Increase in Generic Drug Prices

Dr. Einterz said something that really resonated with me last Monday. He said that even his practice at Eskenazi Health impacted global health. Global health is, of course, a global issue. What happens in the United States also affects what happens in other countries. Successful changes to our health care system may also be implemented abroad. Changes to the pharmaceutical industry in the United States impact the pharmaceutical industry of the entire world. This is especially true due to the fact that the United States manufactures and consumes the majority of the pharmaceuticals of the world. The power of the pharmaceutical industry in the United States is exemplified in the article on transnational corporations we read in class.

Recently, an article in the New York Times addressed the rising cost of generic drugs:

http://www.nytimes.com/2014/10/08/business/officials-question-the-rising-costs-of-generic-drugs.html?_r=0

It explains that in the last year, generic drug prices have increased over 1000%. Because of this, federal officials are investigating why. The increase in drug prices means that more taxpayer money is being spent on Medicare and Medicaid. The article mentions that one example of this is doxycycline, an antibiotic that has been used for many years. It has increased from $20 to $1849 for a bottle of 500 pills. There are many reasons why this may have occurred. One reason is that the one of the ingredients may be in short supply, so it costs the drug company more to make the medicine. Another reason is that other companies who had been making the drug stopped. This would have decreased competition, allowing pharmaceutical companies to charge however much they wanted for the essential medication.

The article also mentions a questionable business practice called “pay for delay.” This is where brand name manufacturers pay generic manufacturers to keep the generic drug off the market longer so that they may extend their time of exclusivity. When I interned at Perrigo, a generic manufacturer, they explained to me the importance of being “first to file.” This is an incentive to be the quickest generic manufacturer to file for approval by the FDA for a new generic drug. They race to be “first to file” with other generic manufacturers in order to gain exclusive marketing rights for the first year. This is a huge incentive for pharmaceutical generic drug manufacturers to get their drugs onto market. They begin working on the generic drug right when a brand drug enters the market.

There are also laws in place for generic drug manufacturers to charge the lowest price to the government. If they do not, they owe the government however much extra they charged the government in cash. While this law may help reduce the number of health care dollars spent on Medicare and Medicaid, it is not enough. There should be more laws in place to keep generic drug manufacturers from participating in business practices such as “pay for delay.” “Pay for delay” would be an example of how neo-liberalism can provide a disincentive to innovation. Laws must be in place to address situations where neo-liberalism fails.

Ready to Use Therapeutic Foods

The first five years of life are a time of major development, growth, and weight gain for children. If a child has lasting improper intake it can lead to many short term and long term complications later in life. In the short-term malnourished children have growth and immune complications, and in the longer term are more likely to more growth and cognitive complications. In 2012, 162 million children under 5 years of age were stunted, 56% of all stunted children lived in Asia and 36% in Africa. 99 million children under five years of age were underweight, 51 million children were wasted, and 17 million were classified as severely wasted. These conditions can lead to some severe nutritional diseases and issues, including acute malnutrition.

Acute malnutrition is caused by decreased food consumption and/or illness that cause sudden weight loss or edema. Checking for signs of underweight, stunting, or wasting diagnoses acute malnutrition. There are three common types of malnutrition: marasmus, kwashiorhor, and marasmic-kwashiorkor.

• Marasmus: is the most common form of acute malnutrition in nutritional emergencies and in its severe form, can very quickly lead to death if untreated. It is characterized by severe wasting of fat and muscle which the body breaks down to make energy. Wasting can affect both children and adults. The body of a wasted child tries to conserve as more energy as possible by reducing activity and growth, and limiting body processes. Can be moderate or severe cases.
• Kwashiorkor: characterized by bilateral pitting oedema in the lower legs and feet which as it progresses becomes more generalized to the arms, hands, and face. All cases of kwashiorkor are classified as severe acute malnutrition. Clinical signs of kwashiorkor include loss of appetite, apathy/irritability, changes in hair color (yellow/orange), and dermatosis
• Marasmic-Kwashiorkor: characterized by the presence of both wasting and bilateral pitting oedema.

Today undernutrition is still a leading cause of death of young children throughout the world. For infants and children under the age of two, the consequences of undernutrition are particularly severe, often irreversible, and reach far into the future. However evidence shows that the right nutrition during the first 1,000 days or 2 years of life can save more than one million lives each year, reduce the human and economic burden of tuberculosis, malaria, and HIV/AIDS, reduce risk of developing non-communicable diseases, improve individuals educational achievement and earning potential, and increase countries GDP.

