Ius Gentium

University of Baltimore School of Law's Center for International and Comparative Law Fellows discuss international and comparative legal issues


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The Mammary Games: Polarity on Breastfeeding Practices

Bryana Spann

Throughout the 2016 election and into the new administration of the President, women’s rights advocates have further reverberated their platform to let the world know that we matter. On January 21, 2017, millions of people around the world took to the streets voicing their outrage towards the insulting rhetoric of the past election cycle. With dozens of speakers and thousands of signs decrying the police brutality, the defunding of Planned Parenthood, and discrimination against minorities, there seemed to be a missing message: the absolute right to breastfeeding.

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Global Discourse on Breastfeeding

The benefits that come with breastfeeding have been highly regarded within the international community for the past few decades. Groups such as UNICEF and the World Health Organization (WHO) recommend that women breastfeed their child within the first hour of birth and exclusively for the first six months of the child’s life.[1] At six months, soft or semi-solid foods be introduced to complement breastfeeding for up to two years or more.[2] Not only does breastfeeding benefit the child’s health, development and nutrition but it also substantially decreases the chances of child and infant mortality.[3] Optimal breastfeeding is especially important in developing countries that have a high risk of disease coupled with low access to clean water or sanitation. In such conditions, an exclusively breastfed child is 14 times less likely to die in the first six months than a non-breastfed child. [4]

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Despite the benefits that come along with exclusive breastfeeding, it’s simply not a reality for the majority of women. With about 830 million women workers worldwide, less than 40 per cent of the world’s infants are exclusively breastfed at the appropriate time. [5] The WHO, UNICEF, and the International Baby Food Action Network (IBFAN) recently published a joint report, citing the inadequacy of national laws to protect and promote breastfeeding.[6] The report tracks country involvement and adaptation with the International Code of Marketing of Breast-Milk Substitutes (the Code) as part of their membership in the WHO.[7] Generally, the Code is aimed towards, “safe and adequate nutrition for infants, the protection and promotion of breastfeeding, and by ensuring the proper use of breastmilk substitutes, when…necessary, on the basis of adequate information and through appropriate marketing and distribution.” [8] Although 135 countries have in place some form of legal measure related to the Code, only 39 countries have laws that enact most or all of the Code. [9] Most of the implementation of the Code has taken place in developing countries of the “Global South”, where the populations are more susceptible to high rates of infant mortality due to respiratory infection and diarrhea. Some of the most pervasive challenges in implementing the Code include the lack of political will to participate, interference from manufacturers and distributors, as well as the absence of coordination by stakeholders. [10]

Taboos and Attitudes towards the Boobs

Despite the global initiatives by UNICEF, WHO, and IBFAN, there still seems to be cultural taboo against mothers who choose to breastfeed in public. Some of the most important elements to successful exclusive breastfeeding is “on demand” feedings and expressing milk when not around the child.[11] This ensures that adequate milk production is maintained throughout the different stages of breastfeeding. Sadly, this becomes more problematic with the lack of maternity leave, as well as the lack of nursing accommodations at work and public places such as restaurants, shops, and airports.

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In May 2015, Rep. Tammy Duckworth from Illinois introduced the Friendly Airports for Mothers (FAM) Act to the House following her travel experiences with her infant daughter [12]. She realized that many national airports didn’t provide suitable space to breastfeed in airport terminals. The FAM Act would require all major U.S. airport to provide “lactation rooms”, with seating, a table and an electrical outlet. Although 62 per cent of the country’s 100 largest airports considered themselves as “breastfeeding-friendly”, only 8 per cent of them provided suitable breastfeeding accommodations. [13] The mandate would aim to bring privacy, comfort, safety, and convenience to traveling mothers. As of 2017, the bill is still with the House Subcommittee on Aviation. [14]

