Thursday, April 14, 2016

Healthcare systems: Should ranks be taken at face value?



Growing up here, I was always fed the idea that the United States was the greatest. The United States of America had been able to survive many wars and hard times to get to where it is now. I was taught to believe that America was the greatest place in the world. This country had all the technology, money, and resources. Why else would my family have come here from our small village in Isiala-Umuozu, Nigeria? It had to be because the United States had better resources than not only Nigeria, but many other countries in the world. That was the only reason. That was something I had been taught to believe growing up.

In college, I learned that the United States is actually not the best country in the world. I learned of the USA's rank in healthcare, education, and happiness among others. I searched those same rankings to see where my home country might have placed, only to learn that Nigeria was failing as a state. After that, I became curious to know where other countries ranked and continued to look up various other countries I had traveled to. But, I started to realize something as I looked through the comparisons of all of these countries. I wondered how they were being compared. I wondered whether things like the history of the country or its current status was taken into account upon assigning those rankings.

As we learned about healthcare in the US and various other countries in this class, I wondered how long it took some of these countries to create the kind of healthcare system they had. We learned about the advantages and disadvantages of the healthcare in each of those different countries but I wondered if it was really fair to compare them to one another. While it is true that we can compare the advantages and disadvantages, I don't think we are able to truly say that one healthcare system is better than another, as I have heard people say generally about healthcare in the United States. When it comes to having the resources and funding to create a perfect healthcare system, each country is not at a level playing field. We have to take into account the history in some of these countries and the current situations whether they are political or social that may affect how healthcare is implemented in those countries. 

I think that it would also be good to think about how long each of these countries have had to create a healthcare system. How many times were they able to go back to the drawing board and start over, building a new healthcare system using the successes and failures of the old as their template. It takes time to create a healthcare system that's effective for its people. That is why I believe that ranking countries by their healthcare systems is not equal because those rankings don't take into account that all of the countries didn't start at the same level. Not only that, but all of the countries in the world didn't start at the same time. Some countries are almost 400-500 years old, while others are 2-50 years old. I believe that factors like that are important to think about when making and interpreting information from those general rankings. Thinking about those factors won't necessarily change the rankings, but knowing the current state of the ranked countries can give insight into why their ranking is where it is.

For example, Nigeria has a very poor healthcare system, according to world healthcare indices.  In the World Health Report 2000, Nigeria's healthcare system was ranked 187/191.  In fact, a majority of countries within the continent of Africa make up the lowest 40 rankings of healthcare systems, with Sierra Leone being ranked last at 191. A majority of these African countries are between 50 and 60 years old. After their liberation from their various colonizers and formation of a country ruled by the people who inhabited it, these countries have not had long to create a healthcare system that works for them. They were left with a healthcare system designed by their colonizers, systems that they did not understand. Their current systems were thrust upon them and they were forced to continue with them upon liberation. Despite the changes that have been made to their healthcare systems, the base template is the same as the one created by the colonizers. 

I think that having a healthcare system that uses the model of another as the base means that healthcare system will not be very successful. A healthcare system has to take the people it serves into account and the unique differences that exist within that country compared to another. Of course, this doesn't mean that inspiration cannot be drawn from the systems of other countries. When trying to be successful, it is only right to emulate those who are successful in some way. However, the base model for the healthcare system should not be based on that of another country because that same model that works for that country may not work for another country.

There are other things that also contribute to the lack of success with a healthcare system in an African country like Nigeria, for example. There is the 'brain drain', a phenomena that occurs when healthcare workers and many other intellectuals from a country choose to leave the country for success in other places. This takes away major resources for a country attempting to create a successful healthcare system. With the best doctor's leaving the country, citizens are left being treated by only a handful of specialists spaced two or three hours apart. Specialized healthcare and medicine would be impossible for a patient to receive if they had to travel two or three hours to reach a doctor.

