Alexandra Martinez-Garcia – Yale Daily News https://yaledailynews.com The Oldest College Daily Thu, 28 Mar 2024 07:27:14 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.3 181338879 State permits Yale New Haven Health System to acquire Prospect hospitals https://yaledailynews.com/blog/2024/03/28/state-permits-yale-new-haven-health-system-to-acquire-prospect-hospitals/ Thu, 28 Mar 2024 07:27:14 +0000 https://yaledailynews.com/?p=188422 The Connecticut Office of Health Strategy established conditions for YNHHS to begin finalizing the terms of its long-awaited acquisition of three state hospitals.

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The state signaled its support for Yale New Haven Health Systems’ acquisition of three Connecticut-based hospitals owned by Prospect Medical Holdings on Wednesday, offering a first step toward a long-awaited deal to bail out the hospitals. 

The Connecticut Office of Health Strategy signed off on YNHHS’s certificate of need, or CON, application to buy Waterbury Hospital, Rockville General Hospital and Manchester Memorial Hospital from Prospect Medical Holdings. Negotiations for YNHHS to acquire the financially troubled hospitals have been ongoing since October 2022. 

The state’s approval of the CON greenlights the way for YNHHS to finalize the terms of the acquisition deal with Prospect Medical Holdings, keeping the hospitals from shuttering their doors. The acquisition would see YNHHS expand its total bed count by 700 and add about 4,400 additional employees, for a total of approximately 33,400. The for-profit Prospect hospitals would also be reverted to non-profit status.

“I am glad that all the parties have been able to reach an agreement on this transaction in a way that ensures that the residents who live in each of the hospitals’ host communities will continue to have local access to essential medical care, and the jobs of the employees who provide this care will be preserved under this new ownership,” Connecticut Governor Ned Lamont wrote in a statement. 

For over a year, Yale New Haven Health has been in negotiations with Prospect Medical Holdings and the state to iron out an agreement to acquire the three, Prospect-owned hospitals.

Following a six-week-long cyberattack on the three hospitals last August, Yale New Haven Health proposed a “Recovery Plan” that lowered its originally proposed purchase price of $435 million and asked the state to provide financial assistance for the deal. In return, the system would provide the three hospitals with support in their efforts to recover from the cyberattack.

Shortly after, negotiations between Yale New Haven Health, Prospect and Connecticut’s Office of Health Strategy for the acquisition deal went confidential to ensure that they continued as efficiently as possible.

“We continue to meet with all parties, including the Connecticut Office of Health Strategy and Prospect, CT to bring the transaction to a successful conclusion,” said Dana Marnane, director for public relations at Yale New Haven Health, in an email to the News in October.

State conditions on YNHHS

The new CON contains 46 conditions that the state’s Office of Health Strategy, or OHS, will require Yale to adhere to, including the hiring of an independent monitor for five years that reports to the OHS at the sole expense of YNHHS. 

“The [Independent Monitor] shall be responsible for monitoring NewCo’s compliance with all of the conditions set forth in this Agreed Settlement and shall produce a schedule of required reports and data to be shared with the [OHS],” the CON stated. 

Many conditions work to ensure current employees at the three hospitals can maintain their jobs. Notably, the agreement requires YNHHS to rehire all non-management employees and use their “best efforts … to minimize the elimination of individuals’ jobs.” YNHHS must also recognize all established bargaining agreements between hospital employees and the previous management. 

Other conditions focus on community-building efforts. YNHHS and the Prospect hospitals must have community representatives on its board of directors. In addition, the hospitals must hold community meetings to engage the public with hospital activities that allow community members to ask questions. 

The hospitals will also work with local health organizations and stakeholders to conduct a Community Health Needs Assessment to systematically identify community needs. To increase accessibility, YNHHS will also make culturally and linguistically appropriate services available and integrated into the hospitals’ operations. 

All three hospitals will adopt the YNHHS financial assistance policies, and all hospitals will continue to offer Medicaid services. Further, YNHHS must increase its aggregate community benefit expenditures across each hospital. 

“For-profit ownership of community hospitals — especially when tied to hedge funds — should never again be tolerated in our state,” John Brady, vice president of the statewide labor federation AFT Connecticut, wrote in an email to the News. “We have been consistent on our priorities – the health and well-being of our communities and caregivers.”

For five years, Northeast Medical Group — the medical foundation associated with YNHHS — will offer semi-annual reports on Medicaid patients’ access to specialty treatments, including medication-assisted treatment for substance misuse, dermatology, ENT services, neurology, orthopedics, and pain management. 

YNHHS will also invest $6 million in behavioral health services that target increasing access to mental health and substance use disorder treatment. 

“With today’s approval by the Office of Health Strategy, I encourage Prospect to work with Yale to reach a deal that will allow them to finalize this purchase and bring a much-needed resolution to this transaction,” Lamont wrote.

Healthcare providers, legislators push to finalize deal

Throughout the negotiation process, many healthcare professionals, legislators and health policy experts around the state have urged the deal should move forward, and should do so as quickly as possible.

Of concern to these individuals is the volatile financial status of Prospect Medical, and the effects that its for-profit business model has had on its hospitals’ ability to provide care.

Following the cyberattacks, State Senator Saud Anwar, co-chair of the Connecticut General Assembly Public Health Committee, told the News in October that the hospitals could not bill their patients or pay medical supply vendors.

As a result, the CT Mirror also reported that the state was also forced to provide a $7 million bailout to the hospitals, which were struggling to stay afloat after being unable to receive Medicaid reimbursements during the attacks. 

“This was a perfect storm from the hospitals’ perspective,” Anwar wrote in an email to the News. “They were already struggling financially, and the fact that their medical records and ability to see as many patients as they usually see, as well as their ability to bill patients as normal, resulted in a financial issue that harmed cash flow, making their ability to manage their finances significantly more difficult.”

Prospect owes the state at least $67.39 million in health provider taxes that date back to March 2022, according to three state tax liens filed against the California-based company. 

The company’s financial struggles and alleged mismanagement have generated widespread frustration among several Connecticut healthcare providers, who told the News that they continue to support the YNHHS purchase of the Prospect hospitals.

Those financial difficulties “call attention to the dire need for responsible, committed new ownership of ECHN’s hospitals,” said Diane Carlson, president of the Manchester Federation of LPNs and Techs United, AFT Local 5144, who works as a licensed practical nurse at Manchester Memorial Hospital. 

The state’s approval of the CON greenlights the way for Yale to finalize the terms of the acquisition. 

“Our patients and our caregivers deserve better than a hedge fund that fails to pay its fair share to the communities from which it profits,” she added.

According to Rep. Jason Doucette, D-Manchester, the state representative for one of the towns containing a Prospect hospital, Prospect’s management style has “negatively affected” the availability of vendors and supplies. 

He believes that Prospect’s financial woes also harm the morale of doctors, nurses and other hospital employees.

“The private equity model of doing business in health care, together with [Prospect’s] inability to refinance certain company debts, then compounded by the cyber attack in mid-2023, created a dire situation where the bills simply weren’t getting paid,” he wrote in an email to the News. “Most of the people I speak to in the community are hopeful that the acquisition by Yale will bring a significant overall improvement to the ECHN system generally, and that frankly anything is likely to be better than the current situation.”

As the deal moves forward after the state’s approval, however, healthcare professionals continue to provide care to Connecticut residents, even as they face uncertainty over future management and job prospects.

Annie-Marie Cerra, president of AFT Local 5055 for Manchester Memorial Hospital Nurses and an emergency department nurse at Manchester Memorial, highlighted healthcare workers’ continued commitment in an email to the News.

“This acquisition process has created a lot of anxiety for all of us. Despite that, our member nurses and health professionals – as well as our physician colleagues – have shown up every day in our hospitals to provide the excellent care our patients and their families deserve.”