Just this year, traveling mothers have had their own issues across the pond. Gayathiri Bose, a Singaporean mother of two, was traveling to Paris from Frankfurt Airport when she was confronted by German authorities.[15] She was traveling without her baby, but with her breast pump so that she could regularly express breastmilk. This raised suspicion with a female police officer. According to Ms. Bose, the police officer asked her to prove she was lactating by asking her to manually expressing her breastmilk. The incident proved to be an embarrassing moment for Ms. Bose, who is now seeking legal action following her encounter. A Frankfurt police spokesman has confirmed that Ms. Bose’s breast pump checked as a possible suspected explosive and denies her allegation. Claire Dunn, travelling from London Heathrow airport found herself in similar debacle when she was questioned by two male security guards over her breast pump.[16] She alleges that the men had no idea what the object was and kept asking her why she needed the pump if she wasn’t traveling with her baby. [17] Anisha Turner, who traveled from London to India, also found expressing to be problematic during her flight in December 2016. [18] Turner was traveling without her one year old daughter and was able to find numerous nursing facilities in the Mumbai Airport but was stuck expressing milk in disabled bathroom stall in Heathrow Airport, evidencing the disparities in attitudes between the “Global North” and the Global South” regarding breastfeeding.

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Traveling mothers seem to have an uphill battle when it comes to nursing on the go. As the Women’s March takes its next steps, it’s important that citizens reach out to leaders in the organization to force this issue into the spotlight. Phone calls, letters, and social media have also been great tools in reaching out to congressmen and governors. It’s going to take a more open and frank conversation on breastfeeding, women’s health, and child mortality to educate government officials and society as a whole on an inherent part of motherhood.  

Bryana Spann is a 2L student at the University Of Baltimore School of Law. She completed her undergraduate studies at the College of Charleston, where she majored in International Studies with a Concentration in Asian Studies. She also spent a semester abroad in Shanghai, where she studied subjects such as the Government and Politics of China as well as Chinese Calligraphy. Currently, Bryana is member of the International Law Society, the Black Law Students Association, and Alpha Kappa Alpha Sorority, Inc. having previously served as its Global Impact Chair for the Gamma Xi Omega Chapter. Having worked as a law clerk with the Lake County Public Defender, her interests include international human rights, civil liberties, as well as pro bono criminal defense.

[1] http://www.who.int/features/factfiles/breastfeeding/facts/en/

[2] Id.

[3] https://www.unicef.org/nutrition/index_24824.html

[4]https://www.unicef.org/nutrition/index_breastfeeding.html#2 (citing Black R. et al. ‘Maternal and child undernutrition: global and regional exposures and health consequences’. (Maternal and Child Undernutrition Series 1). The Lancet, vol. 371 No. 9608, January 2008, pp.243-60

[5] https://www.unicef.org/nutrition/index_breastfeeding.html#2

[6] https://www.unicef.org/media/media_91075.html

[7] Id.

[8] http://ibfan.org/the-full-code

[9] https://www.unicef.org/media/media_91075.html

[10] Id.

[11] http://www.who.int/features/factfiles/breastfeeding/facts/en/

[12] http://www.msnbc.com/msnbc/rep-tammy-duckworth-leads-charge-lactation-rooms-airports

[13] Id.

[14] https://www.congress.gov/bill/114th-congress/house-bill/2530/all-info

[15] http://www.bbc.com/news/world-asia-38767588

[16] http://www.bbc.com/news/health-38809100

[17] Id.

 

[18] Id.


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A Comparative Look at Off-Label Pharmaceutical Use

Jasen Lau

On December 2012, the Second Circuit of the U.S. ruled in favor of the defendant in U.S. v. Caronia, stating that the non-misleading speech of off-label[1] promotion by a pharmaceutical representative is protected by the First Amendment. The case drew nationwide attention by pharmaceutical companies, public health scholars, government officials, and health lawyers. Many worried that First Amendment protections trumped public safety in off-label promotion. While the actual ramifications are debatable, Caronia certainly warrants further inquiry. After all, the U.S. is not the only country where off-label prescription and promotion of medications take place. From France to Germany to Japan to India, off-label prescriptions and policies thereof exist, and while most of the policies are similar on the overarching principles, the subtle nuances reflect an ulterior motive that may or may not be noble. Many nations of the world have different yet very similar approaches to off-label prescription use regulation.

