Blog

The High Cost of Drug Development and its Impact on Neglected Diseases in the Underdeveloped World

stc63 : November 28, 2011 9:35 am : Salubrion

Advances in biomedical technology have revolutionized the pharmaceutical industry’s ability to design therapeutics to treat disease. However, these advances also saw a significant increase in the costs of research and development that are balanced by similar increases in the costs of drugs on the market. The high cost of drug development has many impacts on global health with the end result of preferential delegation of more resources to high profit, long term drugs rather than toward the development of therapies for neglected and infectious diseases that cause high mortality and morbidity among much of the underdeveloped world.

Many factors contribute to the rising cost of drugs. The decision to pursue the development of a new drug is often a gamble, with lengthy and costly research and no guarantee of any viable results. Research and development decisions have long-term ramifications for the economic health of a company and are subject to market and governmental policy changes. First phase research consists largely of investigative work into potential targets and understanding the biochemical basis behind diseases. Chemical compounds are then developed either naturally or synthetically for the target1. Research then focuses on the pharmacokinetics of the chemical, how it affects the body, and any potential side effects. Testing begins first in tissue cultures, then animals, and eventually to human volunteers before seeking approval by the FDA. The entire process, on average, takes 7-10 years with an estimated cost of $802 million2. If approved, further expenses are needed to market the drug to healthcare providers and the general public.

As a result, pharmaceutical companies are more likely to spend on diseases that offer significant financial return in high-income countries. Diseases such as malaria, leishmaniasis, lymphatic filariasis, and dengue continue to plague the less-developed world but drug development for these diseases has been largely ignored. The World Health Organization believes this is due to three factors: failure to use existing tools effectively, inadequate or nonexistent tools, and insufficient knowledge of the disease3. Many of the drugs used to treat tropical diseases are also outdated, remnants of a time when development of tropical pharmacopoeia was driven by imperialism in the early 20th century3. It is estimated that drugs for cardiovascular and central-nervous system diseases account for 35% of the worldwide sales and 28% of new chemical entities with a combined expense of around $35 billion. In contrast, less than $70 million was spent on development for malaria, tuberculosis, leishmaniasis, and African trypanosomiasis combined3. Furthermore, 68% of new chemical entities that hit the market present little or no therapeutic gain when compared to drugs already on the market while no significant increase in the number of drugs delivered or improvement in the degree of innovation can be seen in tropical diseases3.

Thus, the competitive nature of the drug industry and the high cost of drug development have been used to justify the lack of research into diseases of the poor and the high prices of current drugs on the market. Diseases in developing countries represent too small of a market share for the private sector to invest in research and development on diseases in these countries. In 1983, the United States passed the Organ Drug Act, a measure designed to grant market exclusivity and intellectual property protection to companies who market drugs for rare diseases3. However, this act still suffers from the same market-driven logic and constraints; that is, companies are encouraged to make drugs for success in the United States, rather than in countries affected by rare or neglected diseases. Orphan-type legislation has been largely unsuccessful and is unlikely to encourage more research into tropical diseases. While there has been some debate into giving further market incentives to pharmaceutical companies to develop drugs for neglected diseases, the high costs and risk of drug research has largely impeded this approach.

A shift is needed in pharmaceutical drug research to tackle the largely ignored problems of these diseases in the developing world. 97% of pharmaceutical research and development occurs in developed countries, causing a wide disparity in the resources available for countries affected by these neglected diseases to undertake research and development3. As a result, organizations such as the United Nations Development Programme and the Drugs for Neglected Diseases Working Group have been encouraging local research and development to generate the pharmaceutical capacity to tackle the diseases in the countries themselves3. These organizations have been largely focused on building and technology transfer and promoting bilateral and multilateral development cooperation to accommodate and offer economic support as well as economic growth in these countries3. The Drugs for Neglected Diseases Working Group has also been exploring the idea of an international non-profit project to research neglected diseases, thus eliminating the market-driven logic behind the process of drug development3.

