11/1/2018 Policy Brief on The Regulation of Synthetic Human Growth Hormones for Use in Children with Idiopathic Short StatureRead Now POLICY BRIEF ON THE REGULATION OF SYNTHETIC HUMAN GROWTH HORMONES FOR USE IN CHILDREN WITH IDIOPATHIC SHORT STATURE AUTHOR: Sarah Hick Sarah Hick is a fourth year arts and science interdisciplinary student at McGill University in Quebec. She is pursuing a double major in molecular biology and international development. Her academic passion is global health and equity, but she is also fascinated by Russian history and contemporary politics. Executive Summary This paper discusses the issue of the regulation of the use of synthetic human growth hormones (HGHs) in children with idiopathic short stature (ISS). The use of synthetic HGHs in children with ISS raises medical-ethical concerns that have yet to be fully addressed. This paper proposes that Health Canada restrict the use of synthetic HGHs in children with ISS to experimental purposes until more research is completed into the benefits and risks of its use in this vulnerable population. Growth hormones are naturally made in the human body by the pituitary gland to stimulate growth and development, and are thus particularly important in infants and young children[1]. Like with most hormones, certain people will produce more or less depending on their genetic makeup and how well their organs and glands function. Synthetic HGHs were created to be used in hormone therapy for people with significant medical deficits, such as children and adults with genetic growth hormone deficiencies, girls with Turner’s Syndrome who are missing part or all of an X chromosome, and those with certain types of kidney diseases[2]. Humatrope is one such HGH available in Canada and approved by Health Canada and the Food and Drugs Act[3]. In 2006, Health Canada amended its regulation of Humatrope, allowing its use in the treatment of idiopathic short stature (ISS)[4], a decision seen in other developed countries and supported by preeminent journals such as The Journal of Clinical Endocrinology and Metabolism[5]. ISS is not a disease, it is a disorder with no common diagnosable source which causes children to have extremely short stature[6]. These children may grow up to be in the normal adult height range, albeit at the low end, because their growth rate is normal but has been delayed, or may be clinically short their whole lives[7]. Unlike other recipients of HGHs, children with ISS are not physically unhealthy, but due to their height being markedly less than that of their friends and peers, children may be teased, feel inadequate[8], or suffer other psychosocial impacts[9]. Context and Scope Throughout the history of hormone treatment, there has been a debate over the ethics of using HGHs to treat physically healthy children with ISS. Ethically, the use of synthetic HGHs in health children can only be justified if children are suffering significant harms because of their ISS, harms which would be necessarily reduced by treatment. Hormone treatments imply to a child that they are in some way damaged, or less than others, and need to be fixed. This practice redefines short stature as a disability necessitating intervention[10]. The psychosocial consequences children with ISS face exist because of the attitudes of others and society’s understanding of value, not because there is something wrong with them[11]. Furthermore, the generalization that short children will suffer emotional detriments ignores the individuality of each child, and the impact that parental love and support, and other psychological aids like therapy, can have on a child’s well being. Opponents argue that there is no firm evidence to support the argument that negative psychosocial impacts are to be presumed for children with ISS. In their Consensus regarding the use of HGHs in the treatment of ISS, the European Society for Paediatric Endocrinology Workshop stated that, “Overall, both clinical and population studies indicate that most short individuals are functioning within the broad range of normalcy…[12]” As well, a daily regimen of injections, which in most cases has to last years, is physically and emotionally taxing to a young child[13], and further alienates them from their peers. Additionally, as these HGHs were initially tested for use on persons with genetic or pathological hormone abnormalities, recipients, particularly children, without such abnormalities, who were not part of the initial research studies, may not respond as successfully to the treatment as others[14]. There has also been minimal research into the long term effects of prolonged growth hormone use[15]. Finally, these drugs are very expensive, and are not covered under most provincial health insurance plans, and thus may pose a substantial financial burden to parents and families who have unrealistic expectations of the benefits[16]. It is for these reasons that the Canadian government, through Health Canada, is advised to reestablish regulations for the use of human growth hormones for children. Policy Alternatives In 2006, when Health Canada extended the permitted use of Humatrope, it acted in its best effort to protect vulnerable children and offer them, and their parents, a safe option for growth. As well, it determined that ISS children should have the same opportunity to alter their height as children with genetic or pathologically understood causes of short stature[17]. The existing policy surrounding HGHs is thus not founded in maliciousness or cruelty, but rather a genuine desire