The Caronia case arose out of the promotion of a drug called Xyrem, a very powerful central nervous system depressant.[2] The Food and Drug Administration (FDA) deemed the medication’s side effects so severe that the drug warranted a black box warning, the most serious kind of warning the FDA may give.[3] Caronia and Dr. Peter Gleason, representatives for Xyrem’s manufacturer, promoted an off-label use; Gleason said he personally treated patients far younger and older than the approved scope of use. However, the court found that the actual speech of the off-label promotion is protected. In the U.S., off- label promotion is not inherently illegal, but off-label promotion may be used as evidence of misbranding, which is illegal.[4] However, the U.S. does not entirely prohibit all kinds of off-label promotion. In fact, the system is set-up such that pharmaceutical manufacturers may fund research that helps find new off-label uses. The manufacturers may then disseminate the research results.[5] Many concerns arise from Caronia’s ruling: manufacturers will start promoting, while disregarding  public safety; research will no longer be funded; the FDA will be limited in power, and so forth. However, the U.S. is not the only country to tackle the issue of off-label prescription use.

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Off-label use is not a rare phenomenon and nor is it exclusive to the U.S. In fact, off-label use is a very common medical technique used to treat numerous patients worldwide. In Paris, a statistical study suggests that nearly 62% of prescriptions are for an unauthorized use.[6] In the first quarter of 1999, nearly 13% of all prescriptions for children and adolescents in Germany were prescribed off-label.[7] Similarly, 22 German medical centers said off-label use was “common” for a vast majority of the physicians.[8] In Spain, 61% of pediatric physicians prescribe for medications in an off-label manner.[9] 

Yet, how each nation regulates off-label use and the public policies that stem therefrom differ in only the subtlest of ways.The European Union (EU) has established a general policy for off-label use; drugs should be approved and authorized for specific treatments. However, the EU also believes that its Member States should incentivize further research. One possible incentive is a six-month extension to a Supplementary Protection Certificate,[10] extending a manufacturer’s exclusive property rights.[11]  Second, the manufacturer is granted an extra two years of market exclusivity if research is done on a drug that affects less than 5 in 10,000 patients or has become a drug where, without incentives, no pharmaceutical company would want to conduct further research for lack of a justification to the necessary investment of research but the drug still holds potential to treat a condition that otherwise cannot be treated with alternative medicines – also called an orphan drug.[12] The EU did not want “rigid and compelling legal regulations” but a system of incentives to nurture the desire for research over penalizing the lack thereof.[13] This desire stems from the need for pediatric research. Nearly 21% of the EU’s population – nearly 100 million – are vulnerable children with inadequate drug supply.[14] In fact, 50% of medications were never even tested for children before becoming orphan drugs.[15] However, many of the Member States are silent on the issue of off-label prescription in their legislation, relying mostly on the EU. On the other hand, France has a very specific approach that defies the EU’s principles.

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In France, a manufacturer may apply for a “temporary recommendations for use” (RTU) application with the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). A RTU allows manufacturers to promote a current drug for an off-label use for 3 years. However, this approval is a contractual relationship; upon approval, the manufacturer is legally obligated to scientifically observe and evaluate the affected population.[16] To obtain a RTU, the manufacturer must prove that no other viable treatment for a current disease except for the off-label use of the drug in question.[17] This approach places the burden on the manufacturer, with much less incentive than the EU’s approach. Yet, there are other approaches in the world warrant further analysis. For example, in India, off-label use of any kind is strictly prohibited without exception.[18] In Japan, if the medication is for certain diseases, it can be approved for off-label use without the “preliminary clinical evidence of [the drug’s] effectiveness.”[19] So, approaches vary greatly between nations.

