When we last visited it was early in the 2^nd quarter. Now my absent (or possibly heterozygous) “blog gene” has again surfaced and I find myself deep in the 4^th Quarter having not shared the work of POI or my thoughts moving forward with you. However, sometimes things move so fast, I find myself waiting for the final chapter, or at least the “end of the movement”, to take a breath and bring my friends and the family of POI up to date.

We have thrown our hearts, minds and bodies fully into two projects both of which are proceeding in wonderful fashion. Our projects focused on developing a community based model to address preventive health needs (using cervical cancer as our disease target) are progressing well. The PERCAPS project in Manchay and Iquitos Peru is in the follow-up phase and not only was highly successful but helped us think more clearly about our plans to expand the program. We are now in the treatment phase of the first pilot in the CHICAPS project in rural China. Our research team has contributed many new ideas to consider as we try to simplify and streamline the model for the communities to manage. It has been very rewarding for me to witness my colleagues making the transition from controlling all the details as we doctors like to do, towards allowing the community to handle virtually all aspects of the screening process. Ahead on the schedule is a second pilot, followed by a screening “event” for 9000 women. The CHICAPS project also examines secondary screening options for triaging women who test positive, and then treatment using a study arm with cryotherapy vs. the “standard of care” arm of colposcopy/biopsy/LEEP. We are also working on a proposal to reach the 116,000 women between the ages of 30-60 in the Loreto Region of Peru (mostly low and high jungle).  We now believe the rate limiting step is the management of the positives, since screening and determining the results should take no more than 1 month. Intertwined with this work we have completed the development and packaging of our simple self-collection brush “Just for Me”, and will soon have a kit assembled containing the brush, instructions, a solid media specimen transport card and envelope. In addition we will soon be introducing a new direction in HPV testing that we believe will be a “game changer” in terms of processing speed, low cost, accuracy, flexibility and most importantly applicability to virtually anywhere in the world.

Our other project has been all consuming for the POI China coordinator/administrator XinFeng (Steve) Qu and me over the past 6 months. We hope to have a big announcement early in 2012 as POI spreads its wing to embrace cancer prevention strategies for multiple other primary disease sites.

I realize I have left a lot of issues hanging with this blog, but I am very sensitive towards using the proper forum to introduce new science. I also would like to be very sure we are talking about reality not just hopes and dreams. That said I believe for POI the first quarter of 2012 will be a blockbuster so tune in and happy Thanksgiving to everyone.

The Shenzhen Cervical cancer screening trial ,SHENCCAST II, is in an intense writing phase now with our first manuscript published (Am J Clin Pathol 2011;135:790-795), and second one submitted (on self-sampling) and three more currently being prepared. SHENCCAST III, an evaluation of the Cervista 16/18 HPV assay was completed and the study will be presented at Eurogin 2011 in Lisbon Portugal in May. MECCS II, our HPV primary screening study from Mexico also has 2 manuscripts currently in preparation. However, most our time and for sure our energy these first three months has focused on the continuing preparation for PERCAPS – the Peru Cancer Prevention Study, which I am now happy to say is all approved, registered on clinical trials.gov, and on schedule to launch on the 23rd of May. Joining my colleagues from Peru and I will be our good friend Jorge Salmeron from Mexico, who will assume the role as the primary educator and facilitator for the promotoras, clearly the key position in this important project. We are honored to have Jorge on the team. We will also be joined for the PERCAPS project by two MD/MPH research fellows (one a Fogerty fellow from Brown University, and the other a gynecologic oncology fellow from the Cleveland Clinic). We will also have a medical student from Case Western Reserve University with us for her summer project. Our education mission continues to be strong.

The Peru project, PERCAPS (A Mother, Child, Screen, Treat, and Vaccinate Program) will likely run a few months ahead of CHICAPS, the Chinese Cancer Prevention Study. The screening models in these two projects will be our first attempts to develop the community based models we hope can change the way preventive healthcare is managed world-wide.