There is also a large poverty rate in Nigeria. There is no middle class, one is either of high or low socioeconomic standing. This disparity in socioeconomic status plays a large role in the healthcare system. Those who can afford care are able to receive it, but those who have to pay out-of-pocket with little money are unable to be treated. This leads to the statistics we see for Nigeria for things like maternal health, neonatal mortality rate, death from easily treated diseases, and overall life expectancy among others. People cannot be adequately treated if there are only 30 doctors available for every 100,000 individuals in an area. People cannot be treated if they have to walk days to get to the nearest hospital because they are unable to drive over the damaged roads in their villages. People cannot be treated if there is a civil war and terrorism taking place where they live. Most importantly, people cannot be treated if the country is unable to obtain the technology and resources for its most skilled healthcare workers to use. 

In summary, there are many factors that affect the African countries and many other poorly performing countries that we need to think about when looking at these rankings. We have to think about what goes on in those countries, and what barriers prevent them from being able to provide adequate healthcare services to their citizens. Once we begin to think about those things, we can begin to fix them. For me, healthcare is not just about health. It is about everything that encompasses a person's life. To improve those healthcare systems, instead of shaming them, we need to reach out and determine what resources they lack that would help improve their systems. As we talked about in class, some countries believe that healthcare is a basic human right for their citizens. Well, I think that  if healthcare is a basic human right, then we should all be helping one another to provide exceptional healthcare across the world because as we saw with the Ebola virus and how it spread, countries are no longer as isolated as they had thought they were from healthcare issues in other countries. So, to prevent future pandemics across the world, I think it makes sense to help one another so that everyone across the world has access to a great healthcare system.

Grayscale

I grew up in a household where life was very black and white. I attended a private university that was saturated with a homogeneous way of thinking. My life was black and white; very straightforward. However, through various experiences and opportunities/friendships, my life was turned upside down. Everything that I had always known for certain to be “right” became murky.  This progression taught me to question everything and to critically analyze and try to see all the perspectives before coming to any conclusions. 

That being said, I want to play devil’s advocate on the whole cheating scandal that happened recently with my class.  We all know cheating is wrong, it’s been ingrained in our minds since we were children attending elementary school. One major reason why it’s wrong is because it’s unfair; it creates an unfair advantage to the people that have the information beforehand.  The problem is that the system was already unfair to begin with. 

Some students are really good test takers, while others perform much better in real life application when put in the field.  Some students enjoy taking exams and performing well, while others suffer extreme exam anxiety and it’s a huge struggle to even make it through a test. The school system caters to the first student.  So perhaps, with this whole cheating problem, one of the students that received the exam actually put in days upon end of studying, but when it comes down to it, cannot perform well on the multiple choice test placed in front of them.  Due to anxiety, stress, and other factors, the student would have received a poor grade, but if the exam had been oral or perhaps essay form, then maybe this student would have had a shot at getting a good grade.  Perhaps, it was one of these kinds of students that received the exam from a P3.  Does that make it okay? No. Does knowing this background information about the student make this situation fair? No. But it was already kind of unfair to begin with.

As much as we want it to be an even playing field, it never will be.  As much as we might want morals and ethics to be black and white, I don’t think that they are.  Each one of us has our own reality and perspective of life.  What I consider right might be completely wrong to the person sitting next to me.  The world I live in could be turned upside down again at any moment; something I truly believed was right could turn out to be so wrong.  As a professional and as a human being, I need to be prepared to act when placed in a situation that questions my understanding of right and wrong.  Developing critical thinking, to be able to listen and at least try to understand another’s perspective AND THEN have the ability to make my own decision without personal biases or beliefs, will be crucial in my journey on this road I’ve chosen.  


Cheating is an area where it is probably a little easier to understand the ethical decision, I just wanted to point out that even something as seemingly straightforward as cheating has its implications.  As a professional, I hope to continue thinking and developing my ethical repertoire so that I have the ability to take a stand, but to also be compassionate and not lose trust. Only through understanding both sides of a situation can we begin to implement lasting, powerful change.  