More importantly, the underlying policy behind these regulations – or lack thereof – must be assessed. In the U.S., the ability to prescribe for off-label use is a necessary “corollary of the FDA’s mission to regulate pharmaceuticals.”[20] The goals of pharmaceutical regulation are to protect the public safety, ensure a drug benefits specific patients groups as well as the overall population, and ensuring justice and equity in patients’ access to safe and effective drugs.[21] The regulation of drugs is specifically to ensure that physicians know that off-label use is prescribing a drug for a use that the “regulatory body has not stated is safe and effective.”[22] While these are very noble goals, a nation must not forget that off-label use is integral in medicine since many market drugs have no labeling or approved uses for specific populations.[23] For example, in Calabria, “less than 15%” of all the drugs on their market are meant for children on the basis of clinical trials.[24] While many people also fear off-label use for its inherent risks, the use of medicine is always a balancing act of benefit vs. risk. The FDA’s drug approval process requires drugs to be “safe and effective,” with the definition of safety changing on a case-by-case basis.[25] Drugs cannot always be completely void of risks, which is why a balancing act is necessary. However, if all off-label use is prohibited (as it is in India)  or, arguably, greatly stifled (like in France), then it is impossible to do a risk-benefit analysis since there is no chance to know of the benefits.[26] Therefore, a careful analysis of which underlying principle to adopt is necessary.

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The EU’s incentive approach certainly drives more research because there is seldom a greater incentive than financial. However, France’s approach to patient safety and care – while noble – places a greater burden on drug manufacturers without necessarily promising greater investment returns. However, if patient safety were the only concern, perhaps India’s approach to absolute prohibition would be the best, forcing manufacturers to conduct research for each and every possible use. Yet, Japan’s take could also allow much needed access to medications that would otherwise be either unavailable or not covered by insurance.[27] In the U.S., the approach is to allow research funding but not off-label promotion directly by the manufacturer. Each nation has a specific approach but what is truly at hand is the underlying idea of why each regulation is – or is not – viable. Indeed, it is a balancing act between the public safety, the preservation of regulatory authority, incentivizing research, keeping the manufacturers liable, and ensuring patient access to much needed drugs. Certainly, there is no one true answer – merely a set of ideas that should be adopted only after a nation knows what would be best for its people.

Jasen Lau is a third year law student at the University of Baltimore School of Law. He graduated from the University of Maryland in 2013 with a Bachelor of Arts in English. Jasen took it upon himself to become a certified pharmacy technician and studied several continuing education credits that focus on Medicare Fraud and Abuse prevention, HIPAA privacy and security laws, and ethics in the pharmacy workplace. Jasen has long been in the health care field either working directly with patients or as an assistant to providers. During that time, his obsession with working in health care has grown into policy analysis and counseling. Along with being a CICL fellow, he is also a law clerk for Johns Hopkins Hospital.

[1] The term “off-label” is defined as any use that is not authorized by the FDA.

[2] U.S. v. Caronia, 703 F.3d. 149 (2012) (Xyrem’s active ingredient is gamma-hydroxybutyrate more commonly known as the “date rape drug”).

[3] Id. at 155.

[4] 21 U.S.C. § 355.

[5] Mariestela Buhay, Off-Label Drug Promotion Is Lost in Translation: A Prescription for A Public Health Approach to Regulating the Pharmaceutical Industry’s Right to Market and Sell Its Products, 13 J. Health Care L. & Pol’y 459, 488 (2010).

[6]Christian Lenk & Gunnar Duttge, Ethical and legal framework and regulation for off-label use: European perspective, 10 Therapeutics and Clinical Risk Mgmt. 537 (2014).

[7] Id.

[8] N. Ditsch, et al., Off-label use in germany – a current appraisal of gynaecologic university departments, 16 European J. Med. Res. 7 (2011) (22 medical centers responded to a questionnaire, and of those physicians who responded, 91% said they commonly prescribed off-label use medications).

[9] Roi Piñeiro Pérez, Results from the 2012-2013 paediatric national survey on off-label drug use in children in Spain (OL-PED study), 81 Anales de Pediatría (English Edition) 16 (2014).

[10] Lenk, supra.

[11] REGULATION (EC) No 1901-2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768-92, DIrective 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726-2004, Official Journal of the European Union, Dec. 27, 2006, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:378:0001:0019:en:PDF.