to improve. It is this idea of a need for improvement however, that presents a real threat to the very children the decision was intended to serve. As Dr. Chris Feudtner says, “Medicalizing this situation might not give the results we are looking for, even with the best of intentions[18].” A risk benefit analysis of using human growth hormones to treat children with ISS demonstrates that the risks, outlined in the previous section, may not outweigh the potential benefits. The health and wellness of Canadian children should be of paramount importance to physicians, parents, the public and the Canadian government. Young children are particularly vulnerable victims of policy failures, because they lack a conscious voice in society. Specifically, they cannot give autonomous consent to such a demanding clinical intervention[19]. There is therefore a genuine need for change. The alternatives to the current legalization of the use of synthetic HGHs for children with ISS are an outright ban on further use, a temporary ban on further use to permit study of the ethical and medical issues, or a restriction on further use for “experimental use” use only to permit research to be done in the context of clinical trials. Policy Recommendations The best way for Canada to protect the physical and mental wellbeing of its children is for Health Canada to reinstate the permitted use of synthetic HGHs to only those children with diagnosable hormone deficits, and other understood diseases that greatly impact health. That is, Health Canada should revoke their 2006 amendment for this additional-label use of Humatrope. As a second step, Health Canada should permit the use of such HGHs for use in experimentation for children with ISS, to allow for further research to be conducted into the medical and psychosocial risks and benefits to such children in the context of clinical trials conducted in hospitals and other institutions. Health Canada can support these trials by providing funding to researchers for these trials. In the absence of synthetic HGH treatment for children with ISS, the government should provide funding for psychosocial support and therapy for such children who may be struggling. It is very important that if physicians can no longer offer this intervention to their patients, they have other ideas and strategies on hand[20]. It is critical that parents inspire their children to see the positive impacts they have on the world, and to be an available support for when bullies and peer pressure present genuine harms[21]. Physicians and hospitals should be encouraged to offer informational pamphlets on emotional wellbeing, support groups for ISS teens, and other opportunities to help those children who may need it. With these efforts, more research will fill the information gaps that exist in this case, and affected children will receive alternative support in the interim. Consulted Sources Blackwell, Tom. “Hormones to make a medically healthy short kid taller: Confidence booster or ‘child abuse’.” The National Post, September 7, 2012. <http://nationalpost.com/news/canada/short#>
Brody, Jane E. “A Plus Side for Human Growth Hormone.” The New York Times, May 3, 2010. <http://www.nytimes.com/2010/05/04/health/04brod.html> Bucher, Dawn R. “Ethical Considerations: Growth Hormone Treatment in Children with Idiopathic Short Stature.” Online Journal of Health Ethics 4, no. 1 (2007). <http://dx.doi.org/10.18785/ojhe.0401.02> Cohen, P., A. D. Rogol, C. L. Deal, P. Saenger, E. O. Reiter, J. L. Ross, S. D. Chernausek, M. O. Savage and J. M. Wit. “Consensus Statement on the Diagnosis and Treatment of Children with Idiopathic Short Stature: A Summary of the Growth Hormone Research Society, the Lawson Wilkins Pediatric Endocrine Society, and the European Society for Paediatric Endocrinology Workshop.” The Journal of Clinical Endocrinology & Metabolism 93, no. 11 (November 2008): 4210-4217. <https://doi.org/10.1210/jc.2008-0509> James, Susan Donaldson. “Growth Hormones on Rise in Healthy Kids.” ABC News, September 15, 2009. <http://abcnews.go.com/Health/growth-hormones-healthy-kids-increase/story?id=8571628#> Rexall. “Humatrope.” Accessed November 30, 2017. <https://www.rexall.ca/articles/view/1237/Humatrope> Tauer, Carol A. “Growth Hormone a Case Study in Treatment Priorities.” The Hastings Center Report 25, no. 3 (May – June 1995): S18-S20. <http://www.jstor.org/stable/3562126> Verweij, Marcel and Frank Kortmann. “Moral Assessment of Growth Hormone Therapy for Children with Idiopathic Short Stature.” Journal of Medical Ethics 23, no. 5 (October 1997): 305-309. <http://www.jstor.org/stable/27717997> [1] Rexall, “Humatrope,” accessed November 30, 2017, <https://www.rexall.ca/articles/view/1237/Humatrope> [2] Jane E. Brody, “A Plus Side for Human Growth Hormone,” The New York Times, May 3, 2010, <http://www.nytimes.com/2010/05/04/health/04brod.html> [3] Rexall, “Humatrope.” [4] Tom Blackwell, “Hormones to make a medically healthy short kid taller: Confidence booster or ‘child abuse’,” The National Post, September 7, 2012, <http://nationalpost.com/news/canada/short#> [5] P. Cohen, et al, “Consensus Statement on the Diagnosis and Treatment of Children with Idiopathic Short Stature: A Summary of the Growth Hormone Research Society, the Lawson Wilkins Pediatric Endocrine Society, and the European Society for Paediatric Endocrinology Workshop,” The Journal of Clinical Endocrinology & Metabolism 93, no. 11 (November 2008): 4211, <https://doi.org/10.1210/jc.2008-0509> [6] Marcel Verweij and Frank Kortmann, “Moral Assessment of