Birmingham Medical News May 2022

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UAB New Scanner Takes Images Mid-Surgery By anSLey FranCO

sion that I had for many years,” Markert said. “The interoperative MRI allows us UAB Hospital is the first in the state to view brain images taken while the surand only the fourth in the entire southgery is underway to confirm that we have east to open a new surgical suite with an resected as much of the tumor as possible, intraoperative MRI scanner that allows while leaving healthy brain tissue intact. surgeons to take up-to-date images in It also has applications to other surgeries mid-surgery. like the LITT procedure.”

James Markert, MD, chair of The laser interstitial therthe Department of Neurosurgery mal therapy (LITT) is an in the Heersink School of MediMRI-guided laser procedure cine at UAB, was the first to use to destroy brain tissue. Kristhe new suite in February when ten Riley, MD, Neurosurgery he performed a craniotomy to Specialist at UAB, said LITT remove a brain tumor. surgery is most often used on “This suite was sort of a vi- James Markert, MD patients with epilepsy.

The MRI entering the surgical suite from the center room. The track on which it moves is visible at the top of the image, moving on the track that is stationed at the ceiling.

“When we've identified a part of the brain that causes their seizures, once we have localized that, we can destroy that part of the brain with a laser,” Riley said.

Before having the intraoperative MRI surgical suite, surgeons performing a LITT procedure would need to stereotactically place a bolt in the patient's

skull, put them to sleep, move them to an MRI suite in a different location and then begin the procedure within the MRI. “Having the intraoperative MRI in our OR suite makes the procedure much more efficient,” Riley said. “It's better for the patient because, with the whole (CONTINUED ON PAGE 3)

Birmingham Cardiologist Helps Ukraine

By Laura Freeman

On February 24, Russia invaded Ukraine. Since then, as we all know, they have relentlessly bombed cities into rubble, they have raped women, and murdered thousands of innocent people. Many of us feel helpless in the face of this horror.

That’s how Jan Skowronski, MD, interventional cardiologist with Cardiovascular Associates, felt until he realized there was something he could do—adapt the Fortuna Foundation he and Will Hightower, MD had set up to provide endovascular training to cardiologists around the globe so it could also channel donations of supplies to Ukrainian hospitals and refugee centers.

Ivano-Frankivisk regional hospital treats wounded.

“I’m originally from Poland, and several of my family members were born in the area that is now in Ukraine,” Skowronski said. “I’ve travelled there and know people in the area. I felt I had to

do something. It might have been easier to give to one of the large international organizations and hope that some of it eventually reached Ukraine, but I knew the need was urgent, and I wanted every

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Skowronski got in touch with his contacts and tracked down Ivano-Frankivisk regional hospital. It was treating casualties coming in from the front and needed supplies for surgical care and rehabilitation. He also heard about Yazlovets Abbey in the southern part of the country, where nuns were trying to find food and supplies to care for more than 100 children, including orphans and kids with HEALTH their mothers.

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“We found some sources in Ukraine Consider a new savings opportunity through the that were still shipping, we were able to Medical Association of so the State of Alabama.

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Birmingham Medical News

UAB New Scanner, continued from page 1 procedure being done right there in the intraoperative MRI suite, we don't have to take the patient to another location.”

This new surgical suite is also helpful for brain tumor resection and removal.

Markert said it is a constant challenge for brain surgeons to try to figure out if they have taken out all the malignant tissue.

“Sometime, we get to a point in an ordinary surgery suite where we just stop, and then the next day we get an MRI scan to see how we did,” he said.

With the intraoperative suite, surgeons can stop mid-procedure, do a quick closure of the scalp and get new scans of their progress. The MRI is positioned in a room between two operating rooms, and it is fitted to a special track so that it can be moved into one of the operating rooms in about 90 seconds. The machine slides over the surgical table until it is properly positioned, and the entire process takes seven to eight minutes.

“Once we have scanned the patient, we have an updated MRI to tell us how

we are how we are doing,” Markert said.

While the intraoperative MRI scanner will be primarily used for brain tumors, it will also prove useful in deep brain stimulation (DBS) procedures for Parkinson’s disease, dystonia, or essential tremor in which surgeons implant a device that sends electrical signals to brain areas responsible for body movement in an effort to better control tremors.

“At this time, when we do DBS, the majority of our patients are awake during the surgery so we can test them and make sure we're getting the optimal result,” Markert said. “But with the intraoperative MRI, we can stop the surgery when the electrode is in place, and run the scan so that we can be anatomically very precise.

“The MRI suite can be helpful in a variety of procedures, all for the patient’s well-being. We provide outstanding care to our patients, but this is going to allow us to go even one level higher.

It's really a game changer.”

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Cardiologist Helps Ukraine, continued from page 1

Yazlovets Abbey cares for 100 children.

Most had been bought by people trying to flee or for use in military vehicles. We eventually found enough for emergencies if we have to move people quickly.”

Using Zoom and phone apps, Skowronski has been talking with doctors and staff at the hospital to learn more about their needs.

“Because there aren’t many guns in Ukraine, many of the physicians had never seen a gunshot wound before, and didn’t know much about treating the kind of trauma that weapons can cause,” he said. “I was able to locate a university medical center in the U.S. that had a video tutorial on treating gunshot wounds and was able to get it online with a narration in Ukrainian.”

Skowronski is also frequently on Zoom calls with the nuns to see how their refugee center is doing.

“The nuns tell me many of the families had to flee with barely enough time to dress,” he said. “The children had to leave behind their school books, toys and the electronics that kept them connected to their friends and to school.

“The nuns are trying to build a playground so a hundred kids don’t have to sit inside in a crowded convent all day.

We sent them a few pieces of playground equipment to get them started.”

The situation is particularly difficult for teenagers who are too young to fight,

but old enough to understand what is happening. Most of their fathers and older brothers stayed behind to fight. They don’t know where their friends are or if they are still alive, since they usually don’t have phones or computers to keep in touch.

“I’m looking for a school in Alabama that is replacing its computers and might be willing to donate the old ones so we can refurbish them and send them to Ukraine,” Skowronski said. “It would make it easier for the older students to find online information for more advanced classes and to get in touch with family and friends when the fighting is over.”

The needs are probably greatest at the front lines, but aside from a few medical kits, getting help there is next to impossible.