Yale New Haven Hospital was founded as the General Hospital Society of Connecticut in 1826.

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Yale researchers discover gaps between in-person and online facial processing in the brain https://yaledailynews.com/blog/2023/11/09/yale-researchers-discover-gaps-between-in-person-and-online-facial-processing-in-the-brain/ Thu, 09 Nov 2023 06:49:11 +0000 https://yaledailynews.com/?p=185598 A new study at the School of Medicine’s Brain Function Laboratory found that when processing faces on Zoom versus in-person, behavioral indicators and neural activity change.

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Katherine Dick ’27 said that during 2020, “Zoom-school” negatively impacted not only her learning but also the connections between her and her peers.

In the rare moments when students and teachers turned their cameras on, she said, it proved difficult to recognize subtle changes in facial expressions that she would normally never miss in person.

“I remember not feeling connected to my classmates or teachers in the same way I used to be,” Dick reflected.

A new study from the Yale School of Medicine might lend Dick’s sentiment a scientific backing: our brains do not process in-person and online faces in the same way.

Published last month in the scientific journal Imaging Neuroscience, the study found that neural activity in the areas of the brain involved in facial processing significantly decreased during face-to-face interactions on Zoom and similar platforms compared to in-person interactions.

Contrary to accepted models, referenced in the study, of how facial processing operates in the brain — which predict no differences between Zoom and in-person interactions — researchers at the School of Medicine’s Brain Function Laboratory demonstrated that the way our brains interpret these stimuli happen in two separate ways. 

According to the researchers, the importance of human connection might be what makes the difference.

“A single brain is only one half of the most fundamental [social] unit,” said Joy Hirsch, professor of psychiatry, professor of comparative medicine and neuroscience and senior author of the study. “I think that our brains are designed to connect with other brains.”

The researchers’ interest in the brain’s dyadic activity, or activity relating to interactions between two people, during in-person and online settings, was not a result of the COVID-19 pandemic. 


Instead, Hirsch said, she and other members of her lab — including Nan Zhao, a PhD student from China and the paper’s first author — began their work on the potentially groundbreaking research question before the pandemic even began.

In 2020, as the looming COVID-19 pandemic threatened a lab shutdown and Zhao’s student visa neared closer to its expiration date, Hirsch said, the researchers banded together to finish all the necessary experimental trials as quickly as possible.

“We realized how important this question was before the pandemic,” Hirsch said. “And the pandemic actually slowed us down a bit, but helped us on the relevance frame. The study was more relevant after the pandemic, but that was not anticipated.”

Hirsch said that the study was made possible by a new kind of neuroimaging technology developed in-lab known as functional near-infrared spectroscopy, which allows two brains to be imaged at the same time. 

Unlike most other brain imaging done in neuroscience research, which only allows for one brain to be imaged at a time while a patient completes specific tasks, Hirsch explained, fNIRS can simultaneously compare each brain’s activity to the others’.

The new technology allows scientists to examine how the brain behaves while interacting with other people.

“Most of our behaviors in the everyday world are behaviors that relate to other people. We talk to each other, we share things, we seek each other out,” Hirsch said. “So the brain is mostly designed for interactions with other people, but we know very little about that because we haven’t been able to study it.”

Using this technology, Hirsch and other members of the lab have been able to conduct multiple studies to gain new perspectives on facial and language processing — perspectives that allow scientists to begin to look at the inner workings of the brain in a new way. 

Eye contact and attention 

Hirsch said it is widely accepted in the field of neuroscience that most facial processing occurs by the brain analyzing different facial features, with small patches of the brain’s cortex each dedicated to features like the hair, eyes, nose and mouth. The strategy, according to 2019 research from Emory University, allows the brain to identify faces in a wide variety of contexts. 

But under this framework, Hirsch said, there should not have been any difference between the neural activity observed during face-to-face interactions in person or on Zoom. Hirsch and her colleagues speculated that the opposite might be the case.

“We set out to test the hypothesis, knowing full well that it was wrong but not knowing how, and assuming that the answer to how would be extremely informative in the next stages,” she said.

The researchers found that behavioral eye-tracking measures such as pupil dilation and the length of time the eyes lingered on a face increased when two people were interacting in person. The dorsal stream, a stream of visual processing systems related to attention and eye contact, was also found to be more active during real-life encounters than on Zoom.

This finding is consistent with the idea that the in-person stimulus environment for facial processing is richer than that presented to the brain on Zoom, Hirsch said. The differences could come down to a variety of factors, including eye contact and reacting to facial expressions.

“One of the things that one can assume [is that] the eye-to-eye contact conditions, which are very important in personal interactions, are altered, because here we’ve got a slanted camera,” Hirsch said. “So that reciprocity that would go on between us normally in this very fine-to-micro-movement scenario in real life probably doesn’t go on in the online encounter.”

Amy Arnsten, Albert E. Kent professor of neuroscience and professor of psychology, agreed with the hypothesis put forward by Hirsch.

In an email to the News, Arnsten noted the importance of eye movements as critical social signals in humans and other primates. Missing any one of them, she said, could contribute to differences in how we process each others’ faces online.

“It makes sense that there is much less of this on Zoom, as we are not really looking at each other, and people rarely even look directly into the camera,” Arnsten wrote. “Thus, we miss all the small but powerful signals about how a person is responding to us. It makes sense that we would not feel as connected under these conditions.”

Trouble publishing

According to Hirsch, the study has important implications — not just for experts in the field of cognitive neuroscience but also for society as a whole.

The concept that the brain processes faces using additional systems that scientists do not currently understand, Hirsch said, is new. 

As a result, Hirsch said, their proposal was not initially well-received. When she and her colleagues first tried to publish the study, she said they faced significant barriers, which she attributed to a hesitancy within the field to substantially modify an entire school of thought.

“Believe it or not, we had a lot of trouble publishing it,” Hirsch said. “And the reason is that the basic neuroscience community, I think, just wasn’t ready to realize that there’s this whole new domain of neural processes that go on.”

When the paper was published, it achieved what, to Hirsch, seemed to be immediate and widespread attention — not just from experts in the field but from readers from across the world.

Hirsch said that the popular response to the research might be due to how universal the experience of social isolation was during the COVID-19 pandemic, and how integrated Zoom-like platforms are in settings ranging from schools to legal proceedings and telehealth medical appointments. 

She recommended that the scientific community take action to address the knowledge gap and advance neuroscience’s understanding of interpersonal interaction as a whole.

“Our education, our medicine, our learning, our business transactions, you know, our law, whatever it is – all those things need to be investigated,” she said.


The Yale Department of Psychiatry is located at 300 George St.

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Details of Yale New Haven Health’s attempts to acquire three Prospect Medical hospitals go confidential https://yaledailynews.com/blog/2023/11/03/details-of-yale-new-haven-healths-attempts-to-acquire-three-prospect-medical-hospitals-go-confidential/ Fri, 03 Nov 2023 05:57:16 +0000 https://yaledailynews.com/?p=185425 As negotiations over Yale New Haven Health’s acquisition of three Connecticut-based Prospect Medical Holdings hospitals have gone private, officials and health policy experts told the News they hope the deal wraps up soon.

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Negotiations between Yale New Haven Health, Prospect Medical Holdings and the state over YNHH’s attempt to acquire three Prospect Medical hospitals briefly stalled last week, temporarily putting the acquisition in jeopardy, according to reporting by the CT Mirror

However, talks have resumed since the health system and Prospect Medical both agreed to sign a discussion privacy agreement, created by the Connecticut Office of Health Strategies. 

“OHS asked us to sign a confidentiality agreement,” Dana Marnane, director of public relations and communications for Yale New Haven Health, said in an email to the News, “which we did because we felt it was very important to continue productive conversations with OHS.” 