When Biological Science Meets Big Data Science

     Over the last 20 years, talking points around the subject of genomics and personalized medicine have become topics that could revolutionize the way that healthcare providers and other specialized fields handle therapy for patients. In 2007, President Barack Obama introduced a bill to the U.S. Senate titled The Genomics and Personalized Medicine Act of 2007 which sought to secure the promise of personalized medicine for all Americans by expanding and accelerating genomics research and initiatives to improve the accuracy of disease diagnosis, increase the safety of prescription drugs, and identify novel treatments. Buzzwords like bio-banking, genetic testing, and whole genome sequencing hover around this document, bringing mixed thoughts on the issue among the public. The ethics of informed consent upon request of genomic information and what information is to be divulged to the patient upon request can be a difficult issue to de-convolute.  
     The ability to incorporate genomic information to therapy management for individualized care comes from the idea that two individual patients can have entirely different responses to the same drug, and based on the variations in genetic characteristics and biomarkers that result from these variations, it may be possible to predict and prevent serious adverse events for high risk medications. Cutting post-ADR costs at the emergency room can have huge implications to lowering health care spending from a preventive perspective.
     Recently, Xconomy,business and technolgy giant out located in Boston, MA, organized a Forum named Big Data Meets Big Biology in San Diego, hosting experts in fields such as genomics (Stephen Kingsmore, President and CEO, Rady Pediatric Genomics and Systems Medicine Institute), human biology (Nicholas Schork, Professor and Director of Human Biology, J. Craig Venter Institute), and many more to discuss the future challenges of next-generation genome sequencing and how a coordinated systems approach is needed to make steady progress in bringing these technologies to the utilization of the patient. One very interesting quote from Illumina CEO Francis deSouza during that forum was that " the data required by Netflix for all of its digital movies, television series, and other online programs is roughly equivalent to 200,000 human genomes. The centerpiece of a U.S. “precision medicine” initiative announced last year is a population-scale study of 1 million American individuals and their genomes." 
     Currently it is possible to sequence the full genome of a patient for approximately $1000, where it used to be $3 billion for just one patient 15 years ago. I feel that with this trend towards finding more cost-efficient strategies to provide genomic information that can belong to the consumers in healthcare, hopefully this can not only build a road to more cost-effective therapies, but also put the control of individual care into the hands of the patient as they can physically own their own genomic results in a portable way that can be utilized by healthcare providers from numerous fields.