 

References:

 

1. Ogbru, Omudhome and Marks, Jay. “Why Drugs Cost So Much.” MedicineNet.com. 9 Feb 2002. Web. 19 Nov. 2011. < http://www.medicinenet.com/script/main/art.asp?articlekey=18892>

2. Adams, C.P., and Brantner, V.V. “Estimating the Cost of New Drug Development: Is It Really $802 Million?” Health Affairs, 25, no. 2(2006) 420-428. Web. 19 Nov. 2011. < http://content.healthaffairs.org.proxy.library.cornell.edu/content/25/2/420.full>

3. Trouiler, P., Olliaro P., Torreele E., Orbinski, J., Laing, R., Ford, N. “Drug development for neglected diseases: a deficient market and a public-health policy failure.” The Lancet 2006; 359(9324): 2188-2194. 22 June 2002. Web. < http://www.sciencedirect.com.proxy.library.cornell.edu/science/article/pii/S0140673602090967#ref_bib24>

 

Leave a response »

World Pneumonia Day

kms299 : November 15, 2011 11:27 am : Blog, Salubrion

This upcoming Saturday, November 12th, is World Pneumonia Day. While pneumonia is looked at as common and easily preventable/treatable in the United States, it causes more deaths than any other infectious disease in the rest of the world. Every 20 seconds, a child dies from pneumonia somewhere in the world. In respect to World Pneumonia Day and in order to increase awareness, here are a few facts everyone should know about pneumonia and its global impact.

 

What is Pneumonia?

Pneumonia is an infection that affects the lungs. Small sacs called alveoli usually fill up with air when a person breathes, but in someone with pneumonia, these alveoli are filled with pus and fluid. Pneumonia can be caused by either viruses or bacteria and can cause mild to severe illness in people of all ages. It does affect children under 5 years of age and adults 65+ more severely than other groups, as well as those with underlying medical conditions such as diabetes or HIV/AIDS. People who smoke or have asthma are also at higher risk of getting pneumonia. Symptoms of pneumonia can include coughing, fever, fatigue, nausea, vomiting, rapid breathing, shortness of breath, chills, or chest pain.1

 

How is it Spread?

You develop pneumonia when bacteria or viruses living in your nose, mouth, sinuses, or the environment get into your lungs. You can catch these bacteria or viruses from another infected person, whether they are sick or not.  Pneumonia may develop after being sick with influenza or respiratory syncytial viruses. There are also two types of pneumonia – community acquired (when you develop pneumonia without having been in a hospital or other healthcare facility recently) and healthcare-associated (when you likely got the infection during or following a healthcare facility stay).1

 

How is it Prevented?

Pneumonia can be prevented with vaccines that prevent infection by bacteria or viruses that can cause the infection. Practicing good hygiene and avoiding smoking can also help.1

 

What is its Global Impact?

Pneumonia is responsible for more than one and a half million deaths in children under the age of 5 each year. It is the most deadly infectious disease for children globally (even more so than AIDS, malaria, and tuberculosis combined), accounting for 18% of all child deaths.2 While it can be treated effectively with antibiotics and antivirals, only about 30% of infected children receive the care they need. Also, 85% of the burden is centered in South Asia and sub-Saharan Africa.2

 

What is Being Done?

Research has shown that a million child deaths could be avoided each year with proper prevention and treatment of pneumonia. In addition, pneumonia can be prevented with simply interventions and is generally low-cost to treat. In 2009, WHO and UNICEF teamed up to launch GAPP, the Global Action Plan for the Prevention and Control of Pneumonia. GAPP plans to protect children by promoting better hygiene, exclusive breastfeeding, and reducing indoor air pollution; prevent with vaccinations; and treat by increasing access to the best type of care for a particular child – whether community-based or through a healthcare facility.2

 

Citations

1 http://www.cdc.gov/Features/Pneumonia/

2 http://www.who.int/mediacentre/factsheets/fs331/en/index.html

Leave a response »

US Health Care Reform

arb268 : October 31, 2011 11:53 am : Blog, Salubrion

In 2010, USA Today reported that the number of uninsured Americans had risen to 50.7 million. The significance is that one in six U.S. residents lacks access to quality health care.6 Furthermore, this number does not include those that are underinsured  (about 25 million people) or illegal immigrants.3 Our health care system is also one of the most expensive, yet this does not translate into better quality health care. The United States spent 17.6% of its GDP in 2009 on health expenditures.4 Since the 1960’s, the percent of GDP that we have spent on health care has increased exponentially. Individuals and families also spend a large portion of their income on keeping up with the inflation of premiums. From 1999 to 2011, both individual and family premiums have gone up, reaching an average of $5429 for individuals and $15073 per year.5 The struggling economy has also impacted this situation, with high unemployment rates making it harder for middle class Americans to purchase health insurance. So, where does that leave us?

