Home Care In Baldwin, MD

It is crucial for dermatology clinicians to be aware of the impacts of isotretinoin use on patients with acne, including inflammatory bowel disease (IBD), depression, and emergency contraceptive options. During the 2023 Acne and Rosacea Meeting’s (ARM) Yourself With Knowledge webinar, organized by Masterclasses in Dermatology, Hilary Baldwin, MD, reviewed the latest updates in literature and consensus guidelines for acne treatment using isotretinoin.

Baldwin, a board-certified dermatologist and medical director of the Acne Treatment & Research Center in Brooklyn, New York, and clinical associate professor of dermatology at Rutgers Robert Wood Johnson Medical Center, first reviewed recent large case-controlled and cohort studies demonstrating that there is no link between increased incidence of IBD with isotretinoin, despite concerns raised in 2010.

Having acne is an independent risk factor for depression, anxiety, and suicidal ideations in patients, and mainly boys, with severe acne, according to Baldwin. A meta analysis showed that isotretinoin use actually improved the psychological wellbeing of 17 patients with acne. To best help her acne patients taking isotretinoin, Baldwin gives out her personal cell phone number for any emergency calls from her patients.

Lastly, Baldwin noted that there still is not enough clarity for clinicians about what to do with emergency contraceptives and patients taking isotretinoin. “In a survey of 57 pediatric dermatologists, 68% said they had never received any education; it's not part of the core curriculum for residents, and the termination of pregnancy conversation needs to take place basically, regardless of our personal opinion on the subject,” said Baldwin.

Transcript

Hilary Baldwin, MD: Let's talk briefly about inflammatory bowel disease: does isotretinoin cause it is associated? Is it a coincidence? And to answer that question, I think we have to start by looking at the background data. Crohn's and ulcerative colitis are incredibly common in the age group that we're treating with isotretinoin. There's a very high incidence of family history of both of them, especially Crohn's; 26-fold increased risk if a sibling has Crohn's and 50% monozygotic twin concordance, not quite as much for ulcerative colitis. So, we started worrying about this back in 2010. When a case-control study showed a minimal dose-dependent risk for ulcerative colitis, but not for Crohn's. Since then, we've had 4 large case-control and cohort studies showing no link, a large Mayo Clinic study showing a reduced incidence of IBD, and a meta analysis of 9.7 million pulled patients again showing no link with IBD. What are the consensus guidelines saying? Most of them don't mention it. Ours says there's no evidence to support a link or risk. And I think the Canadian guidelines make the most sense saying inquiry about IBD symptoms and family history is prudent prior to instituting isotretinoin care.

Quickly looking at depression we again we have a ton of background noise. Being 18 to 25 is an independent risk factor for mental health issues. It's the highest as well as depression, as well as suicide attempts in that particular age group. Having acne is also an independent risk factor for depression, anxiety, and suicidal ideation, especially in more severe acne and especially in boys. So there's a lot of noise at baseline and we're superimposing isotretinoin treatment on top of that. So does it make any difference? Or is the depression that we're seeing based on the age and the acne condition of the patient? Well, a meta analysis and systematic review looked at 20 studies that met criteria; 3 showed no association, 17 showed an improved psychological wellbeing after the use of isotretinoin. And the conclusion of these authors was that the use of isotretinoin is associated with an improvement in depression symptoms. So what are we going to do? What's the goal here? Keep a high index of suspicion, not so much because we think isotretinoin is causing the depression, but because the patients in our care are in an age group, in a disease group, that are likely to develop depression, make sure the patients with a prior psych history are plugged in. And in my opinion, all patients on isotretinoin should be given 24-hour emergency contact information, not with an answering service, but with me. I share my cell phone number and I have to tell you, in 20 years of doing it, I've never had a patient misuse that right.