“There are reports of Sarin attacks and so many people, including civilians, who are trapped and need food and medical attention. Even the CIA couldn’t get a gas mask into Mariupol,” Skowronski said. “All we can give the people who stayed to defend Ukraine is the peace of mind of knowing if their family fled, there are people who won’t let them go hungry, who will tend their injuries and see that they have a safe place to sleep.”

Helping people in need makes a difference in their lives and it also makes a difference in ours. Instead of seeing suffering and feeling helpless to do anything about it, there is something we can do. Donations of any size are welcome.

“It does my heart good to see the five and ten dollar donations coming in,” Skowronski said. “It shows there are a lot of people here who care. Judging by the email address, many of the donations are coming from either active military or veterans. They understand what’s at stake.”

To donate to Ukraine relief by credit card or PayPal, go to the website, www.Fortunaclinical.com

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Criminal Jeopardy

Will the Criminal Conviction of a Tennessee Nurse Set a New Precedent?

By Laura Freeman

These things we know for sure: the patient is dead. The career of RaDonda Vaught, a critical care nurse with a previously unblemished record, has been destroyed, and now, following a rare if not unheard of criminal prosecution, she stands convicted on two felony counts.

What remains uncertain is what Davidson County Criminal Court Judge Jennifer Smith will do at the sentencing hearing May 13 (by the time this issue is printed, the sentencing may have occurred.) The judge has broad discretion in the case. If the verdict stands, she can choose probation or sentence RaDonda Vaught to up to as much as six to eight years in prison in the medication error death of Charlene Murphy.

“Each state has its own laws governing deaths that occur due to medical mistakes, but it’s usually considered a civil matter to be pursued in a malpractice proceeding,” said Bill McGowin, who is general counsel for Inspirien, an Alabama company specializing in risk assessment, mitigation and malpractice insurance. “What is different and very rare about this case is that criminal charges carrying the potential penalty

of a prison sentence were brought against a healthcare professional for a mistake made during the normal course of her work.”

To bring these charges, Tennessee laws do not require proof of intent to harm. The original charge of Reckless Homicide must only show that the accused knew the danger and acted recklessly without regard for the safety of the person harmed. Prosecutors subsequentially reduced the charge to Criminally Negligent Homicide, and although they made a strong case for negligence due to Vaught giving the wrong drug, the judge can consider a number of mitigating factors and system failures.

The second charge, Gross Neglect of an Impaired Adult, was based on the fact that Vaught, working that day as a float nurse, went on to respond to an emergency room request for assistance after giving the injection rather than staying to monitor the patient. Nurses testified at the trial that, although a more experienced nurse would probably have stayed a few more minutes to make sure there were side effects, the hospital at the time did not include Versed, the drug she thought she was administering, as a drug requiring monitoring. The

Bill McGowin

Lisa Rawlings, RN

drug order had not come with an order for observation, and when Vaught asked, she was told the hospital did not require observation for that drug.

The impact of this prosecution could go far beyond Tennessee.

“If the verdict in a criminal prosecution stands, it will be a very troubling precedent for everyone who works in patient care,” McGowin said. “All humans make mistakes, and being criminally liable for everything you do in the course of your work means care givers will be at constant risk just doing their jobs.”

Lindsey Harris, DPN, president of

the Alabama Nurses Association said, “Nurses in Alabama and across the country are distressed by this verdict and the effect it could have on patient care. Nurses go into the profession because they want to help. I keep hearing nurses say, ‘It could have been me.’”

Rather than putting their freedom and family at risk, some nurses are considering moving away from bedside nursing or leaving the field entirely. Those who have been considering entering healthcare are more likely to have second thoughts, which could make shortages (CONTINUED ON PAGE 6)

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MAY 2022 • 5

Criminal Jeopardy, continued from page 5 worse and patient safety and access to care more difficult.

“Through the ‘Just Culture’ movement, we’ve been working to create a culture of safety for our patients by establishing an environment where caregivers feel safe to report errors so we can get to the root causes of mistakes and prevent them,” risk consultant Lisa Rawlings, RN said. “The point isn’t to punish individuals, but to empower them to feel free to speak up so we can prevent mistakes. This criminal prosecution undermines everything we’ve been trying to achieve. It will make patients less safe.”

RaDonda Vaught immediately reported her mistake. When she heard the code in imaging, she was concerned about the patient she left waiting for a P.E.T. scan and returned to the unit. She told the team working to revive the patient that she had given her an injection and identified the medication bottle.

If criminal prosecution becomes the norm, who will volunteer to incriminate themselves with an admission that could send them to prison? What can we learn from this case that can help us avoid seeing it happen again to us, our patients and coworkers?

If we could turn the calendar back to December 26, 2017, what are the turning points where we could change the outcome?

“Distraction can be very dangerous

when pulling medications,” Rawlings said.

“That day RaDonda Vought was orienting a new hire who was following her as she worked. Someone has to teach new people how to use automated medication dispensers, but answering questions and talking with someone else makes it easy to miss something important.”

More hospitals are establishing notalk zones away from high traffic so that nurses can concentrate on dispensing the medication and making sure it is right.

Warning fatigue is also becoming an issue related to working with electronic medical records and other technologies.

It’s the boy-who-cried-wolf effect. Especially when a new technology is being added, there can be so many incorrect or irrelevant warnings when the system is too sensitive that the warnings become invisible. That is a problem the day there really is a wolf.

In the Tennessee case, an upgrade had created delays in prescription orders and the medical records system and automated medication dispenser weren’t communicating well. The problem had become so serious that getting basic supplies like fluids required a workaround by overriding the system. A memo went out that instructed nurses to use the override when necessary, and it was becoming routine on orders that couldn’t wait for the system to catch up.

Another opportunity for error, and

one of the key factors in this case, arose from the fact that the automated medication dispenser only recognized generic drug names, while some orders came in as brand names. The patient was anxious about having a P.E.T. scan and had claustrophobia issues. Her physician wrote an order for Versed to calm her. The subdural hematoma that brought her to the hospital seemed to be improving, but her doctor wanted to see how the scan looked before letting her go home.

