poiinc.org

2011-The First Quarter

jlb — Sat, 30 Apr 2011 00:01:42 +0000

2011- The First Quarter
The first three months of 2011 have been very busy times for POI, filled with a variety of activities filling all the hours available and moving our mission forward. A big event for POI in January was the annual meeting of our board where we always get strokes for our successes, and wise re-direction when it is warranted. I am personally grateful for the wisdom and friendship of the board.
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

The 4th quarter ends a great year and begins a bright future

jlb — Wed, 15 Dec 2010 19:01:24 +0000

Well it is blog time again. The fortune I am blessed with these days is that POI has a lot going on and much has happened over the past few months.
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.
Jerry Belinson

It’s time for the community

jlb — Wed, 08 Sep 2010 20:05:25 +0000

When told some months ago that I would have a blog on the POI website I absorbed the news very slowly and responded politely with a smile. My father could sit in a room for hours amid a circus of conversations and never say a word. His other gear was a lecture lasting anywhere from 30 minutes to 2 hours. He knew a lot, had a lot to share, but he was never a conversationalist. He could not rap. During the last 15-20 years of my parents’ lives which were fortunately free from chronic ills literally until the day their hearts stopped in their 90’s, I remember sitting with them in the living room recognizing all the characteristics in them that I either liked or disliked about myself.

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.

J L Belinson

Writing from Cleveland, Ohio on September 8, 2010

The Future

jlb — Mon, 17 May 2010 03:38:52 +0000

Greetings to everyone, both new and old followers of our work.

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.

JLB writing from Cleveland

Welcome

jlb — Wed, 07 Apr 2010 17:59:33 +0000

Welcome to the POI website. Please take some time to navigate through the pages to gain an understanding of our organization and its mission. We have a history of successful international research, and look forward to continuation of our efforts around the world. Please visit the site often, as I will be posting the latest information about our projects and sharing my thoughts and experiences.