Growth Hormone Therapy for Children with Idiopathic Short Stature,” Journal of Medical Ethics 23, no. 5 (October 1997): 306-307, <http://www.jstor.org/stable/27717997> [7] Carol A. Tauer, “Growth Hormone a Case Study in Treatment Priorities,” The Hastings Center Report 25, no. 3 (May – June 1995): S18, <http://www.jstor.org/stable/3562126> [8] Cohen, et al, “Consensus Statement,” 4212. [9] Verweij and Kortmann, “Moral Assessment of Growth Hormone Therapy,” 308-309. [10] Tauer, “Growth Hormone a Case Study in Treatment Priorities,” S19. [11] Susan Donaldson James, “Growth Hormones on Rise in Healthy Kids,” ABC News, September 15, 2009, <http://abcnews.go.com/Health/growth-hormones-healthy-kids-increase/story?id=8571628#> [12] Cohen, et al, “Consensus Statement,” 4212. [13] Blackwell, “Hormones to make a medically healthy short kid taller: Confidence booster or ‘child abuse’.” [14] Dawn R. Bucher, “Ethical Considerations: Growth Hormone Treatment in Children with Idiopathic Short Stature,” Online Journal of Health Ethics 4, no. 1 (2007), <http://dx.doi.org/10.18785/ojhe.0401.02> [15] Brody, “A Plus Side for Human Growth Hormone.” [16] Bucher, “Ethical Considerations: Growth Hormone Treatment in Children with Idiopathic Short Stature.” [17] Tauer, “Growth Hormone a Case Study in Treatment Priorities,” S18-S19. [18] James, “Growth Hormones on Rise in Healthy Kids.” [19] Verweij and Kortmann, “Moral Assessment of Growth Hormone Therapy,” 308. [20] Bucher, “Ethical Considerations: Growth Hormone Treatment in Children with Idiopathic Short Stature.” [21] Cohen, et al, “Consensus Statement,” 4212-4213. AN ANALYSIS OF MENTAL HEALTH in INDIGENOUS COMMUNITIES IN CANADA AUTHOR: NEHA GULATI Neha is in her second year of Health Sciences at Western University. Her research explores the development of sexual assault policies in South Asian countries, and their reflection of cultural values. Neha was awarded the Health Studies Student Achievement award in her first year, and was previously recognized by Young Sustainable Impact as one of the world’s Top 20 Under 20 environmentalists. During the summer of 2014, I travelled with the Students on Ice Foundation to the high Canadian Arctic and Greenland. Throughout the trip I visited various northern communities that are inhabited by Inuit people- Aboriginal people living in the northern part of Canada. From my experiences in the formal education system, I have learned very little about Indigenous communities; what I did learn demonstrated that they receive various benefits, such as tax exemption and free post-secondary education. After only a few interactions with these Inuit people, I learned that despite their well-deserved, minimal compensation, there are many obstacles they must overcome. I heard stories from elders about lack of fresh water, food insecurity, and the challenge that resonated with me the most, poor mental health across all of their communities. A miserable state of mental health in Indigenous communities has been built up over time though the historical mistreatment of Aboriginal people, however modern day factors such as impoverished living conditions and a lack of available support services also contribute to the problem. Any examination of the mental health of Indigenous people must consider the direct impact which precedent contact with Euro-Canadian culture has clearly had on the stature of their overall health. According to the Regional Health Survey, half of First Nations adults living on-reserve said their health and well-being had been negatively affected by the residential school experience (Public Health Agency of Canada, 2011). Survivors of residential schools have displayed symptomology quite similar to Post-Traumatic Stress Disorder (PTSD). Specifically, there are recurrent intrusive memories, nightmares, occasional flashbacks, and quite striking avoidance of anything that might be reminiscent of the Indigenous residential school experience (Brasfield, 2001). PTSD is a serious mental illness and studies have demonstrated that traumatic experiences can induce behavioural disorders that are passed down from one generation to the next; this mental illness can be hereditary. (ETH Zurich, 2014). Despite the fact that few generations of Aboriginals have directly suffered through Colonialism, the scars left on their mental health are present in current generations. In contrast, the current living conditions of Indigenous people have deteriorated their mental health as well. Many First Nations suffer from high unemployment, low income, low education levels and overcrowded housing. Studies indicate a strong correlation between poverty, along with the social deprivation it causes, and poor health among Canadians (Raphael, 2007). As a result, quality of life is compromised, which has an impact on mental health. It is evident that mental health concerns may arise in any person’s life, but low quality of life, which is certainly present in Indigenous communities, can increase one’s chances of being afflicted. Moreover, the mental health care available to Indigenous people within Canada is subpar at best. Based on the antecedent factors that contribute to poor mental health, it is expected that Aboriginal people would receive ample support for these issues, but this is not the case. In Ontario, for instance, mental health services on reserves are "at best probably minimal and at worst non-existent," according to Sol Mamakwa, health adviser for Nishnawbe Aski Nation, an organization representing 49 Aboriginal communities within a vast area of the