Flagship Project on Precision Medicine

March 1, 2016
Flagship Project on Precision Medicine for Underserved Women Will Advance Learning Health System

Washington, D.C. – On February 25th , President Obama participated in a panel discussion at the White House Precision Medicine Summit Initiative (PMI), marking the one year anniversary. The panel featured remarks from inspiring patients, researchers and others working in the PMI field.

More than 40 private-sector organizations and a variety of federal agencies are making commitments to new actions and principles that are spearheading the Precision Medicine Initiative. One such flagship project, “Precision Medicine for Underserved Women with Polycystic Ovary Syndrome (PCOS),” aims to align precision medicine with the vision embodied by the Learning Health System (LHS) Core Values. The PCOS genetic disorder causes infertility that eventually ends up in a disease state of diabetes, heart disease or cancer creating an enormous cost to the healthcare system.

The Learning Health Community, a grassroots, multi-stakeholder movement aimed at transforming our nation’s health system into one that is capable of engendering learning from every experience of every consenting patient, and rapidly feeding back lessons learned to empower better decisions that improve people’s health.

President Obama said, “The (PMI) goal is to create a common database of ultimately a million people that is diverse. Ultimately we can take a disease that may be rare and start seeing patterns we may not have seen before.”

Marc Wine, a supporter of the LHS – Precision Medicine PCOS Project and participant in Learning Health Community initiatives, who attended the summit hosted by the president said, “One goal is to seek collaboration with underserved communities in genomics, open data and integrative medicine. This will result in engaging individual patients in ways that will move them from dependency on fragmented healthcare to the point where patients can use their own evidence-based genetic information to make the very best health decisions.”

The Precision Medicine PCOS Project is aimed at developing a protocol for women with PCOS while employing an integrative medicine approach to treatment based on the participant’s molecular makeup, clinical data and available scientific knowledge.

The PMI includes ongoing efforts through the Department of Veterans Affairs (VA), the Department of Defense (DOD), the Food and Drug Administration (FDA), the Office of the National Coordinator for Health IT and the Office for Civil Rights, all in line with Vice President Biden’s Cancer Moon-shot initiative.

“The LHS is the fabric that weaves together and enables various use cases aimed at improving health including precision medicine, Patient-Centered Outcomes Research (PCOR), public health surveillance, patient engagement, quality improvement, patient safety, and further uses not yet envisioned,” said Joshua C. Rubin, JD, MBA, MPH, MPP, a leader in the LHS movement.

The LHS vision has been the subject of over 16 reports of the Institute of Medicine since 2007, and now represents the pinnacle goal of federal health IT strategic planning for the coming decade.

Through aligning the LHS – Precision Medicine PCOS project with this larger vision, the project team is working to ensure that infrastructure and key components created to advance this flagship project will support future use cases.

The Precision Medicine PCOS Project was recently launched in Atlanta at Medici Medical Arts Clinic, with Chief Medical Officer, Dr. Sonny Dosanjh and a group of 37 women who have PCOS, a complex and chronic syndrome that affects 7 million women in America. Ten of these initial women will form the Patient Advisory Team resulting in ongoing involvement in systems design, learning and education systems and participating in the use of their molecular data. This provides unique involvement so women with PCOS will have access to not only their data, but also how the clinical support and care is delivered individually.

By building such efforts upon a sturdy foundation of Learning Health Systems “Core Values,” this Precision Medicine PCOS Project will collaboratively build the big data, Artificial Intelligence infrastructure large enough to include all individuals and populations through open knowledge sharing.

The Precision Medicine PCOS Project with LHS, aligning with the president’s PMI and the underserved, has taken the initiative to launch its innovation in Atlanta, phasing-in a large cohort of women with PCOS which is the number one cause of infertility in women. As a complicated endocrine and metabolic disease, PCOS has received limited attention by the medical community.

Of the estimated 7 million women with PCOS, less than 0.1% of the NIH budget is focused on research to help these women. This Precision Medicine PCOS Project was started in December 2015 and may be the largest ever project to use state of the art genetic and molecular research, science, evidence-based integrative medicine and technology to help this growing underserved community of women.

The Precision Medicine PCOS Project is acting to build a nationwide collaborative to empower women with PCOS to manage this complex genetic disease throughout their lifetime.

