Santa Clara University

STS Nexus

The Swanson Foundation Health Award

Craig Stephens

Introduction

                The most serious challenges facing the majority of the world’s population, who live in poverty in economically underdeveloped nations, were articulated by the United Nations in the Millennium Development Goals in 2000. One of the broad themes of this “blueprint for building a better world” is to improve global public health by focusing on poverty-related issues. The 2007 Health Laureates have brought technological innovation to bear on such issues, including access to safe drinking water, disease prevention and detection in resource-limited settings, and indoor air pollution from cooking fires. Through the dedication of the individuals and organizations we honor here, millions of lives will be saved or improved.

                In 2007, we received 55 applications in the Health category, from 17 countries representing every continent except Antarctica. The majority of the applications came from U.S. based organizations, but nearly all involved international projects. The Laureates demonstrate clearly that technological innovation in the service of humanity is not limited to any particular type of organization. The Diagnostics Development Unit at the University of Cambridge, which develops low-cost diagnostic devices for infectious diseases, is an academic lab working with a start-up company in Silicon Valley. Vaxin, Inc., which is developing a novel vaccine for avian influenza, is also a start-up company based originally on university research. Don O’Neal, who developed a low-cost, highly efficient cooking stove that reduces the incidence of severe burns and virtually eliminates indoor smoke pollution in Guatemalan homes, works with HELPS, a non-profit organization. PATH, a larger non-profit, worked in collaboration with a for-profit company (TempTime) to develop heat-sensitive labels for vaccine vials that monitor vaccine storage conditions to ensure their efficacy. Finally, Proctor and Gamble (P&G), which developed the PUR water treatment system, is a huge, for-profit, consumer products enterprise. Their stories are told here.

Diagnostics Development Unit, University of Cambridge & Diagnostics

for the Real World, U.K.

                Providing high quality medical care in resource-poor regions of the world presents many challenges, including limited availability of trained medical personnel (physicians and nurses), few support facilities (e.g.,  clinical laboratories), and limited funding. Under these circumstances, the ideal diagnostic method is fast, cheap, and simple, and, of course, accurate. The “need for speed” is particularly important when patient contact is infrequent and fleeting. If test results can be obtained quickly at the point of care, while the patient is present, the opportunity to initiate treatment is immediate, reducing chances that a disease will progress, and/or be passed to other victims. Developing new diagnostic tools that meet all of these criteria takes careful thought, and clever design.

At Diagnostics Development Unit, Dr. Helen Lee is up to the challenge. Dr. Lee was in the midst of a successful career in medical research and development at Abbott Laboratories when she decided to change her focus, to apply herself to the development of low-cost diagnostics targeted toward globally underserved populations. She gave up her position at Abbott and moved with three of her staff to the University of Cambridge in the mid-1990’s to set up the Diagnostics Development Unit. Since then, her group has made major strides, including development of a generic signal amplification system to increase the sensitivity of molecular diagnostic tests, a novel urine collection system (First BurstTM) that boosts the ability to detect pathogens in urine, and low-cost, rapid tests for several viruses and bacteria.

                The product, at the most advanced stage of development, detects the bacterium Chlamydia trachomatis, the most common sexually transmitted disease in the U.S.  This pathogen causes two distinct types of infections: an eye disease called trachoma, the leading infectious cause of blindness in the world, and sexually-transmitted genitourinary tract infections with potentially serious consequences in both men and women. Chlamydia infections are fairly easy to cure with antibiotics, but they are difficult to diagnose before significant damage is done. Sensitive methods to detect Chlamydia molecules are marketed by several western companies, but they require clinical labs and are too expensive for widespread application in the developing world.

                Dr. Lee’s group took on the problem, using a unique signal amplification method to produce a sensitive test for Chlamydia in either the genital form, or as trachoma. The test uses a “dipstick” format––a thin strip of paper loaded with antibodies to detect Chlamydia proteins. When dipped into a clinical specimen, an indicator band on the dipstick will change color within 30 minutes if Chlamydia are present. The dipstick test is easy to use; a version has been produced that can be carried out at home, like a pregnancy test. To commercialize the Chlamydia dipstick, Diagnostics for the Real World (Sunnyvale, CA) has been established.  Published trials of the Chlamydia dipstick’s use in Tanzania show that it performs better than a trained ophthalmic nurse in diagnosing trachoma, and nearly as well as the “gold-standard” laboratory test. Given that neither ophthalmic nurses nor laboratory tests for trachoma are routinely available to most Tanzanians, and that over 50% of children are infected in some villages, the Chlamydia dipstick is a major advance toward preventing blindness from trachoma. With respect to genitourinary Chlamydia, progress is being made as well; for example, Doctors Without Borders has used thousands of Chlamydia dipsticks in sexually transmitted disease (STD) programs in several countries. With European regulatory approval already in hand, distribution of Chlamydia kits in wealthier western nations will soon commence. The Cambridge Diagnostics Unit and Diagnostics for the Real World also are moving forward with tests for HIV, hepatitis viruses, and other infectious agents.