The Impact of Drug Shortages on the US Health System

Although drug shortages are now widely recognized as a global issue, this was not always the case. Between 1996 and 2002, there was a total of 224 drug shortages as tracked by the University of Utah Drug Information Service. But in 2015 alone, ASHP reported 207 drug shortages. So it is important to understand the implications of drug shortages; why they occur; and how to alleviate them.
Drug shortages have many implications to the patient and the healthcare system. First and foremost, patients suffer the brunt of drug shortages when they occur. In one common scenario, a patient comes to the pharmacy to pick up his medication, only to find out that it is out of stock due to a drug shortage. The patient must choose whether to purchase a costly alternative medication or try to wait it out, without the benefit of his doctor's advice. Drug shortages also have a large impact on the healthcare profession, especially in the in-patient setting. In one example, a nurse might administer an unfamiliar alternative drug - let's say, IV hydromorphone - but at the intended dose of morphine. This could be lethal! Or when limited supplies of a life-saving drug exist, clinicians are forced to make difficult ethical decisions: what patients get it? And no matter what decision they make, they are at an increased risk of litigation by patients who believe they received improper care due to the drug shortage.
On the health system level, institutions also face ethical dilemmas with respect to drug shortages. What if an out-of-stock drug is available through the gray market? Knowing a drug’s pedigree with 100% certainty is nearly impossible, which raises questions about its safety, authenticity, or efficacy. But what if a local compounding pharmacy could manufacture the drug on demand? However, the 2012 meningitis outbreaks due to improper handling at the New England Compounding Center show the risks of using compounding pharmacies. So it is important for every health system to formulate its own regulations to deal with these issues BEFORE a drug shortage occurs.
So how do drug shortages occur? The most common reasons for shortages are: manufacturing difficulties, regulatory issues, and product discontinuation for any reason. Manufacturing difficulties arise from lack of raw materials, equipment breakdown, or even loss of personnel. Additionally, drug shortages may occur when manufacturers halt production due to regulatory issues, particularly due to not following cGMPs (current Good Manufacturing Practices). Although cGMPs are not mandated by law, pharmaceutical companies recognize that compliance is necessary for products to enter and remain on the market per the FDA. So, sometimes manufacturers preemptively recall products to avoid even the risk of FDA legal action. Product discontinuations also lead to drug shortages. It is important to note that manufacturers do not discontinue drugs only when they are unprofitable – even revenue-generating drugs may be discontinued. If production capacity is filled to the max, the company will analyze its product line up to determine which products are the lowest performers. By cutting those products, the company can focus on manufacturing its best performers and thus improve revenues.
Unfortunately the FDA cannot force a manufacturer to produce a product. Additionally, manufacturers are not required to report discontinuation plans unless they are the “sole manufacturer of a drug that is life supporting; life-sustaining; or intended for use in the prevention of a debilitating disease or condition”. The problem is that this is a very narrow range of drugs.
It will take the collaboration of the health system, FDA, and manufacturer in order to prevent or mitigate drug shortages. Health systems should implement a set of universal guidelines before drug shortages occur, and notify the FDA as soon as a drug shortage is detected. Although the FDA has limited authority over manufacturing companies, it can take certain steps to mitigate existing shortages. For example, it can incentivize other pharmaceutical companies to increase production of the product. Finally, manufacturing companies must also take responsibility for drug shortages. Although firms are not required to report discontinuation plans to the FDA, I believe that they should still be held morally accountable for reporting such plans to the public. If manufacturing companies were held to a higher moral standard, patients could only benefit.


Americas unique position in the global landscape of healthcare: why are we this way and where are we going?



My favorite part of this class was the Global Healthcare presentations and the large variety of countries and systems that were presented on and discussed. Just like Stephanie I assumed that somewhere out there was a model that would work for the US and all we had to do was convince the American public that adoption of that model would be the solution to our problem. However, when the systems in the other countries were explored it was obvious that they are all deeply connected to the history, people and culture of their respective countries. While there are similarities to be seen in countries that are near to each other, such as Japan and South Korea or Sweden and Norway, they are still distinct systems that reflect that countries common beliefs about healthcare. The United States was founded in a way that is unique and this has shaped not only our political landscape but our views on healthcare. As Madeline, Pauline and Nicole pointed out it is this individualistic viewpoint has led to the people in the US unwilling to be inflicted with the healthcare costs of those who can’t afford healthcare. This viewpoint stands out in contrast to many other developed nations and deeply effects how we make moral decisions regarding healthcare. 

Hannah pointed out that she doesn’t necessarily feel that healthcare is a right and yet she is bothered by the injustices that can be seen, such as that with Mike Hindt and his experience in a clinical trial. I think that this reflects the beliefs of many Americans in that we don’t want to pay for someone’s elective surgery and yet we feel there is injustice when someone is denied life-saving medical care, so where do we draw that line? This class has made me question my own belief as to whether or not I believe that healthcare is right or a privilege and while I have been exploring my own feelings in this regard it has occurred to me that in some ways this viewpoint is irrelevant. I think one of the things that stood out to me from the presentations that concerned countries with more developed universal healthcare coverage was this idea of the whole country deciding that healthcare was a priority and making an effort to cover everyone. One country that was not presented on, but discussed in class, was England and I am struck by the fact that the founding of their National Health Service in 1948 came so soon after WWII. During WWII Britain suffered heavily from bombings, particularly London, forcing many people to flee to the country to stay with relatives or strangers which helped to create a “we’re all in this together” type of attitude of which the NHS was a natural consequence. I believe that it is the lack of such an attitude that lays at the heart of our problem in the US with developing a national healthcare system. So where is our team spirit? Given the number of professional team sports in this country I find it surprising that we can be so proud of “Team USA!” and yet fail to recognize that the person on the corner holding the sign “will work for food” is also a member of that team. Don’t teams work together to support and nurture their fellow team members? Without the idea that everyone must rise together how to we improve our systems?

