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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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.

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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).


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Research and Public Welfare: Working with the French, We Can Have Our Cake and Eat It Too!

Jasen Lau

The US healthcare system is a system that ultimately prioritizes research. However, that is not to say we cannot have public universal healthcare. No system can offer absolute public welfare without taking away funding from research, but there can be a system that doesn’t take away as much. Keeping the research oriented priorities in mind, the US can still adopt a sort of inverted French healthcare system to provide public universal healthcare without significantly hindering medical and pharmaceutical research.

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The World Health Organization praised France for having the best healthcare system in the world[1]. Indeed, they are often touted as having the closest to perfect system in terms of patient satisfaction[2], and their system works because it is regulated but not socialized. The French healthcare system is delivered through their Social Security(SS), and financing their SS works much like ours; much of the money for SS comes from income and payroll taxes. This money is then used to insure patients through general funds, and this general fund covers around 70% of all expenses[3]. The rest of the amount owed is either paid out of pocket or through the more popular choice of voluntary insurance. This voluntary insurance works much like the private payer of the US and is often offered through employment. So, on paper, it seems that the French have most or even all of their healthcare costs covered, which is true[4]. However, the French government plays a big role in these prices.

Unlike the US, the French regulate and control the costs of medical services, products, and pharmaceutics. For example, doctors are often paid much less in France than the US[5]. So, these lowered costs are more easily covered by both the public insurance and the voluntary insurance. Therefore, to follow any model of the French healthcare system, some regulation of costs would be necessary. For the US, and to preserve the goal of research rather public welfare, absolute regulation is not necessary – just some to limit the financial burden on the government.

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Rather than having SS pay for the majority, the US could complement private insurance. Of course, this would require that the person have insurance in the first place, now mostly possible due to the Affordable Care Act (ACA) and its individual mandate, requiring everyone to have insurance or suffer penalties. Therefore, the US need only cover the gaps not paid by the private insurer. Further, the US government would also have to regulate either insurance payment or cost. To avoid significantly hindering research in the US, regulating insurance payments would not interfere with funding research. To regulate costs means to ask physicians, medical technology manufacturers, and pharmaceutical companies to relinquish money from funding in order to serve the public welfare. Thus, the US can adopt an inverted French healthcare system and regulate insurance companies to achieve a public universal healthcare.

With the ACA requiring everyone to have insurance, the first step of this proposal is met: almost everyone will have some level of insurance. The person will have their choice of what insurance to get, but to get people to choose the right insurance, the patient will have to pay premiums and some amount of copayment for services. After all, if there is absolutely no cost to the patient, everyone in the nation will, undoubtedly, choose the best – and often most expensive – coverage policy. However, if that is the scenario, that the patient should able to afford such prime insurance that all needs and wants are fully covered, then there is no need for that patient to be a part of the supplemental SS insurance. Perhaps, in those situations, a tax break could be offered. Otherwise, SS can then pay for coverage gaps in a person’s private insurance, and such funding will come from where it always has: mainly payroll and income taxes and, if need be, subsidy by other government bodies. Now, the SS payment need not cover all copayments or costs. In France, patients still have copayments, though they may simply be an extraordinary low[6]. The US can and should follow suit. The key costs to keep would be insurance premiums. To avoid excessive costs to both the healthcare system as a whole and to the supplemental SS system, patients should be made aware to buy only what is necessary to their needs. This, again, is to emphasize the concern patients must establish in choosing healthcare. Putting in baseline copayments – even if nominal – will tell the patient what can be considered a costly or non-preferred treatment.

There will need to be some insurance regulation. For if there is no insurance regulation, insurance companies court contract with providers to let the federal government bear the financial burden instead of the private insurance. So, there has to be some regulation that deters or otherwise prohibits insurance companies from diverting costs from themselves. There can be no solid solution without great deliberation, but a good starting point would be a percentage coverage regulation. Such a regulation would require that the insurance cover some reasonable amount that does not greatly deviate from what they would cover had the patient not have a federal gap coverage plan. As for physicians, reimbursement rates would be on par with Medicaid or medicare reimbursement rates, relatively low[7]. On that note, this plan would take the place of Medicare but not in the place of Medicaid. Like the US Medicaid, French Social Security offers healthcare to those who are poor[8]. The poor would not have the option to purchase private insurance to later be supplemented by SS coverage. Medicare however, is not inherently for the poor, merely the elderly, the permanently disabled, and those with end-stage renal disease.[9] So, Medicare should be replaced with this proposed private-SS coverage plan.