[12] REGULATION (EC) No 141/2000 OF THE EUROPEAN PARLIMENT AND OF THE COUNCIL of 16 December 1999 on orphan medicinal products, Official Journal of the European Communities, Jan. 22, 2000, http://ec.europa.eu/health/files/eudralex/vol-1/reg_2000_141/reg_2000_141_en.pdf

[13] Id.

[14] Id.

[15] Id.

[16] Lenk, supra.

[17] Joseph Emmerich, et al., France’s New Framework for Regulating Off-Label Drug Use, 367 New Eng. J. Med. 1279 (2012)

[18] Sukhvinder Singh Oberoi, Regulation off-label drug use in India: The arena for concern, 6 Persp. In Clinical Res. 129 (2015).

[19] Id.

[20] 124 Am. Jur. Trials 487 (Originally published in 2012).

[21] Lenk, supra.

[22] Id.

[23] Oberoi, supra.

[24] Francesca Saullo, et al., A questionnaire-based study in Calabria ont he knowledge of off-label drugs in pediatrics, 4 J. Pharmacology * Pharmacotherapeutics 51 (2013).

[25] 2013 Aspatore Special Rep. 5.

[26] Oberoi, supra.

[27] Ditsch, supra; Pérez, supra; see also E. L. Trimble, et al., International models of investigator-initiated trials: implications for Japan, 23 Annals of Oncology 3151 (2012) (In all nations, unless some form of off-label use is either properly documented or approved, the state health insurance will not cover the medication).


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International Clinical Trials: Shaky Grounds for Bioethics

Jasen Lau

Isai in the Moldavian region of Romania, Megrine in northern Tunisia, Tartu in Estonia, and Shenyang in Northern China all have something in common. Unfortunately, they are not the world’s best vacation spots. No, large pharmaceutical companies have targeted these locations as places to run clinical trials.[1] These towns are among many similar towns – poor, distant, and isolated from major cities – that are often favored by many pharmaceutical companies. This recent globalization of clinical trials has raised many questions about both the ethics and efficacy. As international clinical trials grow in popularity, serious consideration needs to be given to the bioethics of conducting such trials in developing countries.

Clinical trials are the backbone of pharmaceutical development. The Food and Drug Administration (FDA) requires them before a drug can be marketed to the public.[2] Clinical trials are often broken into four segments – Phase I, II, III, and IV – and are used to assess the safety and efficacy of the developing drug.[3] Phase I begins with a smaller sample – usually around 20 to 30 people – and is the most dangerous part of the trials.[4] Phase I is where the level of safety and efficacy of the medication is mostly unknown. As the trials progress to Phases II and III, so, too, do the number of participants. Phase IV is post-market observation.[5] This phase monitors the drug after it has been released and is meant to document what effects arise from large-scale use. Clinical trials are meant to uncover the dangers and risks of medication, but this procedure can often take a lot of time and money.

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Most clinical trials can take around a decade.[6] During such time, costs can be around $2.6 billion – not including post-market procedures.[7] These costs come from advertising, subject compensation, and general research procedures, like conducting international clinical trials. With such high costs, many pharmaceutical companies seek to lower costs. International clinical trials have been very popular since 2008.[8] Currently, roughly 60% of the clinical trials being conducted are recruiting research subjects outside of the U.S.[9] By conducting trials overseas, pharmaceutical companies are saving vast amounts of money. For example, in India, a case report from a “first-rate” research center costs $2,000, which is less than one tenth the cost of recreating that same report in a “second-tier” research center in the U.S.[10] This is where the research subjects from developing countries come into play.

In nations where income is low[11], the chance of receiving state of the art medicine is a welcomed opportunity. However, in these remote locations where the US holds no jurisdiction, what assurances do these subjects have that they will be treated fairly? The Nuremberg Code requires basic ideas such as voluntary consent, maximizing benefits while minimizing costs, and taking patient care as first priority.[12] In addition, the Declaration of Helsinki expands upon this and includes the idea of protecting vulnerable populations (the elderly, incarcerated, pregnant, and children), a duty to protect the integrity of the patient, ensuring that those who are harmed are compensated.[13] These codes are meant not just for the U.S. but the global practice of medicine. It is important to note, however, that these ethical guidelines are precatory – not mandatory. Further, prior to the start of the trial, research groups must submit their proposal or application to an Institutional Review Board (IRB). These IRBs are comprised of both medical and non-medical staff that determine the safety of the trial and ensure the welfare of the test subjects.[14] While these protections are in place, the question becomes to what extent and how thoroughly do these guidelines and procedures protect the subject?