When the order for Versed came in, the patient’s regular nurse was busy, so as float nurse, RaDonda Vaught was asked to take a dose of Versed down to imaging and administer it. She looked up the patient’s file, but Versed had not been added to her list of medications.

There was some time urgency, since the patient seemed too anxious to tolerate the procedure without sedation. Vaught was told if medication couldn’t be given before the patient was scheduled for the procedure, she would have to be rescheduled for the next day, leaving her in the hospital an extra day during the holidays and adding another day of hospital charges to explain to Medicare. In such situations, a nurse like Vaught, who had only been working two years, might feel more pressure to prevent a delay.

Vaught overrode the system to get the medication, an act that the prosecution focused on during the trial. Versed was the

name commonly used in the hospital, but it wasn’t the generic name. Instead of entering midazolam, she entered VE, which brought up vecuronium, the generic name for a powerful paralytic.

There was an obvious label on the top and front of the bottle, but Vaught said she only looked at the directions on the back. She said she thought it was odd that the drug was a powder with directions for mixing with water. A more experienced nurse would likely have realized a powder was wrong.

When Vaught got to imaging, she looked for a scanner to scan the medication against the patient’s arm band. A scan would have immediately identified the medication as the wrong drug. No scanner was available in the department, so Vaught visually checked the armband against the medication order to see that she had the right patient and asked a second medical professional to confirm it.

Nurses on social media have frequently commented on how much they hate doing injections in the imaging department because of the lack of scanners and often the lack of rescue equipment which requires them to bring equipment if they have to monitor a patient and take action if there is a problem. Making sure scanners and rescue equipment is reasonably near anywhere medication is given would seem to be a good improvement in patient safety.

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MAY 2022 • 7

The Challenge of Osteoporosis

By Jane Ehrhardt

tion. All which could be That makes checking for eliminated if she had been the chronic condition diagnosed and treated for with a fracture imperathe condition. tive, whether high or lowOsteoporosis weakenergy cause, to get the ens the bones by leechpatient on treatment. ing minerals out of them “The only thing that through the blood. “Your can be done to improve bones are like wood on bone density is medicathe outside, but flush with tions,” Heck says, though blood in the spongy inload-bearing exercises can side,” Heck says, “which is decrease that rate of loss.

Chris Heck, MD why X-rays miss the signs “Supplements also help to of the disease because they primarily ila degree, but no one knows how much gets luminate only the outside of the bone.” into the blood.”

When the body cannot find enough Osteoporosis medications fall into two needed minerals, such as calcium, magcategories. Anti-resorptive medications, nesium and phosphorous, from the daily such as Fosamax (alendronate sodium), diet, it starts pulling them from the bones. block the body from absorbing the minWomen are particularly susceptible erals inside the bone. “If you’re already because of menopause. Everyone loses low density, it just prevents you from getabout three percent of their bone density ting lower. It does not make your bones per year starting around age 30, which is stronger,” Heck says. “But studies do show when humans attain the maximum dena statistical decrease in the rate of future sity. Because of the hormonal changes of fractures, so they have a purpose.” menopause, however, women start to lose If a patient breaks a bone while on density at 10 percent per year, and can an anti-resorptive, they should switch to an show signs of osteoporosis in their 50s and anabolic drug. This second category of os60s. Men also get the disease, just not typiteoporosis medications actually increases cally until their 70s and 80s. the bone density. “Depending on how low Once someone with osteoporosis you’ve gotten, you may never reach where breaks a bone, they have an 80 percent you want to get, but the statistics show they chance of breaking another in the future. decrease the risk of future fracture by 75

“The main reason osteoporosis is such a poorly appreciated and treated problem is because, in and of itself, it doesn’t directly cause pain or death,” says Chris Heck, MD, an orthopedic spine surgeon and osteoporosis physician champion at Southlake Orthopaedics.

Yet bone fractures related to osteoporosis are responsible for more hospitalizations than heart attacks, strokes, and breast cancer combined, according to the Bone Health and Osteoporosis Foundation (BHOF), which recommends that any patient 50 or older who suffers a fracture be evaluated for osteoporosis. The cause of the injury — whether a low-energy or high-energy fracture — does not matter.

Heck had an older patient come into surgery after breaking both her ankles in car wreck. She had never shown any signs of osteoporosis. “When I operated on her ankles, her bones were like mush. It was like operating on mashed potatoes,” he says. “She definitely had osteoporosis.”

But she had never even had a slipand-fall at home. Her condition led to extra surgeries to fix her ankles because the severely weakened strength and density of the bones inhibited the ability to anchor the surgical screws. The worst-case scenario in these cases leads to amputa-

percent,” Heck says.

The anabolics can also be helpful in building up bone density prior to elective orthopedic surgeries in osteoporosis patients.

Studies using anabolic medications post-operative also showed increased success rates.

For patients reticent to take medications, Heck points out studies that show if an osteoporotic patient breaks a hip, they have a one in five chance of breaking the other one in the next 12 months. More persuasive still is talking to their children and showing how readily osteoporosis can indirectly lead to death. If someone over 65 years old with osteoporosis breaks a hip, studies show a one in three chance of dying within a year. Causes include blood clots, pneumonia, and infections, such as from bed sores. “You die due to complications from your age and recovery from a hip fracture,” Heck says.

Approximately 10 million Americans have osteoporosis and 44 million are at high risk for its development due to low bone mass, according to BHOF. Orthopedic surgeons hold a unique opportunity to identify osteoporotic patients. Their usual fix-and-release routine on surgical procedures with osteoporotic patients can be expanded to include bone density tests with a recommendation to see their primary care physicians for treatment. “It’s a silent killer,” Heck says.

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New Drug Options for Treatment of Metabolic Syndrome

Relax. Recover. Regain.

By Marti Webb Slay

Barry McLean MD, PhD treats many patients for metabolic syndrome, and he seeks to address it before it becomes a more serious condition which cannot be cured. Unfortunately, many of the newest treatments are not always covered by insurance.

“Metabolic syndrome is quite common,” he said. “It’s generally associated with people who are overweight which gives them a predisposition to develop Type 2 diabetes, and they frequently have other problems as well. It is a potentially deadly situation because it can lead to progressive heart disease and other complications. The syndrome is typically recognized by the presence of central or abdominal obesity.”

McLean encourages general practitioners and internists to screen for metabolic syndrome in all their patients.