The project’s leader and Founder of Open Source Health, Inc., Sonya Satveit, said, “As women, we have been underserved in healthcare for too long, if I can make a difference, I have accomplished my life-long dream. To have such an incredible team, that shares my passion, come together around this critically underserved area of women’s health, gives me confidence that we will make a difference and give hope to women with genetically caused infertility. “ The project expects to see the first results in late 2016.

For more information see:
Open Source Health, Inc.: http://opensourcehealth.com/
Learning Health Community: http://www.learninghealth.org
The White House Precision Medicine Summit: https://www.whitehouse.gov/blog/2016/02/25/precision-medicine-health-care-tailored-you

New Pharmaceutical Warnings Placed on Proton Pump Inhibitors (PPIs)

Greetings!

This month’s Pharmaceutical Alert highlights the ongoing problems with PPIs, the Proton Pump Inhibitors. We wrote to you about the problems with these drugs more than a year ago, and finally the FDA is taking action, issuing a Warning Alert. We hope you will read through the following story and then take the appropriate action.

 drgersh

Sincerely,
Felice L. Gersh, M.D.
Medical Director
Integrative Medical Group of Irvine

FDA Warning Alert on Proton Pump Inhibitors

The FDA issued a warning alert yesterday, Wednesday, February 8th, that the risk of serious intestinal infections is increased in persons using the class of nexiumdrugs known as proton pump inhibitors. These include Nexium, Prevacid, Prilosec (Omeprazole), Aciphex, Protonix, and Dexilant. The increased risk involves the development of diarrhea due to Clostridium difficile. This is particularly worrisome, since new strains of this bacteria are both more virulent and anti-biotic resistant than were previous ones. The bacteria is also more widely dispersed than before, so exposure is far more likely. C. difficileinfection is a potentially life-threatening event.The warning comes after a review of data from the agency’s Adverse Event Reporting System (see below). Medical literature has suggested such a link for quite some time, as indicated by a meta-analysis reported at the 2010 meeting of the American College of Gastroenterology. pillsPPIs block nearly all production of stomach acid. Although stomach acid has been vilified by the pharmaceutical companies, it is actually essential for the proper digestion and absorption of food nutrients. In addition, it protects the body from infections caused by pathogenic bacteria carried on the food we eat.At IMGI, we have been talking about the dangers of PPIs for several years and have successfully weaned many of our patients off these drugs.

FDA Warnings

Less than a year ago, the FDA issued several other warnings concerning this class of pharmaceuticals and declared that fully 70% of patients placed on these medications were done so inappropriately. prilosecPPIs are associated with osteoporosis, Vitamin B12 deficiency, severe total body magnesium deficiency, and other nutrient deficiencies. Additionally, they are associated with higher levels of pneumonia and the development of gastrointestinal dysfunctions. Barrett’s Esophagus, considered a significant risk factor for esophageal cancer, is actually not reduced by these drugs, as the elimination of stomach acid does nothing to decrease the reflux problem and the fluids, minus the acid, which continue to reflux can be damaging to the esophagus.

What should you do?

One should never, ever just stop taking these drugs. Because of the severe reduction in stomach acid, the body compensates by putting out great quantities of the hormone gastrin in an attempt to stimulate the stomach into making more of the necessary acid. If the drug is suddenly stopped, the high quantities of this hormone will stimulate huge amounts of acid to be produced, resulting in great discomfort. Additionally, there are a small number of people who should not be taken off these medications or have never had their symptoms properly diagnosed.

Dr. Yoojin LeeDr. Gersh has been extensively trained in all aspects of this important medical condition at her Integrative Fellowship at the University of Arizona. She works closely in this with Dr. Lee, our expert naturopathic doctor, whose training focused in great detail on the function and therapies of the digestive system. In addition, we have teamed with a highly qualified gastroenterologist who will be available to perform upper GI endoscopies when clinically indicated prior to the weaning-off process. Once a patient is off these dangerous drugs, we can offer many natural and safe ways to alleviate, or even eliminate, heartburn, gastritis, and other such conditions.Please share this information with your many friends and family who are using these medications. And if you are interested in getting off of your drug, please contact the office.

Adverse Event Reporting System

The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products. Participation in this system is voluntary for doctors, patients and hospitals. For more information on AERS, click here.