Mar. 2, 2007). 3 Gardiner Harris, FDA Links Drugs to Being Suicidal, N.Y. TIMES, (Sept. 14, 2004). 4 See for example Miller v. Pfizer, Inc., 356 F. 3rd 1326 (10th Cir. (2004)). 5 World Health Organization (WHO), http://www.who.int/countries/en/ (last visited June 13, 2008). 6 Id. 7 Id. 8 Id. 9 Religious Tolerance In Pakistan, http://www.religioustolerance.org/rt_pakis.htm (last visited June 13, 2008). 713 termini.indd 713termini.indd 713 8/5/08 11:54:11 PM8/5/08 11:54:11 PM Vol. 63714 Food and Drug Law Journal of 71 percent of the population.10 The separation of church and state is a founding doctrine of the United States. Given these vast differences, Pakistan and the United States offer a diverse comparative opportunity to look at the impact that culture, government and the law have on the psychological health of our children. Culture impacts all aspects of human life. The culture of the United States is arguably more diverse than Pakistan due to diversity of religions, ethnicities, lan- guages and freedoms experienced in America. However, it is equally arguable that the cultural impact on mental health is much more significant in Pakistan today.11 American history of the treatment of those afflicted with mental health disorders, such as depression, is similar to the current status in Pakistan. In the late 17th and early 18th centuries, individuals with mental health disorders experienced harsh treatment by caregivers in the United States.12 Since depression does not manifest itself visually, the origin of diagnosis has a complex history. Initially, the Ameri- can view of mental health disorders was characterized as “demonic.” Individuals suffering from mental disorders were once regarded as being “possessed by evil spirits.”13 Others attributed mental disorders to the changes of the moon, which were thought to cause cyclical periods of insanity.14 The later belief is evidenced by the origin of the word, “lunacy,” which is the Latin term for “moon.”15 Americans who were diagnosed with such conditions were commonly treated with physical restraints, including arm and leg chains.16 Many in the American and European mental health profession credit Clifford Beers for beginning a cultural shift in the approach to psychological illnesses.17 Clifford Beers describes his struggle with mental illness in his autobiography, A Mind That Found Itself.18 Detailing his psychological journey through his ailment, he describes the fear of being arrested for attempting suicide, which was a common punishment in early 18th century America, as well as the “torture” of the physical restraints, which precluded any significant physical movement during his nights of hospitalization.19 Today’s Pakistan is all too similar to 18th century America regarding the stigma and treatment of those who suffer mental health anomalies. Eventually, Pakistan repealed the Lunacy Act of 1912, which was the “most important piece of psy- chiatric legislation in Pakistan.”20 According to Ahmed Ijaz Gilani, member of 10 Religious Practices and Faith Groups, http://www.religioustolerance.org/chr_prac2.htm (last visited June 13, 2008). 11 Interview with Kalim Ahmed, MBBS, MD, Waynesboro Hospital, in Waynesboro, PA. (June 12, 2008). 12 History of Mental Health Movement, National Mental Health Association (NMHA), http:// www1.nmha.org/about/history.cfm (last visited June 12, 2008). 13 Ann Palmer, 20th Century History of the Treatment of Mental Illness: A Review, accessed at http://www.mentalhealthworld.org/29ap.html (last visited June 10, 2008). 14 Id. 15 Origin of word, “lunatic,” http://www.askoxford.com/consice_oed/lunatic?view=uk (last visited June 13, 2008). 16 NMHA and the History of the Mental Health Movement, available at http://www1nmha. org/about/history.cfm (last visited June 10, 2008). 17 The Clifford Beers Foundation, Welcome, http://www.cliffordbeersfoundation.co.uk/ (last visited June 13, 2008). 18 Clifford Whittingham Beers, A Mind That Found Itself (Kessinger Publishing June 17, 2004) (Mar. 1908). 