“If you identify these people early, you are able to emphasize diet and exercise to delay the development and prevent many of the complications. You can actually prevent diabetes and heart disease,” he said.

Family history is a key indicator.

“Pay very close attention to family history,” McLean said. “If your family members had diabetes or high cholesterol, you may be at risk to develop those as well. Metabolic syndrome is something you can cure and prevent if you know about it and understand what you can do.”

McLean said there are several new medications that are beneficial for treating the syndrome.

One is the anti-diabetic drug Met-

Barry McLean MD, PhD

formin. “Technically it’s a treatment for Type 2 diabetes, but you can begin it as a preventive drug for patients with metabolic syndrome,” he said. “It does help them lose weight and change their metabolism, so they are less likely to develop full-blown diabetes.”

Another treatment option is the class of GLP-1 inhibitors. “These drugs, such as Ozempic and Trulicity, are injectable,” McLean said. “You give yourself a shot once a week and reverse the pathology of the metabolic syndrome. So you can use them for metabolic syndrome and to treat excessive weight as well. Wegovy is another brand, but it is sold specifically for weight loss. People who are overweight but don’t have any other indications of metabolic syndrome can use it.

“Unfortunately, the GLP-1 inhibitors are expensive and insurance doesn’t always provide the kind of coverage they should. You have to go through an approval process to justify why you want to do that. Many times new drugs are approved and put on the market, but they aren’t covered until insurers are sure

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MAY 2022 • 9

Effective July 11 Alabama Has New Telehealth Rules: What Physicians Need To Know By: Angie C. Smith

Telehealth is not new, but during the pandemic, it has received renewed attention and support because of its ability to expand access to health care. On April 12, 2022, Governor Ivey signed Act 2022302 that repealed existing law regarding the practice of medicine across state lines and implemented laws for the use of telehealth in Alabama. The Act takes effect on July 11, 2022. Prior to the passage of this Act, Alabama did not have any rules or regulations pertaining to telehealth or telemedicine for physicians.

Repeal of Practice Across State Lines In 1997, the Alabama Legislature passed Act 97-166 addressing the practice of medicine across state lines. The legislature acknowledged that with technological advances “the practice of medicine or osteopathy is occurring with increasing frequency across state lines and that certain technological advances in the practice of medicine or osteopathy are in the public interest.” See Ala. Code § 34-

Angie Cameron Smith

24-500. The purpose of the Act at that time was to ensure that the state had the ability to discipline physicians who would otherwise not fall under its jurisdiction because he was not licensed in Alabama.

These laws have been replaced with the new telehealth rules.

New Laws Governing Telehealth Under the new law, telehealth is defined as “the use of electronic and telecommunications technologies, including devices used for digital health, asynchronous and synchronous communications, or other methods, to support a range of medical care and public health services.”

Ala. Code § 34-24-701(14). Synchronous refers to “real-time” exchange of information versus asynchronous communication that involves the exchange of health care documents that does not occur in real time such as the collection and transmission of medical records or laboratory results. Ala. Code § 34-24-701 (1), (13).

Licensure requirements In order to provide telehealth services, a physician must possess a full and active license to practice medicine or osteopathy issued by the Alabama Medical Licensure Commission or must fall within one of two exceptions: • Services are provided on an irregular or infrequent basis, i.e. less than 10 days or involving fewer than 10 patients in a calendar year; OR

• Services are provided in consultation, as defined by law, with an Alabama licensed.

The law specifically states that it is not intended to affect any other health care provider’s provision of telehealth services so long as those services are within the practitioner’s scope of practice.

Impact on the practice of medicine The law does not change the duty owed by the physician to the patient, and the Act incorporates the Alabama Medical Liability Act (AMLA) so that the AMLA applies to any lawsuit asserted against a physician for services performed via telehealth. If a lawsuit is filed, Alabama courts have exclusive jurisdiction regardless of citizenship of the parties and services are considered rendered where the patient is located at the time of the telehealth visit.

Ala. Code § 34-24-703. Additionally, a licensed physician can provide telehealth services from any physical location (distant site). Ala. Code 34-24-701.

When providing telehealth services, the physician would need to do the following (if it would otherwise be required):

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• Establish a diagnosis through the use of acceptable medical practices, which may include taking a patient history, mental status examination, physical examination, disclosure and evaluation of underlying conditions, and any diagnostic and laboratory testing; • Disclosure of any diagnosis and the evidence for the diagnosis as well as the risks and benefits of treatment options; • Provide a visit summary to the patient, and if needed, inform the patient of the availability of, or how to obtain appropriate follow-up and emergency care.

In addition to performing the above functions as part of the provision of telehealth services, a physician should do the following prior to providing the service: • Verify the identity of the patient.

• Require the patient to identify his physical location, including city and state.

• Disclose the identity and credentials of the physician and any other personnel.

• Obtain the patient’s consent for the use of telehealth as an acceptable mode of delivering health care, including consent to the mode of communication used and its limitations. Acknowledgment of this consent must be documented in the patient’s medical record.

If a physician or practice group provides telehealth services more than four times in a 12-month period to the same patient for the same medical condition without resolution, the physician must ei-

ther (1) see the patient in person within a reasonable amount of time, not to exceed 12 months, or (2) refer the patient to a physician who can provide in-person care within a reasonable time (not to exceed 12 months). A practice group is, at a minimum, a group of providers who have access to the same medical records.

For purposes of the in-person follow-up, the telehealth services can be performed using video communications to a patient with in-person assistance of a person licensed by the Alabama Board of Medical Examiners or the Board of Nursing.

Mental health services are excluded from this section of the law that relates to telehealth services on a repeat basis.

Prescribing drugs with telehealth Any person who possesses an active Alabama controlled substance certificate or a Qualified Alabama Controlled Substances Registration Certificate may prescribe a legend drug, medical supplies or a controlled substance to a patient as a result of a telehealth service if the person is authorized under applicable state and federal law. The prescription must be issued for a legitimate medical purpose.

For controlled substances, the telehealth visit must include synchronous audio or audio-visual communication using HIPAA compliant equipment with the prescriber, and the prescriber must have had at least one in-person encounter with the patient in the preceding 12 months. The in-person requirement does not apply if the physician is treating a

medical emergency.