I believe that while progress is slow, more and more Americans are coming to the realization that universal healthcare is both desirable and inevitable. I think this can be seen in the viewpoints of the younger generations who are witnessing the social injustices wrought from the rise of large anti-union companies and the erosion of the middle class and how these factors, among many others, lead to injustices that make it impossible for many people to afford food and a place to live, much less healthcare. The path we forge toward universal healthcare will be our own and will reflect the unique aspects of this country that make it the distinctive place that it is. This path will most likely continue to come in small steps such as the adoption of Medicare Part D and the ACA and while I wish that we could move more quickly to find a way to help more people perhaps the slow way will, in the end, be better. We need look no farther then China, Spain and Ireland to know that having a financially unsustainable healthcare system does us no good in the long run when we then have to rush to correct it later. So here’s hoping that America continues down its slow road to universal healthcare and the eventually discovery of our team spirit.

Wednesday, April 13, 2016

Ethical Considerations in Immunotherapy Clinical Trials

I read an article in Time Magazine recently called “What if your immune system could be taught to kill cancer? Inside the brutally selective, hugely expensive, lifesaving trials of immunotherapy” by Alice Park. This article touched on several topics from class, including drug discovery and development, personalized medicine, and ethics that I’d like to elaborate on and discuss.

The idea of immunotherapy in this article circulates around a treatment known as adoptive T-cell transfer. With this therapy, a patient’s own T-cells are modified in a lab so that that when they are infused back into the patient, they have the ability to identify and attack cancer cells. When you’re talking personalized medicine, it doesn’t get more “personal” than this. The patient who received this treatment from the article was in a phase 1 safety study, and this is not yet approved. Some of the potential side effects include fever, hallucinations, coma, and death.

Patients have to be extremely sick and in most cases, failed all other treatments on the market, before they can try adoptive T-cell transfer. According to the article, this is making some patients very upset. It’s hard enough to endure failing multiple treatments, and to look for a clinical trial as a back-up plan that might improve your condition makes things even more difficult. Every clinical trial has a set of inclusion and exclusion criteria, but as the chief medical officer of the American Society of Clinical Oncology puts it,

“It used to be that if you had lung cancer, you could find a clinical trial for people with advanced lung cancer… Now, advanced lung cancer isn’t enough. You have to have advanced adenocarcinoma lung cancer with an ALK mutation that only occurs in 2% of lung cancers.”

The patient discussed in this article was a man named Mike Hindt. Mike was diagnosed with metastatic pancreatic cancer and qualified to enroll in an immunotherapy trial after failing treatment. He was in the trial for a grand total of six weeks before the drug company, Acerta Pharma, told him he could not continue with it because the lesions on his liver were growing faster than the trial’s protocol. What are people in Mike’s situation left to do?


I don’t personally think that clinical trials should be portrayed as an answer to patients who have failed all other treatments since the goal is to examine the safety and efficacy of a new drug before it is approved for widespread use and it’s possible they won’t qualify. But once you get into a trial – in a situation where there is no other treatment option, is it ok to take away the treatment when it looks promising because the patient doesn’t fit the criteria of the study 100% of the time? Financially it’s a good option, but is it right ethically? I’m not quite sure how to answer this question myself. I think it comes back to the idea of whether or not we believe that health care is a right and not a privilege. Does this patient have a right to receive this treatment? As you can probably guess from my answers in class, I don’t think that he does. However, there’s something about the fact that he already started the treatment and had to stop it that bothers me. We’ll never know if this patient could be saved if he had continued the treatment, but I think it’s a possibility even though over time he did not fit the study’s protocol.