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Informed consent is one of the many things required when conducting research. Without going too deeply into the nuances, what true choice do these subjects from developing countries have? Even in a developed country, such as the U.S., many scholars have speculated the true need for informed consent in the practice of medicine.[15] In the end, in part due to the extreme disparity in medical knowledge expertise between subject and researcher or patient and doctor, the subject is more or less consenting to the trustworthiness of the doctor – not the actual procedure. Likewise, the subjects of these nations may not truly be consenting to the research procedure. Rather, their need for medical care at no cost to them greatly incentivizes assent. If that is the case, what point is there, then, in informed consent for these kinds of subjects?

IRBs play a key role in approving clinical trials. However, they are American citizens. Their job is to determine if the trials are ethical and take patient welfare into consideration, but they are not present to routinely monitor the clinical trials.[16] Even the FDA, those who ultimately approve a drug based on these trial results, do not inspect all – nor even a significant number of – these international clinical trials. In fact, the FDA inspects only around 0.7% of such trials.[17] If an IRB is not physically present to protect patient welfare, and the FDA seldom inspects these trials, who is actually protecting these test subjects?

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With the benefits of a relatively large population, all of whom are nearly always willing to partake in studies, and being outside the jurisdiction of the FDA, pharmaceutical companies are greatly incentivized to conduct their research outside of the U.S. There is concern that this will eventually lead to more harm than benefit. There is no assurance that researchers will abide by ethical guidelines, and even if the researchers practiced according to those guidelines, harm can still come to the subjects. When a test subject is harmed, where are they to turn for treatment? Or does this globalization turn a cold shoulder to international research subjects? Further, if the medication is mostly tested on international citizens, whose diets, lifestyle choices, and environmental factors greatly differ from American citizens, how safe is the medication for the average American?

 

The unfortunate conclusion to these rhetorical questions is that clinical trials are growing ever more appealing. While there is not yet currently any solid argument for harm, the obvious threat looms over subjects from developing countries. Such subjects, in need of modern western medication, may not be able to give informed consent to research. Yet, without these treatments, some of these subjects will be no better off than before. Globalization of clinical trials leads to a plethora of bioethics issues, and as it often is with bioethics, there is rarely a concrete answer now nor will there be one in the near future. Adding on the increased complexity of international jurisdiction, the question is whether these American pharmaceutical companies should be made more responsible, and if so, who should – or can – enforce that kind of duty or even impose it? The best thing that can be done at the moment is consistent, thorough analysis of all clinical trials. At the very least, the FDA should increase investigation of these international trials. The future merely holds a balance of powers and desires: cost-saving options for pharmaceutical companies and the bioethics thereof versus the length of reach of FDA’s regulatory authority.

Jasen Lau is a third year law student at the University of Baltimore School of Law. He graduated from the University of Maryland in 2013 with a Bachelor of Arts in English. Jasen took it upon himself to become a certified pharmacy technician and studied several continuing education credits that focus on Medicare Fraud and Abuse prevention, HIPAA privacy and security laws, and ethics in the pharmacy workplace. Jasen has long been in the health care field either working directly with patients or as an assistant to providers. During that time, his obsession with working in health care has grown into policy analysis and counseling. Along with being a CICL fellow, he is also a law clerk for Johns Hopkins Hospital.

[1] Donald Barlett & James Steele, Deadly Medicine, Vanity Fair, Jan. 2011, http://www.vanityfair.com/news/2011/01/deadly-medicine-201101.

[2] Step 3: Clinical Research, U.S. Food and Drug Admin., Nov. 23, 2015, http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm.

[3] Id.

[4] Id.

[5] Id.