So just one word on pregnancy. I think we do not understand well enough what to do with emergency contraception. And I think it's very important in treating our women of childbearing potential with isotretinoin. It's barely mentioned in the iPLEDGE brochure. In a survey of 57 pediatric dermatologists, 68% said they had never received any education, it's not part of the core curriculum for residents, and the termination of pregnancy conversation needs to take place basically, regardless of our personal opinion on the subject. If we're not having the conversation with them, someone in the office needs to have that conversation. And this of course, is even more important since the reversal of Roe v Wade. And speed is of the essence here because we have 2 options. The much easier is the morning-after pill on the left often called Plan B, which has to be taken within five days of intercourse. The mechanism of action here is that it delays or inhibits ovulation. This does not affect implantation. So specifically, the Dobbs V. Jackson lawsuit that overturned Roe v Wade does not include the activity of plan B as the destruction of what Roe called "potential life." So, it's not nearly as difficult to deal with as the abortion pill on the right, which is way more expensive. It can be taken, however, up to 70 days to after the last menses and does cause a medical abortion. So, this is something that we need to consider. We need to think about, we need to educate ourselves on it so that we're prepared when the patient calls and says, “what do I do? Last night the condom broke,” or “last night I had unprotected intercourse.”

[Transcript lightly edited for clarity]

Reference

Baldwin H. Isotretinoin's impact on irritable bowel syndrome, depression, and need for emergency contraception. Presented at: 2023 ARM Yourself With Knowledge: Acne and Rosacea Meeting; October 3, 2023.

August 9, 2023

Redwood City – In her first interview as San Mateo County’s Health Officer, Dr. Kismet Baldwin-Santana said her vision includes addressing the opioid epidemic, improving disaster preparedness and expanding health equity.

Baldwin-Santana this week began her tenure as health officer, a role that gained widespread public attention during the COVID-19 pandemic. She succeeds Dr. Scott Morrow, who retired after 31 years of service, and is the first woman to hold the post in the County’s history.

“The role of health officer is uniquely challenging,” said Dave Pine, president of the Board of Supervisors. “While the pandemic thrust health officers into the spotlight, the day-to-day work involves improving the overall health of our entire community.”

“Dr. Baldwin-Santana is uniquely positioned to guide us as we continue to shape a public health system that will help San Mateo County residents live longer and better lives,” Pine said.

Appointed by the Board of Supervisors, the pick vaults Baldwin-Santana into a role with broad authority under California law to prevent disease and the authority to issue health orders. The health officer serves as a principal spokesperson and a trusted voice during outbreaks or emergencies.

Yet the majority of the day-to-day work entails developing public health policy, working with community-based organizations and advising elected officials on public health strategies.

Most recently the interim health officer in Sonoma County, Dr. Baldwin-Santana has been a deputy health officer in Sonoma County, a health officer in San Joaquin County, and a quarantine medical officer for the Centers for Disease Control and Prevention.

Baldwin-Santana has been deeply involved in public health work since earning her bachelor’s degree in microbiology and a Doctor of Medicine degree at Ohio State University. She did post-doctoral work at UCLA where she studied ways to reduce the incidence of sickle cell disease.

Early in her career as a neonatologist in New Hampshire, Baldwin-Santana developed treatment plans and managed care for newborns experiencing neonatal abstinence syndrome due to exposure to opioids in the womb.

Babies often suffered from tremors, poor feeding reflexes, and irritability. In some cases, she found that mothers who had developed an addiction to painkillers often escalated to heroin and other street drugs during their pregnancies.

She teamed up with obstetricians and gynecologists working in methadone clinics to help get mothers into treatment programs. Such first-hand experiences helped to shape her career.

“I really enjoyed that work,” she said. “It allowed me to see the upstream aspect of medicine, addressing the causes of the problems facing my patients.”

Such work led her to the broader field of public health. She has worked with coalitions involving law enforcement, schools, substance use disorder treatment providers, general health care providers, emergency medical services and other key players to tackle opioid overdoses and deaths.

Her interest in community health led her to San Joaquin County, where she served as health officer from 2018-19. She focused on programs for communicable disease, sexually transmitted infection and tuberculosis. This included a mobile team of community health workers, disease investigators and nurses to perform rapid testing and vaccine administration.

As COVID-19 pandemic began, she served as a quarantine medical officer for the Centers for Disease Control and Prevention at San Francisco International Airport. She supervised entry-screening procedures and assessed travelers’ disease exposure, working with local health care providers and agencies, including San Mateo County Health, to prevent further spread.

As Sonoma County’s deputy health officer, she oversaw COVID-19 testing, vaccine administration, case investigation and contact tracing and participated in the region’s coordination and response through the Association of Bay Area Health Officials.