On March 23, 2010, President Barack Obama signed the revolutionary health care bill, also known the Patient Protection and Affordable Care Act, into law.2 The main provisions are as follow2:

  1. Health insurance will be available to every person starting in 2014, regardless of pre-existing conditions.
  2. Medicaid will expand to cover more people, especially non-disabled adults that do not have children.
  3. People won’t be able to get discarded from their health insurance plan just because they fall ill.
  4. Preventive care like immunizations, mammograms, and physicals will become “free,” meaning that no copayment or coinsurance will be needed for preventive services.
  5. A Patient Bill of Rights will be established.
  6. Premiums will be calculated without regard to gender or health condition.
  7. State health insurance marketplaces (similar to Orbitz in scope and capability) will be set up for consumers to shop for health insurance.

Cost-wise, this reform will be beneficial. The cost of the Affordable Care Act over 10 years is estimated around $940 billion, and the Congressional Budget Office estimates that the law will reduce spending by $124 billion over 10 years.2 Small businesses with an equivalent of 25 full-time employees are currently eligible to receive tax credits as a form of relief in order to provide health care to their employees.2 Beginning in 2014, individuals that are under 400% of the Federal Poverty Level, will qualify for tax credits to help them purchase health insurance.7 Another provision that begins in 2014 makes it mandatory for individuals to buy health insurance or pay a fee.7 This is perhaps one of the most controversial parts of the legislation. Although many states have worked to get it repealed, it still remains law. It is a way of spreading risk. It makes it more feasible to provide health care when both the sick and the healthy are paying for health insurance, otherwise people would only purchase health insurance when they became sick.2

 

It is a fact that our health care system has been fragmented and unregulated. Obamacare, as the health care reform law has been come called, is supposed to provide affordable and accessible health care for the masses. Whether you have pre-existing conditions or are poor, the Affordable Care Act has provisions to provide you with the means of receiving health care. Young adults under the age of 26 can remain under their parent’s health insurance policy without needing to be financially dependent, or a full-time student.7 Medicaid will be expanded to cover more people. Medicare will close the “donut hole.” This shift in policy will provide millions of Americans with health insurance. It is not perfect, but it is a good first step in establishing a more equitable health care system.

-JeanPierre

Works Cited:

  1. “Affordable Care Act to help improve care for Medicare beneficiaries.” Department of Health & Human Services. 24 Oct. 2011. Web. 27 Oct. 2011. <http://www.hhs.gov/news/press/2011pres/10/20111024a.html>
  2. Illinois Health Matters. “Illinois Health Matters.” IHM, 2011. Web. 27 Oct. 2011. <http://illinoishealthmatters.org/>
  3. Reinberg, Steven, “25 Million Americans Are ‘Underinsured’,” US News, 10 June 2008. Web. 27 Oct. 2011 <http://health.usnews.com/health-news/family-health/articles/2008/06/10/25-million-americans-are-underinsured>.
  4. The Kaiser Family Foundation, Kaiser Fast Facts. Data Source: Centers for Medicare and Medicaid Services, Office of the Actuary, National Health Statistics Group, available athttp://www.cms.hhs.gov/NationalHealthExpendData/ (see Historical; NHE summary including share of GDP, CY 1960-2006; file nhegdp06.zip), accessed on Oct. 27, 2011, available at http://facts.kff.org/chart.aspx?ch=202.
  5. The Kaiser Family Foundation, Kaiser Fast Facts. Data Source: Kaiser/HRET Survey of Employer-Sponsored Health Benefits, 1999-2011, accessed on Oct.27, 2011, available at http://facts.kff.org/chart.aspx?ch=2281.
  6. Wolf, Richard. “Number of uninsured Americans rises to 50.7 million.” USA Today. 17 Sept. 2010. Web. 27 Oct. 2010. <http://www.usatoday.com/news/nation/2010-09-17-uninsured17_ST_N.htm>
  7. “Young Adults and the Affordable Care Act.” HealthCare.gov, 2011. Web. 27 Oct. 2011. <http://www.healthcare.gov/news/factsheets/2011/08/young-adults.html>