Other laws to consider Other federal laws also impact the practice of medicine via telehealth including HIPAA, DEA rules and reimbursement requirements. Physicians should

review these rules in conjunction with Alabama’s new law.

Angie Cameron Smith is a partner at Burr & Forman LLP practicing exclusively in the firm's healthcare industry group. For more information, please contact acsmith@burr.com or 205458-5209.

New Drug Options for Treatment of Metabolic Syndrome, continued from page 9 they will work. If you could start someone on these medicines without worrying if they’ll be covered or not, we’d all be better off. You might go through the whole process with a request that looks like a million dollars and then be told they don’t cover it.

“It’s getting easier to get coverage for Ozempic, but it’s almost impossible to get the drug for weight loss approved in Alabama. We have several hundred patients who should be covered, but we have only gotten it approved for one or two.”

That’s one of the reasons McLean encourages his patients to modify their diet and increase exercise to address metabolic syndrome, if possible, rather than seek to treat it with medications. “A lot of people eat fast food, but unfortunately, fast is fattening,” he said. “We live in such a hurried society that many people don’t take the time to eat a healthy diet. Having a regular exercise plan is

also very preventative for these patients.

We try to work out a schedule where they walk, say, three times a week.” He said jogging, light weights, stationary bikes are all viable alternatives as well.

He admits that convincing patients to make these changes is not easy. “Unfortunately, the best I can do is provide the information and tell them they are at high risk to develop something significant,” he said. “I stress it will be in their best interest to reverse that process as soon as possible.”

“I always remind my patients that unlike diabetes and heart disease, metabolic syndrome can be cured. Whether it’s treated by diet and exercise or medication, it’s important to address this condition early. It really is beneficial for them to know about this, to know what they can do about it, and to know if they make these changes, they are much less likely to develop problems down the road.”

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MAY 2022 • 11

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the precision medicine field, and 95 percent of the time, they’re talking about oncology,” says Joseph Cohil, head of Suite D106 Synergy Oncology, a division of SynHoover, Alabama 35242 ergy Laboratories. Also called personalized medicine, this specialty takes an innovative approach that delves into Crossroads at Greystone more than the name of the disease to 5406 US Highway 280 determine treatment options.

Suite D106 Generally, patients diagnosed with Hoover, Alabama 35242 a specific cancer would be prescribed the Non-Surgical Sports Interventional Medicine Physicians Interventional Spine Orthopaedic Surgeons same chemo drug. “Now everyone can Non-Surgical Sports Medicine Physicians Spine Orthopaedic Surgeons have a treatment specific to their genetic Non-Surgical Sports Medicine Physicians makeup, molecular profiling, and their diicine Physicians Interventional Spine Orthopaedic Surgeons agnosis, which is much different than years ago,” Cohil says. That precision optimizes the impact of existing treatments and helps alleviate trial and error with treatments.

Synergy, headquartered in Mobile, Christopher S. Carter, MD Emily Bell Casey, MD Rachel G. Henderson, MD Jody O. Ortega, MD Charles T. Carnel, MD Wayne McGough, Jr., MD Michael K. Ryan, MD Daryl Flanagan, PA will soon be launching their own personalized medicine test. “Our test, which named WeChristopher offer same day appointments for acute injuries.

S. Carter,day/next MD Emily Bell Casey, MD Rachel G. Henderson, MD Jody O. Ortega, MD Charles T. Carnel, MDwe’veWayne McGough, Jr.,TOTALITY, MD Michael K. Ryan,analyzes MD cine Physicians Interventional Spine Orthopaedic Surgeons Daryl Flanagan, PA genes from a single tumor biopsy, pro(On-Site Provider) viding physicians with a compact report 205-939-3699 Interventional Spine Orthopaedic Surgeons that matches the detected molecular alterations with FDA-approved therapies and clinical trials,” Cohil says.

G. Henderson, MD Jody O. Ortega, MD Charles T. Carnel, MD Wayne McGough, Jr., MD Michael K. Ryan, MD AndrewsSportsMedicine.com AGGRESSIVELY PURSUING VICTORY OVER INJURY The Human Genome Project, Daryl Flanagan, PA (On-Site Provider) launched in 1990, worked to unlock the 205-939-3699 sequence of the human genome and identify the genes contained within.

By the end of the project in 2003, they estimated that humans have between G. Henderson, MD Jody O. Ortega, MD Charles T. Carnel, MD Wayne McGough, Jr., MD Michael K. Ryan, MD 20,000 and 25,000 genes. Each of these Daryl Flanagan, PA AndrewsSportsMedicine.com AGGRESSIVELY PURSUING VICTORY OVER INJURY (On-Site Provider) carry information to make the proteins 205-939-3699 in the body that determine, among other We offer same day/next day appointments for acute injuries. things, how well someone metabolizes food or reacts to infection.

Synergy’s diagnostic test, which can be used for all cancer types, looks at 523 205-939-3699 Aggressively Pursuing Victory Over Injury genes. “We know specifically what a lot of those genes do. Some are kind of exAGGRESSIVELY PURSUING VICTORY OVER INJURY (205) 939-3699 | AndrewsSportsMedicine.com ploratory. We know there’s something

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important there,” Cohil says. “The remainder are what we call future genes, a reflection of how vast and unmapped the field of genes remains in medicine. These are genes that we learn about as we go.

So you can see how these tests are benefitting patients now and future patients.”

The information collected from precision medicine tests not only adds to genomic knowledge, but also to drug development and treatments for cancer.

The information from each patient’s test, once gathered from the tumor biopsy and blood sample, runs through a massive database of historic information on genetics, immune responses, biomarkers, and types of cancers. “It’s a national database from a bioinformatics company we partner with,” Cohil says.

This data of the molecular makeup of the tumor is so vast, and always expanding, that artificial intelligence is utilized to analyze the information quickly. The outcome is a list of options based on FDA-approved treatments, including what chemo drugs will work, as well as which drugs may not work. “Your doctor takes this and determines how he will treat you,” Cohil says.

“We look at the whole big picture. Everything we examine will help determine what the outcome is going to be.”