Medical care world-wide is in a crisis. In the developing world there is a lack of care and too little funding. In the western world we have too much care that has developed from too much funding, both from personal as well as third party sources. In addition in the US we have a distribution problem, since on all of our doorsteps it is not difficult to find signs of America’s 3rd world. The challenges are enormous and I am of the firm belief that the problems are not due to bad, misdirected, greedy, uncaring people, or governments for that matter. Surely there are a few, but the problems at hand are way beyond the damage from a few.

In the developing world many skilled individuals representing a vast array of organizations have literally spent lifetimes trying to reach the needy with their hearts, their energy, and their collective skills. The question in everyone’s mind is “where do we start to bring about truly effective change?” In my opinion there are similar issues that may have a common solution and for now POI will focus on one common conceptual change.
Healthcare reform in the US has been a bloody battle and the struggle ahead may be worse than what we have seen to date. There is of course no shortage of opinions, and as you might guess after more than 30 years of medical practice I have mine. I, for one, do not believe cutting costs for current services, and paying a small percentage of even regulated fixed fees, is the answer. To some extent it may be necessary but it will not solve the problem. Doctors are working very hard these days to continue to deliver quality care, yet satisfy all the regulations with the required documentation for compliance. The efforts being mounted by individuals as well as institutions to practice efficiently and safely, and cut costs are quite remarkable. I see it daily when I am home and at the Cleveland Clinic. However, there are simply too many smart physicians, and scientists interacting every minute of the day searching for the next best test or treatment. Everyday new studies are published advancing the practice of medicine. These advances are expensive and both doctors and patients want them. And I am here to tell you that in thirty-five years of practice I have rarely encountered a physician who did not want to do the best he or she could for their patients. Proposals and legislation that are in effect roadblocks to progress simply never work. That is why I strongly believe the right approach is not to cripple what we do well, and not to demoralize the caregivers and the innovators, but to identify those elements than can be removed from the medical model and in fact will work better on the outside. To that end POI now pursues the development of a new preventive healthcare model.

An enormous amount of the healthcare dollar is spent identifying who is needs medical care and who does not. We hope by using our expertise with cervical cancer screening, we can develop a preventive healthcare model using cervical cancer prevention as the target medical intervention. We fully expect that many other cancer prevention strategies, some that currently exist and some just peeking around the corner of clinical application, will follow and easily move into our model. We will focus on using a community based participatory research orientation, building the bonds and relationships that will allow us to hand the power to the communities and let them take ownership for those elements of healthcare that in my opinion they will do better, i.e. more efficiently, cheaper, and in vastly larger numbers. This will allow the health infrastructure to direct its finances, knowledge, and energy toward those individuals identified as needing the medical model as it was intended, to heal. There certainly are doctors among us who have made a living doing cancer screening. For some their skills and technology will still be needed, but some may have to re-tool and change their focus. At this point in my life and the life of POI, I know it is immensely easier to develop systems where you have little or none to tear down. For now, that is the world POI chooses to live and work in, but hopefully our outcomes will reach our expectations and the developed world will find some pertinent solutions in our work.

So let’s get going, wish us well!

Jerry Belinson, Cleveland, Ohio, April 22, 2011

This past quarter started as you can see from the homepage with an amazing few days as guest of the Chinese government to receive the Friendship Award. Although the well-rehearsed protocols were in full evidence, I and the other 49 awardees from 18 foreign countries were treated like kings. The Friendship award is the highest honor China bestows on a foreigner and there was no question all of us recognized the specialness of the occasion. I met some amazing people from around the world with widely diverse contribution to China from oil exploration to roses, from cultural preservation to astrophysics. Most of all I felt very proud for POI and the recognition of our work and the work of all of our Chinese collaborators who truly shared in the recognition.

The SHENCCAST II trial which finished this summer has now moved to the writing phase. Our first manuscript “A Population Based Clinical Trial Comparing Endocervical High-Risk HPV Testing using Hybrid Capture II and Cervista from the SHENCCAST II Study”, has been accepted for publication by the American Journal of Clinical Pathology. Several more papers are being prepared. In addition SHENCCAST II provided important pieces to the self-collection story that in large part has charted our new direction.

