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COVID CRISIS SPURS HEALTHCARE INNOVATIONS

“UCSF Fresno, as a pioneering institution, we asked how we could help in contributing to the science and most importantly by being advocates for the Central Valley and giving patients here early access to treatments that might not be available anywhere

else ” Eyad Almasri, M.D.

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BY ERIN M. KENNEDY

When the human immune system encounters a new pathogen it triggers a response that makes the body faster and more adept in dispatching the threat the next time it arises. External pressure helps muscles and bones grow and strengthen. After mild trauma, brains compensate with functional hyperconnectivity. Healthcare has reacted similarly to the coronavirus crisis, becoming smarter, stronger, more resilient and connected. Local hospitals and medical practitioners have responded to the unprecedented stress and challenges with collaboration and innovation, finding new efficiencies, treatments and ways to reach patients. Telehealth visits exploded, more than 15 clinical trials with area patients helped speed science and local COVID recoveries, and physicians became Central Valley PPE pioneers. “The amount of work that our organization accomplished in (the first) three months is stunning,” said Thomas Utecht, M.D., Community Medical Centers’ Chief Medical & Quality. “In this crisis, things move at hyper speed,” agreed Dr. Jeffrey Thomas, Vice President and Chief Medical & Quality Officer for Community Regional Medical Center. “Things that can take six to seven months normally have come to fruition in weeks. I think any time there’s a crisis, it tends to bring people together to work for the common good.”

Shahzad Jahromi, M.D. Kaiser Permanente Fresno’s Physician in Chief, observed that the pandemic also forced normally bureaucratic organizations to speed up their processes and decision making: “A lot of organizations, including ourselves, can get rid of a lot of red tape.” He marveled at “seeing the collaboration between the hospitals that are typically in competition.”

Kaiser Permanente Fresno reached out in early March to Fresno area hospitals to share a COVID-19 treatment booklet developed by Kaiser Permanente’s regional medical group. Valley Children’s Hospital extended its laboratory resources to Community until it could acquire testing technology in-house during the pandemic’s early days. More recently, California State University Fresno provided sub-zero freezer space until Community could acquire special storage for the COVID-19 vaccine. The university’s freezer, used by the Department of Chemistry and Biochemistry, can reach temperatures of -86 degrees and holds 95,000 vaccine doses.

Hospital staff also noted how great coordination has been with the Fresno County Department of Public Health in tackling the pandemic collaboratively across the region.

“The partnerships and relationship between our public health department has been something we should be really proud of and something that’s the silver lining for me,” Dr. Utecht said. “Hopefully that working relationship will continue whenever the pandemic is over.”

LOCAL RESEARCH HELPED VALLEY PATIENTS GET NEW TREATMENTS EARLY

Relationships forged over decades with the University of California, San Francisco, and the long history of research in the Valley put local patients at the forefront of the newest COVID-19 treatments.

“Between March and the month of May no one had access to remdesivir, but our patients did,” said Eyad Almasri, M.D., who is board certified in Internal Medicine, Pulmonary, Critical Care and Sleep Medicine, and has been on the forefront of COVID-19 treatment research locally. “People in this hospital (Community Regional) had

access to a drug that was later found to help.”

Dr. Almasri, who is Community Regional’s critical care medical director and a UCSF associate clinical professor of medicine, said he had been paying attention to emerging diseases after being involved in 2014 with preparations for possible Ebola patients.

“UCSF Fresno, as a pioneering institution, we asked how we could help in contributing to the science and most importantly by being advocates for the Central Valley and giving patients here early access to treatments that might not be available anywhere else,” Dr. Almasri said.

“So late in March when we saw our first COVID patients, I was already six weeks into talks with Gilead” Dr. Almasri continued. Gilead Sciences is the inventor of the antiviral remdesivir, which was created as a possible treatment for hepatitis and later studied as an Ebola treatment. Dr. Almasri was too late to get into the early phases of the clinical trials, which were double-blinded with patients and doctors not knowing if they were receiving or administering a placebo.