Sen. Saud Anwar, deputy president pro tempore of the Connecticut Senate and co-chair of the public health committee, said that conversations about the recovery plan and overall acquisition deal are still ongoing. 

“We’re hopeful these conversations will allow clarity on the financial impact Yale would have with the current situation,” Anwar wrote in an email to the News. 

In 2022, Yale New Haven Health initially announced its intent to purchase three hospitals — Manchester Memorial, Rockville General and Waterbury Health — from Prospect Medical Holdings. However, in the summer of 2023, anonymous actors launched a cyberattack on the hospitals, largely hindering their abilities to bill patients and pay for medical supplies. In the attack, the personal information of over 24,000 Prospect Medical employees was potentially leaked. 

Following the breach, YNHH proposed a “Recovery Plan” to amend their original acquisition deal. In an email sent to the News earlier this month, Marnane said that the new plan would provide the hospitals with immediate recovery assistance to ensure continued healthcare access in the region. 

The Recovery Plan would also change how the system will pay for the hospitals. In the aftermath of the cyberattack, YNHH requested a lower purchase price from Prospect Medical and roughly $80 million from the state, spread out over five years, to assist them in purchasing the hospitals. 

As negotiations have gone private, little information is available on the current status of the acquisition deal and whether the process is leaning toward one outcome or another. 

In an email to the News, Howard Forman, professor of radiology and biomedical imaging and director of the M.D./M.B.A. program at Yale, wrote that he thinks the acquisition deal move forward as soon as possible, due to the number of Connecticut residents any decision on the deal will affect. 

“There are a LOT of individuals with something at stake: there are patients and their families living in the surrounding communities; there are workers at the hospitals; there are physicians who practice solely or partly there; and there are companies that would like to build their businesses and want to offer their employees the opportunity to have world-class care in their community,” Forman said. 

Forman cited previous circumstances in 2015 in which the state provided monetary assistance to hospitals in need of it. 

Forman wrote that he thinks the state is capable of supporting an acquisition that it believes serves the public good. 

“[The state] should not be picking winners and losers, but rather making sure that crises are averted,” Forman said. “I cannot judge whether the closure of any or all of these hospitals would result in a crisis, but I can imagine that many individuals would be harmed by such an outcome.” 

Anwar also said that it id imperative to wrap up the acquisition deal so that the hospitals csn continue providing healthcare to the people living in the Manchester, Rockville and Waterbury regions. 

If this deal does not move forward, Anwar said, the state’s health and well-being may be negatively impacted. 

“The stakes are very high,” Anwar said. “Connecticut could lose 3,000 jobs and 600,000 people could lose health care if the wrong decisions are made.” 

Prospect Medical Holdings owns 16 healthcare facilities across California, Connecticut, Pennsylvania and Rhode Island. 

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Following cyberattack, YNHH seeks state funding, price cut to acquire hospitals https://yaledailynews.com/blog/2023/10/13/following-cyberattack-yale-new-haven-health-asks-for-state-aid-lowered-price-to-aquire-connecticut-hospitals/ Fri, 13 Oct 2023 08:29:01 +0000 https://yaledailynews.com/?p=184967 Yale New Haven Health’s plans to acquire three Connecticut hospitals remain in flux due to financial troubles and a recent cyberattack targetting three Prospect Medical Holdings facilities.

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Content warning: This article contains one non-graphic mention of suicide.

Two years ago, Yale New Haven Health agreed to acquire three financially-troubled hospitals in Connecticut. 

Now, the deal is on unsteady footing in the wake of a six-week long cyberattack against the hospitals, with YNHH requesting to pay a lower price and receive financial support from the state.

The attack targeted Manchester Memorial, Rockville General and Waterbury Health Hospitals — the medical centers that YNHH is poised to acquire, which are currently owned by the Los Angeles-based company Prospect Medical Holdings.

YNHH proposed a flurry of changes to the acquisition deal in an attempt to address the hospitals’ financial issues, many of which were exacerbated by the cyberattack. Under its “Recovery Plan,” YNHH would provide management services to all three hospitals to aid their recovery from the cyberattacks. 

In the meantime, according to YNHH’s plan, Prospect Medical Holdings would decrease the purchase price of the three hospitals — originally $435 million — and Connecticut’s state government would lend financial support for the deal. With the acquisition, YNHH would gain over 700 new beds and add about 4,400 additional employees, for a total of 33,400. The for-profit Prospect hospitals would also be reverted to non-profit status.

Dana Marnane, director of public relations and communications for Yale New Haven Health, emphasized the need for communication between the players involved in the acquisition process regarding the hospitals’ current financial situations.

“We need everyone to sit down to get a full understanding of the current financial condition of Waterbury and [Eastern Connecticut Health Network] hospitals, including the impact of the recent cyberattack, and determine a path forward,” said Marnane.

Cyberattack worsens financial status of Manchester Memorial, Rockville General and Waterbury Hospitals

Early in August, the Eastern Connecticut Health Network — which includes the Manchester and Rockville hospitals — and Waterbury Health experienced a simultaneous systemwide network outage. That outage was later identified to be the result of a halting cyberattack on the Prospect Medical Holdings company.

In August, the CT Mirror previously reported that Manchester Memorial issued multiple “divert notifications” to emergency responders. These messages indicated that they could not accept patients to their emergency room. The hospitals closed their ER to new patients 29 times and canceled more than half of elective surgeries. At all three hospitals, staff individually monitored patients as they lacked functional technology, causing staffing shortages to surge. 

The attacks may also have compromised the personal information — including social security numbers — of over 24,000 Prospect Medical Holdings employees.

Information released to employees explained that the attack occurred between July 31 and Aug. 3. AFT Connecticut — the workers’ union representing almost 1,000 registered nurses and allied health professions in five local unions at Manchester Memorial and Rockville General Hospitals — statewide vice president John Brady said the attack was then discovered through an investigation on Sept. 13.

However, Brady said, employees only learned of the breach on Sept. 29 — almost two months after it originally occurred. While employees lacked official communication about the cyberattack and data breach, Brady said, the effects of the attack were clear in the workplace.

The attacks also caused severe financial challenges for the Prospect hospitals.

State Senator Saud Anwar, co-chair of the Connecticut General Assembly Public Health Committee, told the News that the hospitals were not able to properly bill their patients nor pay their medical supply vendors, creating a financial roadblock for the facilities that worsened their already-deteriorating financial statuses.

As a result, the CT Mirror also reported that the state was also forced to provide a $7 million bailout to the hospitals, which were struggling to stay afloat after they were unable to receive Medicaid reimbursements due to the attacks. 

“This was a perfect storm from the hospitals’ perspective,” Anwar wrote in an email to the News. “They were already struggling financially, and the fact that their medical records and ability to see as many patients as they usually see, as well as their ability to bill patients as normal, resulted in a financial issue that harmed cash flow, making their ability to manage their finances significantly more difficult.”

Strained finances and Prospect’s past

Negotiations for the acquisition are occurring during a period of financial strife for YNHH. In 2022, the system lost $240 million on the heels of the COVID-19 pandemic: a deficit that forced YNHH to fire 72 hospital managers during the worst fiscal year in its history. This year, YNHH budgeted for an even larger $250 million deficit.

Prospect Medical Holdings, which owns 20 for-profit hospitals around the country, is also plagued by a checkered history. In 2018, CBS News reported that its owners took out a $1.12 billion loan, using proceeds to pay themselves and their shareholders a $457 million dividend. To pay it back, the company sold land and buildings in three states — including Connecticut — to a real estate investment trust and leased the hospitals back.

In 2019, according to a ProPublica investigation, Connecticut’s Joint Commission on Hospital Accreditation initially denied Waterbury’s accreditation — which is required for facilities to receive Medicare and Medicaid funding — after finding 42 quality standards out of compliance. In one case, according to the investigation, the hospital had failed to monitor two actively suicidal patients. After one patient died, the hospital failed to inform police.