Many years ago upon taking my first job at the University of Vermont, my wise chairman Dr Leon Mann told me to pick a focus. I remember him saying the focus will continue to grow and new doors will open. Well the energy at POI these days is like the birth of a child. After years of studying new technologies, and designing ways to improve the old, we have now decided to focus our energies developing methods so the people most in need can actually take advantage of the technologies that we now have. Not an easy task, but therein lies the mission of POI. No one ever described this work as easy. I can tell you it is so rewarding, and so self-fulfilling that if it were not so difficult the streets of discovery would be very crowded indeed.

A number of concepts have become progressively clearer to me as we work our way down our new path. First, I now believe it is not necessary to think simple and small to reach the earths needy. Certainly one size will not fit all, but a very high percentage of the world’s medically underserved now live in middle income countries. That says to me think high tech, high through put and the massive volumes possible with proper organization will control the per/patient cost. Second, think events, not continuous care. The medical model has always been a continuous care model. Designing the whole program to avoid lost to follow-up when only very few may actually need continuing care. Clearly continuing care is the only way to adequately provide the needed care for many problems. However, many interventions can be confined to events which organize large screening or vaccination days and only when positives are identified from the detection algorithm does the healthcare staff become involved for management. Third, for many conditions, we spend an enormous amount of the healthcare dollar identifying the majority of people who will ultimately test negative. We need to consider new paradigms to allow the healthcare workers to focus on the positives. Fourth, the more local the paradigms and the more involved the community in designing the program, the greater will be the participation and the lost to follow-up segment will shrink.

There are many gaps to fill, but we have enough filled to begin. Therefore in the 1st quarter of 2011 we expect to initiate a mother, child, screen, treat and vaccinate program in Manchay and Iquitos Peru. The primary focus will be the development of a preventive healthcare model using community based participatory research methodology. By the 2nd quarter in 2011 we hope to initiate a program with a similar primary focus in China, with the added elements to determine optimal management of the women who test positive. I personally have never seen the future so clearly. We obviously continue to work hard to generate the funding to allow us to continue this work. The message we believe is very compelling. We have the technology to prevent cervical cancer world-wide, now let’s develop the model to make it happen. The solution is more than money; it will be a well-designed, well-organized community based model that brings the people and the technology together.

Happy holidays to all of our friends around the world, we are a community.

International Talent Feature

Help Chinese Women Keep Cervical Cancer at Bay

English translation

A decent job with handsome salary and compensation is the goal of most ordinary people. However, to high level experts, their pursuits go far beyond a decent and well-paying job.

When they reach certain living standards, they will quit their jobs and go to poverty-stricken areas or the third world countries, to serve the local people, thus realizing their own worth. They believe it’s the true meaning of personal success, and it’s the kind of life they want.

And Dr. Jerome Belinson is one of them.

Jerome Belinson, President of POI, Professor of Gynecology, and former consultant to the Bill Gates Foundation “START Project Through The Program For Appropriate Technology In Health(PATH)”, to relieve the numerous patients in developing countries from pain, Dr. Belinson retired two years ahead of schedule and gave up his superior position, to explore for feasible ways for cervical screening in China, India, and Mexico. Dr. Belinson and his team’s researches have brought good news to countless patients.

Recently, their researches have made important breakthroughs. According to their design, in the future, women will be able to do self sampling for cervical cancer as easy as doing an early pregnancy test. The procedures are as follows: After a woman does her self sampling,she will send the sample to a hospital, to be tested for the possibility of cervical cancer. Women are spared of the original complex processes. Meanwhile, doctors do not have to spend a tremendous amount of time collecting samples. They can focus on the treatment for patients. Such a model (self-sampling) makes it possible to conduct cervical cancer screening in remote rural areas, and breaks new ground for global cervical cancer treatment.

The design for this solution has been completed. Fund-raising has accumulated half of the targeted amount. What needs to be done next is to raise the remaining half, through the concerted efforts of parties involved, so that the 10,000 experimental screening and the improvement of the designed plan can be funded. When a plan has been finalized, further steps will be taken for implementation.