“Gilead called me and said, ‘We have something that is better. We have this Phase 3 Expanded Access program. We think it works and it’s safe so we’re going to give you something right away for your patients,’” Dr. Almasri described how the Community Regional was able to get remdesivir even before it was approved for use by the FDA. “It was a 10 days’ course and we started realizing early that the mortality of COVID was not 70% like in Italy or New York, but probably about 20% or lower.” Gilead and other pharmaceutical companies have been keen to conduct trials with institutions who have a history of conducting clinical trials and to find ways to involve more Black and Latino patients. “Our diversity was really a big asset,” said Dr. Almasri. “Our success (with remdesivir) started raising our name within a lot of medical research institutions and they started reaching out to us,” Dr. Almasri said. “Because of that, we now have 15 ongoing clinical trials, most of them well respected double-blind trials.”

Anna Kazaryan, M.D., a rheumatologist and UCSF Fresno faculty member, has been conducting other kinds of research with COVID-19 patients, looking at the connection between Vitamin D levels and who gets sick with COVID-19. “Those who were deficient in Vitamin D ended up in the ICU. The level of Vitamin D correlated with the severity of COVID and predicted outcomes,” she explained her findings. “Nearly 80% of those with deficient levels ended up in the ICU.”

Dr. Kazaryan said she’s been fascinated since medical school with the immune system, the concept of

© Can Stock Photo / crampinini

autoimmunity and the complexity of diseases as a consequence of lack of immune control. She noticed that her autoimmune © Can Stock Photo / AndreyPopov patients had flare ups their chronic conditions and were more prone to infections when their Vitamin D levels dropped. That made her wonder if she’d see the same with COVID-19. Dr. Kazaryan looked at both outpatient and inpatient data to see if Vitamin D levels made a difference with who got COVID and who got really sick with it. She said her findings made sense: “Vitamin D plays such an important role in the immune system by regulating of UCSF residents “working tirelessly” and skilled hospital the immune cells to help fight off infections and reduce staff. inflammation. If you are deficient in Vitamin D, you don’t Fresno’s also had access to the ECMO team have that key player.” (extracorporeal membrane oxygenation) at Community Regional. Mohamed Fayed, M.D., a UCSF colleague of Dr. Almasri’s who is certified in Internal Medicine, Pulmonary Disease and Critical Care Medicine, has been overseeing ECMO use with COVID patients who seemed nearly beyond hope, helping them be discharged back to their families and their

Next Dr. Kazaryan’s seeking approvals to start a phase previous lives. 2 study exploring if Vitamin D can be used as a preventative and a therapeutic for COVID-19.

While local infection rates have been skyrocketing, mortality rates have remained low, said Dr. Almasri, crediting colleagues like Dr. Kazaryan for helping advance knowledge about the disease and treatment. “If you do the math, we’re at less than 2% (mortality rate),” he said in midDecember about Fresno County. “We’re in line with the rest of California, which is a little bit higher.”

With lower than national average numbers of ICU beds per capita and pulmonologists per capita in California and big physician shortages in the Valley, Dr. Almasri marveled at the region’s outcomes. He attributed the high COVID-19 recovery rate to access to early clinical trials, collaboration among physician experts locally, the presence

If you do the math, we’re at less than 2% (mortality rate). “We’re in line with the rest of California, which is a little bit higher. REMOTE MEDICAL CARE BECAME ROUTINE The pandemic prompted innovation and fast adoption of new ways of treating patients. “We had planned before COVID to do some video visits,” Dr. Jahromi said of Kaiser Permanente. “COVID has pushed that forward by a magnitude of years. Initially there was a goal of 20% telehealth and that quickly went up to 80%.” Having such a highly contagious and potentially deadly disease compelled medical professionals to quickly learn tele-medicine technology, Dr. Almasri said. “We use Zoom, Ring Central, Go-to-Meeting, whatever now. Honestly without COVID you could not force busy physicians to learn this,” he said. “I just finished

a full half-day of telehealth visits. I asked every single patient if they wanted to continue this after COVID and only one out of nine said they would rather come back into the office.”

For his patients in Coalinga or Mariposa being able to connect virtually and feel like they received the same quality care has been a welcome convenience and timesaver, said Dr. Almasri.

“It has been wonderful for our complex children who we wanted to just protect and be able to keep them in their homes. I’ve been able to triage to actually see who I need to see in the office and manage the rest remotely,” said Hailey Nelson, M.D., a pediatrician at the Charley Mitchel Clinic at Valley Children’s Hospital. She finds it an advantage to be able to see her pediatric patients in their home setting.

“That really has added value to see them in their homes,” Dr. Nelson said. “Kids love it too. They can show me their favorite toy and you get to interact with them in a different way. In the office, I’m wearing a mask and goggles and you can’t see my face. With a little kid during an exam you would say ‘Open your mouth’ and typically you would open your mouth and show them what to do. They can’t tell that anymore because of the mask.”