            So how dowe make this happen? Ensure that mothers and the young get necessary vitamins and minerals, promote good nutrition practices, and treating malnourished and under-nourished children with ready-to-use therapeutic foods (RUTF). 

So what is a ready-to-useTherapeutic food? RUFT’s are high-energy, lipid-based spreads used in any cultural setting for the treatment of severe acute malnutrition. Designed to provide the same nutritional profile as F100 therapeutic milk. RUFT may be the sole source of food, except water and/or breast milk during period of use. They have a shelf-life of two years and delivers 520 to 550 calories per 100 grams of product. Therapeutic foods are usually have a long shelf-stability, do not need to be mixed with water, heat, or kept cold or hot. These foods also can be kept “fresh” or safe longer.

Nutriset, a French company, founded by Michel Lescanne, was the first company to develop Ready to Use Therapeutic Foods; which is now the gold standard for treatment of malnutrition and have been endorsed by all international nutrition leaders. Lescanne goal was to invent, produce and make accessible solutions for the treatment and prevention of malnutrition, thereby contributing to the nutritional autonomy of developing countries. In 1996, Nutriset revolutionized the management of severe acute malnutrition (SAM) around the world by developing Plumpy’Nut®, the first ready-to-use therapeutic food (RUTF) which made it possible for children and adults with SAM to receive home-based, medically supervised treatment instead of being treated in a hospital setting. This made it possible to increase the number of children receiving treatment and has significantly improved the recovery rate. With was revolutionary because this was the first product created for the treatment of malnutrition without constraints of needing clean water, refrigeration, and in-patient medical supervision.

Ebola and Quarantine

Governments all over the world are concerned about the health of their people especially with the advent of the Ebola Crisis in West Africa. Every nation is vigilant and some countries have trained personnel to respond in case of any eventual outbreak in their territories. Committees are formed to investigate and measures are put in place to monitor anyone returning from the Ebola Zone. Countries like China and Britain even had simulations to test their abilities to cope with an outbreak. At the onset of the Ebola crisis, Liberia shut down public services for three days as a measure to restrict movement or just quarantine people in general to avoid uncontrollable widespread of the virus. However these measures of quarantine or shutting down the whole government apparatuses to a standstill has economic toll on people and businesses: food shortages, rising prices, social isolation etc….

Nigeria’s success story of controlling the spread of the Ebola virus is a result of those draconic measures taken by government agencies to quarantine the first case, that of the infected Liberian civil servant that arrived in Lagos late August for a conference. Though, the virus claimed seven documented lives mostly the medics, it is amazing how Africa’s most populous country chalked that success. The lesson to learn in my opinion is to understand that Nigeria’s control over the spread of the virus could be attributable to the quarantines.

We also heard in the News of an infected Spanish nurse that returned to Madrid and was quickly quarantined by Spanish authorities to avoid the spread of the virus. So far there are no known new cases in Spain except for the woman’s husband, dog and others who she might have come into contact with and those people are being monitored at close range.

A UN official infected in Liberia and sent to Germany is also put in isolation or quarantine and undergoing treatment. Dr. Iris Minde, Head of Leipzig St. George Clinic said “as a result of the quarantine, there is no danger of infection for relatives, visitors or the public”.

It seems like quarantine approach is the easiest way to nations are able to monitor people who came into contact with infected people or the virus itself. The United States, having reported one Ebola death, have also taken quarantine measures to control a widespread of the disease. A few days ago, Governors of some States like New York and New Jersey have requested for stricter measures to quarantine returnees or anyone coming from the Ebola hot Zones into those States. However, there are numerous protests about this policy as it is claimed not to be scientifically proven that quarantine is the remedy to widespread. Scientists believe that anyone in contact with virus could be contagious if their viral load in bodily fluid is high. Based on this understanding of the nature of transmission of the disease, Doctors and other medics who volunteered in West Africa and are now returning to the US find it difficult to adhere to the new quarantine policy. Who knows if those returnees even developed immunity to the virus? Shouldn’t their blood or plasma sample be collected rather for research purposes? Draconic quarantine approaches worked in places like Nigeria, Liberia, Spain with symptomatic people, and the question is should those same measures be applied to asymptomatic returnees to the US or elsewhere?

 

 Retrieved: October 28, 2014, http://www.nejm.org/doi/full/10.1056/NEJMe1413139

Ebola Brings Salience to Global Health Issues

The spread of Ebola virus disease (EVD) has enthralled the United States. Major media publications, internet blogs (like this one!), experts and lay people alike tuned into the development of the conditions in west Africa and even more acutely to those here at home. This media attention provides an opportunity for global health issues discussed in this class to get more attention from the general public than they normally would. This attention from the general public, in turn, opens a window of opportunity for members of the global health community (or people who care enough to read this blog) to engage laypeople in discussion about global health issues. I would like to present some media articles that touch on topics discussed in this course, if only to provide evidence of how salient global health is at this particular date. Whether the attention is merited outside of instances when of endemic diseases spread beyond their border is a separate issue, and I do not plan on discussing that question.