The general French system offers coverage for those who have worked. Those who are poor or have not worked at all are given a special fund for their coverage, often subsidized by the wealthy and working. Implementing this in the US, states could keep their Medicaid, of which the federal government subsidizes. However, Medicare will be eliminated and replaced with this proposed inverse French Healthcare system. Though, no significant harm shall come of this. Private insurance companies can and will step in to cover seniors with specific plans designed to cater to the medical needs of the elderly. In fact, much of that already occurs now. Medicare Part C is a plan handled almost exclusively by a private insurer instead of Medicare. When an elderly patient needs a plan that caters to their personal needs – of which Medicare cannot meet – patients are able to seek out Medicare Part C plans through private insurers[10]. Therefore, this inverted French plan is no different than putting every elderly person on Medicare Part C. There are, however, some elderly patients who are unable to afford private insurance. In the US, about 10% to 11.5% of those above 65 live below or at the poverty line[11]. For those patients, Medicaid would apply. This way, the vast majority of the population will be covered without extensive inhibitions to research funding.

AideMedicale.jpg

An inverted French healthcare system can benefit the general welfare of the US. Granted, this does come at a slight cost to funding research. The coverage gap, of which would have been normally paid in full out of the patient’s pocket, is now paid at a lesser rate due to this proposed federal coverage gap insurance. However, this is a small cost to pay for the public welfare of the US citizens.

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.who.int/whr/2000/media_centre/press_release/en/

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

[3]http://www.npr.org/templates/story/story.php?storyId=92419273

[4] Id.

[5]http://prescriptions.blogs.nytimes.com/2009/09/11/health-care-abroad-france/?_php=true&_type=blogs&_r=0

[6]http://www.slate.com/articles/business/dispatches_from_the_welfare_state/2014/01/french_socialized_medicine_vs_u_s_health_care_having_a_baby_in_paris_is.2.html

[7]http://www.forbes.com/sites/merrillmatthews/2015/01/05/doctors-face-a-huge-medicare-and-Medicaid-pay-cut-in-2015/

[8]http://www.npr.org/programs/day/features/2008/jul/france/dutton.pdf

[9]https://www.cms.gov/medicare/eligibility-and-enrollment/origmedicarepartabeligenrol/index.html

[10]https://www.medicare.gov/sign-up-change-plans/medicare-health-plans/medicare-advantage-plans/how-medicare-advantage-plans-work.html

[11]https://www.americanprogress.org/wp-content/uploads/issues/2008/07/pdf/elderly_poverty.pdf; see also http://kff.org/other/state-indicator/poverty-rate-by-age/


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Universal Health Care vs. Research – Why the United States Must Prioritize the Latter

Jasen Lau

Universal health care is a hot topic in America. Many other countries have already implemented universal health care, and to many, America seems backwards, late, and uncaring of its citizens. The truth is that America is not uncaring, but rather, America has its focus elsewhere. America, unlike many other countries, focuses on research, development, and advancement of medical technology and pharmaceutics instead of public welfare. Now, that isn’t to say that America is uncaring. America still has state medical assistance for those below the poverty line, Medicare for the elderly, and child health insurance programs for children whose families are above the poverty line yet are too poor to purchase private insurance, but the American healthcare system is designed to ultimately pay manufacturers and research institutes, not go back into the public. America currently leads the world in medical technology and pharmaceutics, producing more than half the world’s medications[1]. The American healthcare system rewards and incentivizes research instead of the public welfare of one nation because the goal of the US is to advance medicine as a whole, not just improve one nation.

Stethoscope World

With the advent of the Affordable Care Act (ACA), many people in the US now have healthcare. However, the ACA only required the purchase of insurance[2]. The ACA is not universal healthcare. Quite to the contrary, the ACA pushes more money goes into a system of healthcare professionals that ultimately fuel research. Patients pay premiums to pay for insurance companies; the insurance companies pay providers; those providers then have money to purchase medical equipment, pharmaceuticals, or other healthcare assets; those purchases further fund the institutes that directly advance the research for better medical technology; and they get their money from selling those technologies and advancements to providers. This unending cycle does not exist within many other countries.

Other nations, like England, Germany, Japan, Korea, Australia, and many, many others, have a ministry of health which directly provides healthcare to its citizens. For example, England follows a health constitution, the National Health Service Constitution for England (NHSC), to regulate how health care is covered. The system promises that no one will be denied care and that all health care is free[3]. On the surface, this sounds like what many people in the US want. However, the NHSC limits when the care may be provided. Directly on their main page, the NHSC suggests that vaccinations for the Shingles disease be given to people age 70 and up[4]. However, the Center for Disease Control (CDC) in the US recommend the vaccination as early as 60 years of age. Even the European Medicines Agency recognizes that the Shingles vaccine is meant for people as early as 50[5]. Therefore, how significant is a difference of 10 years? According to both England and the US, Shingles can often lead to pain – ranging from mild to moderate and described as sharp and stabbing pain[6]. In fact, the pain from Shingles is so debilitating that it is cited as the number two reason for suicide in elderly adults[7]. Further, 15 of 100 elderly people who suffer from shingles may become blind[8]. Most universal healthcare nations, however, cannot afford the vaccine on a nationwide scale that early. The point of determining when healthcare is allowed is to stagger the payments. It’s better to have 10 separate payments made instead of one massive lump sum. However, in the US, providers and hospitals are not state employees that must rely on taxpayer money to buy vaccines from drug manufacturers or machines from medical technology companies.