Dr. Nelson said she’s had to become more creative in how she examines her patients virtually: We’ve been singing ‘Head, Shoulders, Knees and Toes’ so I can tell how they are moving their body and how everything is working.”

Karen Dahl, M.D., Vice President of Quality, Patient Safety and Medical Affairs at Valley Children’s Hospital, said she’s found tele-medicine benefits both physicians and patients. “We can reach so many more people.”

NEW HOPE WITH A VACCINE AND OUTPATIENT TREATMENT

After months of scrambling for resources, and shifting protocols and treatments as there were new discoveries about this novel virus, physicians said they’ve felt worn down. But December brought new hope with deliveries of COVID-19 vaccines to Central Valley hospitals and approval of new treatments.

“The entire month I’ve been energized by the news,” said Dr. Dahl, who also is Medical Director of Employee Health at Valley Children’s Hospital. “Bad as the surge has been, the availability of monoclonal antibody therapy for outpatients and the vaccine delivery has really been the best news we’ve had all year.”

Dr. Dahl has been listening to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices live meetings and said she’s been encouraged by the experiences of patients in Pfizer’s and Moderna’s clinical trials: “This is in line with other vaccines for the kind of side effects and the percentage getting side effects. I’m really confident in this vaccine and the process it went through to evaluate its efficacy and its safety.”

The administration of a COVID-19 vaccine, however, is a bit more involved than the flu shot, she said. “It’s taken a week to do all the prioritization and planning for this. It’s not like you can line everybody up and run them through. There is extra paper work because of the EUA status and social distancing limits the number we can get through a clinic during a single session.”

The Advisory Committee on Immunization Practices is recommending that hospitals stagger administration among doctors and clinical staff in a department, Dr. Dahl said. In addition, Pfizer and Moderna vaccines need to be stored in specialized freezers and once taken out must be administered within a short time period. And both require a second dose 21 or 28 days after the first in order to be effective.

Valley Children’s was chosen to be Central California’s storage and distribution site of the COVID-19 vaccine because it has enough ultra-low freezer capacity for 200,000 doses. It’s one of 33 pre-positioning sites chosen by the California Department of Public Health to store and help distribute the vaccine.

DOCTORS BECAME SUPPLY CHAIN AND PPE INNOVATORS

Dr. Dahl said this offers a lot hope for preserving the resources and beds in crowded hospitals for only the sickest COVID patients. COVID-19 has forged connections and collaboration between healthcare and the greater community, as people stepped up to help during early shortages of protective equipment. Dr. Nelson, a pediatrician at Valley Childrens Hospital, helped organize Clovis Unified School District teachers and students to make N95 respirator masks and face shields. “I knew my son’s second-grade teacher did robotics and he got me connected to the high school robotics team just as the schools were shutting down,” explained Dr. Nelson. “I was able to coordinate with all the teachers to take home their 3-D printers. We went through various prototypes to figure out the right mask and how to make them fit and went to work on production.” Parents and students helped sterilize and package

Valley Children’s began vaccinating staff on Dec. PPE for shipping to whoever needed it. All the materials 16, Kaiser Permanente Fresno followed on Dec. 17, and and labor was donated. In the span of two months, the Community Medical Centers began vaccinations Dec. 18. group had produced 2,000 face shields, and 800 3-D St. Agnes Medical Center and Adventist Health Hanford printed masks began providing immunizations to their direct patient Next Dr. Nelson became a fabric broker, coordinating care staff on Dec. 21. Valley Children’s vaccinated only its drop offs to students all over Fresno who cut out mask employees at highest risk for COVID complications with patterns and put them together in kits for home sewers who its first shipment. turned out nearly 500 masks for the public. She managed

As healthcare providers and staff lined up for their all this, her busy practice seeing children with complex first shot, hospitals were also working out details to provide conditions and three children at home, she said, because outpatient IV therapy to patients with mild to moderate COVID-19 symptoms. “Most of the I knew my son’s second-grade teacher did robotics and he got public will recognize me connected to the high school robotics team just as the monoclonal antibody schools were shutting down therapy as what was given to President Trump,” said Dr. Dahl. “It’s received Emergency Use Authorization from the FDA because of its her toddler wasn’t sleeping through the night when the efficacy in reducing the need for an emergency room visit or pandemic started. “I would snuggle her and learn about hospitalization. There is data to show it can alter the course filtration for PPE. Or I would send out these coordination early in the disease and keep people out of the hospital.” emails at 2 a.m.,” she said.