19 Id. 20 Ahmed Ijaz Gilani et al., Psychiatric Health Laws in Pakistan: From Lunacy to Mental Health, Public Library of Science (Sept. 20, 2005), available at http://medicine.plosjournals.org/perlserv/ ?request=get-document&doi=10.1371%2Fjournal.pmed.0020317 (last visited June 7, 2008). termini.indd 714termini.indd 714 8/5/08 11:54:12 PM8/5/08 11:54:12 PM 2008 715ANTIDEPRESSANTS FOR CHILDREN IN THE U.S. AND PAKISTAN the Department of Basic Health Sciences, Shifa College of Medicine, Islamabad, Pakistan, and his colleagues, the statute was “woefully inadequate and obsolete for the needs of a modern state.”21 The Lunacy Act was replaced with the enactment of the Pakistan Mental Health Ordinance.22 Although the Mental Health Ordinance varies significantly from its predecessor, realistically the impact remains question- able. The new statute was adopted into law on February 20, 2001; however, as of May 2008, the specific tenets of the law had yet to be implemented.23 Yet, mental health disorders are mainly viewed with the negative connotations and stigma as “lunacy.” According to pediatrician Dr. Fouzia Rishi, who earned her medical degree from Dow Medical College in Karachi, Pakistan, the subject of depression was considered “taboo” and she received nothing in her training specific to the treatment of mental health.24 Dr. Rishi explained that little emphasis was placed on the study of psychiatric illness and virtually none on the pediatric population.25 In 2005, Ahmed Ijaz Gilani and several colleagues published an article regarding mental health in Pakistan where they concluded that even in the modern realm of today’s world, mental illness is still “attributed to supernatural causes it is considered to be a curse, a spell or a test from God.”26 This perception is echoed in multiple publications regarding mental illness in Pakistan. The limited psychiatric services that are available are underutilized due to the “popular misconception” that “mental illnesses are considered to be due to ‘possession’ or caused by evil … or supernatural evil forces.”27 In fact, Pakistan’s official language, Urdu is “devoid of terms” that generically describe mental health ailments and would be easily understood by lay people.28 Dr. Kalim Ahmed, who studied medicine at Sind Medical College in Karachi, Pakistan, describes the cultural view of depression as “more accepted now with globalization and the changes in the media.”29 Yet, Pakistan remains “a male chauvinistic society and depression is considered a weakness.”30 Despite a clinical diagnosis of depression, proper treatment remains problematic and this diagnosis is rare in the pediatric population.31 In contrast to the United States, there is minimal reliance on antidepressants.32 Treatment for adults continues to consist of being “chained, beaten, burnt and scars are made on [patients’ bodies] especially in skulls with serious consequences.”33 21 Id. 22 Government of Pakistan, Mental Health Ordinance (2001), available at http://www.emro.who. int/MNH/WHD/Pakistan-Ordinance.pdf (last visited June 13, 2008). 23 Muhammad Iqbal Afridi, Mental Health: Priorities in Pakistan, 58 (No. 5) J. PAKISTAN MED. ASS’N. 225, 226 (May 2008). 24 Telephone interview with Fouzia Rishi, MD, Pediatric Specialists of Franklin County, PA, (June 6, 2008) (Dr. Rishi earned her medical degree in 1984). 25 Id. 26 Ahmed Ijaz Gilani et al., Psychiatric Health Laws in Pakistan: From Lunacy to Mental Health, Public Library of Science (Sept. 20, 2005), available at http://medicine.plosjournals.org/perlserv/ ?request=get-document&doi=10.1371%2Fjournal.pmed.0020317 (last visited June 7, 2008). 27 Muhammad Iqbal Afridi, Mental Health: Priorities in Pakistan, 58 (No. 5) J. PAKISTAN MED. ASS’N. 225 (May 2008). 28 Id. at 225. 29 Interview with Kalim Ahmed, MBBS, MD, Waynesboro Hospital, in Waynesboro, PA, (June 12, 2008). 