province's north. (The Canadian Press, 2016). In 2004, the average number of psychiatrists practicing per 100,000 people in Ontario was 13.1; however, in northwest Ontario, the rate was only 3.3 psychiatrists per 100,000 population; these communities consist mainly of Indigenous people (Durbin et al, 2007). The services which are crucial to these communities are simply not being provided. Overall, the previous abusive experiences, consistent state of poverty and absence of sufficient health care services among Indigenous communities, all attribute to the unfortunate state of mental health which their people encounter. As a student, I acknowledge that mental health is undeniably important, and in today’s busy world we often lose sight of the concept of maintaining good mental health. Very rarely do I come across a friend or classmate who has not been affected by mental illness; whether it has impacted them directly or someone to whom they are close, it is something with which many youth are struggling. I personally have dealt with mental illness, and overcoming that obstacle opened my eyes to how valuable mental health is. It is important that we take care of our health on every level, which is why when I see large groups, such as Aboriginals, struggling with mental health is becomes clear that it is a concern for our nation. A corrupt state of mental health resulting from the aforementioned factors can not only impact day to day life, but create more severe issues. Statistics show that First Nations youth die by suicide approximately five to six times more often than non-Aboriginal youth. The suicide rates for Inuit people are among the highest in the world, at 11 times the national average, and for young Inuit men the rates are 28 times higher (Mental Health Commission of Canada, 2012). There are an extensive number of potential solutions to the issue present throughout Canada; they exist on various levels, targeting poor Indigenous mental health in a variety of formats. There are nation-wide initiatives, such as the Government of Canada’s Mental Wellness Help Line for Indigenous People. This project began in October of 2016 and was designed to provide immediate and culturally appropriate assistance to those in need. The Help Line is being funded as part of the $69 million announced by the Government of Canada in June 2016 to support crisis response teams, mental wellness teams and increased access to mental health care services (Government of Canada, 2016). It is amazing that the government has devoted both time and money to this issue, however projects with such a large scope can often be ineffective as the outreach tends to be impersonal. There’s a lack of direct connection with those the program is servicing, and in order for them to receive this support they must be the ones to reach out. In contrast, projects with smaller-scale audiences, such as North in Focus, have had quite the impact. North in Focus was created by Western and McGill University students; it is a non-profit organization that promotes mental wellness, reduces mental health stigma, and empowers individuals to reach out for support (North In Focus, 2016). Their team conducts week long workshops for youth in northern, Indigenous communities with the goal of promoting positive mental health. They work closely with students by building personal relationships and bringing assistance directly to them. Focused programs such as these can be much more intimate, allowing contributors to see the direct and visible impact they are having. In order to make effective change, solutions to the Indigenous mental health crisis must deal with the issue on a personal level. In summary, what I was faced with in the Arctic truly opened my eyes. Although anyone can struggle with their mental health, the Indigenous people of Canada have been placed in circumstances that only nurture the negative effects. The quality of our mental health can alter the quality of our lives. We must find ways to support these suffering communities, because no one should feel alone when it comes to mental health. References Brasfield, C. (2001, March). Residential school syndrome. Retrieved from http://www.bcmj.org/article/residential-school-syndrome
Durbin, J., E. Lin, B. Rush, K. Thibault, and B. Smith. (November 2007). Impact Study: Midterm Report. Systems Enhancement Evaluation Initiative. ETH Zurich. (2014, April 13). Hereditary trauma: Inheritance of traumas and how they may be mediated. Retrieved from https://www.sciencedaily.com/releases/2014/04/140413135953.htm Government of Canada. (2016, October 17). Government of Canada announces mental wellness help line for Indigenous peoples. Retrieved from http://news.gc.ca/web/article- en.do?nid=1137119 Mental Health Commission of Canada. (2012). The facts. Retrieved from http://strategy.mentalhealthcommission.ca/the-facts/ North In Focus. (2016). North In Focus: At a glance. Retrieved from http://www.northinfocus.org/at-a-glance/ Public Health Agency of Canada. (2011, March 15). The human face of mental health and mental illness in Canada 2006. Retrieved from http://www.phacaspc.gc.ca/publicat/human-humain06/15-eng.php Raphael, D. (2007). Poverty and Policy in Canada: Implications for Health and Quality of Life. Toronto, ON: Canadian Scholar's Press. The Canadian Press. (2016, November 27). Lack of services contributing to indigenous mental health crisis: frontline workers. Retrieved from http://www.ctvnews.ca/health/lack-of- services-contributing-to-indigenous-mental-health-crisis-frontline-workers-1.3178797 |