Ebola Vaccine, Ready for Test, Sat on the Shelf, Denise Grady, New York Times, Oct. 23

An Ebola vaccine developed a decade ago and shown to be successful in primates never begins human testing. The market for a vaccine that prevents a disease endemic to resource-poor nations may not have a market to support sales of a drug that cost $1 billion to $1.5 billion to develop.

“There’s never been a big market for Ebola vaccines,” said Thomas W. Geisbert, an Ebola expert here at the University of Texas Medical Branch in Galveston, and one of the developers of the vaccine that worked so well in monkeys. “So big pharma, who are they going to sell it to?” Dr. Geisbert added: “It takes a crisis sometimes to get people talking. ‘O.K. We’ve got to do something here.’ ”

Now three vaccines are entering stages of human testing. Investment in completing the development of an EVD vaccine a decade ago would surely have saved much of the nearly $600 million spent thus far on attempting to control the spread of EVD, a number that will continue to rise as the year continues on. Monetary concerns aside, it would have prevented immeasurable human suffering and angst across the globe. Issues of pharmaceuticals and global health prioritization readily present themselves in the article.

Nurse quarantined in New Jersey after returning from Ebola mission is released, Abby Ohleiser and Cecilia Kang, The Washington Post, Oct. 27

Discussions of stigma and social determinants of health were prevalent in our Oct 27th seminar, including a discussion about the stigmas facing health care workers who treat infectious diseases such as EVD or HIV. A Doctors Without Borders nurse who had recently returned from treating symptomatic Ebola patients in Sierra Leone was detained by the State of New Jersey after arriving at Newark Liberty International Airport with a fever of 101 degrees F and held in quarantine until her symptoms had subsided for a full 24 hours. Since released, Kaci Hickox spoke to the media while in quarantine about her feelings on how she was treated and how other returning health care workers may be treated:

Still in isolation, Hickox fears colleagues will meet the same fate. “I had spent a month watching children die, alone. I had witnessed human tragedy unfold before my eyes. I had tried to help when much of the world has looked on and done nothing,” she wrote for the Dallas Morning News. “I sat alone in the isolation tent and thought of many colleagues who will return home to America and face the same ordeal. Will they be made to feel like criminals and prisoners?”

Although allowed to leave the state to travel to Maine, Hickox is still subject to quarantine if she returns to New Jersey. So what happens now? If more states with international airports adopt similar policies, could we expect a decline in volunteerism to travel to west Africa? The uncertainty of freely being allowed to travel home is, in my eyes, a possible outcome that any volunteers will have to take into consideration. In a country that believes in personal agency and widely approves of management by experts, how can a policy such as this even be enacted? How will this episode affect Kaci Hickox personally and professionally? Upon her return to her family and workplace, she may have to navigate through conversations about how she practices healthcare, risky behaviors, her political leanings (she directly challenged New Jersey Gov. Chris Christie) and potentially undesired media attention.

The protocol in New Jersey extends past people who are EVD symptomatic to anyone they have come into contact with as well. If you were faced with extended quarantine and public knowledge you may have come into contact with a deadly disease, would you report yourself to the state or seek medical care in your home state?

Ebola has brought the challenge of "health for all" into a new context and the obstacles to achieving that goal into focus here in the States. Perhaps we can leverage this attention to gain ground in the fight for "health for all" through asking ourselves and colleagues questions about global health issues and values, and participating in the Ebola discussion.

Every Newborn Action Plan

            To go along with our topic of discussion last week, maternal and child health, I discovered the "Every Newborn Action Plan" that is being implemented worldwide in order to reduce newborn deaths. The main goal of this plan is to make a significant reduction in neonatal mortality rates because they seem to be lagging behind the maternal, infant, and child mortality rates. According to the Every Newborn Action Plan website, we have the resources as well as the education and knowledge to prevent 2/3 of the neonatal deaths that occur. One of the important objectives of this action plan is to " provide everyone with a roadmap and joint action platform for the reduction of preventable newborn mortality".  The aim is to allow policy makers to hasten national plans that will allow achievable and purposeful results for newborn mortality rates. In the process, there will be targets, objectives, visions, and recommended tactical actions that will help implement the strategies in the action plan.