Yale New Haven Health’s ‘Recovery Plan’

In light of the cyberattacks and the hospitals’ deteriorating financial conditions, YNHH proposed an amended deal that would allow them to purchase the hospitals for a lower price. 

Dana Marnane, director of public relations and communications at Yale New Haven Health, said that the proposed YNHH “Recovery Plan” is essential to ensure that the three hospitals stay afloat.

“Yale New Haven Health proposed a Recovery Plan in which Yale New Haven would provide immediate management support to [Waterbury Health] and ECHN to help them recover from the cyberattack,” Marnane wrote in an email to the News. “Prospect would adjust the purchase price and the State would provide financial support to the [Waterbury Health] and ECHN hospitals to account for their deteriorating condition. We need all parties, including the State, to join in the Recovery Plan to make this transaction happen.”

Prospect Medical Holdings did not respond to multiple requests for comment.

State legislators, including Anwar and Governor Ned Lamont, along with YNHH, Waterbury Health, ECHN, and Prospect Medical Holdings officials will convene in a special meeting within the next week to discuss the proposed plan and the progression of the overall acquisition deal.

Along with the challenges of providing continued care to patients, Anwar mentioned concerns over the Prospect hospitals’ outstanding bills. 

“Many vendors have not been paid and that’s why I sense a need of urgency of moving forward with the acquisition so that a stronger health care system can provide support and change the trajectory of health care systems still struggling at this time,” Anwar said. “I hope vendors understand that as soon as a transaction happens, things will improve.”

Anwar also mentioned the importance of the upcoming meeting to move the deal along. 

An influx of cash from the YNHH acquisition could do more than pay Prospect’s bills to vendors; it could keep the hospitals from closing down, he said. 

“YNHH does have an excellent record and provides very high-quality care, and has been collaboratively working in many communities”,  Anwar added. “Hospitals have the ability to generate their own funding, but they do need some investment and technical know-how to improve quality of care and increase capacity.”

The acquisition has been met by hesitation from some officials, including Ted Doolittle, the state’s former appointed healthcare advocate, who say that patients might face higher prices.

The deal would mean that, alongside the Hartford HealthCare system, YNHH would own over half of all hospitals in Connecticut. 

“It could be good, but it’s probably more likely to be a net negative for the families in the state,” Doolittle told the News last year.  “When hospitals do merge and expand, the end result is that the prices paid by consumers and families and insurance companies tend to go up.”

According to the American Hospital Directory, there are 51 hospitals in Connecticut. 

The National Suicide Prevention Lifeline is a hotline for individuals in crisis or for those looking to help someone else. To speak with a certified listener, call 988. 

Crisis Text Line is a texting service for emotional crisis support. To speak with a trained listener, text HELLO to 741741. It is free, available 24/7 and confidential.

To talk with a counselor from Yale Mental Health and Counseling, schedule a session here. On-call counselors are available at any time: call (203) 432-0290.  Appointments  with Yale College Community Care can be scheduled here.

Students who are interested in taking a medical leave of absence should reach out to their residential college dean.

Additional resources are available in a guide compiled by the Yale College Council here.

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CDC director Mandy Cohen MED ’05 visits Yale https://yaledailynews.com/blog/2023/10/10/cdc-director-mandy-cohen-med-05-visits-yale/ Tue, 10 Oct 2023 12:18:45 +0000 https://yaledailynews.com/?p=184837 In multiple classroom visits and colloquiums this past Friday, Cohen — who was newly appointed CDC director — spoke to students from various schools on the progression of her career and the importance of interdisciplinary involvement in healthcare

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Mandy Cohen MED ’05 returned to her alma mater in New Haven this past weekend — but now as the director of the Centers for Disease Control and Prevention, also known as the CDC.

In a trip jointly organized by Cohen’s CDC staff and Howard Forman — a professor of radiology and biomedical imaging who also teaches classes in health, economics and management at Yale — visited the Yale Schools of Medicine and Public Health, along with an undergraduate class and a Fair Haven community health facility on Friday.

Cohen spoke with both undergraduate and graduate students about her unique career path in healthcare, offering advice to those interested in medicine, public health and health policy. 

“Advice I would give is to be uncomfortable,” Cohen said. “Make sure you’re stretching yourself and putting yourself in opportunities where you can build new skill sets that might be outside your comfort zone.”

Cohen’s visit to Yale had been planned since April while she was still working as the chief executive officer of Aledade Care Solutions, Forman explained in an email to the News. Even after her appointment to the role of CDC director, Cohen still expressed interest in visiting the University. Forman then continued coordinating with her staff at the CDC in late July.

While the recent near-shutdown of the government temporarily put the trip in jeopardy, Forman noted, he and others involved, including his former student and current CEO of Fair Haven Community Health Center, Sue Lagarde, continued working to plan a vaccine awareness event at the center. He said that only “by a stroke of luck” did this event, Cohen’s visit to Yale and Fair Haven breaking ground on their new building fall on the same day.

“The Fair Haven events were incredibly well-attended, including by numerous Yale faculty and alums, as well as President Salovey and Marta Moret,” Forman said. 

Visits to Yale are not a novel concept for Cohen. The director and YSM alumnus noted that she tries to come back almost every year to meet with current students and advise them on their career paths. She lauded Yale for giving its students the space to explore different academic fields and potential careers.

While a student at Yale, Cohen explained, she got the chance to spend time in South Africa, learning about global health, and in Washington, D.C., engaging in advocacy. The intersection between policy and practice did not stop there. During her time as a student at YSM, Cohen also obtained a master’s in public health at Harvard University. Opportunities like these, she emphasized, are what allowed her to expand her thinking.

“It was really when I came to Yale that they allowed me to explore different parts of what it meant to be a physician and be a leader in healthcare,” Cohen said. “The fact that Yale makes it so flexible to allow us to do that, again, [it’s a] really supportive environment.”

Besides providing advice to students interested in medical and governmental healthcare careers, Cohen also sought to create transparency around the inner workings of the CDC, from data and guidance to the decision-making process, Forman noted. 

For Forman, Cohen’s visit reflects her steady commitment to promoting public awareness of the need for vaccinations as respiratory virus season begins, improving population health and addressing the challenges of the social determinants of health.

“You need to understand how policy gets made, how decisions about money get made and how we communicate with the public sector,” Cohen said to the News following her morning press conference. “No matter what you’re thinking about, whether it’s public health, healthcare, business, spend some time, at least a couple of years in public service, to make sure you’re understanding how that’s happening.”

Cohen’s advice was well-received by students who attended her talks. Rachel Diaz SPH ’24, a public health student studying social and behavioral sciences, was supposed to work with Cohen this past summer before she was appointed to the CDC. 

She said that it was inspiring to hear Cohen’s life story in person and to see the CDC director interacting with the public.

“I love that [the event] was open to the public,” Diaz said. “When there is such a big change in administration, showing up in person, in these spaces, makes her feel more approachable and in touch with the people she is serving.” 

Diaz also said that it was important to see Cohen highlight issues she is currently studying, such as sharing public health data and whole person health, a medical practice that seeks to treat the entire patient rather than merely a specific disease. 

Students in Forman’s health economics class praised Cohen’s continued openness and honesty in her new role as director of the CDC. In a message to the News, Coby Wagonfeld ’26 noted how Cohen’s visit helped him understand “what the CDC does and how important they are,” along with the integral role they play in protecting the country.

Abhinav Karthikeyan ’25, another student in Forman’s health economics class, also praised her continued openness in her new role as director of the CDC.

“[I] honestly was very surprised by her candor given she’s a public official,” Karthikeyan said. “My impression of her as a whole was that I was extremely impressed.”