During the pandemic, she also made time to complete a master’s degree in public health at the University of California, Berkeley.

“I really liked the ethics class and the course on implementation science,” she said. “How do you get people to take a vaccine? The COVID-19 vaccines were well tested and very effective, but they were a tough sell for many communities.”

As she steps into the role as the County’s top public health official, Baldwin-Santana praises Morrow’s decades of service and the support for public health from elected leaders and the community. “There’s a really strong foundation here,” she said. “I’m excited to take a broad look. What are the best initiatives and policies and how can we all collaborate to move things forward?”

Louise Rogers, chief of San Mateo County Health, said, “I’m excited to welcome Dr. Baldwin-Santana to our county, where we share her passion for working to address the underlying causes of poor health in the community. She brings a wealth of experience that we can all learn from.”

In her spare time, Baldwin-Santana enjoys salsa dancing, hiking and cycling with her husband. Together, they have a cat named Diego.

Photo Source: WebMD

Posted Thursday, June 29, 2023 7:59 pm

Executive Editor[email protected]

A fifth-generation farm in Daphne, a 400-employee nursery in Loxley and a U-pick farm with Airbnb rentals in Fairhope are all waiting to pioneer for the state its venture into medical cannabis.

The Alabama Medical Cannabis Commission voted on June 12 to award medical cannabis business licenses to 21 applications, including three from Baldwin County.

According to the law, which was signed by Gov. Kay Ivey in May 2021, the Commission could award up to 12 cultivator licenses, four processor licenses, four dispensary licenses and five integrated facility licenses. The number of licenses for secure transport and state testing lab licenses was not specified.

Flowerwood Medical Cannabis LLC is based in Loxley. As one of the five integrated facility licenses awarded, the company will grow, process and sell products. According to Kevin Northrop, chief operating officer, dispensaries will be in Loxley, Mobile, Monroeville, Montgomery and Gadsden.

"We went to (Commission) meetings and listened to the need," Northrop said. "It wasn't your stereotypical need of a user, it was old church ladies and white-collar professionals who were expressing a real need for this in our state because they've tried other things and it wasn't working for them or a family member."

Flowerwood Nursery has been operating for 85 years and has been in Loxley since the '40s. They employ roughly 400 employees depending on the season and maintain 2 million square feet of greenhouse space. The nursery grows, ships, markets and delivers to brands as big as Home Depot and Lowes, and they are the brand owners for Encore Azalea.

That experience in commercial-scale horticulture is what uniquely qualifies Flowerwood for the integrated facility role, Northrop said.

Flowerwood Medical is a separate company from the nursery, and they've partnered with local farming families like Christina Woerner McInnis, CEO and founder of SoilKit, one of the largest producers of sod in the country.

While those involved and approved have voiced excitement for moving forward with the pioneer program, a bump in the road appeared just a few days after the initial announcement of approvals. The Commission voted June 16 to stay all proceedings after discovering "potential inconsistencies" in how the applications were tabulated.

The Commission will use an independent review of all scoring data.

The stay paused procedural requirements, meaning the approved applications have not yet had to pay license fees, and likely they won't get their licenses by July 10. Those who were denied have been given a pause on submitted a request for investigating hearings by the end of June.

Once the stay is lifted, the award of licenses will be reconsidered, and a new timeline will be given for procedural requirements.

"We are excited to begin working with those applicants who were awarded licenses to meet the needs of so many Alabamians who are living with debilitating conditions that can benefit from medical cannabis," Commission Director John McMillan said at the initial June 12 meeting.

Heather Stringfellow and her husband, Tynes, said they hope the stay works itself out so they and the other licensees can move forward.

The Stringfellows opened Weeks Bay Plantation in Fairhope in 2000 as a plant nursery and got certified as USDA organic. Since opening, they've opened a commercial blueberry farm, event venue and Airbnb lodges on 60 acres of land that includes a 10-acre spring-fed lake, and they are known for sending their tomatoes to chefs and produce stores around the area.

They sprouted two greenhouses for hemp with it was legalized in Alabama and started researching the medical side when that path started clearing for Gulf Shore Remedies LLC.