 

 

Leave a response »

The Increasing Threat of Non-Communicable Disease in the Developing World

arb268 : October 23, 2011 3:15 pm : Blog, Salubrion

Global health has been typecast with images of AIDS, malaria, and other infectious diseases. While these diseases are certainly a huge problem, the truth of the matter is that “diseases of the rich” traditionally associated with first world countries such as diabetes, cardiovascular diseases, and cancer are now showing up more and more in developing countries as well; the rise of non-communicable diseases in these countries will impose a double burden on the global health community as both infectious and noninfectious diseases begin to affect the world’s populations1,2. Indeed, It is predicted that by 2020, non-communicable diseases will account for 80% of disease and 7 out of 10 deaths globally1.

 

Evolution of NCDs in developing countries (in million) [1,8,9]
Non-Communicable Diseases Communicable Diseases
+ Maternal + Perinatal
+ Nutritional

Injuries

total
1990 18.7 (47%) 16.6 (42%) 4.2 (11%) 39.5 (100%)
2000 25.0 (56%) 14.6 (33%) 5.0 (11%) 45.0 (100%)
2020 36.6 (69%) 09.0 (17%) 7.4 (14%) 53.0 (100%)

 

Boutayeb and Boutayeb International Journal for Equity in Health 2005 4:2   doi:10.1186/1475-9276-4-2

 

The difficulty with the rise of non-communicable diseases in developing countries involves both prevention and mitigation of risk factors as well as the expensive treatment that is involved once contracted1. Developing countries lack the infrastructure and health-care systems to not only recognize these diseases but also the proper medication and equipment to diagnose and treat them1,3. Once diagnosed, it is often too late for treatment. In Uganda, for example, there is only one cancer treatment center for 34m people with only 4% of all cancer cases formally diagnosed by a medical practictioner3. The country also only has 7 dialysis machines to treat kidney failure3.

Deaths caused wordwide by specific diseases (× 103)
Deaths & %
Disease
2002 [1] 1990 [8]
Ischaemic heart disease 7000 (12.6%) 6260 (12.4%)
Cerebrovascular disease 5400 (09.6%) 4380 (08.7%)
Lower Respiratory Diseases 3700 (06.6%) 4300 (08.5%)
COPD 2700 (04.8%) 2211 (04.4%)
Cancer(all types) 7100 (12.6%) 6200 (11.2%)
Diabetes 3200 (05.6%) 2400 (05.0%)

 

Boutayeb and Boutayeb International Journal for Equity in Health 2005 4:2   doi:10.1186/1475-9276-4-2

 

This puts economic development efforts in these countries in a paradoxical situation: increased wealth and globalization brings many improvements in health, but at the same time, contributes to increasing rates of non-communicable diseases and widening disparities among the poor4. Furthermore, old and new diseases often compound each other. For example, patients with diabetes are three times more likely to contract tuberculosis and HIV patients are more likely to develop cancer and diabetes2. This double strain on treatment coupled with a lack of resources and woefully unprepared health care contributes to a cycle of expensive treatment costs, bringing patients back into poverty and thus exposing them to increased levels of communicable disease3,4.

 

To address these challenges, efforts should be made to improve global cooperation and increased awareness on these issues. The first step will be to bring the attention of policymakers to this problem. The contradiction between spending billions of dollars on communicable diseases but none on non-communicable diseases may actually put patients in more danger2. While efforts should still be made on increasing economic growth and improving infrastructure in these areas, proactive awareness on risky behavior and lifestyles should be stressed. Decreasing the cost of drugs or combining therapeutics into a single medicine could lower costs, expand accessibility, and help control multiple risk factors that lead to better control of both spectra4. Though infectious diseases have often monopolized the attention of international cooperation, the growing threats of non-communicable diseases need to be addressed and may serve as a unique opportunity to unite high, middle, and low income countries in a common purpose3.