Forman also expressed appreciation for Cohen’s openness to dialogue and engagement with the students present at her lectures on Friday.

As someone who never backs away from a challenge, Forman said, Cohen can be described as not just an inspirational figure, but a born leader who has devoted her career and time to improving the health of those around her in multiple positions.

“I am confident that many of our undergraduate and graduate students came away with a greater understanding of public service, of the levers that our government has to enact positive change and how kindness is not incompatible with successful leadership,” Forman said.

Cohen stepped into the role of CDC director on July 10

William Zhang and Giri Viswanathan contributed reporting.

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Rising xylazine use in Connecticut: what to know and how to stay safe https://yaledailynews.com/blog/2023/09/22/rising-xylazine-use-in-connecticut-what-to-know-and-how-to-stay-safe/ Fri, 22 Sep 2023 07:17:44 +0000 https://yaledailynews.com/?p=184319 As xylazine becomes increasingly prevalent in Connecticut’s drug supply, public health officials and substance use experts spoke with the News about increased xylazine use across the state and recommendations for the public on how to stay safe.

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New Haven’s public health officials have grown increasingly concerned about climbing rates of xylazine-related overdoses and deaths.

Found in increasing numbers in Connecticut’s drug supply since 2013, xylazine — a sedative hypnotic agent used as an animal tranquilizer in veterinary settings — poses what Maritza Bond, New Haven director of public health, labeled a “unique public health danger.” 

The drug has not received FDA approval for use in humans, yet in recent years, it has been increasingly mixed with opioids such as fentanyl. According to Bond, this mixing creates a false sense of euphoria thanks to xylazine’s powerful sedative effects.

New Haven public health officials and other substance use experts spoke with the News about the dangers xylazine poses to human health and recommended various strategies for community members to keep themselves and those around them safe.

Since xylazine use was first identified in Connecticut in 2019, Bond said, the number of xylazine-related deaths in the state has skyrocketed. According to Bond, the state recorded 141 deaths related to xylazine use through the entirety of 2020, while there have already been 150 deaths in 2023 so far. 

In New Haven, Bond said, 40 xylazine-involved deaths of residents occurred between August 2019 and July 2023.

However, experts are still unclear as to why the prevalence of xylazine in the state’s opioid supply has continued to rise in recent years.

“It [is] not entirely clear why it is being increasingly found in the unregulated opioid supply, but it has been proposed it is present because it has an additive depressant effect,” Kimberly Sue, assistant professor of medicine with the Program in Addiction Medicine at the School of Medicine, said with regard to the drug’s effects on the central nervous system.

Consumption of xylazine, especially in combination with opioids like fentanyl, can put users’ health at significant risk.

Bond explained in an email to the News that the drug slows a user’s heart rate and increases difficulty breathing. 

“Xylazine, in combination with fentanyl, may increase the severity of an overdose because of worsened respiratory depression,” William Eger MPH ’21,  a doctoral student in interdisciplinary research on substance use at the University of California San Diego and San Diego State University, wrote to the News. 

Bond, Eger and Sue each noted that severe skin wounds can evolve at injection sites as well, which can lead to regional necrosis, or skin tissue death, in the injection area.

At present, most research on xylazine is either anecdotal in nature or primarily featured in small studies; Eger said further investigation of the drug’s effects on unhoused users is critical.

“Xylazine also causes a deeper — and potentially longer — sedation than fentanyl which might make people who are unsheltered more vulnerable to violence or other challenges,” he said. “I’m not sure how reported that is in the literature, but from my work and experiences, this is true.”

Xylazine-opioid mixtures like the one Eger mentioned are a prominent concern among public health experts. Individuals are at risk of unintentionally ingesting the drug, Bond said, because it has increasingly been mixed with street-bought substances — and is indistinguishable from them after mixing.

Eger attributed the general lack of knowledge regarding xylazine to the limited amount of research available regarding xylazine in humans. He also pointed to a lack of interventions to specifically address xylazine and evidence-based treatments for those who are suffering from addiction to the drug.

An additional concern tied to xylazine, Bond explained, is that it does not respond to naloxone, an anti-overdose medication commonly known as Narcan. However, she emphasized that it is still important to administer Narcan if someone is suspected of overdosing on drugs.

“If someone has taken a drug with both xylazine and fentanyl, they may not become immediately alert after receiving naloxone because they are still sedated from the xylazine,” Bond said. “Rescue breaths are also critical after someone has overdosed to ensure they have enough oxygen in their blood supply.”

The New Haven Health Department and its Harm Reduction Taskforce are working to combat the issue by “actively raising awareness” through outreach to people who use drugs and “mobilizing community partners to respond,” Bond said.

She highlighted resources that the department has made available to community members, including free naloxone trainings and information about ways to prevent drug overdose available on online.

Eger mentioned harm reduction approaches as being a way to reduce stigma and promote community awareness of xylazine.

“These articles you see on xylazine calling it the ‘Frankenstein drug’ and ‘flesh-eating’ are simply not true and are catchy headliners to make people scared,” Eger said. “Yes, xylazine is scary, but the best thing we can do is destigmatize drug use so people talk about their challenges, get help when they need it and utilize the evidence-based strategies that we do have available.”

In partnership with the Connecticut Harm Reduction Alliance, the New Haven Health Department has also placed harm reduction “rovers” at community locations throughout New Haven. The rovers contain harm reduction supplies such as xylazine test strips, naloxone and fentanyl test strips.

These rovers are located at the Downtown Evening Soup Kitchen in New Haven, the APT Foundation in West Haven, North Haven and New Haven, Project More Reentry, and with the COMPASS response team. People can also pick up supplies at the Health Department at 54 Meadow St., Monday through Friday from 9 a.m.to 5 p.m., “no questions asked,” Bond said. 

Bond and Sue recommended additional strategies to promote community safety at the individual level. The Yale Community Health Care Van provides people with a place where they can bring drugs to be tested for xylazine without fear of prosecution. Located at 270 Congress St., the van is open Monday through Friday from 9:30 a.m. to 3:30 p.m.

Bond, Eger and Sue all recommended that individuals never use drugs alone in case an overdose were to occur. 

“If you are alone, call the never use alone hotline at 1-800-484-3731 before using,” urged Bond.

In June 2023, 88 people in Connecticut died from an unintentional or undetermined drug overdose.

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How to get flu and COVID-19 vaccines at Yale https://yaledailynews.com/blog/2023/09/14/how-to-get-flu-and-covid-19-vaccines-at-yale/ Thu, 14 Sep 2023 04:45:13 +0000 https://yaledailynews.com/?p=183974 Following the CDC’s recent approval of updated COVID-19 vaccines, boosters should be available on campus by October.

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The start of the school year marks the beginning of vaccination season at Yale.

An updated version of the influenza vaccine is currently available to all Yale students, faculty and staff, while the updated iteration of the COVID-19 vaccine is set to be available on campus by October.

The new COVID-19 vaccines will be available nationwide later this week, following their approval by the Food and Drug Administration and the Centers for Disease Control and Prevention on Monday and Tuesday, respectively. The booster shots’ arrival on campus coincides with an uptick in COVID-19 cases in the Yale and New Haven communities, which has raised concerns among Yale public health experts who spoke with the News.

How do this year’s COVID-19 and flu vaccines work?

While last year’s version of the COVID-19 mRNA vaccine was a bivalent booster that protected against two separate variants, the vaccination’s latest update will be monovalent and focused on providing protection against the XBB.1.5 omicron variant alone.

According to Richard Martinello, medical director of infection prevention at Yale New Haven Hospital and Yale New Haven Health, XBB.1.5 is no longer the most common circulating variant. However, recent data has demonstrated that the updated vaccine still helps the body to generate an effective immune response against the Omicron variants that are circulating.