shingles-button-lg

In many countries where there is public universal healthcare, the vast majority of providers are state employees. Taking everything into account, nations like England have one insurance, one large organ of healthcare providers, and therefore one major purchaser of healthcare technologies and pharmaceuticals. With one entity fueling the money in a system, the layman would believe that money would be better controlled, and to a certain extent, that is correct.

Insurance companies negotiate reimbursement rates for providers[9]. So, the standard $100 rate for cash paying patients may be less for certain insurances where the doctor only gets $70, as an example. With a promise of lowered rates, though, insurance companies boasts their number of subscribers. So, the tradeoff is a lowered rate for the prospect of an increased number of patients and payment security. In America, where there are many insurance companies, providers are often given a wide selection with whom to contract and power to negotiate rates. However, in nations such as England, providers are employees of the State. The government need only compensate the provider at an agreed salary rate, and all the money for providers and research comes from taxes. These same taxes, therefore, are also used to purchase MRI machines, purchasing pharmaceutics, and developing whatever research is possible with the miniscule amount of money remaining. So, the entire financial burden of setting up hospitals, paying for providers, and buying medical equipment fall upon one single entity that controls nearly the entire healthcare system, and this can have grave consequences.

medical-research

No other country in the world rivals the US in availability of medical testing. MRI machines, for example, are more readily available in the US than any other country. For example, the US has more than 11,000 MRI machines, around 35 machines per 1,000,000 inhabitants. The second highest country is Korea, having only around 1,200 MRI machines or roughly 24 machines per 1,000,000 inhabitants[10]. Having a lesser number of machines available for use means an expected wait time in many other countries. Therefore, wait times in many other countries can exceed two weeks just for a simple scan[11]. In America, though, hospitals need not wait for taxpayer money from the government. As their own business, hospitals may purchase newer, more efficient medical technology in whatever quantities they deem necessary. This is what runs the US healthcare system: the flow of money back into research, not into the 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]http://www.forbes.com/sites/gracemarieturner/2012/05/23/though-the-u-s-is-healthcares-world-leader-its-innovative-culture-is-threatened/

[2]42 U.S.C.A. § 18091 (West)

[3]The National Health System for England, The NHS Constitution, https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/448466/NHS_Constitution_WEB.pdf (last visited Sept. 1, 2015).

[4]The National Health System for England, Shingles, http://www.nhs.uk/conditions/shingles/pages/introduction.aspx (last visited Sept. 1, 2015).

[5]http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000674/human_med_001185.jsp&mid=WC0b01ac058001d124

[6]The National Health System for England, Shingles, http://www.nhs.uk/conditions/shingles/pages/introduction.aspx (last visited Sept. 1, 2015). The Center of Disease Control and Prevention, Shingles (Herpes Zoster), http://www.cdc.gov/shingles/about/prevention-treatment.html (last visited Sept. 1, 2015).

[7]Ricardo J. Gonzalez-Rothi, One shingles shot can prevent future pain (2012), available at http://med.fsu.edu/uploads/files/newsPubs/print/Shingles%20shot,%20Gonzalez-Rothi,%20democrat.pdf

[8]The Children’s Hospital of Philadelphia, A Look at Each Vaccine: Shingles Vaccine, http://www.chop.edu/centers-programs/vaccine-education-center/vaccine-details/shingles-vaccine#.VeYv6vlVikp (last visited Sept. 1, 2015).

[9]http://www.hcplive.com/physicians-money-digest/practice-management/negotiating-contracts-with-insurance-companies-fontes

[10]Magnetic Resonance, 21-01 What is the Organ Distribution of MRI Studies?, http://www.magnetic-resonance.org/ch/21-01.html (last visited Sept. 1, 2015).

[11]Martin Beckford, Britain has fewer high-tech medical machines than Estonia and Turkey, The Telegraph (Mar. 30, 2011), http://www.telegraph.co.uk/news/health/news/8413647/Britain-has-fewer-high-tech-medical-machines-than-Estonia-and-Turkey.html.