Dr. Belinson says, “We believe that when we say “Our technology advantages are prominent and feasible.It’s time that we found a way to apply the technology to more people. Now is the time to do that.”

Seeking Partnership. Breaking New Ground In China

Dr. Belinson’s friendship with China dates back to many years ago.

In 1996, Dr. Belinson learned through a report that the prevalence and mortality rate of women with cervical cancer is 10-20 times than in developed countries. As a gynecologic oncology expert, Dr. Belinson knows that such high prevalence of cervical cancer, means in China, a country with over one billion people, there’re 130,000 women who have cervical cancer. Every year, 20,000-30,000 women will die of cervical cancer. Cervical cancer can be prevented by having regular screening and an early diagnosis. Such amazing data left an impression on Dr. Belinson. As a renowned gynecologic oncology expert, Dr. Belinson decided to utilize his influence in gynecologic oncology to promote cervical cancer screening in China and to contribute to lowering the prevalence of cervical cancer and mortality rate of Chinese women who have cervical cancer. In 1998, Dr. Belinson came to China and started a 12-year journey for cervical cancer prevention, treatment and research in China.

Dr. Belinson’s research is focused on the new technologies of preventing cervical cancer, and aims at providing feasible screening methods in the poorer countries and regions, and providing cervical cancer screening to women who have never had the opportunity for screening before.

Dr. Belinson believes that poor and less developed regions have a higher prevalence of cervical cancer. Regions with high prevalence of cervical cancer need cervical cancer screening the most, and can work as a pilot project for screening all over China. With that in mind, Dr. Belinson started to seek co-operation opportunities with Chinese experts.

At that time, researcher Qiao Youlin from Chinese Academy of Medical Sciences co-operated with American researches on esophagus cancer and lung cancer. After two years’ preparation and planning, Dr. Belinson came to China for the first time, and started co-operation with Qiao Youlin on cervical cancer prevention and treatment in China. With the funding raised by Dr. Belinson from the international community, Dr. Belinson and Qiao Youlin used international state-of-the-art technologies to conduct “Cervical Cancer Screening” for a great number of women, which set the precedent of using advanced technology for cervical cancer screening in China.

After many years’ efforts, the situation regarding cervical cancer in China has improved. Currently, in the urban areas of China, the prevalence rate and death rate of cervical cancer are quite close to those in the US. However, the prevalence rate and death rate of cervical cancer are still very high in the rural areas of China. Women living in the villages of China and India account for a large portion of the prevalence and death cases of cervical cancer of the world.

Given the circumstances, Dr. Belinson resolved to develop an easy and practical technology, for cervical cancer screening in the poverty-stricken and less developed regions.

Founding POI

To seek an economical and effective screening solution for cervical cancer, which will provide women in poverty-stricken areas access to timely screening, Dr. Belinson and his colleagues have conducted a tremendous amount of exhaustive research on the sensitivity and differentiation of various screening technologies. To advance the research, Dr. Belinson joined hands with world renowned experts in multiple disciplines and built a specialized organization – POI (Preventive Oncology International, POI). The mission of POI is to conduct cervical cancer prevention and treatment researches aimed at developing countries, and to meet the humanitarian needs of cervical cancer prevention and treatment.

After the establishment of POI, POI has completed 12 major cervical cancer screening projects in China. The screening subjects came from unscreened women in poverty-stricken areas and the poor areas in cities.

In 2007, Dr. Belinson got to know a Chinese gynecology expert Dr. Wu Ruifang, who commented, “He’s an extraordinary leader in the cervical cancer prevention initiatives in China. And he’s also the only person I know who sleeps less than me.”

For the project with Peking University Shenzhen Hospital, POI, headed by Dr. Belinson, invested 3.5 million USD for project funding, and 1.5 million USD for equipments and materials. More than 32,000 women participated directly in the project screening, about 150,000 people benefited from the project indirectly. In addition, Dr. Belinson trained and nurtured a highly capable team of researchers for cervical cancer prevention and treatment in Shenzhen. More than 100 researchers were trained by him directly. During the project with Oncology Hospital of Chinese Academy of Sciences, Dr. Belinson personally treated 970 women.