"We have a veteran with cancer and a mother who has Alzheimer's. I'm amazed at what we know so far about what it can offer people, and we're all for it," Stringfellow said. "My husband has been a horticulturalist for over 40 years."

Her father served in Vietnam and brought back a Purple Heart, Gold Star, "the whole nine yards. When people see him, they immediately stand up."

He was living in Texas in 2020 when the cancer diagnosis came. He was told he wouldn't make it to November. They did surgery, moved him to Fairhope. Both of Stringfellow's parents are still alive.

"He dabbled with CBD when we produced hemp, and we've seen an amazing change in him," Stringfellow said. "He's another person I'm in this for."

Once available, participating physicians can certify patients for medical cannabis use for 15 conditions, including cancer, weight loss, chronic pain, Chron's and Parkinson's diseases, depression, epilepsy, HIV/AIDS-related nausea, panic disorders, PTSD, sickle cell, multiple sclerosis, Tourette's, spinal chord injury or a terminal illness.

Patients will receive a card to obtain products from licensed dispensers. The law says products can be available as tablets, capsules, tinctures, gelatins, lozenges, oils, gels, creams, suppositories, transdermal patches, nebulizers or inhalable liquid. The law prohibits medical cannabis from being smoked, used as raw plant material or consumed in food.

WASHINGTON – U.S. Senators Bill Cassidy, M.D. (R-LA) and Tammy Baldwin (D-WI) today introduced the Protecting and Transforming Cyber Health Care (PATCH) Act, to ensure that the U.S. health care system’s cyber infrastructure remains safe and secure for American patients. Over the course of the pandemic, there have been a number of ransomware attacks within medical devices and larger networks. These attacks affect patients, hospitals, and the medical device industry.

“New medical technologies have incredible potential to improve health and quality of life,” said Dr. Cassidy. “If Americans cannot rely on their personal information being protected, this potential will never be met.”

“In recent years, we’ve seen a significant increase in cyber-attacks that have exposed vulnerabilities in our health care infrastructure, impacting patients across Wisconsin and the country. We must take these lessons learned to better protect patients,” said Senator Baldwin. “I am excited to introduce the bipartisan PATCH Act to ensure that innovative medical technologies are better protected from cyber threats and keep personal health information safe while also finding new ways to improve care.”

U.S. Representatives Michael C. Burgess, M.D. (R-TX) and Angie Craig (D-MN) introduced the companion legislation in the House of Representatives.

“The U.S. health care system is and will always remain to be a critical infrastructure,” said Congressman Burgess. “We must take action and necessary steps to ensure that it remains cyber secure. Throughout the pandemic, there was spike in ransomware attacks within medical devices and larger networks. These attacks affect hospitals, the medical device industry, and most importantly American patients. This legislation will implement cybersecurity protocols and procedures for manufacturers applying for premarket approval through the Food and Drug Administration to ensure that users are properly equipped to deal with foreign or domestic ransomware attacks. It is time to examine how to modernize and protect our health care infrastructure. I’d like to thank Congresswoman Craig, Senator Cassidy, and Senator Baldwin for joining me in this important initiative and the stakeholders involved in the process and making of this critical legislation.”

“Over the past several years, bad actors have increasingly relied on cybersecurity vulnerabilities to take advantage of unsuspecting individuals and undermine our national security. That trend is especially alarming when it comes to personal medical devices, which can be exploited by cybercriminals – threatening the health and wellbeing of countless Americans,” said Congresswoman Craig. “I’m proud to join Representative Burgess and Senators Baldwin and Cassidy in this effort to bolster security in the medical device industry and defend American patients from ransomware and other attacks.”

The PATCH Act would:

Lewisburg, Pa. — Evangelical Community Hospital has added three new physicians, officials announced this week.

The hospital welcomed neurologists Kelly Baldwin and Christopher Cummings, and critical care doctor Katherine Patil to its staff.

As neurologists, Drs. Baldwin and Cummings specialize in diseases and treatment of the nervous system. Both physicians are practicing at Neurology of Evangelical. As a critical care physician, Dr. Patil specializes in serious and critical illnesses and injuries. She joins the Hospital’s Critical Care Group in caring for patients on the Critical Care Unit and is also available for inpatient pulmonary consultations and bronchoscopy.