A unique aspect to Synergy’s TOTALITY test includes listing any pertaining clinical trials. National guidelines recommend all cancer patients be considered for clinical trials, but under five percent of patients participate. Most may not know they have the option or how to find these treatment trials. “TOTALITY brings clinical trials within their reach and identifies the appropriate trials based on their results,” Cohil says.

Biden’s cancer initiative has also helped lead this technology to become part of national guidelines. “This is great news for patients,” Cohil says.

“The American College of Gastroenterology has already recommended this technology in their guidelines. With personalized medicine tests being added into the guideline. It’s a domino effect and the outcome allows us to create that perfect formula for treatment.”

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Birmingham Medical News

MAY 2022 • 13

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Birmingham Medical News

FDA Issues Draft Guidance on Cybersecurity in Medical Devices and Begins Comment Period

By James F. Henry Phelps Dunbar, LLP

updated draft guidance is intended to address (with thanks to Amanda Nelson, changes in the technologthird year student at Cumberland ical landscape as well as School of Law, for her assistance) the FDA’s increased understanding of potential APRIL 21, 2022 cybersecurity threats and mitigation tactics that can On April 8, the Food be deployed throughout and Drug Administrathe total product life cycle tion issued draft guidance (TPLC) of a device. titled “Cybersecurity in James F. Henry The 2022 draft guidMedical Devices: Quality ance differs from its predecessors in that System Considerations and Content of it places a greater importance on makPremarket Submissions.” This updated ing sure medical devices are designed draft guidance replaces the agency’s securely and in such a way that they can 2018 draft guidance of the same name mitigate emergency cybersecurity risks and, when finalized, will supersede their throughout a device’s total product life 2014 guidance titled “Content of Precycle (TPLC). The guidance also clarimarket Submissions for Management fies and expands upon the FDA’s recomof Cybersecurity in Medical Devices.” mendations for premarket submission In releasing this guidance, the FDA eminformation to address cybersecurity conphasized the need for effective cybercerns. There are four general principles security to ensure that medical devices for device cybersecurity discussed in the are safe in a time where many of these updated guidance, titled as follows: “Cydevices are connected to the internet bersecurity is Part of Device Safety and and facilitate the electronic exchange the Quality System Regulations,” “Deof important health information. The

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signing for Security,” “Transparency,” and “Submission Documentation.”

There is also a specific emphasis placed on the utilization of Secure Product Development Frameworks (SPDF’s) to manage cybersecurity risks that are inherent to medical devices. According to the FDA, an SPDF is “a set of processes that help reduce the number and severity of vulnerabilities in products.” These frameworks cover all aspects of a product’s life cycle and can prevent devices from needing to be re-engineered when connectivitybased features are added post distribution or after vulnerabilities are discovered. An SPDF can also be used as one way to adhere to the Quality System Regulation (QSR) requirements located at 21 C.F.R. Part 820. While the utilization of an SPDF is not the only approach that manufacturers can take to satisfy premarket submission requirements, the FDA believes that it is an effective method to manufacture and maintain devices that are safe, effective, trustworthy, and resilient. To assist manufacturers in implementing these frameworks, the guidance gives recom-

mendations regarding the ways they may be created and used, how they complement the QSR requirements, and the documentation that should be submitted for review as part of premarket submissions.

The issuance of this draft guidance signals a growing necessity for cybersecurity in the medical space. In recent weeks, legislation has been introduced to the Senate and the House of Representatives that aims to increase medical device security by adding certain cybersecurity and monitoring requirements for manufacturers.

The full text of the updated draft guidance is available on the FDA’s website, fda.gov. Those wishing to submit comments should visit the guidance’s webpage and either submit a comment online by clicking “Submit Comments Online” or submit a written comment via mail to the address provided. Comments must be submitted by July 7, 2022.

James F. Henry is a partner with Phelps where he helps healthcare providers comply with the law and achieve their business goals.

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MAY 2022 • 15

The Murky Waters of Long COVID Limited answers are available for pandemic’s shadowy sister

By LYNNE JETER

tal health consequences, ranging from prolonged illness to hospitalization.

Yet controversy has swirled concerning the laundry list of debilitating ongoing symptoms, such as muscle pain, unrelenting fatigue, breathlessness, anxiety, depression and brain fog. For example, fatigue and brain fog are comprised of more than 200 symptoms. Brain fog has recently been added to the Collins Dictionary as an “usually temporary inability to concentrate and think clearly,” but the term also covers neuropsychiatric problems including migraines, high anxiety, fatigue, insomnia and even autism.

Other common issues include heart palpitations, loss or smell or taste, and joint pain.

“COVID took my hair and after two years, it’s still not back to normal,” said 51 year-old Tami Lairamore of Littleton, Colorado, who contracted COVID-19 in November 2020 and again in July 2021 and has been sporting hairpieces. “Now I need a hip replacement, which I’m not sure is related to the inflammation issues I’ve had since COVID round two. I didn’t have a problem before. I keep wondering when these symptoms will disappear or at least become more manageable.”

The CDC has limited its symptom

The suicide last May of Long COVID sufferer Heidi Ferrer rocked the COVID-19 world, lending a face to the debated diagnosis.

A TV writer for Dawson’s Creek and Wasteland, Ferrer had been battling extended COVID symptoms for nearly a year when she called it quits. She foreshadowed her death when she posted on her social media blog: “In my darkest moments, I told my husband that if I didn’t get better, I did not want to live like this. I wasn’t suicidal, I just couldn’t see any quality of life, long term, and there was no end in sight.”

Demographically, Ferrer was smack in the middle of Long COVID sufferers. Female, white, age 50, and income of more than $85,000 annually.

Defining Long COVID An estimated 30 percent of COVID-19 patients have Long COVID symptoms, with middle-aged white females representing the lion’s share. But what exactly are those symptoms? Long COVID has been used as an umbrella term to include both physical and men-

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list of Long COVID to 13 primary indications that Pennsylvania attorney Michael Fumento called “worthless in distinguishing Long COVID from other illnesses.”

National Institute of Allergy and Infectious Diseases Director Anthony Fauci, MD declared at a December 2020 symposium that Long COVID is “quite real and quite expensive.” He later called Long COVID symptoms “highly suggestive” of myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS).

Adding to the Confusion Long COVID symptoms sometimes mimic autoimmune diseases, which are more prevalent in women ages 40 to 60.