30 Id. 31 Id. 32 Id. 33 Muhammad Iqbal Afridi, Mental Health: Priorities in Pakistan, 58 (No. 5) J. PAKISTAN MED. ASS’N. 226, 225 (May 2008). termini.indd 715termini.indd 715 8/5/08 11:54:12 PM8/5/08 11:54:12 PM Vol. 63716 Food and Drug Law Journal It seems that only limited progress has been made in Pakistan regarding mental health treatment. For example, Dr. Irshad Sethi, a practicing pediatrician in Karachi, Pakistan stated that he prescribes antidepressants to approximately two children per 100 seen, typically in the age range of six to 12.34 Dr. Sethi said that diagnosing and treating depression is becoming much more common than in the past; though, people still predominantly rely on their faith to deal with childhood depression.35 In fact, shamans, who is a person “who acts as intermediary between the natural and supernatural worlds, using magic to cure illness,”36 far outnumber child psychiatrists in Pakistan. According to Malik Hussain Mubashir, Vice-Chancellor of Lahore’s University of Health Sciences, there is only one child psychiatrist for every “four million children estimated to be suffering from mental health issues.”37 The number of practicing shamans in Karachi alone numbers approximately four hundred and a popular form of treatment includes amulets, which are charms worn around the neck to guard against evil.38 Other methods include spiritually treated water or incantations.39 Shamans also prescribe medication, which is often readily available over the counter and not as controlled as in the United States.40 The United States in comparison to Pakistan had 8.67 child and adolescent psychiatrists per 100,000 youth in 2001.41 Yet, the prevalence of child psychiatrists in the United States is considered inadequate to meet the needs of the country’s children.42 Compounding the Pakistani shortage of mental health professionals is the fact that many medical practitioners who train in psychiatric care in Pakistan ultimately end up practicing their specialty in other countries.43 This is due, in part, to the stigma that is present among Pakistanis and the vast opportunities available in other coun- tries and virtually nonexistent in Pakistan.44 Further, “only 7.6 percent of third-year medical students from four medical colleges” in Pakistan, “have reported psychiatry to be either their chosen career or a highly likely choice.”45 The current stigma regarding mental health in the United States has begun to be specifically studied in order to provide guidance to initiatives such as the President’s New Freedom Commission (Commission) on Mental Health.46 The Commission emanated from the United States Public Health Service Office of the Surgeon Gen- eral report that reiterated the findings that stigma is the “most formidable obstacle to future progress in the arena of mental illness and health” in the United States.47 A group of mental health professionals specifically examined the stigma related to 34 Telephone interview with Irshad Sethi, MD, Karachi, Pakistan (June 9, 2008). 35 Id. 36 http://dictionary.reference.com/browse/shaman (last visited June 23, 2008). 37 Integrated Regional Information Networks, Pakistan: Millions Lack Access to Mental Health- care, http://www.irinnews.org/Report.aspx?ReportId=75204 (last visited June 13, 2008). 38 The New Lexicon Webster’s Dictionary of the English Language 31 (1989 ed.). 39 Amin A. Muhammed Gadit, Psychiatry in Pakistan: 1947-2006: A new balance sheet, 57 (No. 9) J. PAKISTAN MED. ASS’N. 455 (Sept. 2007). 40 Id. at 455. 41 Aaron Levin, Rural Counties Suffer from Child Psychiatry Shortage, 41 (No. 14) PSYCHIATRIC NEWS 4 (July 21, 2006). 42 Id. 43 Only 7 percent of Our Medical Students Want to Become Psychiatrists, DAILY TIMES MONITOR, Karachi, (Mar. 29, 2008), accessible at http://www.dailytimes.com.pk/default.asp?page=2008\03\29\ story_29-3-2008_pg12_10 (last visited June 13, 2008). 44 Id. 45 Id. 46 Achieving the Promise: Transforming Mental Health Care in America, The President’s New Freedom Commission on Mental Health Final Report (July 2003). 