“We have a very good understanding of the safety of these mRNA vaccines now,” Martinello said in an interview with the News prior to the CDC’s approval of the new COVID-19 vaccines. “So we’re very comfortable anticipating [the vaccines] becoming available.”

The vaccine protecting against the flu, on the other hand, is a quadrivalent vaccine, Martinello explained. It contains components that provide protection against four different types of the flu: the H1N1 and H3N2 strains of influenza A, and the Victoria and Yamagata strains of influenza B.

Additionally, unlike the mRNA-based COVID-19 vaccine, the flu vaccines are made up of a protein called hemagglutinin that is purified away from the four different strains of influenza the vaccine provides protection against.

“It’s been well-known that this hemagglutinin protein is very immunogenic and can help, when vaccinated, to produce a protective response against the virus,” Martinello said. “So when we get a shot of a flu vaccine, it’s actually those proteins that are purified from the virus itself that help to immunize us and protect us.”

Who should get the COVID and flu vaccines?

According to a University-wide email sent by Madeline Wilson, the chief campus health officer and chief quality officer at Yale Health, everyone over the age of six months should receive the flu vaccine.

The CDC also recommends that people in that same age range receive an updated COVID-19 vaccine, according to a news release published Tuesday.

Martinello highlighted additional versions of the flu vaccine that are specifically formulated for different age groups. A half-dose pediatric formulation is available for younger children, while a higher-dose formulation is recommended for individuals over the age of 65.

Depending on their position at Yale, certain individuals will be required to receive the flu vaccine, both Martinello and Wilson said. Yale health care workers and health care students are required to receive the updated flu vaccine by Dec. 1.

However, the University has not yet made a decision as to whether the new version of the COVID-19 vaccine will be mandated for all students, faculty and staff. The primary series and additional booster vaccines are currently required.

Martinello said the University expects to engage in “further discussions” regarding any changes to the mandate after hearing new guidance from the FDA and CDC. 

“Even if we do not mandate the new vaccine, I would really strongly encourage everybody to get out and get vaccinated,” Martinello said, “because we know how beneficial that vaccine is not only in protecting people against COVID, but for those who do get COVID.”

Where and when can I get the COVID and flu vaccines?

Because this iteration of the COVID-19 booster vaccine has just received approval, Yale does not yet have it in stock, Wilson explained.

In an email to the News, Wilson said the University expects supplies by October, “if not sooner.” She added that an email with information about vaccines is scheduled to arrive in students’ inboxes later this week. 

Students, faculty and staff can periodically check for updates on the availability of the vaccine through the Yale Vaccine Program website and, once Yale receives a supply of the vaccine, will be able to make appointments to receive it. Wilson noted that the University made some of these appointments available for October, but that all the October appointments have already been booked.

While the COVID-19 vaccine will not be immediately available on campus, appointments to receive this year’s flu vaccine are readily available. Students, faculty and staff can schedule their vaccinations at any one of a number of locations, including both adult and family flu clinics. An option to receive a flu shot at an already-scheduled appointment with Yale Health, unrelated to getting the vaccination, is available as well.

Why should I get vaccinated?

Martinello and Wilson strongly emphasized the importance of getting vaccinated against both COVID-19 and the flu.

In her University-wide email, Wilson cited the capacity of the flu vaccine to prevent infection or decrease the severity of illness if one contracts the virus. She also emphasized the vaccine’s ability to provide protection to not just the recipient, but to everyone around the recipient as well.

“Vaccine reduces the risk of spreading infection to vulnerable members of your family and community, including infants, pregnant people, older individuals and those with weakened immune systems,” Wilson wrote.

In a college campus setting, where students and staff may interact with dozens of people per day, Wilson said, such community protection is vital to allowing classes, extracurriculars and other activities to move forward without posing any danger to those involved.

Ned Swansey ’25 agreed with Wilson’s sentiment, citing students’ responsibility to not just their own health but to that of their peers and professors.

“As a large and relatively insular community, there’s a lot of potential for illnesses to spread if people don’t get vaccinated,” Swansey wrote to the News. “I believe that as students, we have a responsibility to get vaccinated not just for our own health but also to protect other students, faculty and staff.”

A risk for significant complications and a recent increase in the number of hospitalizations due to COVID-19-related illness also factors into the importance of getting vaccinated, according to Martinello.

As COVID-19 becomes endemic in a similar way to the flu, he explained, the public should take the lessons learned from the pandemic into their wider mindset towards preventing the transmission of respiratory viruses.

“During the years of COVID, we’ve come to learn that the transmission of these respiratory viruses is in large part preventable through what we would call non-pharmaceutical interventions — so, doing things like keeping your distance, staying home when you’re sick and wearing a mask,” Martinello said. “And I think not only should we continue to apply those behaviors when we’re concerned about COVID, but I think we should think more broadly about them to include other respiratory viruses, especially influenza.”

The Campus COVID Resource Line is available at (203) 432-6604 from 8:30 a.m. to 5:00 p.m., Monday through Friday.

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‘That’s the kind of person you want’: colleagues and friends reflect on Yale School of Medicine alumna Mandy Cohen becoming CDC director https://yaledailynews.com/blog/2023/09/06/thats-the-kind-of-person-you-want-colleagues-and-friends-reflect-on-yale-school-of-medicine-alumna-mandy-cohen-becoming-cdc-director/ Wed, 06 Sep 2023 06:19:44 +0000 https://yaledailynews.com/?p=183675 After President Biden’s June announcement that Cohen would step into the role over the summer, the News spoke with Cohen’s former advisors and colleagues about her career.

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President Joseph Biden tapped Yale alumna Mandy Cohen MED ’05 to serve as the next director of the Centers for Disease Control and Prevention this summer. 

Biden selected Cohen on June 16 and she formally stepped into the role on July 10. She brings a wealth of experience from different fields to the role, having previously served in governmental positions at state and federal levels and as CEO of private company Aledade Care Solutions. In interviews with the News, Cohen’s friends and former colleagues reflected on her new role. Cohen was not available for comment. 

Nancy Angoff, MED ’90 SPH ’81, the former associate dean of student affairs for the medical school, remembered Cohen as a student who was “quite mature” upon first impression and “thoughtful.” 

Having met with Cohen several times throughout Angoff’s studies at the Yale School of Medicine, Angoff noted that Cohen was someone whose burgeoning interests in healthcare and involvement in leadership were clear from the start. 

In light of her hard work, Cohen’s new role at the CDC did not come as a complete surprise to Angoff.

“In Mandy’s case, I think she foresaw making a difference in the bigger way that medicine is practiced out there in the world, as opposed to maybe in my office or even in my community,” Angoff said in an interview with the News.

As a summer intern in college, Angoff said, Cohen had already started getting involved in government by working 

Later on during Cohen’s medical studies, Angoff explained that Cohen’s desire to “make an impact in a big way” in the world of health care led her to pursue a Master in Public Health degree at Harvard and travel to South Africa to analyze home-based care programs for those with HIV and AIDS.

After completing an internal medicine residency at Massachusetts General Hospital, Cohen moved to the Centers for Medicare and Medicaid Services in 2013, where she worked alongside Andy Slavitt, CMS’s former administrator and a senior advisor to the Biden administration’s COVID-19 response coordinator.

Slavitt first promoted Cohen to chief of staff at the agency, after which she eventually gained the additional title of chief operating officer. In these positions, Slavitt said in an interview with the News, they co-ran the agency together, where he observed first-hand Cohen’s value-driven approach to healthcare leadership.

“She’s someone who brings purpose and heart … to everything she does,” Slavitt explained. “She is very ethically, morally driven to do the right thing.”

One of Cohen’s former advisors during her time at Yale, Howard Forman, a professor of economics and of radiology and biomedical imaging at YSM, echoed that sentiment.