© Can Stock Photo / crampinini

MARATHON CRISIS TESTED ENERGY, RESOURCES, BUT ALSO BROUGHT POSITIVE CHANGE

“I’ve never done anything in this realm, but it’s all about connections,” Dr. Nelson said. “You don’t have to have the full answer you just have to go for that next step.”

It was connections to her handyman neighbor and creative thinking spurred by necessity that turned Athira Nair, M.D, a UCSF pediatric cardiologist, into a PPE innovator. After seeing how a Taiwanese doctor used a box

over patients to protect caregivers from the COVID-19 virus, she thought something similar might help protect her Community Regional colleagues if she should figure out how to make it.

She enlisted her next-door neighbor Jay Russell to help. After a few tries he figured out how to make a lightweight Plexiglas box with armholes that can be placed over a patient’s upper body and that physicians can reach through during procedures and examinations. Droplets breathed out are trapped in the box. Early in the pandemic, during the height of mask shortages, the boxes were put to use in Community Regional’s emergency department.

Besides becoming innovators outside their realm because of PPE shortages, Dr. Jahromi noted healthcare was forced to become much more efficient: “As a country we’re a country of one-time use. But now this shows us that we can reuse things.”

Patrick MacMillan, M.D., Director of Palliative Care at Community, hopes those new efficiencies and discoveries serve healthcare well into the future, but worries about the pandemic’s lingering effects on his colleagues and hospital staff. “What’s going to be the long-term cost to the health industry in terms of what people have seen and experienced?” he wondered. “This is not like anything I imagined living through. COVID-19 has been the most unpredictable disease. Everything is In my neighborhood the number of people I see different. Everything has changed. I’m hopeful outdoors walking, roller-blading, cycling has things will recalibrate in a way that is helpful to healthcare and to humans.” really increased because there’s nothing else to Dr. Dahl has the same hopes: “In my do. I hope those habits will persist and I hope neighborhood the number of people I see that’s a long-standing benefit from this. outdoors walking, roller-blading, cycling has really increased because there’s nothing else to do. I hope those habits will persist and I hope that’s a long-standing benefit from this.” She’s been excited to see more families being outside together – and also rediscovering family meals. “This has brought back family dinners. We’re spending time together as a family so that’s a positive,” she said. Dr. Almasri observed that the pandemic has definitely pulled the community together to work toward a common enemy. “The silver lining for me is that COVID has shown society how valuable we are,” he added. “I’ve been a doctor 25 years and I’ve never felt so proud to be a doctor, nor felt so valued, as I did this year.”

It’s Ok To Ask For Help

RESILIENCY CONSULTATIONS

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RECONNECT JoyTO YOUR of

Medicine

DR. RAIS VOHRA, INTERIM PUBLIC HEALTH OFFICER AND DR. JOHN ZWEIFLER, PUBLIC HEALTH PHYSICIAN

The ongoing toll of the COVID-19 we can look forward to adding bioengineering, and equally a symbol pandemic has included economic another powerful tool, because of humane scientific research in its shutdowns, job losses, substance COVID-19 vaccines are coming, and finest hour. Many other vaccines and addictions, illnesses, hospitalizations, not a day too soon. therapeutics are also in the pipeline, and hundreds of thousands of deaths COVID-19 vaccines offer and we are hoping that they can all nationwide. COVID-19 has haunted the hope for a return to normalcy; help us wake from the nightmare of our neighborhoods in Fresno County they represent the one scientific this pandemic. and throughout the Central Valley, breakthrough which, if adopted Operation Warp Speed was affecting virtually every a federal initiative hour of our days for involving the many months. Despite The Fresno County Department of Public Departments of Health the grim statistics and many losses, we are Health (FCDPH) needs all clinicians to and Human Services, and Defense to produce grateful that so many help win this fight and deliver 300 Valley residents have million doses of safe helped to flatten the and effective vaccines curve by supporting safe health broadly, promises to transform with the initial doses available by practices, and enduring many COVID-19 from a perpetual headline January 2021. Operation Warp hardships related to restricting our to a medical footnote, similar to Speed has partnered with several social activities, wearing masks, and polio and hopefully just as rare. Two pharmaceutical companies and maintaining strict precautions around mRNA-based vaccines, developed manufacturers to develop an array our elderly and frail neighbors and in record time, are a testament of strategies including vaccines and friends. To these layers of protection, to advances in genomics and other therapeutics, in some ways

parallel to the Manhattan Project in WW2, in order to combine and unite resources and information against a common enemy. Interestingly, Pfizer, which was not part of Operation Warp Speed, was the first vaccine to be approved by the FDA.