Kelly Baldwin, MD, MSMEd

Dr. Baldwin received her Doctor of Medicine Degree from the West Virginia University of Medicine and went on to earn her Master of Science in Medical Education Degree from Lake Erie College of Osteopathic Medicine. She completed her Internal Medicine Internship at the University of Pittsburgh Medical Center and Neurology Residencies at the University of Pittsburgh Medical Center and West Virginia University, W. Va. She is Board Certified in Neurology. Dr. Baldwin has served as an Assistant Professor in Neurology at several institutions, most recently she served as an Associate Professor of Neurology at Tufts University School of Medicine.

Dr. Baldwin comes to Evangelical from Maine Medical Center, Portland, where she was a Neurology Hospitalist. In addition to her role as a neurologist, Dr. Baldwin will serve as the Medical Director of Medical Education at Evangelical, which oversees student education and advancement of shadowing and clinical education programs at the Hospital.

Christopher Cummings, MD

Dr. Cummings received his Doctor of Medicine Degree from Mount Sinai School of Medicine, N.Y. He completed his Internal Medicine Internship and Neurology Residency at the University of Pittsburgh Medical Center. Dr. Cummings is Board Certified in Neurology and Vascular Neurology by the American Board of Psychiatry and Neurology.

Dr. Cummings comes to Evangelical from Maine Medical Partners – Neurology, where he served as an attending Vascular Neurologist and the Stroke Clinic Director.

Katherine Patil, DO

Dr. Patil received Doctor of Osteopathic Medicine Degree from Lake Erie College of Osteopathic Medicine. She went on to complete an Internal Medicine Residency at the University of Connecticut. She completed a Fellowship in Pulmonary and Critical Care Medicine at the Lahey Clinic Medical Center, Mass. Dr. Patil is Board Certified by the American Board of Internal Medicine in Critical Care Medicine, Pulmonary Disease, and Internal Medicine.

Dr. Patil comes to Evangelical from Pottstown Medical Specialists, where she served as a Pulmonary, Critical Care, and Sleep Medicine attending for 10 years in the Philadelphia area. She also currently serves as a teaching attending in Critical Care Medicine and Pulmonology at Conemaugh Memorial Medical Center.

About Evangelical Community Hospital

Evangelical Community Hospital is a non-profit organization that employs 1,900 individuals and has more than 170 employed and non-employed physicians on staff. The facility is licensed to accommodate 131 overnight patients in private rooms designed for healing, patient safety, and positive patient experience.

The hospital provides a comprehensive array of services in both inpatient and outpatient settings and serves residents throughout the Central Susquehanna Valley, including those living in Snyder, Union, Northumberland, and Lycoming counties.

More information can be found at www.EvanHospital.com.

Hilary Baldwin, MD, medical director, Acne Treatment and Research Center, explains the microencapsulation technology in Twyneo cream and what research went into its development. Galderma announced the launch of the tretinoin .1% benzoyl peroxide 3% cream at the American Academy of Dermatology Annual Meeting, March 25-29, 2022, in Boston, Massachusetts.

Transcript

Can you explain what Twyneo cream is, and what makes it different from current facial acne treatments?

Twyneo is a brand new combination of 3% benzoyl peroxide and .1% tretinoin, and we remember that .1% tretinoin is the strongest of the tretinoins that we have. Now you might say, what's new about that? Tretinoin is 50 years old, benzoyl peroxide is 60 years old. You can call them old, or you can call them tried and true. We wouldn't still be using them if they weren't good medications. This ain't your grandmother's benzoyl peroxide and it ain't your grandmother's tretinoin. In this product, they are microencapsulated, so individually, benzoyl peroxide crystals and tretinoin crystals are microencapsulated in a silica shell. Those tiny little capsules, which are mostly less than 10 microns in size, are put into a moisturizing creamy base.