While Forman and Cohen only met a few times during her time as a student at Yale, in subsequent years they grew to become close colleagues and friends. Forman told the News that Cohen’s personality is strongly reflected in her approach to her work.

“What I would say is that she is an enormously capable and empathetic person who approaches public health and healthcare delivery in the same compassionate way that she provides clinical care as an internist,” Forman said.

After her time at the Centers for Medicare and Medicaid Services, Cohen served as the director of North Carolina’s Department of Health and Human Services for half a decade, where she received significant praise for coordinating the state’s response to the COVID-19 pandemic. Cohen worked for a year at Aledade Care Solutions after stepping down as North Carolina’s Department of Health and Human Services’ director. 

Cohen now steps into the highest leadership role at an agency faced with a wide range of challenges.

Both Angoff and Forman expressed their concerns about the CDC that Cohen is set to inherit. Angoff noted the significant political controversy and public distrust enveloping the agency, while Forman cited issues with bureaucratic organization and morale within the agency.

“I think that her stepping in at this specific time in history is a tough one, because I think, from what we understand, morale has been low,” Forman said. “There are a lot of concerns about how do you get morale back up? How do you get people to take pride in their work and to appreciate it?”

Slavitt said Cohen’s strength lies in being “more of a uniter than a divider” when it comes to tackling not just the COVID-19 pandemic, but other public health issues like the opioid epidemic and mental health crises where “everybody wants a solution.” 

Slavitt applauded the work Cohen has done so far as director, highlighting her efforts to promote clear, accurate information about the COVID-19 virus and vaccines to the American public, despite the issue’s political divisiveness.

“In jobs like this in Washington, you can’t be afraid of tough decisions and tough situations,” Slavitt said. “And what sets her apart is that she runs towards those situations, solves those problems, faces them with real accountability and execution. So if you’re talking about somebody who’s going to improve the culture at CDC, which has been beaten up quite a bit over the last few years, that’s the kind of person you want.” 

The Centers for Disease Control and Prevention is headquartered in Atlanta, Georgia. 

Kayla Yup contributed reporting.

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First administration of gene therapy clinical trial for Wilson’s Disease completed at YNHH https://yaledailynews.com/blog/2023/03/06/first-administration-of-gene-therapy-clinical-trial-for-wilsons-disease-completed-at-ynhh/ Tue, 07 Mar 2023 04:15:39 +0000 https://yaledailynews.com/?p=182064 A new gene therapy for Wilson’s Disease hopes to provide patients with alleviation of severe symptoms associated with the condition.

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For decades, Wilson’s Disease has evaded comprehensive treatment. The wide-ranging physical and neurological symptoms of the condition have upended afflicted patients’ lives, with no potential cure in sight. However, a new clinical trial at Yale has provided one of the most effective treatments to date to control the disease and its symptoms and has the potential to alleviate some aspects of life with Wilson’s.

A groundbreaking new gene therapy clinical trial headed by Michael Schilsky — professor of medicine and medical director of adult liver transplant at Yale New Haven Transplantation Center — was administered to its first patient in the world at Yale New Haven Hospital.

The treatment aims to enable the patient’s body to produce the copper transporter protein that is missing in those with Wilson’s Disease — the absence of which causes toxic levels of accumulation of copper in the body. In fostering the presence of the protein, the hope is to alleviate some of the symptoms associated with Wilson’s Disease and empower the patient to be able to return to different physical and emotional aspects of their lives before their Wilson’s diagnosis.

“We have limited treatments for Wilson’s Disease … [that] are just to control the disease, not to cure the disease,” said Daksshi Hettiarachchi, primary care coordinator of the clinical trial. “If this gene therapy works, if they don’t have to take this [D-penicillamine] treatment, it’s going to be a huge, huge plus for them.”

A rare inherited condition, Wilson’s Disease is expressed at various levels from patient to patient. Symptoms include, but are not limited to, jaundice; Kayser-Fleischer rings, which are copper-toned rings in the eyes; speech and physical coordination problems; and fluid buildup in the legs and/or the abdomen. 

Schilsky explained that the signs and symptoms of the disorder may be present in a patient for a long time, and the disorder is best treated when diagnosed early at a time of minimal to no symptoms. Upon diagnosis, he continued, patients may either feel relieved to learn the cause of their illness or undergo a life-changing reckoning if they experience disabling symptoms.

“Some of the physical impairments due to the neurologic expression of the disease may make work impossible and create difficulty with activities of daily living,” Schilsky said. “The mental health changes may cause disruption in relationships and isolation and even require hospitalization if severe.”

Due to the nature of the impact of Wilson’s Disease on patients’ personal lives, interest in conducting an increased number of new clinical trials to combat the symptoms and causes of Wilson’s has exploded over the past decade, according to Schilsky. He explained that novel treatment agents are not the only center of attention in this effort; previously-existing copper chelator treatments, such as choline tetrathiomolybdate and trientine tetrahydrochloride, are undergoing comparison testing to assess their effectiveness in combating Wilson’s and alleviating the deterioration of neurological disease seen in some patients whose symptoms unexpectedly worsen upon receiving treatment.

Schilsky said one standout example of this increased interest was found at the University of Navarra in Spain, where Gloria Gonzalez-Aseguinolaza, director of innovation and transfer at the university, and her colleagues were able to build and test a small construct of the Wilson’s Disease gene inside a viral vector, a tool used to deliver genetic material into the cell.

Desiring to support a gene therapy project, Schilsky spoke with colleagues who had heard of Gonzalez-Aseguinolaza’s work and wanted to bring it into clinical practice.

“My answer was yes, and I thought that since the disease has available treatments, the patient could be given the treatment and then assessed for its function before their standard of care treatment was withdrawn — making it safer for the patient,” Schilsky said.

Bringing and testing a Phase 1 clinical trial treatment at Yale necessitated the establishment of strict criteria for selecting which patient(s) could be viable candidates for the trial. According to Hettiarachchi, the rigorous screening process to ensure that the patient’s disease condition is stable takes about three months to complete before treatment can begin.

Upon passing the screening criteria, Hettiarachchi continued, the patients receive an IV treatment of the gene therapy, which goes into immediate effect.

“I think immediately, [the liver] starts to produce the copper transporter protein that we expected for the gene therapy to produce,” Hettiarachchi said. “And then we have a lot of frequent lab work to assess that the gene therapy is working, whether the protein is being produced […] After three months, we do a radio copper assessment on these patients. And then that’s where we definitely know whether the gene therapy is working.”

The timeframe for the entire clinical trial will likely take three to 10 years due to its dependence on the success of early Phase 2 treatments, according to Schilsky. He explained that one of the key components of the trial’s success is to see whether there is a dose response in human patients, as was observed in preclinical animal testing, and that the dose level is safe and effective during and following treatment.

Upon receiving the novel treatment, Warren — the Wilson’s Disease patient treated at Yale — has seen improvement in symptoms associated with the disorder and looks to return to a normal diet instead of the restrictive one that Wilson’s patients undertake due to complications associated with copper buildup in the body.

While the safe administration of the gene therapy and preliminary symptom alleviation seen in Warren is promising, Ricarda Tomlin, clinical research manager for the trial, noted that the same success needs to be seen in multiple patients to call the trial as a whole successful.

“A single treatment is not scientifically very convincing, and we don’t know if the treatment for Warren was successful yet or not, we just know it was safely administered,” Tomlin wrote in an email to the News. “The study needs to enroll 16 patients for this Phase 1/2 segment and follow them for a number of years, before we have enough data to call it a success.”

Tomlin noted that the trial is currently recruiting more patients at Yale and around the world, and that if overall success was observed in those 16 patients, the trial would enter Phase 3, after which the FDA would review it and determine whether it could be offered as a widespread medical treatment for Wilson’s Disease.