For instance, conditions such as rheumatoid arthritis, Hashimoto’s (thyroid) disease and lupus are two to three times more common in middle-aged women than men.

“It’s possible, that for such women, the body’s immune system turns on to fight COVID, but then can’t turn back off and so remains on the attack, creating other problems in different organs and parts of the body, similar to an autoimmune response,” said Sharon Stills, NMD, a naturopathic medical doctor specializing in menopausal women. “This

means that lurking behind the scenes in all this could be inflammation.”

Limited Research So Far With the pandemic occurring barely more than two years ago, it’s little wonder research is lacking.

In two British studies last year, there’s debate whether Long COVID sufferers actually had COVID. The largest study as of September 2021 was published last July by researchers at University College London, which acknowledged that 27 percent of Long COVID sufferers had evidence of exposure to the SARSCOV-2 virus, whether antigen or antibody. A smaller British study, conducted in August, determined only 17.2 percent were test-confirmed positive. The greatest complaint: sufferers felt terrible, with symptoms mimicking COVID. Former NIH Director Francis Collins recognized Long COVID by having his agency assign the name “Post-acute Sequelae of COVID-19 (PASC).” Soon after, Congress approved $1.15 billion in funding over four years to support research on PASC. Parenthetically, the average NIH grant is $500,000, with an application success rate of roughly 20 percent.

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President Biden Rallies Surge in Long COVID Research On April 5th, President Biden continued a national research push on Long COVID, instructing federal agencies to support patients dealing with the enigmatic condition. The White House also acknowledged Long COVID as a disability.

“The emphasis on treatment for Long COVID and recognizing that this could be a source of ongoing dis-

ability are long overdue,” said Lena Wen, MD, a former Baltimore health commissioner.

The Department of Health and Human Services has been tasked with building on the $1.15 billion RECOVER (Researching COVID to Enhance Recovery) Initiative, already ongoing at the National Institutes of Health. The study calls for 40,000

participants with and without Long COVID symptoms.

In particular, Biden targeted federal agencies to support patients and physicians by providing sciencebased best practices for treating Long COVID, preserving access to insurance coverage, and protecting the rights of workers dealing with Long COVID, particularly concerning mental health.

Vanderbilt Team Helps Long COVID Sufferers Battle Cognitive Issues The Adult Post-Acute COVID Clinic at Vanderbilt University Medical Center (VUMC) recently unveiled new studies determining the cause of symptoms and the value of treatments such as physical therapy and cognitive training for Long COVID patients.

VUMC is also seeking answers outside mainstream medicine. For example, the Nashville-based center is participating in a study to determine whether a video game development for children with attention deficit disorder by Boston-based Akili Interactive may also improve cognitive functioning in post-acute COVID patients.

In March, nearly 30 new patients entered the video game study from support

groups, “with some patients sufferers and their families. literally crying when they learn “We are increasingly getthat they’re eligible to parting referrals from physicians ticipate,” said James Jackson, around the country who know PsyD, research professor of about the work we’re doing medicine and lead psychologist and send their patients to us,” for the Critical Illness, Brain Jackson said.

Dysfunction and Survivorship James Jackson, PsyD A CIBS Center patient, (CIBS) Center at VUMC. 38 year-old Jane Storie of “We’re clear about it not being a Hermitage, TN, contracted COVID-19 panacea,” he said. “We don’t know if it in October 2020 and continues to be works. That’s why we’re studying it. But plagued by debilitating symptoms. the emotionality the patients have shown “It’s a sobering reality,” Storie said. has been a reminder for us of how debili“As a society, we expect doctors to know tated they really are.” everything, but realize that nobody knows Concurrently, several colleagues much, and everybody’s doing the best from the CIBS Center are leading online they can to figure it out.” peer support groups for Long COVID

Murky Waters of Long COVID, continued from page 16

The Depressive Component “You’ll get no NIH funds hypothesizing that Long COVID is essentially depression and that therefore, it needs to be treated like depression,” Fumento wrote. “Instead, you’ll propound on how it’s a mystery disease with as yet no successful therapies.”

The New England Journal of Medicine perhaps got ahead of the controversy by saying “some commentators have characterized it as a mental illness which augurs poorly for many people with Long COVID.” Regardless, Ferrer’s demise took away the “just snap out of it!” formula that some misinformed practitioners have used with depressives. The federal government estimates that nearly two-thirds of Americans who commit suicide were primarily depressed.

Now, depression among Long COVID patients who suffer from persistent fatigue, mental and physical slowing down, and difficulty concentrating is a pathology that has been described as being as real cancer and heart disease.

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Birmingham Medical News

MAY 2022 • 17

GRAND ROUNDS

Cullman Regional Receives UAH Community Partner Award

tor; Louise O’Keefe, PhD, CRNP Interim Associate Dean UAH College of Nursing

Breast Cancer Research Foundation of Alabama Funding

(L to R) Karen Frith, PhD, RN, Dean UAH College of Nursing; Kelly Burnham, RN, Cullman Regional Clinical Educator; Tracie Morgan, DNP, Program Coordinator; Louise O’Keefe, PhD, CRNP Interim Associate Dean UAH College of Nursing

University of Alabama in Huntsville (UAH) College of Nursing Graduate Program chose Cullman Regional as the recipient of its annual Community Partner Award which recognizes Cullman Regional’s commitment to provide nurse practitioner students important precepting opportunities despite the challenges during the COVID pandemic.

“Nursing is the backbone of healthcare,” said Charna Brown, RN, Chief Nursing Officer at Cullman Regional. “We commend these students for continuing their education in nursing.”

On average, Cullman Regional hosts 125 graduate and undergraduate student nurses each semester for onsite group clinical training with their instructors and individual preceptorships with Cullman Regional staff nurses.

(L to R) Karen Frith, PhD, RN, Dean UAH College of Nursing; Kelly Burnham, RN, Cullman Regional Clinical Educator; Tracie Morgan, DNP, Program Coordina-

For 2021, The Breast Cancer Research Foundation of Alabama (BCRFA) invested a total of $1,225,000 in Alabamabased breast cancer research with grants funding 20 research projects, including the O’Neal Comprehensive Cancer Center at UAB, Auburn University, CerFlux, the Mitchell Cancer Institute at the University of South Alabama, the University of Alabama, Southern Research, and HudsonAlpha Institute for Biotechnology. The 2021 grant awards increase the BCRFA’s lifetime investment total to over $12 million since 1996.