With COVID-19 cases and deaths surging, there is urgency to distribute the COVID-19 vaccine, and federal and state agencies are working feverishly even now to make sure these products are able to immunize the public as soon as possible. Pfizer and Moderna are expected to provide a total of about 40 million doses of their respective vaccines nationwide by the end of the year, enough to give up to 20 million people the required two doses.

“WHO GETS IT FIRST?”

It’s not just a dry theoretical exercise for a medical school ethics course, it is a real-life dilemma that demands practical solutions, and quickly. A Centers for Disease Control and Prevention (CDC) advisory committee recommended that the first doses be given to the approximately 21 million health care personnel in the U.S., with another 3 million going to residents of long-term care facilities. In Fresno County, the first 7800 doses of the Pfizer vaccine have been allocated to area hospitals to administer to their highest risk employees—not just physicians and nurses but also therapists, ancillary

and administrative staff. Skilled nursing facilities and assisted living facilities will be able to receive onsite immunizations for patients and staff from pharmacies including CVS and Walgreens through the Federal Pharmacy Partnership for Long Term Care Program. When more vaccine doses become available in early 2021, other high-risk groups are next in line, including health care workers in ambulatory settings, essential workers, and persons who are elderly or have chronic conditions. In all of these phases and plans, a focus on equity and transparency has been paramount.

There are challenges with storing and distributing COVID-19 vaccines. The Pfizer vaccine must be stored at an ultra-cold temperature of -70 degrees Celsius, which requires a special freezer or dry ice, while the Moderna vaccine must be stored at -20 degrees Celsius, which can be achieved in most freezers. However, once thawed, the Pfizer vaccine can be stored in a refrigerator for up to five days, and the Moderna vaccine for up to 30 days. Both the Pfizer and Moderna vaccines require two doses, 21 days apart for Pfizer, and 28 days

In Fresno County, the first 7800 doses of the Pfizer vaccine have been allocated to hospitals to administer to their highest risk employees

for Moderna. phase of the vaccine experience is that administer the vaccine.

Despite the challenges, the COVID-19 vaccines now available All health care providers COVID-19 vaccines have been shown offer the quickest and surest way to administering the COVID-19 vaccine to be highly effective- over 90% in escape the pandemic. will need to enter vaccine-related adult patients including the elderly. Because the vaccine is designed to ADMINISTERING THE information into the California Immunization Registry (CAIR) stimulate an immune response side VACCINE database. If your office is not already effects from the immunizations, are The Fresno County Department registered with or entering data fatigue, muscle aches, fever, joint pain, of Public Health (FCDPH) needs into CAIR or for more information headache, pain and redness at the all clinicians to help win this fight. on the information registry, go to injection site. As is the case for influenza vaccines www.cairweb.org/covid. If you are

In clinical trials, these side and childhood immunizations, planning to vaccinate healthcare effects were reported in less than 10% medical offices will play a key role personnel and are willing to vaccinate of patients, mainly in those healthcare personnel that under 55 years of age, and are not your staff, please no serious long-term side contact the FCDPH effects have been noted yet. Despite the challenges, the at covidvaccine@

Important questions COVID-19 vaccines have been shown fresnocountyca.govand about the COVID-19 to be highly effective- over 90% in include those details that in vaccine remain to be adult patients including the elderly. the email. answered, including how In summary— long vaccine immunity vaccines have saved lasts, and whether you can countless lives and promise transmit the virus even to do so with this viral if you yourself are protected from in immunizing our communities. pandemic as well. This is a time to illness. We will continue to learn The FCDPH is looking to medical show leadership, courage, ingenuity, much more about the virus, and the professionals to support its efforts and lead our patients by the examples weapons we have developed to defeat to communicate the value and we set as we forge ahead in the fight it, in the weeks and months ahead. importance of the COVID-19 against COVID-19. Let’s all give this What we do know even in this early vaccines to the public, as well as to fight out best SHOT!