For those that may not see success following participation in the trial, Schilsky explained, future options include going back on the most common medication for Wilson’s Disease, D-penicillamine, and potentially gene repair or replacement via CRISPR-based technologies.

According to Hettiarachchi and Schilsky, as the only Center of Excellence for Wilson’s Disease in the Northeast, experienced adult and pediatric hematologists, neurologists, psychiatrists and transplant specialists can work with clinical researchers to apply their expansive banks of knowledge to developing and administering novel powerful treatments.

“Yale has a clinical trials unit dedicated to helping support the infrastructure to be able to do innovative treatments with close monitoring and obtaining the necessary biosamples that are inherently needed to measure safety and outcomes of treatments,” Schilsky said. “So yes, these partnerships are invaluable.”

Tomlin recognized the important contributions of many different departments at Yale in bringing this clinical trial together, including ophthalmology, neurology and MRI experts, Yale’s Positron Emission Tomography Center, YNHH’s investigational pharmacy, the Hospital Research unit, and members of the ethics boards.

She also emphasized their gratitude towards patients with conditions like Wilson’s who willingly participate in complex, time-intensive clinical studies to help the research team determine that the trial will be safe and efficient for everyone.

Wilson’s Disease occurs in about 1 in every 30,000 people.

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Digestive Health Center provides care to over 1000 patients in first three weeks of operation https://yaledailynews.com/blog/2023/02/23/digestive-health-center-provides-care-to-over-1000-patients-in-first-three-weeks-of-opera/ Thu, 23 Feb 2023 06:21:18 +0000 https://yaledailynews.com/?p=181763 The newly-opened Digestive Health Center combines patient care, clinical research and community education in New Haven.

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Yale New Haven Hospital’s Digestive Health Center in North Haven — which seeks to advance digestive research and comprehensive medical care for weight management — has already served over 1000 patients in its first three weeks since opening. It is recommended you read more about them so you can see what services you might need.

The new clinic, which opened to the public on Jan. 31, serves as a central hub for digestive health needs. In addition to holding face-to-face visits from patients, it contains a lab space which researchers can utilize to conduct their clinical trials. 

The clinic also offers comprehensive resources for patients through all the steps of weight management, from early prevention training to post-operative care. This is made possible by the work of medical providers, surgeons, nutritionists, physiologists and social workers, for all of whom the digestive health center serves as a central collaborative space. 

This achievement underscores the pressing health concerns faced by people, especially the elderly, in managing their digestive health effectively. It is highly advisable to explore more about the center’s services, possibly through a resource like life line review, to better understand how it can address specific health needs, ensuring the well-being and quality of life for individuals of all ages.

In recognizing that achievement and maintenance of target weight is a multifaceted and lifelong journey, [we have] assembled a multidisciplinary practice offering a comprehensive range of services to help patients achieve long-lasting weight management,” center founders Bubu Banini and Loren Laine wrote in a joint statement to the News. 

Banini, an assistant professor of medicine in digestive diseases, and Laine, a professor of medicine in digestive diseases, wrote that they felt a “disconnect” between the specialties involved in weight-related care, noticing how these professions were usually placed in separate locations. Pointing out the importance of holistic weight loss treatment, they pushed for the creation of a digestive health service line by Yale New Haven Health, collaborating with community medical specialists, as well as gastroenterologists and surgeons from the School of Medicine. 

The North Haven facility is the second location created in their mission to build high-quality digestive health centers across Connecticut, starting with the Westport center which opened in August 2022. The newest center is the larger of the two, with over 9000 square feet of clinical space, 15 exam rooms and four consultative rooms. 

The campus also houses and pilots new medical technology. Each exam room comes with a touchscreen monitor that allows patients to make telehealth visits or visualize important test results presented by their doctors. Diana Rivera, patient services assistant and manager at Yale New Haven Hospital, described these new opportunities for patient engagement and interaction as a “step in the right direction.” 

“Patients have been very receptive to utilizing this technology,” Rivera told the News. “It helps to accommodate patients where they are — we can use [the monitors] for educational videos, maybe to show them some information prior to the provider coming into the room to see them.” 

Since its opening on Jan. 31, the center’s nursing team has seen patients with ailments including motility disorders, delayed gastric emptying, fatty liver disease, obesity and liver scarring and more. While Rivera recalled formerly having to play “phone tag” to follow up with patients and connect them to the right specialists, she noted the convenience of having one place which covers all types of conditions — what she called a “one-stop shopping type of deal.”

This centralization not only eases the burden of staff communication, but also makes patients feel more familiar and welcomed in their medical journeys. Though the center has not been open long enough to collect data on current experiences, ambulatory practice nurse Alexis Langston observed that her patients seemed happier with their streamlined form of care. Langston also spoke positively about the closer relationships she could craft with familiar patients.

“We know our patients, and our patients know where to come,” Langston said. 

Beyond immediate treatment, the center offers wraparound support for patient wellness — bariatric surgical patients, for instance, have access to nutritionists, physiologists and social workers following their surgery. 

“It’s a great space, and it will treat patient[s] as a whole, as opposed to having the patient take other steps to take care of their problem,” Angelica Rucker, an ambulatory practice nurse at the digestive health, said. “We want to do it right here. We’re cutting out the middleman.”

For individuals with obesity who do not qualify for surgery — an extensive process with rigorous financial, mental and physical vetting — the center teaches alternative strategies toward weight loss. Patients are provided guidance on how to self-administer their medications by injectables, and nurses follow up with providing additional resources and check-ins. 

The paragon of treatment beyond the operating room, the Irving and Alice Brown Teaching Kitchen is one of the hallmark features of the center’s offerings for patients and providers alike. As the first of its kind in Connecticut, the kitchen will couple state-of-the-art equipment with interactive in-person and online cooking classes led by a chef and registered dietitian. While the chef will help people make meals they enjoy, the dietitian will work to create an individualized nutrition plan for each patient. The result is “food which not only taste[s] good, but promote[s] wellness,” according to Banini and Laine.

“I think it’s really going to be transformational for patients in their lives,” Rivera said. “And, you know, helping to support them and leading [a] healthier lifestyle.”

The kitchen is set to open in March or April, and Banini and Laine expressed excitement about its capacity to “build cooking skills and confidence.” They highlighted its educational and outreach components as well, providing nutritional education to low-income communities that may lack access to healthy food.

Additionally, the clinic seeks to cultivate professional development and learning for its nursing team. Combined with its function as a research facility, it will provide nurses and other health practitioners with opportunities to work alongside research coordinators and principal investigators in clinical trials. Already, Banini has created and presented a session called “Clinical Research for Non-Researchers: An Overview” to the center’s staff.

Such opportunities seek to benefit researchers and nurses alike. As nurses gain hands-on experience in clinical research, ongoing clinical trials receive nurses’ expertise on patient conditions. Rivera hopes the nurses’ personal knowledge and care for patients will help them identify individuals that could be viable candidates for new clinical trials. 

In an interview with the News, ambulatory practice nurse Leah Imperial-Gomez said that the center has already provided her with a new and valuable perspective on patient care. As she and many of the nurses were previously in-patient settings, Imperial-Gomez said they often missed out on seeing the ambulatory perspective of care.

“It’s really refreshing to see the other side when the patient’s not acutely recovering or ill, and how we can help prevent them from having to go to the hospital,” Imperial-Gomez said.

As the center continues to develop and unveil new programming, the organizers and staff look optimistically toward the future. Banini and Laine made mention of educational and research collaborations on the horizon, while the patient services team emphasized the human-centric care the clinic has already fostered.

“We’re able to accommodate any and every patient,” Rivera said. “Regardless of their situation, or needs, we’re able to accommodate them.”

The Digestive Health Center in North Haven is located on 8 Devine St. 

 

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