What that does is 2 things. The first is that most of us will remember that tretinoin and benzoyl peroxide don't play well together in the sandbox: the benzoyl peroxide inactivates by oxidizing tretinoin so that it's no longer effective. Here, because the 2 are segregated inside the cream, they do not come into contact with each other and that is no longer a problem. The second issue is that you might think, the strongest of the tretinoins and 3% benzoyl peroxide, they're both concentration dependent irritants. Isn't that going to be too much for the patient? Well, that microencapsulation means that it takes a while for the active ingredients to get out. They escape through microchannels in the layers of silica—which is sort of like the head of a cabbage, for example—[and] sneak out slowly about 50% over an hour's time. So, because it's coming out slowly, you don't end up with 1 big bolus of medication on the skin all at once, which reduces irritation and results in the good tolerability data that this drug has shown.

What can you tell us about the clinical data and research that went into this product?

Twyneo has finished its phase 3 clinical trial, in which patients were randomized in 2 separate studies to receive either Twyneo or the vehicle in a 2:1 ratio daily for a 3 month period of time. The efficacy data was quite good. Overall, at the end of 12 weeks, 32% of patients [were] clear or near clear, with a reduction of both inflammatory and noninflammatory lesions in the high 60s. More importantly though, perhaps: at 2 weeks and at 4 weeks, a very high reduction of both inflammatory and noninflammatory lesions of about 25% and then 40%.

Now, what does that mean to us as clinicians? It means that the patients are getting better rapidly, and that means they're more likely to comply with therapy so that, ultimately, they get up to that high level of of improvement. So a nice jackrabbit start so the patients are quickly seeing results and tending to use their medication more regularly.

The flip side of the coin, of course, is tolerability. The most efficacious drug on the planet isn't going to get used if it's not tolerable. So [Twyneo was] very well tolerated despite the fact, again, that it's the strongest tretinoin and benzoyl peroxide together in 1 product. Looking at local tolerability in both of those studies, the mean tolerability scores of all parameters—erythema, stinging, burning, itching, peeling—[were] all well below mild. Even with a little blip at that 2 week mark, just the way we normally see for topical retinoids, returning right back towards vehicle in a very short period of time, so extremely well tolerated over the long haul.

Hilary Baldwin, MD, medical director, Acne Treatment and Research Center, explains why tretinoin 1% benzoyl peroxide 3% cream is an important addition to the existing acne product market, and what other unmet needs she hopes to see researched.

Transcript

Why is it important that we have another acne product on the market?

It's always important to have new tools in our acne toolbox. Patients often come in to see us and they say, "I've tried everything, and nothing has worked for me before." It's always nice to have that new product that hasn't been tried before, so that's one issue. The second issue is that tretinoin is a really good active ingredient, but it's a problem child in some ways. Unless you formulate it correctly, it doesn't do well in ultraviolet light, it doesn't do well in combination with benzoyl peroxide, our primary other agent that we frequently use topically. So it can be a problem child, and in this particular formulation, it's not. The problems have been solved and we are able to use this very good active ingredient along with benzoyl peroxide—our other favorite active ingredient—together in one product that our patients are more likely to be compliant with, because they only need to use it once a day. So I think it's a win-win situation and a very good addition to our acne toolbox.

What are some other unmet needs in acne, and how do you hope to see them further researched?

[Regarding] unmet needs in acne right now, we're doing pretty well, I think. We recently had a topical sebum inhibitor added to our armamentarium, which kind of completes my wishlist. I guess if I had one area in which I would be most anxious to have an alternative, it would be in the very severe acne patients. Wouldn't it be lovely to have an alternative to isotretinoin with perhaps fewer issues associated with it, maybe fewer side effects, for example? Isotretinoin [is] clearly the best drug we have for the treatment of acne, and I'm in no way saying that it's not a great drug, but it would be lovely to have an alternative where we wouldn't have to worry about maybe teratogenicity. Pie in the sky, clearly, but I guess that's where my wishlist would lead me.

by Bill Snyder

Steroids are commonly given to infants during open-heart surgery to reduce inflammation, but whether the drugs significantly improve patient outcomes has not been settled — until now.

Results of the STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS) trial, co-led by investigators from Vanderbilt University Medical Center, were published Nov. 6 in The New England Journal of Medicine, and presented Nov. 8 at the American Heart Association Scientific Sessions 2022 in Chicago.

Approximately 40,000 operations for congenital heart disease are performed annually in the United States, the majority in infants younger than 1 year of age. Congenital heart disease surgery in infants is a high-risk procedure, with death and complications often directly related to severe systemic inflammatory response syndrome after cardiopulmonary bypass.