47 U.S. Department of Health & Human Services (HHS), Office of the Surgeon General, SAMHSA, Mental Health: Culture, Race and Ethnicity (2001). termini.indd 716termini.indd 716 8/5/08 11:54:13 PM8/5/08 11:54:13 PM 2008 717ANTIDEPRESSANTS FOR CHILDREN IN THE U.S. AND PAKISTAN mental healthcare in children.48 The results illustrate that “the public holds a set of cultural beliefs and attitudes that suggests more recognition of and support for treatment of childhood depression.”49 More respondents in the study viewed depres- sion in children as “serious, as needing treatment, and as resulting from underlying genetic or biological problems.”50 Regardless of any stigma, 1.5 million children in the United States are currently being treated with antidepressants.51 While modern United States still has a stigmatized view of mental health, Pakistan’s cultural view is similar to 18th Century America in multiple ways. Similar to Clifford Beers’ experience in the early 1900s in the United States, today under Pakistani law, which is based on the tenet of Islam, “both suicide and deliberate self-harm are il- legal acts,” punishable with imprisonment and a financial penalty.52 Further, when an individual experiences a negative outcome associated with medication use, lawsuits are essentially non-existent in Pakistan.53 Dr. Kalim Ahmed pointed out that the rea- sons for this are complicated and deep-rooted.54 According to Dr. Ahmed, a mistrust of the legal system exists. “People are afraid to get involved so they do not sue.”55 Additionally, to file a lawsuit in Pakistan is costly.56 This is a significant barrier and deterrent to access to the Pakistani judicial system since the gross national income per capita in Pakistan is $2,500.57 This pales in comparison to the gross national income per capita in the United States, which is $44,260.58 An even more entrenched reason for the lack of litigation in Pakistan is described by Dr. Ahmed as follows: “Pakistan is now like the United States used to be 60 years ago. There is a basic belief that a physician will do no harm. People trust the physi- cians and resist believing that the physician did anything wrong. There is a great deal of trust [between] the patient and the physician.”59 This belief system is very strong according to Dr. Ahmed and consists of the idea that a “cure comes from God and if something negative happens, people believe that God did not want that person to get better.”60 Dr. Amatul Khalid, who studied at the University of Punjab and is now practicing Internal Medicine in the United States, echoed this statement. She revealed that if a negative outcome occurs, it is believed that “it was supposed to happen that way. It is attributed to God.”61 An additional complication to access to one’s legal rights in Pakistan is a lack of education and awareness.62 According to one commentator, less accountability 48 Bernice A. Pescosolido, Ph.D., Culture, Children, and Mental Health Treatment: Special Section on the National Stigma Study Children, 58 (No. 5) PSYCHIATRIC SERVICES, 611 (May 2007). 49 Id. at 612. 50 Id. at 612. 51 Parent Group Says Public Unaware that Antidepressant Induced Suicides are in the Tens of Thousands, ABLECHILD, (Nov. 5, 2007), accessible at http://www.prlog.org/10036793-parent-group-says- public-unaware-that-antidepressant-induced-suicides-are-in-the-tens-of-thousands.html (last visited June 13, 2008). 52 Murad M. Khan, Suicide Prevention in Pakistan: an impossible challenge?, 57 (No. 10) J. PAKISTAN MED. ASS’N. 478 (Oct. 2007). 53 Interview with Kalim Ahmed, MBBS, MD, Waynesboro Hospital, in Waynesboro, PA, (June 12, 2008). 54 Id. 55 Id. 56 Id. 57 WHO, http://www.who.int/countries/en/ (last visited June 13, 2008). 58 Id. 59 Interview with Kalim Ahmed, MBBS, MD, Waynesboro Hospital, in Waynesboro, Pa. (June 12, 2008). 60 Id. 61 Telephone interview with Amatul Khalid, MD, Chambersburg Medical Associates (June 12, 2008). 62 Telephone interview with Irshad Sethi, MD, Karachi, Pa