 

References

1. Boutayeb, Abdesslam and Boutayeb, Saber. “The burden of non communicable diseases in developing countries. International Journal for Equity in Health 2005, 4:2. <http://www.equityhealthj.com/content/4/1/2>

2. “Noncommunicable diseases now biggest killers.” World Health Organization Media Centre. 19. May 2008. Web. 23 Oct. 2011.  <http://www.who.int/mediacentre/news/releases/2008/pr14/en/index.html>

3. “Growing pains.” The Economist. 24 Sept. 2011. Web. 23 Oct. 2011. <http://www.economist.com/node/21530099>

4. Venkat Narayan, K.M., Ali, M.K., B., Ch., and Koplan, J.P. “Global Noncommunicable Diseases-Where Worlds Meet. New England Journal of Medicine 2010; 363: 1196-1198. 23 Sept. 2010. Web. 23 Oct. 2011. < http://www.nejm.org/doi/full/10.1056/NEJMp1002024 >

Leave a response »

Infant and Child Deaths Across the World: An Examination of Neonatal and Child Mortality

jmh547 : October 11, 2011 2:41 pm : Blog, Salubrion

Since 1990, the number of neonatal and child deaths before the age of five has greatly been reduced. It has reduced around 28% from 1990 to 2008 and the number of deaths for children under five has reduced from 12.5 million to 8.8 million. The main causes of deaths in children ranges from various neonatal causes to other diseases like pneumonia, diarrhea, malaria, and AIDS.

The reduction of child deaths goes in accordance with the UN’s millennium goal—2/3 reductions of child and infant deaths between 1990 and 2015. Although much ground has been gained, the rate hasn’t been dramatic enough. Many of the deaths that have occurred could have been prevented with better funding. With a more substantial budget, low income countries may have been able to better fund preventative measures such as antibiotics for respiratory infections, immunizations, insecticidal mosquito nets, and drugs for malaria.

The highest rates of child deaths occurs in sub-Saharan Africa. The child mortality rate of children before the age of five is one in seven and 33 out of the 34 countries that still have infant mortality rates above 10% are all in sub-Saharan Africa (Afghanistan represents the 34th country in this category). This rate of child deaths is catalyzed by this poor access to adequate treatment accompanied by high levels of fertility (Reduce Child Mortality).

Although the percentages of deaths occurring in children under five has decreased, the proportion of neonatal period deaths has increased. Neonatal mortality is defined as death within the first 28 days of death. These rates of neonatal mortality have grown in eight countries, with five of those located in Africa. Globally, 41% of the deaths in kids under five occur in the neonatal period. Within this 41%, around half of the neonatal deaths occur in one of these five countries: China, Congo, India, Nigeria, and Pakistan (Latest Frontier).

% Change in Neonatal Deaths from 1990-2009.

Neonatal deaths are even a problem in the United States. According to a new analysis by the Public Library of Science, the U.S. now ranks 41st in neonatal mortality rates. Although the neonatal mortality rate in the US has decreased since 1990, it has decreased at a slower rate than some of its counterparts and is higher than in 117 other countries, including all of Western Europe, Cuba and Slovakia.

In industrialized nations, the leading cause of neonatal deaths is Sudden Infant Death Syndrome (SIDS). Many babies that die from SIDS have poor health conditions from the beginning of life, such as low birth weight or premature birth. Some infants that die from SIDS also have impaired brain functioning, such as low levels of serotonin. However, the most prevalent correlating factor is simply the way that babies sleep. Babies that sleep on their stomach have a much greater chance of dying from SIDS. However in 1992, during a “Back to Sleep” public health campaign, the American Academy of Pediatrics recommended that babies sleep on their backs to reduce the occurrence of SIDS. Since then, the rates have dropped (Rethinking SIDS).

Infant Back Sleeping Rates vs. SIDS death rate from ’92 to ‘08

Neonatal and childhood mortality is still a prevalent issue today in international health. Although great strides have been taken to reduce these rates of mortality, there still remains much work to be done, especially in areas like sub-Saharan Africa. Many organizations like the UN and the World Health Organization (WHO) are working to combat this problem and globally reduce the rates of neonatal and childhood deaths.

 

Works Referenced:

Berk, Laura E. “Chapter 3: Prenatal Development.” Infants and Children: Prenatal through Middle Childhood. Boston: Pearson/Allyn and Bacon, 2008. Print.