            This action plan is partnered up with the Global Strategy for Women's and Children's Health as well as the Every Women Every Child movement. There are also several other partnerships with global health organizations such as UNICEF and the World Health Organization. In order to make this plan feasible, there has to be some sort of prioritization towards the issue. As seen in the Millennium Development Goals, the idea of neonatal mortality specifically wasn't addressed as an issue. The Every Newborn Action Plan sees this as a problem because of the slow rate of improvement in neonatal mortality rates compared to under-5 deaths and maternal deaths. There are currently numerous evidence-based solutions, interventions and approaches that exist to reasonably and appropriately address this issue, so there is really no reason why it shouldn't be dealt with.

            A statement about the vision of this action plan, as proposed on the website, states that, " The action plan sets out a vision of a world in which there are no preventable deaths of newborns or stillbirths, where every pregnancy is wanted, every birth celebrated, and women, babies and children survive, thrive and reach their full potential".  The website for the Every Newborn Action Plan talks about how over 3 million newborn lives could be saved each year if their plan is implemented and the targets are reached. There are 5 strategic objectives that are addressed in the plan:

1. 1.     Strengthen and invest in care during labor, birth and the first day and week of life
2. 2.     Improve the quality of maternal and newborn care
3. 3.     Reach every women and newborn to reduce inequities
4. 4.     Harness the power of parents, families and communities
5. 5.     Count every newborn through measurement, program-tracking and accountability

             These all have specific rationales that are explained even further in the action plan. I have attached it at the bottom if any of you are interested to read into it more! It is definitely a different take to maternal and child health and is worth taking into consideration.

References:

http://www.everynewborn.org/Documents/Full-action-plan-EN.pdf

http://www.everynewborn.org/every-newborn-action-plan/

Street Children

            Many people seem to think that homelessness in youth and adolescence is an issue for developing countries. A recent article that I read about homelessness and human trafficking talked about the presence of this in developed countries and how big of a problem that it has become. Human trafficking has become an issue that goes hand in hand with homelessness in youth and adolescence.  In the United States alone, there are 1.7 million homeless adolescents. Most of these youth (roughly 75%) use drugs and have a range of health problems. These people often times have less education, are under-employed or unemployed and make them a prime target for sexual abuse. According to the article, "The National Network for Youth report that the rate of sexual assault on these youth are up to three times higher than the general public. This includes being assaulted on the streets and in shelters".

            One of the most common problems seen with these adolescence is survival sex -- "the exchange of sex for necessities needed to get through the night such as food, shelter, safety, or drugs to ease the discomfort of withdrawal from a particular substance". These people are often sexually abused and their labor is demoralized. In order to stay safe, a lot of these children travel in groups in order to protect themselves. The teens find themselves staying in 24-hour neighborhoods, which are neighborhoods in which the activity level is high so that the large pack of teenagers traveling together doesn't draw negative attention. These often times aren't the best areas to reside because of their prostitution and drug trade issues.

            These homeless children are known around the world as street youth, and worldwide, there are over 100 million of them. The causes of homelessness can greatly differ around the world. For example, in the United States, the more common reasons for homelessness in youth are abuse at home, bullying from peers because of their sexual orientation, poverty, or substance abuse. In other countries, the more common reasons for homelessness in youth are extreme poverty, civil war, parental death from HIV or AIDS, and sometimes natural disasters.

            Back in 1992, the United Nations created the Resolution on the Plight of Street Children, which called for nations to work together to protect the children, specifically from violence and hardship. Numerous developing nations with street children lack the resources that are demanded in order to help these kids, which has mainly resulted in a lack of interest towards the subject matter. 

            Many children express shame and displeasure from the "jobs" that they have to work in order to continue living. A lot of children experience mental illness such as post-traumatic stress disorder from the events that they encounter during their jobs. One of the biggest concerns is to provide these people with the resources and help that they need because of the magnitude of the issue. There is a lot of violence, criminal activity and health related problems associated with these homeless communities and it is time that people become aware of the problem, even in developed countries.

Reference

http://www.fairobserver.com/region/north_america/homeless-youth-the-worlds-100-million-street-children-75309/

Fear, AIDS...and Ebola???

The recent increase in media coverage and concern about the possible spread of the Ebola virus in the United States raises many questions about the role of fear in health communication.  For years, health communicators have been using fear appeals to change behaviors and raise awareness of health issues like HIV/AIDS.  Even though fear appeals continue to be used in messaging, I think there are still many questions and conflicting views about their effectiveness.  When is fear an effective strategy?  When is it inappropriate to use fear to encourage the public to reduce risky  or undesirable behaviors? 