[6] Cost to Develop and Win Marketing Approval for a New Drug is $2.6 Billion, Tufts Ctr. for the Study of Drug Dev., Nov. 18, 2014, http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study.

[7] Id.

[8] Daniel Levinson, Challenges to FDA’s Ability to Monitor and Inspect Foreign Clinical Trials, Dept. of Health & Human Serv., June 2010, http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf.

[9] Trends, Charts, and Maps, ClinicalTrials.gov, February 2016, https://clinicaltrials.gov/ct2/resources/trends (54% of the studies are recruiting exclusively outside the U.S. while an additional 6% is recruiting both in and out of the U.S.).

[10] Seth Glickman et al., Ethical and Scientific Implications of the Globalization of Clinical Research, 360 New Eng. J. Med. 816 (2009).

[11] Romania Average Salaries & Expenditures, World Salaries, (Feb. 26, 2016), http://www.worldsalaries.org/romania.shtml (Prices have been converted to U.S. currency for ease of understanding. A dentists average salary is less that $500 a month, engineers make about $700 a month, and physical therapists makes just over $400); see also China Average Salaries & Expenditures, World Salaries, (Feb. 26, 2016), http://www.worldsalaries.org/china.shtml; Occupational Employment and Wages, May 2014, Bureau of Labor Statistics, Mar. 25, 2015, http://www.bls.gov/oes/current/oes291021.htm; see also Occupational Employment and Wages, May 2014, Bureau of Labor Statistics, Mar. 25, 2015, http://www.bls.gov/oes/current/oes291021.htm (The average salary of dentists and physical therapists is about $14,000 monthly and $6,800 monthly, respectively).

[12] The Nuremberg Code, U.S. Dept. Health & Human Serv., Nov. 7, 2005, http://www.hhs.gov/ohrp/archive/nurcode.html.

[13] WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, World Med. Ass’n, (Feb. 26, 2016), http://www.wma.net/en/30publications/10policies/b3/.

[14] Clinical Trials, MedlinePlus, January 28, 2016, https://www.nlm.nih.gov/medlineplus/clinicaltrials.html.

[15] Peter Schuck, Rethinking Informed Consent, 103 Yale L.J. 899, 1994.

[16] Glickman, supra.

[17] Levinson, supra at 15.

 


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Does Universal Healthcare Fix Racial Disparity in Healthcare? Investigating France

Jasen Lau

Racial disparity still infects the US healthcare system.[1] To counter this disparity, many suggest that an universal healthcare will solve the issue, and to a certain extent, that may be true. If the true issue in the disparity is merely access to physicians, universal coverage will solve the racial disparity. However, disparity is not solely reliant upon access to medical coverage. For if the only issue in racial disparity in healthcare is merely access, then, logically, all nations with universal healthcare should have no racial disparity. Turning to France, touted as having the best healthcare system in the world,[2] studies show that racial disparity still exists in France despite having the best universal healthcare.

Assuming racial disparity in healthcare is purely about access to medical coverage, analyzing France is the first step to finding out if improving access would solve racial disparities in the US. Even now, there are French health institutes that do not have properly implemented protocols to handle what the article calls “migrants.” One primary concern is how to properly administer health when the patient, being foreign and “migrant,” does not speak French. A natural thought process would be to have an interpreter available, but the article indirectly suggests that there is no policy to implement such a service.[3] Granted, the patient may bring their own interpreter, but of course, this assumes the patient has one on hand and ready or can even afford one. Curious, too, is that certain French health institutes are attempting to find a balance between accommodating for cultural differences while making an extra effort to ensure the facility is not associated with any one particular religion or culture.[4] As an example, if a French hospitals treats Islamic patients, that institute must respect certain dietary or religious preferences out of respect for the patient. In that situation, the hospital must be Islamic friendly without being associated with the particular Islamic race. This, too, leads to certain issues.