BCRFA dollars often function as seed funding for developing studies, allowing researchers to generate data needed to attract major national funding. Many BCRFA-funded projects have later received national grants from the National Institute of Health and others.

UAB Studies Whether Exercise Can Boost Epileptics’ Memory Researchers at UAB are exploring the possibility that exercise might help improve memory in people with idiopathic generalized epilepsy.

“Approximately half of the 3.4 million persons with epilepsy in the Unit- Jane Allendorfer, PhD

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ed States have cognitive problems, and memory deficits are the most common,” said Jane Allendorfer, PhD, an assistant professor in the Department of Neurology, UAB Heersink School of Medicine.

“Recent studies have shown that formal exercise training can help with memory in healthy individuals. We have reason to believe exercise can help boost memory in people with epilepsy, too.”

Allendorfer and her team are enrolling 114 persons with idiopathic generalized epilepsy between the ages of 18 and 55. The study is funded by a $3.1 million grant from the National Center for Medical Rehabilitation Research at the National Institutes of Health.

Half of the participants in the study will be randomized to immediately undergo supervised endurance and resistance training three times a week for six weeks at the UAB Center for Exercise Medicine’s Exercise Clinical Trials Facility, while the other half will have a sixweek delay prior to exercising.

Improvements in memory in the immediate exercise group will be assessed and compared to the delayed exercise controls. All participants will be followed for an additional six weeks.

“Exercise appears to boost blood flow in the brain, and we know that functional connectivity between brain regions changes with exercise. Improved connectivity may result in improved memory,” Allendorfer said.

Kassouf Launches App In March, Kassouf & Co launched its app that allows clients to easily access some of the firm’s most popular services.

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1917 Clinic Know Overdose Initiative With deaths related to overdose of prescription and illicit drugs having increased by nearly 25 percent in Alabama during the pandemic, Marsha Hawkins, RN Marsha Hawkins, a nurse with UAB’s 1917 Clinic, began working on a quality control program. Along with other nurses at the 1917 Clinic, Hawkins started the Know Overdose Initiative which educates, identifies and prescribes Naloxone for individuals who have been identified as at high risk for overdose.

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Naloxone, used for the temporarily reversal of the effects of opioid medicines, acts as a blockade between the opioid and the receptors in the brain.

It has no effect in people who have not taken opioids, so if the person has overdosed on another substance, it will not help but also will not hurt.

Jefferson County reported more than 300 opioid- or fentanyl-related overdose deaths in 2020 — the highest ever.

“Many of our aging patients are prescribed opioids for things like post-surgical pain and cancer, and I noticed some patients may not have taken it as prescribed,” Hawkins said. “One part of the initiative is to educate providers, since some think Naloxone can be misused. But this medication has no abuse potential. It is not a narcotic or an opioid. It saves lives.”

Hawkins suggests family members of opioid patients should be aware of the signs of overdose, which include: • Unusual sleepiness and the person is not able to be awakened by a loud voice.

• Slow or shallow breathing in someone difficult to awaken.

• Pinpoint pupils in someone difficult to awaken.

Wise Studying Social Determinants of Cardiovascular Health in HIV Patients Jenni Wise, PhD, RN, assistant professor in the UAB School of Nursing, has received a grant to support her research on the impact of social determinants of health on cardiovascular health in individuJenni Wise, PhD, RN als with HIV. “People with HIV are at an increased risk for chronic diseases, especially those associated with aging,” Wise said. “Antiviral drugs now allow individuals with HIV to live long lives, but we see an increased risk for certain diseases in this population. For example, individuals living with HIV face about two times the risk for cardiovascular dis-

ease of the general population.”

“HIV is predominantly a socioeconomic disease, which is why it is important to study social determinants of health alongside HIV. The study will focus on hypertension, diabetes and dyslipidemia.”

Cullman Regional Starts Construction Expansion

Rendering: Tower crane places the steel foundation and framing.

story vertical tower expansion at Cullman Regional Medical Center, part of the $30 million project that will increase the hospital’s bed capacity from 145 to 175 and double the size of the hospital’s critical care unit.

The workhorse of the tower expansion is a 130-foot ballasted tower crane used to place the steel foundation and framing to extend the hospital’s west bed tower by 84 feet, which will enable the hospital to add 13 new critical care and 12 medical/surgical patient rooms.

The tower expansion also includes previously completed renovations to existing spaces which created five additional beds for a total of 30 new beds.

Construction will also be completed the hospital’s emergency department this summer. The project will feature a larger, more modern patient lobby and increase ED capacity by 80 percent.

Photo: Rendering: Tower crane places the steel foundation and framing.

Birmingham Recovery Center Accredited The Birmingham Recovery Center has earned The Joint Commission’s Gold Seal of Approval® Accreditation for addiction treatment.

The Birmingham Recovery Center, which opened last summer and is an outpatient substance use disorder facility, underwent an in-depth, onsite review.

During the visit, a team of Joint Commission reviewers evaluated compliance with addiction treatment center standards.

The Joint Commission’s standards are developed and informed by scientific literature and expert consensus to help health care organizations assess and improve performance.

Baptist Health Foundation Donates Automated CPR to BBH Hospitals Baptist Health Foundation has donated six automated CPR devices plus software to Brookwood Baptist Medical Center, Brookwood’s Freestanding ED

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at Greystone, Citizens Baptist, Princeton Baptist, Shelby Baptist and Walker Baptist.

The LUCAS device is a mechanical chest compression device that helps teams deliver quality, guidelines-consistent chest compressions to sudden cardiac arrest patients in the field, on the move and in the hospital. The device removes the close human contact needed for traditional CPR and brings in the element of automation which means consistent, continuous and quality chest compressions to sustain vital circulation to the heart and brain.

“It removes a lot of the risk of COVID exposure for our healthcare workers and also helps cut down on fatigue when delivering CPR,” said Bruce Burns, MD, chairman of the department of emergency medicine for Princeton Baptist Medical Center. “We are so appreciative to the Foundation for this donation.”

Construction has begun on a four-

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The Princeton Baptist team with the LUCAS device.

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