The randomized STRESS study, the largest prospective clinical trial ever conducted in the field of pediatric cardiology, compared methylprednisolone to inactive placebo in 1,200 infants under 1 year of age who underwent elective cardiac surgery with cardiopulmonary bypass at 24 U.S. congenital heart disease centers, including VUMC.

Compared to placebo, methylprednisolone did not reduce the likelihood of “worse outcomes,” including death during hospitalization or within 30 days after surgery, heart transplantation during the hospitalization, and a long postoperative hospital stay. Steroid use also was associated with a higher likelihood of hyperglycemia (high blood glucose) requiring insulin treatment.

However, the odds of postoperative bleeding requiring a second operation were lower in the methylprednisolone group, and patients undergoing less-complex operations were more likely to benefit from steroid administration.

These findings are particularly relevant to congenital heart surgery centers, said Scott Baldwin, MD, director of the Division of Pediatric Cardiology at Vanderbilt, and the study’s co-principal investigator. Roughly half of these centers give steroids during surgery, he said.

“This unprecedented study has settled an important question in the surgical treatment of congenital heart defects,” said Prince Kannankeril, MD, MSCI, who directs the Vanderbilt Center for Pediatric Precision Medicine. “While the results are nuanced, they suggest that further study and patient stratification could lead to a more personalized medicine approach to this difficult problem.”

Kannankeril, who holds the Richard B. Johnston Jr. MD, Chair in Pediatric Research, and Baldwin, the Katrina Overall McDonald Professor of Pediatrics, were among three co-authors from VUMC. The third was David Bichell, MD, chief of Pediatric Cardiac Surgery and William S. Stoney Jr. Professor of Cardiac and Thoracic Surgery.

Clinical trials, particularly those involving young children, have been hampered by the limited number of patients at a single institution and the high cost of patient recruitment.

STRESS utilized the Society for Thoracic Surgeons database, which includes 98% of congenital heart disease surgeries performed in the United States and Canada. By identifying patients through registries, the cost of conducting this study was cut by about two-thirds, compared to traditional clinical trials with similar enrollment.

“Using the ‘trial within a registry’ model, it was the cheapest per patient cost,” Baldwin said. “This is important because even though our final end point showed no definitive benefit, we could figure that out without a spending a fortune.”

Kevin Hill, MD, MS, chief of Pediatric Cardiology at Duke University Medical Center, and a former Pediatric Cardiology fellow and graduate of the Master of Science in Clinical Investigation program at Vanderbilt, is the paper’s first and corresponding author.

The trial was co-sponsored by the Duke University/Vanderbilt University Trial Innovation Center and supported in part through the Pediatric Trials Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

After weeks of calls from fans around NWSL to sell his stake in the Washington Spirit, Steve Baldwin has released a statement via the club’s social media saying that he has resigned as the Spirit’s CEO and Managing Partner.

The statement reads as follows:

In recent days, I have spent a lot thinking about the future of the Washington Spirit and the vision I laid out just three years ago. I have also listened—to team leadership and staff, investors, fans and players—to concerns about the Spirit’s workplace culture and our prior coach’s conduct. While there is a range of opinions on how we got here, and how to move forward, everyone—none more so than me—is committed to improving the club’s culture, removing distractions, and returning the focus to the players and the pursuit of a championship. With that goal in mind, and at the recent request of our players, I have decided to resign as CEO and Managing Partner of the Washington Spirit, effective immediately. Club president Ben Olsen will have full authority over all club operations.

This was an extremely difficult decision for me. I have poured everything into building this club and care deeply for the players, staff and fan base. I have no doubt made some mistakes, but my efforts and focus were always on building a professional experience for our players, the club’s profile and the beautiful game in the DMV. I hope that stepping back removes me as a distraction and allows the club to thrive.

Baldwin’s statement does not clarify whether he plans to sell his stake in the team, which has been the focus of Spirit supporters in recent weeks. Earlier today, Pablo Maurer of The Athletic reported that Baldwin yesterday named a price at which he’d sell his 35% share in the Spirit to Y. Michele Kang (who, buying the full stake, would own 70% of the club).