“Chinese samples tested in China”

Dr. Belinson adheres to the principle of “testing Chinese samples in China”, which results in the introduction of various international advanced testing technologies for cervical cancer to China.
Dr. Belinson’s work in China has always emphasized mass screening, so that more people can benefit. Besides, definite goals are set, to stay alert to the pathological changes and canceration before the cervical cancer, and to save more lives. Meanwhile, he came up with a simple and easy-to-implement treatment solution for pathological changes before the cervical cancer, enabling the patients to get treatment more easily. For all projects, Dr. Belinson was the project manager and principal technical expert, and he devised project implementation plans for each project. During the implementation of each project, he visited the project location and trained staff in person. He also managed project procedures, sampling and data processing directly, to ensure the scientific value and accuracy of the research results.

Economical and not wasteful.

To ensure that the raised fund is used on the Chinese women in need, Dr. Belinson has always been economical and does not allow waste or unreasonable expenses.

Ever since the project was started in China, Dr. Belinson has always adhered to the principle of “lowering costs to the largest extent, and spending every penny on the people in need.”, a principle he set forth when he founded POI. Dr. Belinson practices what he preaches, and has high standards for himself. He has always traveled economy class on international flights and does not waste money on traveling. His work schedule is always full. Each long haul flight makes him very tired, but he works indefatigably so that more women in poor areas can have access to cervical cancer screening.

During a project in Guizhou, Dr. Belinson injured his back because of long distance traveling. To get to five screening locations, he still had to surmount a couple of mountains. And the roads were extremely bumpy. The project members saw his pain and wanted to hire a taxi for him, he refused adamantly. He insisted on traveling together with other project members on the bus. At each screening location, no matter how harsh the conditions were, Dr. Belinson stayed in the same hotel and ate the same food as other project members, and has never asked for any special treatment. What he did touched the project members and many local women who participated in the project.

Dr. Belinson awarded the 2010 “China Friendship Award” by the Chinese government.

In September 2010, Dr. Belinson was awarded the highest honor for foreign experts -”China Friendship Award” by the Chinese government. In his award-receiving speech, he thanked Chen Yun, Wu Ruifang, Cai Zhiming, Qu Xinfeng, Yang Bin, Qiao Youlin and other Chinese friends who have worked with him. He said,”Winning the China Friendship Award” is a recognition of POI and the work done by all of my Chinese colleagues. The significance of our work is not limited to implementing the project itself. Personally, I sincerely hope that the award will attract more attention from all walks of life to the significance of our work, and attract various forms of support that we need to implement prevention and treatment for cervical cancer, including charity donations and project funding support.”

He suggested that, to better support foreign experts, China make public the fields and circumstances in which foreign experts will receive support from the Chinese government. In this way, foreign experts will know, under what circumstances, they can use government support to realize their objectives. For example, if air pollution is pressing issue in China, the government can post the information on the Internet, to seek help from foreign experts. When foreign experts see the information, they can contact relevant authorities, and present their solutions and plans, which will be evaluated by relevant authorities based on China’s needs. Problem solving is accelerated in this way. In this way, the government can go beyond giving out awards to achievements. Instead, the government gives support to the project from the beginning, which is undoubtedly a good model for co-operation.

In closing, he said, “Although I have worked full-time in gynecologic oncology treatment and research for more than 30 years, my work in the Chinese areas that have shortage of medical resources are the highlight of my career. I’d like to take this opportunity to extend my heart-felt thanks to my colleagues at Cleveland Clinic and partners, who have always supported my notion of “global community” and provided me support whenever I needed it, and left comfortable working conditions behind to work with me side by side, and helped me with their excellent expertise and experience.”

Renowned Clinician and Researcher Jerome L. Belinson, M.D., receives China’s highest honor for foreign experts. He was recognized for his cancer detection and prevention efforts in rural china

Jerome L. Belinson, M.D., professor of surgery in Cleveland Clinic Lerner College of Medicine and founding director of Preventive Oncology International , Inc. (POI), received the prestigious Friendship Award today from the People’s Republic of China. C hinese Vice Premier Zhang Dejiang recognized Dr. Belinson in a ceremony during this year’s National Day celebrations in Beijing.