For more information, see: http://www.haem.cam.ac.uk/transmed/pages/lee.html. 

Donald O’Neal, U.S.

                Indoor fires are used for cooking in millions of homes around the world, where modern appliances are not affordable or gas or electricity are not readily available. Indoor cooking practices using open fires or inefficient wood-fired stoves have several pitfalls, perhaps the greatest being smoke, which is seldom fully vented to the outside, posing a significant health hazard. The World Health Organization estimates that indoor fires (mostly for cooking, but also for heating and lighting) underlie 2.7% of the global disease burden. That translates into millions of deaths and respiratory illnesses each year, largely in women and children (who spend a larger percentage of time tending cooking fires than men) from inhalation of irritating particulates and toxic combustion products such as carbon monoxide. Indoor air pollution is not the only downside of solid fuel fires. Obtaining the fuel itself can be a major challenge; a family member must either cut wood or scavenge fuel frequently, or the family must pay for it, draining already limited resources. Wood gathering can contribute to deforestation, and may in some cases be outright dangerous, as in the vicinity of refugee camps in areas of conflict. Finally, thousands of children and adults are burned severely each year by cooking-related fires. There is clearly a great need for safer, cleaner burning, more efficient stoves that are affordable in resource-poor settings.

                There is no single answer to this problem. Cooking styles, fuel availability, living arrangements, and cultural sensitivities all factor into the acceptability of a particular design in a particular geographic region. Donald O’Neal, an engineer and businessman working with HELPS International (a non-profit organization providing development assistance in Guatemala), is recognized as a Laureate this year for his role in designing a safe, efficient, and popular stove for Guatemalans. The ONIL stove is made from durable cast-concrete. The combustion chamber is well insulated, greatly reducing the possibility of burns to children, while simultaneously increasing the combustion chamber temperature to increase efficiency. Wood combustion and heat transfer to the cooking surface in this stove are so efficient that 60-70% less firewood is used compared to cooking by the traditional method. Another consequence of efficiency is that the stove produces 50-fold less carbon monoxide, and 100-fold less particulates. Over 40,000 of the ONIL stoves, which cost significantly less than $100, have been distributed in Guatemala. The stoves are currently manufactured in two Guatemalan factories at a rate of 2,000 per month, and a third factory is under construction to fill a backlog of several thousand units. Organizations in several other Central American countries are interested in manufacturing these stoves as well.

You can find out more about the ONIL stove at:  http://www.onilstove.com.

PATH, U.S.

                Large-scale vaccination programs have reduced the global death rate from infectious diseases enormously over the past 50 years. But with few exceptions (e.g., smallpox), disease-causing germs have not been permanently eliminated, so infants and children should be protected by vaccination whenever possible. In wealthier countries, childhood vaccination regimes are nearly universal. In contrast, vaccination programs in poorer nations face many obstacles, even when vaccine procurement is subsidized by international aid. Vaccines are generally perishable biological products. Most are sensitive to both high and low temperatures, and must be kept refrigerated at 2oC–8oC from the time of shipping until use. Failure to maintain the “cold chain” risks inactivation of the vaccine, meaning that inoculated children may not become resistant to the disease the vaccine is designed to target.

                Careful planning must go into “cold chain maintenance” during vaccine distribution, which is far from trivial under the rugged conditions in many developing nations. Transportation can be unreliable, and cartons of vaccine vials can be stuck in transit for days or weeks before being delivered to rural clinics. Once the vaccine has arrived at its intended destination, appropriate refrigeration may not be available as well. Until recently, there was no easy way to determine if a vial had been properly handled. In the 1980’s, PATH (Program for Appropriate Technologies in Health, a non-profit organization based in Seattle) began working on technologies to produce vaccine temperature-sensitive packaging that revealed heat-damage. Considerable funding and effort went into developing “time-temperature indicator” (TTI) packaging for the food and pharmaceutical industries, but until PATH’s intervention, this technology was not being transferred to vaccines.

                Through several different chemistries, TTI packaging is able to achieve the goal of an irreversible chemical reaction that is predictably accelerated by elevated temperature to generate a colored reaction product. 

