Creation of John Paul II Medical Research Institute
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The Catholic Church has a long-standing history in health care, education and medical research. The Church was the first during the Middle Ages to create the university system and medical centers. Some of the early scientists were clergymen like Gregor Mendel, who was one of the fathers of genetics. The Catholic Church has served as the largest non-governmental provider of healthcare in the world. Catholic education and medical care were born out of the social teachings of Jesus to care for the sick and the poor.
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Yet, over the past seventy years there has been a progressive secularization of medical research and healthcare. Prior to World War II, there was no organized government funding of biomedical research. Yet, after WWII the government established a federal grant program through the National Institutes of Health and the National Science Foundation to support academics, basic medical research and education. Secular medical schools took advantage of this federal money and built physical facilities to recruit and train scientists and doctors. In contrast, Catholic medical schools, which were always smaller in number than secular medical centers, maintained their historical emphasis on vocational training on patient care. Consequently, a pervasive level of secular influence permeated into our academic medical centers, governmental institutions and pharmaceutical industries. This has led to abortion; in vitro fertilization; abortifacient medical devices and medicines; and fetal and embryonic stem cell research.
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Since the aforementioned secular institutes now dominate medical research and healthcare, Catholics have experienced decreasing influence in medical research and healthcare and have been treated mostly as outsiders in determining policy. Yet, the Apostolicam Actuositatem, which was decreed by the Second Vatican Council urges the Catholic laity to integrate their faith into their professional life. In the area of healthcare and medical research it is important that the Catholic laity do what it can to influence medical research and healthcare in a fashion that is consistent with the teachings of Jesus Christ.
Notwithstanding the ethical issues surrounding embryonic stem cell and fetal research, there are 4 major challenges in healthcare from my point of view:
1) Currently 75% of the total healthcare cost is directed to chronic diseases. The pharmaceutical industry's approach to addressing chronic diseases is by treating its symptoms and by trying to control the diseases progression. This paradigm does not alter the healthcare cost curve. The only cost effective way of handling chronic disease once a patient gets it is by repairing/regenerating the organs affected by the disease (whether it is neurodegenerative diseases like ALS, Alzheimer's, Parkinson's or whether it is heart disease, diabetes, lung disease, etc.). With our present national deficit and unfunded future liabilities, these problems are only going to get worse and pose a real possibility for healthcare rationing in the future;
2) The pharmaceutical industry's cost and timeline for getting a drug approved now takes over 1 billion dollars and 12-15 years. This substantial cost means that a drug company has a very short window in its patent enforcement period to recoup all of its investment and make a profit. For this reason, pharmaceutical companies are inherently financially bound and driven to keep returning customers that are dependent on their drugs, rather than offering them a cure. Finding a cure possesses an enormous financial and scientific risk that pharma is unwilling to accept. One consequence of drug development is that the cost has become prohibitive for many patients. For example, cancer patients frequently become destitute when they require expensive chemotherapy;
3) The failure rate for developing a successful drug for most diseases is between 80-95%, with cancer and neurological diseases having the highest failure rate;
4) The medical research community is overwhelmingly secular, with most private medical foundations supporting embryonic stem cell research. If the earliest of life is devalued, then there is a slippery slope that this attitude could impact society's compassion towards the sick, poor and disabled.
The people around the world are now just becoming aware of the John Paul II Medical Research Institute (JP2MRI) due to the highly effective and popular ALS ice-bucket challenge. Our website has been flooded with hits and our Institute has received lots of donations, phone calls, emails and media attention. People hearing about JP2MRI for the first time have been asking a variety of questions, including: Who are we and what makes us unique?; What research and diseases does JP2MRI conduct and focus on?; Do we conduct ALS research?; Are we pro-life?
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The JP2MRI was established to create a new paradigm to address these problems with the following objectives:
1) Create a non-profit biotech model focused on decreasing the cost and time for drug development. Our Institute is focused on applied research, not academic research where one publishes articles and faculty get tenure;
2) Focus on developing core technologies and a platform that will address all diseases;
3) Place the majority of our financial resources towards #1 and #2 above;
4) Do this within a pro-life value system.
The Institute focuses on the following areas: 1) neurodegenerative diseases (i.e. ALS, Alzheimer's, Parkinson's, etc.); 2) Cancer; 3) Rare Diseases; and 4) Adult Stem Cell Therapies. We chose these areas because they suffer from serious but common structural challenges. We are able to address these challenges because there are certain things that we do well, perhaps better than anyone else. This includes: (1) recruiting patients; (2) collecting tissue; (3) creating stem cells and primary cancer cells from these patients. These 3 criteria are significant requirements for addressing the aforementioned barriers.
Despite a limited budget, here are some of the Institute's scientific achievements to date:
1) The Institute has helped facilitate the use of commercial adult stem cells for medical research;
2) The Institute has helped facilitate one of the largest repositories of adult stem cells in the world;
3) The Institute has helped facilitate the development of induced pluripotent stem (IPS) cell technology. IPS cell research involves taking a patient's cell and, through genetic manipulation, creating a pluripotent stem cell that has all of the biological features of an embryonic stem cell but without the need to destroy embryos;
4) The Institute helped create technology to convert stem cells into neurological cells;
5) The Institute has been able to show "proof of concept" that by taking stem cells from a rare neurodegenerative disease, one can create an effective "disease in a dish model." These cells growing in a dish can then be subjected to a drug to see how they react and based on that data one can predict successful clinical outcomes. The Institute tested this notion on children with a condition called Niemann Pick Type C, which at the terminal stage of this disease has many of the same clinical features of ALS;
6) The Institute has established a clinical infrastructure that allows us to recruit patients from private centers around the country without the bureaucracy and red tape found in academia and government;
7) Many of the adult stem cells that the Institute has generated have therapeutic potential for ALS and other diseases.
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The Institute never actively went out raising money for ALS research because our research objective was always more broad. The ice-bucket challenge created awareness among pro-life individuals about ALS and the supportive position of the ALS Association towards embryonic stem cell research. With all of attention given to this media phenomenon, pro-life individuals just stumbled across the Institute and decided to give us financial support to conduct research on ALS since we also operated on neurological diseases and did so without using any embryonic stem cells.
With the funding that donors are specifically directing us to use towards ALS research, our objectives will be to scale up our operations and focus more attention to ALS research. The Institute has also received funding to support our research mission towards other diseases like Alzheimer's, Parkinson's disease, cancer and diabetes. The Institute is currently focusing its research efforts in the following manner:
1) Recruit more patients around the globe;
2) Collect clinical data from patients;
3) Create personalized stem cells specific to individual patients;
4) Screen drugs on patient stem cells to find the best lead drug candidates for entering into clinical trials;
5) Manufacture FDA approved adult stem cells that could be approved for clinical trials;
6) Participate in those clinical trials; and
7) Work in collaboration with scientists in academia, government and industry to accomplish these goals.
How much the Institute can accomplish at any time will depend directly on the level of funding that we receive from donors that direct us to research ALS or any other disease. However, an important byproduct of our ALS research efforts and one that separates us from our peers who solely work on ALS, is that the cost of ultimately building the necessary ALS research infrastructure will decrease the cost and time to work on the next disease, since the platform will already have been built.
One can visualize and understand this approach by thinking of a tree, where the trunk represents the infrastructure and platform we are perfecting and the many branches of the tree represent different diseases. The trunk has to first form and grow before the branches form. Thus, the return on investment from ALS research will get amplified to help other diseases as well.
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Alan Moy MD
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