The Friendship Award, established in 1991, is China’s highest award given to a foreign expert who has made outstanding contributions to China’s economic and social progress.

For more than 14 years, Dr. Belinson has worked to bring gynecologic cancer screening integrated with clinical trials to rural China, an area of the world with a high prevalence of female cancers. Through his efforts and the work of his POI colleagues, almost 40,000 women who participated in the studies received screening for cervical cancer, often for the only time in their lives. Dr. Belinson and his team have been recognized for their careful adherence to human values and the proper conduct of studies involving human subjects in the Third World.

“After more than 30 years in the full-time practice of gynecologic oncology, my work in China has been the highlight of my professional life,” said Dr. Belinson. “Our mission is far from done, and it is my sincere hope that this award will draw attention to the continuing need for support for our efforts.”

Dr. Belinson’s initial study, The Shanxi Province Cervical Cancer Screening Study (SPOCCS I), continues to serve as a model for study design in epidemiology courses around the world. SPOCCS II and SPOCCS III have also been completed, providing data on self-sampling technologies, a better understanding of false negative and false positive visual screening and diagnostic tests, and the epidemiology of the HPV virus in China.

In addition to the multiple scientific contributions, the SPOCCS studies have also resulted in the 1 st approval of liquid based cytology and HPV testing in China, numerous educational sessions and international exchanges for Chinese physicians. The Chinese collaborators who began their work with Dr. Belinson have now established a cervical cancer consortium throughout China, and they have developed collaborations between Chinese researchers and the World Health Organization and the Gates Foundation.

“Cleveland Clinic is proud to be able to call Dr. Belinson one of our own. His work has brought valuable gynecologic cancer detection and prevention information and services to women in a part of the world where there is a tremendous need for care,” said Joseph Hahn, M.D., Chief of Staff at Cleveland Clinic. “Through his efforts, Dr. Belinson has also opened the door for clinicians both here and around the world to take an active role in public health initiatives that will have a lasting impact on women’s health.”

In addition to expanding his work into other regions of China and exploring preventive strategies for other types of cancers, Dr. Belinson is currently initiating large projects in the Peruvian jungle. He will also be bringing his research skills back to Northeast Ohio for a project in East Cleveland designed to study cancer prevention strategies in underserved populations.

Dr. Belinson is the former chair of the Department of Obstetrics and Gynecology and is currently a consultant to the Department and the OB/GYN & Women’s Health Institute at Cleveland Clinic. He is the founding director of Preventive Oncology International, Inc., a research organization that blends humanitarian work with investigative science.

So  it comes as no surprise to me, but I am sure not the case to some POI staff or supporters, that it has taken almost 4 months for me to return to the blog page. I even had to contact our webmaster for a refresher course. I never realized I was heterozygous or possibly absent my blog gene. Well fighting through this bit of inheritance, let me bring you up to date.

When we last spoke I identified for you our recent revelation that our work with self-sampling combined with high through-put technology that had high analytical sensitivity for HPV, resulted in very high clinical sensitivity. I also said that I now wanted to change our primary focus to try to develop methods to allow us to actually use the amazing technology that many of our colleagues in industry had developed. To that end let me tell you about two recent developments.

First, several weeks ago POI was notified that our proposed study “The Development of a “Mother/Child, Screen, Treat and Vaccinate Program” in Diverse High Risk Environments in Peru” had been funded by Merck, Inc.  I was personally thrilled by this news for many reasons. Most importantly, I believe it is validation from a great company with a history of innovation. They too recognize, that unless we develop effective healthcare delivery systems, the remarkable diagnostic and therapeutic advances of our day will never reach their potential in changing the human condition. For this project we will ultimately head to Iquitos in the Peruvian jungle to try to develop our community based healthcare model in one of the world’s more challenging environments. We will link the care for the mothers’ with that of their children and in doing so set the stage for a health education and delivery model able to be expanded to multiple other preventive medical strategies.