                PATH’s initial “vaccine vial monitor” (VVM) prototype for measles vaccine (circa 1990) had major limitations that rendered it unacceptable for most other vaccines, especially important but delicate products such as oral polio vaccine. PATH began working with Lifelines Technology on a promising new chemistry. After years of persistent research and development supported by PATH, a robust chemistry was developed into the HeatMarker product line, which includes markers aligned with the temperature-sensitivity profiles of various vaccines that can be printed directly on vaccine vial labels. (HeatMarker labels are a product of TempTime Corporation (New Jersey, U.S.)  the successor to LifeLine Technologies).

                PATH organized field trials of VVMs, and worked closely with the World Health Organization and vaccine manufacturers to encourage widespread adaptation of VVMs. As of 2006, 10 years after the first vaccine batches containing VVMs were distributed; these monitors are required on all major vaccines. Their universal adoption may save thousands of lives each year by ensuring the efficacy of hundreds of millions of vaccine doses.

                For more information, see http://www.path.org/projects/vaccine_vial_monitor.php. 

P&G’s Safe Drinking Water Program, U.S.

                In the U.S., we take it for granted that our tap water is completely safe for drinking, cooking, and bathing. Unfortunately, more than a billion people worldwide lack routine access to clean, safe water for daily use, and over a million children will die this year from diarrheal diseases they acquired from contaminated water. As with cooking stoves, there are many ways to provide safe water. In wealthier nations, most people are served by municipal water supplies in which millions of liters of water per day are subjected to extensive physical and chemical disinfection before being piped to end users. Such large-scale systems require large capital outlays for treatment plants and distribution networks, but serve so many people that the end-cost per person is small and easily affordable. Until such infrastructure is present, the billion people who lack clean water must settle for smaller scale solutions.

                In 2004, Ashok Gadgil was recognized as a Tech Awards Laureate in the Health category for the “UV Waterworks” device, a low-cost village-scale system that uses ultraviolet light for disinfection. This year, we honor Proctor and Gamble (P&G) for the PUR chemically-based water disinfection system. The PUR “Purifier of Water” product is a single-use sachet that produces 10 liters of clean, safe water in less than 30 minutes. The PUR sachet combines alum, which induces flocculation to remove particulates, and chlorine-based disinfection to kill bacteria, parasites, and viruses. The sachet is emptied into 10 liters of water in a bucket and stirred for 5 minutes. The mixture is then filtered through cloth (to trap the coagulated particulates) into a clean bucket, and let stands for 20 minutes to complete the disinfection process. Even when starting with filthy, highly turbid water, the result is safe, clear water for drinking, cooking, and other everyday uses. The cost is approximately $0.10 USD per sachet – a penny per liter. 

                PUR was developed by P&G with global public health benefits in mind. Despite its seeming simplicity, development of PUR as a viable option for water treatment in individual households took several years of research and field testing, before the product’s market debut in 2000. Once on the market, it became apparent that P&G’s traditional approach to marketing would not ensure a profitable future for PUR, despite its public health value. Basically, the consumers most in need of this product had such limited means they were unwilling, or unable, to afford a few cents per liter of water. (This may seem hard to believe in the U.S., where consumers readily pay more than a dollar for less than a liter of commercially bottled water.)

                Rather than drop the product line, P&G decided not to focus solely on profits from PUR. It shifted responsibility for PUR to its Corporate Sustainable Development Office, which created the Children’s Safe Drinking Water (CSDW) Program to manage production and sales of PUR on a non-profit basis. CSDW partnered with Population Services International, a well-established non-profit organization with a global reach, to coordinate marketing and distribution of PUR in developing nations, in conjunction with education programs to raise awareness of the importance of clean water and train people to use the PUR system. Children’s Safe Drinking Water program  is now an undeniable success in the last two years, over 50 million PUR sachets have been distributed, to treat over 500 million liters of water. Most of this has been for routine daily use, but PUR sachets have also been very valuable for disaster relief, helping to provide safe water after tsunamis, hurricanes, and earthquakes disrupt established water treatment systems.

For more information, see http://www.pghsi.com and http://www.csdw.org.

Vaxin, Inc., United States

                Human history is punctuated with massive disease outbreaks, from Black Death in medieval times, to smallpox epidemics when Europeans came to the New World, to the 1918 influenza (“flu”) pandemic. The latter may have killed more than 50 million people worldwide. Of course, hundreds of millions of people globally are infected with the flu every year. On average not more than a few million people (mostly elderly) die from influenza each year because most healthy people fight off the virus and generate immunity after every infection. We also try to stay ahead of the virus with vaccinations for the most vulnerable, but the virus itself is constantly changing. Sometimes (such as in 1918), potent new flu viruses tear through the population–virus strains that are different enough that people lack immunity.