The statement also alludes to a request from players. According to a report from Molly Hensley-Clancy at the Washington Post, the squad submitted a letter to Baldwin that included a demand that he step down as CEO and Managing Partner. However, according to The Athletic’s Meg Linehan, Baldwin’s statement does not answer everything the players asked for in their letter:

Reporting with @MLSist: The players of the Washington Spirit are currently training and have yet to see Steve Baldwin’s statement. Sources told us that the players had sent a letter to Baldwin yesterday with asks, and believe today’s statement does not meet them. #NWSL

— Meg Linehan (@itsmeglinehan) October 5, 2021

A new report at The Athletic went into further detail, noting that sources believe that Baldwin’s move today is “undermining” what the players demanded in their letter. The report also notes conclusions from the recent league investigation into the Spirit’s internal culture, including multiple violations of the league’s anti-harassment policy from Burke and former assistant coach Tom Torres, explosive new details alleging that the club “rage-traded” USWNT stars Rose Lavelle and Mal Pugh, issues with hiring Human Resources staff from Baldwin’s company Qbase, and claims that club President of Sporting Operations Larry Best helped create a difficult work environment for staffers that disagreed with the choices he and Baldwin made.

Spirit players responded en masse this evening, posting a statement across social media channels. Per the statement, Baldwin stepping down was not enough, and that they are calling on him to sell his stake in the club to Kang.

The full statement is as follows:

Steve,

Today you stepped down as CEO and Managing Partner.

We are disappointed and frustrated that we received no direct response from you to our letter, or even an acknowledgement that you received it. We have shown incredible restraint by not commenting publicly on all the infractions committed by the club and abuse we have experienced. We were open and honest with you, after holding our voices for a long time.

In your statement, you declared your commitment to returning the focus to the players. Returning to our phones post training with yet another news story about our club is a distraction to our game preparation, our season and our careers. We realize some of your efforts may have been sincere, but that time is past.

Right now, as we look across the soccer landscape, packed with painful stories of sexual abuse, emotional abuse, and team mismanagement, we, along with our peers are suffering. We want to stand in solidarity with them, rather than being dragged into what appears to be an ego-driven battle. We would like for the focus to actually return to the players.

When we asked you to step aside, step back from management, we clearly meant you should not retain any management control. We are sure you understood that. You still have a firm grip as majority owner on the decisions that need to be made at the club even if they are made from behind a veil. In your final act as Managing Partner, you passed the baton to someone you hired who has virtually no experience in the role you left him. We have no confidence in that management structure, especially on the soccer operations side, and we don’t have reason to believe that you won’t be involved. This is not a fresh start.

Let us be clear.

The person we trust is Michele. She continuously puts players’ needs and interests first. She listens. She believes that this can be a profitable business and you have always said you intended to hand the team over to female ownership. That moment is now.

Please sell to Michele at a reasonable price and uphold your stated intention, in 2019, of donating any profit you see to the Maryland Soccer Foundation.

Baldwin’s departure from a day-to-day role at the Spirit comes amid a wave of player-driven change throughout the NWSL. After a devastating report detailing years of sexual coercion and misconduct at multiple clubs, NC Courage coach Paul Riley was fired, and US Soccer announced that his coaching licenses have been suspended. The aftermath of that report included commissioner Lisa Baird and league general counsel Lisa Levine both stepping down.

The Spirit have been in upheaval for nearly two months now after Hensley-Clancy’s report of abusive conduct from former coach Richie Burke. Former players, including the on-the-record account of Kaiya McCullough, detailed verbal abuse, a culture of fear, and racially insensitive remarks at the club. That eventually lead to Kang pushing to buy Baldwin out, with Kang saying in a statement to fans and investors that Baldwin had even committed to do so on August 13. It is also worth noting that Baldwin has publicly declared a “commitment to donate my economic proceeds to the Maryland Soccer Foundation when my interest in the Spirit is transitioned to someone else.”

Amid all of this, the Spirit have a crucial game against NJ/NY Gotham FC tomorrow night at Subaru Park in Chester, PA. The NWSLPA has said that while they have more demands of the league coming, players have agreed to go forward with tomorrow’s games. It is unclear what will happen with the slate of games from this past weekend, in which players informed the league of their intention to not play, leading to the league calling those games off.

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