I recently returned from China where I participated in an event that best translated from the Chinese is “study identification”. The SHENCCAST II trial, a 10,000 women screening study of a new self-sampling technology, two new HPV assay technologies, and a new computer assisted cytology diagnostic system (funded by Hologic Inc., POI, and the Shenzhen Female doctors Assoc.), was presented to the governmental health officials from the city of Shenzhen, and Guangdong Province. In addition, there was present a panel of real experts who discussed the work after it was presented, voted on its worthiness, and then was charged with making a recommendation to the government whether this project should be “identified” as a foundation project for future government funding. With all the days, weeks and months I have spent in China, this was a new experience for me. I went from feeling very casual about the event, to hearing my colleagues from Peking University Shenzhen Hospital grilled as if from a “thesis committee”. My casual manner quickly shifted to heightened attention as I became acutely aware of the thoroughness of this review. The questions were well conceived, they were important, and I became increasingly proud of our Chinese collaborators who had grown immensely as investigators with this project. The experts then left the room for about 1 hour for a private discussion, returning to the conference room with everyone on their edge of their seats. The moment had come, the room filled with our scientific group, the expert panel, government officials, and many other interested physicians went totally silent as the committee chairman reviewed the rules and then summarized their recommendations. The result was overwhelming approval, but there was an unexpected bonus. The government officials found the self-sampling data so compelling, discussions begin immediately and continued for the next few days among our research group focusing on our next project. Fortunately, I had already written a concept protocol, we had discussed it among ourselves during a prior visit, and we were totally poised to swiftly take advantage of the opportunity.

So now we are moving forward with further development of the community based healthcare model I currently believe so strongly is a key to changing the face of cervical cancer and many other preventable diseases world-wide. However my original 1^st study of 5,500 has now grown to 10,000 and it is part of a 50,000 – 80,000 woman proposal that we believe will have strong government support. The funding is not by any means complete but we will get there, we must, this step is just too important.

POI has had a great last 12-18 months with 3 large studies now winding down in China and in Mexico. We are very excited about our future, but at the same time nervous, because as one study finishes the process of generating new funding based our results begins. However this time something unanticipated has happened. First let me provide a bit of background.

Cervical cancer screening beginning more than 60 years ago was cytology based. Then with the revelation that HPV was the necessary cause of the disease the focus turned to HPV for screening. Our work and the work of many others has clearly demonstrated the strength of testing for the presence of high-risk types of HPV in a primary screening role. Unfortunately most of these new technologies have been correctly identified as too expensive for a large portion of the world’s underserved environments where the overwhelming majority of the cervical cancer occurs. Very low tech, low resource demanding technologies then became the focus, including a big effort to develop a fast, inexpensive, low tech HPV test. The focus of the problem, to reach the world’s low resource populations, a be able to screen and treat in one visit so as to not lose patients to follow-up. As you might imagine some compromises were made (such as in test sensitivity and through-put) to allow these results. All good in my opinion, and very laudable.

Over the past 14 years we have been focusing on self-sampling for HPV, which up to now has always fell 8-15% behind a direct sample (health provider obtained) in sensitivity. During our SPOCCS III trial we discovered that self-sampling with PCR based technology was as sensitive as a direct sample. Now in SHENCCAST II we have demonstrated it is possible to combine self-sampling with a very high through-put technology (5000 samples/day) at a very low per/patient cost. Suddenly we realized that if one does the math, screening massive numbers of patients quickly makes the initial cost of high-end, high through-put technology, not very expensive when viewing the entire program. We are now ready to explore making the communities the focus with strong community involvement in the planning and implementing of the screening algorithm. Using a community based participatory research model the focus will be advance education, registration, training in self-sampling and specimen transport to a central testing site. We believe by moving caregivers rather than patients, and completing the screening, triage, and treatment phases quickly, problems of lost to follow-up and sustainability will be re-defined.

So now we have our direction defined, we have of sites identified and our protocols written to provide care and advance the science. We have some identified partners for this next journey and continue to look for more. We are moving quickly now in the world of cervical cancer control, and I could not be more excited.