                Where do these strains come from? Influenza viruses that infect humans are closely related to flu viruses that infect other mammals and birds. When people mingle with livestock and domesticated poultry on a large scale, flu viruses adapted to each of these hosts have an opportunity to mix genetically. In a worst case scenario, new viruses are produced that retain the ability to infect humans, but are different enough in their surface molecules that our immune systems cannot effectively deal with them. Such a virus is a recipe for disaster.

                Avian influenza, caused by flu viruses adapted to birds, is a constant threat to the worldwide poultry industry, because the incredibly dense flocks of chickens, turkeys, and ducks found on commercial poultry farms provide perfect conditions for flu to spread rapidly. When an avian flu outbreak strikes a farm, millions of birds in the surrounding area may ultimately need to be culled to stop the spread of the virus. Worse yet, there have been over 300 cases in Asia the past three years of people acquiring avian influenza subtype H5N1. Nearly 200 of those infected have died, indicating that this virus strain has an extraordinarily high mortality rate. Fortunately, these cases seem to have resulted from bird-to-human transmission; there is no evidence yet that H5N1 can move from person-to-person, like a human-adapted flu virus would. But given the known ability of bird flu strains to recombine with human-adapted strains and produce new pandemics, it seems clear that it is in our best economic and public health interests to minimize the spread of avian flu.

                Vaxin, Inc. has developed a new vaccine against bird flu that is effective in chickens and mice. Preliminary data suggests it will also work directly in humans. The Vaxin product uses genes for flu proteins that have been engineered into another virus, an adenovirus that has been modified to grow only in special lab cultured cells. The recombinant virus vaccine induces immunity to avian flu in animals, even though it cannot reproduce outside the lab. This vaccine is especially useful for the poultry industry; it can be administered to chick embryos before the egg hatches, and high-throughput robotic injection of eggs is a very cost-effective way to protect commercial flocks. In humans, the vaccine can be applied as a nasal mist. Manufacturing the vaccine in cell culture, rather than in eggs as is currently done for flu vaccines, allows it to be produced more quickly, and altered more quickly if and when new strains develop. The Vaxin bird flu virus is not yet FDA-approved for use in humans. If this can be accomplished, its potential for use in both birds and humans could provide tremendous benefits to humanity by delaying or mitigating the next flu pandemic.

                For more information, see:  http://www.vaxin.com. 

Conclusion

                Technological innovation can play a major role in achieving the Millennium Development Goals. As we see in the 2007 Health Award Laureates, innovations that can change the world are happening in university labs, in non-profit organizations, and in corporate labs large and small. They happen thanks to visionary scientists and engineers like Helen Lee of Cambridge University, Donald O’Neal of HELPS, De-Chu Tang of Vaxin, and Greg Allgood of Proctor and Gamble, who have worked tirelessly to overcome scientific, technical, social, and financial challenges in the name of improving global healthcare.  

                These Laureates also show that innovative medical technologies need not be epitomized by incredibly sophisticated imaging systems, or miniaturized electronic devices, or sophisticated software. Such technologies can be remarkably powerful and medically valuable, but they are probably also going to be out of reach of most of humanity. To achieve the Millennium Development Goals, technological innovation must help make disease prevention, medical care, and health maintenance accessible and affordable for citizens of every nation, in a way that is sustainable for future generations. Only then will achieving and maintaining health be a realistic goal for all.

 

The Panel

Craig Stephens, Chair, Associate Professor and Chair, Biology Department,
Santa Clara
University

Marie Barry, Consultant, ALZA Corporation

Stephen J. Eglash, President and CEO, Cyrium Technologies

Leilani Miller, Associate Professor of Biology, Santa Clara University

Russ Sampson, President and CEO,
Sierra Surgical Technologies

Jonathan Showstack, Assistant Vice
Chancellor and Co-Chief Information
Officer, Office of Academic and Administrative Information Systems, and Professor of Medicine and Healthy Policy, University of California, San Francisco

Peter Sullivan, Vice President of
Emergency Medicine, California Pacific Medical Care

 

 
About the Author

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Craig Stephens is an Associate Professor of Biology at Santa Clara University, and Chairman of the Department of Biology.  He has a B.S. degree from Roanoke College a Ph.D. in Biology from the University of Virginia, and was a post doctoral scholar in Developmental Biology at Stanford University.  His research program, which is funded by the National Science Foundation focuses on microbial genetics, genomics, and physiology.  He has taught courses on microbiology, biotechnology, and cellular and molecular biology at SCU, was the founding Director of the Biotechnology program, and is a faculty affiliate of the new Bioengineering program.



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