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Allegedly, patients discriminating against hospital staff is an ever rising issue.[5] Patients refuse to be treated by certain providers based either the race, gender, or even sexual orientation. This, of course, inhibits the healthcare system if certain providers must be found in order to accommodate a racist, patient request. This extends to other services by the hospital, too: food, routine examinations by technicians, pharmaceutical intervention, and so forth. Quite in fact, one determining factor of those who are most at risk for healthcare disparity is the religious region from where the patient hails.[6] There is clearly racial disparity in France. While access to healthcare may be solved in France, access, in of itself, is not the sole source nor even the primary source of racial disparity in healthcare.

Understanding healthcare requires a broader sense of the word. A truer definition of current healthcare involves socioeconomic factors: poverty, living conditions, and education. In France, there is no study which directly correlates poverty to minorities. However, there is no doubt that migrants and foreigners, who have been historically disadvantaged, are most likely subjected to poverty, unsanitary living conditions, and a lesser likelihood of employment.[7] This historic and systemic disadvantage has left the foreigners and immigrants to a poor self-image, having a lower opinion of their own health despite having adjusted for all socio-economic factors.[8] This leads to further doctor visits of whom, as stated above, will have continued problems treating those patients, and the cycle repeats itself. Similar analysis must be taken into account in the US.

A brief study of the early 20th century reveals that the greatest innovation of healthcare did not involve the practice of medicine. Despite the discovery of penicillin in 1928,[9] above the creation of the polio vaccine in 1952,[10] and more impactful than gene therapy in 1985,[11] clean water and plentiful food have had more impact to general health than any form of medical treatment to date. With the advent of plentiful food and clean water, diseases have decreased in occurrence[12] and have much later dates of onset.[13] Yet, the pervasive fact remains that racial disparity exists, leaving the last key factor in question: socioeconomic factors. There is no contest that the most poor, most uneducated, more residentially unstable are minorities.[14] Perhaps access is not the biggest issue of healthcare today.

racisme

Perhaps, then, racial disparity in healthcare is an issue far beyond just access to the clinic or the pharmacy. Perhaps racial disparity is much more systemic and beyond merely the Department of Health and Mental Hygiene. Perhaps, just perhaps, an unfair system – disfavoring minorities – is a root cause of racial disparity in everything and not just healthcare.

Jasen Lau is a third year law student at the University of Baltimore School of Law. He graduated from the University of Maryland in 2013 with a Bachelor of Arts in English. Jasen took it upon himself to become a certified pharmacy technician and studied several continuing education credits that focus on Medicare Fraud and Abuse prevention, HIPAA privacy and security laws, and ethics in the pharmacy workplace. Jasen has long been in the health care field either working directly with patients or as an assistant to providers. During that time, his obsession with working in health care has grown into policy analysis and counseling. Along with being a CICL fellow, he is also a law clerk for Johns Hopkins Hospital.

[1] http://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/nhqdr14/2014nhqdr.pdf ; see also http://www.cdc.gov/mmwr/pdf/other/su6203.pdf

[2] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1447687/#r5

[3] https://www.ifri.org/fr/publications/editoriaux/diversite-lhopital-identites-sociales-discriminations

[4] Id.

[5] http://faceaface.revues.org/344

[6]http://www.sherpa-recherche.com/wp-content/uploads/2015/01/FS-Racisme-et-discriminations-contexte-SSS.pdf

[7] https://remi.revues.org/5611

[8] Id.

[9] http://www.ars.usda.gov/Research/docs.htm?docid=12764

[10] http://www.cdc.gov/vaccines/vpd-vac/polio/default.htm

[11] https://history.nih.gov/exhibits/genetics/sect4.htm

[12] David M. Cutler & Grant Miller, The Role of Public Health Improvements in Health Advances: The Twentieth-Century United States, 42 Demography 1, 6 (2005); the amount of diseases both water-borne or otherwise significantly decreased as the 20th century progressed with the implementation of water treatment

[13] Robert W. Fogel, Secular Trends in Physiological Capital: implications for equity in healthcare, 46 Perspectives in Biology and Med. S24, S33 (2003); many diseases were much less prominent in younger people. For example, arthritis started occurring in those above 60 years of age instead of mid-50’s

[14] Robert J. Sampson, The Neighborhood Context of Well-Being, 46 Perspectives in Biology and Med. S53, S54 (2003).