Hensley, Scott. “Latest Frontier In Reducing Childhood Mortality: Neonatal Deaths : Shots – Health Blog : NPR.” NPR : National Public Radio : News & Analysis, World, US, Music & Arts : NPR. 31 Aug. 2011. Web. 10 Oct. 2011. <http://www.npr.org/blogs/health/2011/08/31/140086085/latest-frontier-in-reducing-childhood-mortality-neonatal-deaths>.

Hsu, Andrea. “Rethinking SIDS: Many Deaths No Longer A Mystery : NPR.” NPR : National Public Radio : News & Analysis, World, US, Music & Arts : NPR. 15 July 2011. Web. 10 Oct. 2011. <http://www.npr.org/2011/07/15/137859024/rethinking-sids-many-deaths-no-longer-a-mystery>.

“United Nations Millennium Development Goals.” Welcome to the United Nations: It’s Your World. United Nations. Web. 10 Oct. 2011. <http://www.un.org/millenniumgoals/childhealth.shtml>.

1 Comment »

“Contagion”

kms299 : October 3, 2011 7:28 pm : Salubrion

If you follow movies, you may have noticed global health making an appearance on the big screen in Steven Soderbergh’s “Contagion” in the past few weeks. The action-thriller follows the outbreak of a deadly, fictional (yet totally plausible) virus as it spreads like wildfire across the globe. While similar to movies in the past, “Contagion” stands out with an extremely realistic and well-researched plot line that emphasizes not only the scientific race to stop the virus, but also the terrifying fear and social hysteria that could result from a pandemic. Ultimately, it possesses the ability to make any global health-lover giddy with excitement.

The movie opens with Beth Emhoff (Gwyneth Paltrow) coughing in a Chicago airport on her way home from Hong Kong to her young son and husband Mitch (Matt Damon). By the following evening, Beth is dead. What follows is a montage of the same thing happening in Hong Kong and London as new clusters of infection begin to show up on the map. Soon, the Centers for Disease Control (CDC) is alerted and begins to track the virus. CDC investigator Dr. Erin Mears (Kate Winslet) heads to Minneapolis to investigate Emhoff’s death and other new city cases, while World Health Organization investigator Dr. Leonora Orantes (Marion Cotillard) is sent to China to begin tracing the roots of the virus. In the mean time, CDC doctors Ally Hextall (Jennifer Ehle) and David Eisenberg (Demitri Martin) begin to search for a vaccine. And on top of all of this, blogger Alan Krumwiede begins to report on the story, feeding the paranoia of the public. The race to stop the hypothetical MEV-1 virus (which is based on the Malaysian Nipah, Chinese SARS, H1N1, and  Kitwit Ebola outbreaks) is on.1

What happens next is a well-crafted balance of all the stories into one fact-paced, serious plot that will leave you wishing you could take a bath in hand sanitizer. Not only do we see the struggle of CDC and WHO scientists to track down the virus and find a vaccine that works (and a sensible way to distribute it), but we also see what could be the scariest part of a pandemic: mass hysteria. As the news leaks into the public, society begins to crumble. The movie recognizes the struggles and failures of government and science as they rush to control the pandemic while also portraying what happens when the media gets involved.1

Following the release of the movie, CNN sat down with Laurie Garrett, a senior fellow for global health at the Council of Foreign Relations and also one of three scientific consultants to Warner Bros. Garrett was consulted early in the writing process about how to make the movie the most realistic and explains in this article what she was thinking during the process. To her, the movie needed to “demonstrate that disease threats in the 21st century are global threats, but the world lacks an appropriate system of governance and trade to permit a genuinely equitable response.”2 What the audience gets to see is “the best rendition of events likely to unfold in such a pandemic as can be estimated, based on how governments, public health leaders, scientists, drug companies, communities, law enforcement, and international agencies have responded to recent outbreaks of less virulent germs,” according to Garrett.2

“Contagion” is obviously well-researched and horrifyingly plausible. Despite little bits of Hollywood thrown in, the plot line and scientific details will satisfy your inner-nerd while completely freaking you out (just watch people try to avoid touching the doors on the way out of the theater!). And if you love global health, you will be riveted and left wondering, “What if?”

 

1http://www.cnn.com/2011/09/13/opinion/garrett-contagion-virus/index.html?hpt=hp_c1

2http://collider.com/contagion-review/113947/

Leave a response »
« Page 1 »