Green and Witte (2006) provide support for the effectiveness of fear appeals.  The study employed fear appeals to reduce risky behaviors associated with HIV/AIDS in Africa.  Interestingly, many experts were opposed to using the same messaging in United States due to a concern with causing reactance.  Green and Witte (2006) argued that, at that time, the use of fear appeals in HIV/AIDS messaging in the United States was discouraged due to concerns of the messages impeding on Americans beliefs about freedom and post-revolution sex values. 

Unlike Green and Witte (2006) which found fear appeals to be effective among individuals living in Africa, other studies like Muthusamy, Levine, and Weber (2009) argue against the use of fear appeals.  Muthusamy, Levine, and Weber (2009) claims that fear appeals are ill advised and ineffective in some situations.  The study employed fear appeals in HIV/AIDS messaging among individuals living in Namibia (Muthusamy, Levine, & Weber, 2009).  Findings suggest that the fear appeals were ineffective when individuals were already experiencing high fear before exposure to the experimental messages (Muthusamy, Levine, & Weber, 2009).

How does the past literature on fear appeals and HIV/AIDS inform decisions and perceptions on the use of fear to encourage individuals to reduce risky behaviors related to Ebola?  Some have gone as far as to draw parallels between the potential threat of Ebola and the global HIV/AIDS epidemic. One of the controversial topics currently being covered by the media is the need to implement travel restrictions for individuals living in the United States who have been exposed to the virus and those traveling from West Africa.  One of the main arguments against such restrictions is that they will increase fear among Americans and cause individuals to start hiding symptoms and not disclosing where they have traveled. 

Hopefully, the virus can be contained.  In the unfortunate, yet conceivable, chance that Ebola continues to spread, what approach should be applied to messaging?  I am sure the answer to this question is not simple.  The problem is complicated and challenging because if messaging does not induce some level of fear, individuals may not feel that they are susceptible.  If fear is heightened by isolating individuals and restricting certain known freedoms, stigmas and negative perceptions may be linked to the virus and individuals suffering from its symptoms.  In short, to be effectively managed, the Ebola threat requires a strategic communication plan that acknowledges all possible consequences and reactions. What are your thoughts?

Aquaculture: Who Knew?!

 This semester in addition to this course, I am also taking an interdepartmental course titled, World Food Problems. In this class we discuss numerous topics (much like International Health) and discuss how these issues and topics affect the food supply and health of all populations. Last week in World Food Problems, we had a guest lecture from the department of agriculture economics at Purdue, Dr. KwamenaQuagrainie, come speak to us about aquaculture. As this was my first exposure to what aquaculture is and it’s impact in developing countries, I thought I would share this topic with you all.

Aquaculture, while often confused with hydroponics, vastly differs from using water to grow land-based plants. Aquaculture is the breeding, rearing, and harvesting of aquatic plants and animals in controlled environments. This process can take place in ponds, raceways, or pens/cages in lakes or oceans.

Pen/Cage Method

Raceway method

Pond Method

• Pond aquaculture is the most common form and is usually found inland or near mangroves. This method requires the removal of dirt and a water source to fill the pond. Most pond aquacultures grow carp, catfish, shrimp, and tilapia. 
• Raceway aquaculture uses the running water of a river or stream to contain and grow the different types of fish. Rainbow trout is the most common fish raised in this condition.
• Pen/cage aquaculture can be found throughout the world and require much more capitol to establish. One benefit of this method is that fish can grow in their natural habitat. Bass, Salmon, and Pompano are the most common fish types grown using the pen/cage method.

Aquaculture is the fast growing food producing sector and currently accounts for 50% of the world’s food fish. It is estimated that by 2030, globally, we will need 400 million tons of fish to feed the population. However, in 2012 we only produced 138 million tons. Currently, Asia is the main producer of aquaculture-raised fish, with China accounting for 63% of all production. The rest of the Asia accounts for 26% of production, leaving the rest of the world claiming only 11% of production.

Aquaculture can be extremely beneficial to the populations and groups of people who use it. One benefit of aquaculture is that it offsets the shortfalls in natural fisheries. This will help us meet the additional food requirements of our growing population. Fish are a great source of nutrition for households, and with the increased supply of fish, more people will be able to add this great source of protein into their diet. Additionally, aquaculture brings in much need opportunities for employment and income. It was estimated that in 2010, 55 million people were connected and engaged in some part of fish production using aquaculture.

While a new area to some students, such as myself, aquaculture is the future of aquatic animal and plant production globally.  Using this method of production more people will have the ability to access and afford fish. Additionally, when this method is introduced into other countries it will have the ability to build the economic, creating increased health outcomes and better quality of life.