Ashita TolwaniEach September, organizations from across the country honor the contributions of women in medicine. At UAB, we are fortunate to have faculty and staff who continually push to advance their respective areas of medicine. Recently, award-winning Ashita Tolwani, M.D., Assistant Nephrology Fellowship Director and Director of ICU Nephrology, was able to get FDA approval during the COVID-19 pandemic to use a solution she created in 2004.

Raised mostly in Birmingham, Dr. Tolwani’s parents instilled in her the importance of being independent, resilient, working hard, and seeing things through to the end. As an adolescent, Dr. Tolwani knew she was going to pursue a career that would allow her to help people and incorporate her strengths in math and science—for her; this made medicine the apparent choice.

After getting her undergraduate education at Birmingham Southern College, Dr. Tolwani attended medical school at UAB School of Medicine and Harvard for her Master’s of Science in Epidemiology. Originally, Tolwani planned on specializing in Pulmonary and Critical Care; however, she was approached to do a fellowship at the end of her Nephrology rotation. Impressed by the department physicians’ ability to handle anything that came their way, Dr. Tolwani saw this as an opportunity to combine her passion for Critical Care with the intensity of Nephrology.

As a result of her training in both Critical Care and Nephrology she was able to develop expertise in continuous renal replacement therapy (CRRT), a type of dialysis used for critically ill patients with kidney failure. Her experience with this type of dialysis would soon lead her to become one of the experts in the field and allow her to teach this therapy around the world.

During Dr. Tolwani’s early days as a junior faculty member at UAB, she was put in a position to help shape the Nephrology fellowship program. While reviewing the program materials, Tolwani realized much of the material was unnecessarily complex. As someone whose brain naturally breaks down complicated information and simplifies it, Dr. Tolwani was fit to refresh the program with a common sense first mindset.

After serving as faculty for several years, Dr. Tolwani was named the Nephrology Fellowship Program Director. Then, when the largest professional society in Tolwani’s field—American Society of Nephrology—announced they were looking for program directors interested in curriculum development on a national level, she knew she had to apply.

Using what she helped develop for the fellowship program, Dr. Tolwani caught ASN’s eye—being immediately placed on the ASN Training Program Directors Executive Committee and having her work shared on the ASN national website for other institutions and universities to model their programs. Her teaching tools for fellowship were used to help Nephrology fellowship programs throughout the United States.

The notoriety Dr. Tolwani gained from her work positioned her to be an excellent candidate for the American Society of Nephrology Robert G. Narins Award—given to people who have made substantial contributions to education and teaching. Nominated by her Division Director, Anupam Agarwal M.D., Tolwani had people from across the world writing letters of support for her recognition.

Upon the announcement in late August, Dr. Tolwani recalled the moment she learned she had been selected as the winner, “I received the phone call in the middle of taking care of COVID patients, so I was overwhelmed—essentially in shock. It took me a few minutes to really understand what the person was telling me.”

Humble by nature, Dr. Tolwani attributes much of her success in Critical Care and Nephrology to the concentration’s size and her simplistic way of thinking about the subject matter. This combination has allowed Tolwani to trailblaze not only educational components of Continuous Renal Replacement Therapy (CRRT) but also the solutions used to make it possible.

Using a specific type of dialysis, Dr. Tolwani administers critically ill patients, CRRT, a treatment that runs for 24 hours a day. In this process, blood leaves the body and is filtered through the dialysis machine. To prevent the blood from clotting in the dialysis machine, a blood thinner is usually required.

Typically, a blood-thinning drug commonly associated with heart attacks (Heparin) is used; Tolwani explains, “Heparin is a drug that thins the patient’s blood. We want the blood only in the machine not to clot—we want the patient to clot normally. The problem when you’re dealing with critically ill patients is that they already have a high risk of bleeding, you don’t want to give them blood thinner.”

Therefore, when dealing with CRRT dialysis, a citrate solution can be used. This method creates regional anticoagulation—meaning only the blood in the machine will not clot. However, Dr. Tolwani informs us that while “the substance has been there for years, it has not been used extensively in this type of dialysis [CRRT] because the formulations used are made for blood banking and have electrolyte combinations that could be dangerous to the patient if done incorrectly. It can cause lots of errors because it’s very complicated.”

Seeing first-hand the issues critically ill patients could encounter from having the wrong electrolyte combinations, Dr. Tolwani laid awake at night thinking, there had to be a better way. Then, it came to her—a beautifully simple solution that would be hard to mess up and safe for the patient.

Using part of the citrate solution that was already available, Tolwani combined it with her own formulation of electrolytes that matched the patient’s blood. After seeing positive results from its use at UAB, Tolwani’s pharmacy friend and research colleague convinced her to patent the solution.

Baxter logoAfter publishing the data in 2006, Dr. Tolwani was contacted by a company called Gambro, now known as Baxter. Through the course of a few discussions, Tolwani decided to let them market the drug in countries and continents all over the world (Europe, Canada, Australia, Malaysia, and others). With the help of Baxter, the citrate solution, later-named Regiocit, has now been used countless times—preventing numerous errors and potentially life-threatening situations. Yet, up to this point, the FDA had not approved Regiocit for use in the United States. That was, until COVID-19.

Prior to COVID-19, the FDA had not approved Regiocit based on the fact they wanted to see it used in other places that did not have the same expertise as UAB. However, the pandemic has allowed Baxter to file for emergency use approval. In an article announcing the FDA’s emergency use approval, Baxter clarified the drug’s ability to help COVID-19 patients. The company stated, “acute kidney injury (AKI), a potentially life-threatening condition where the kidneys suddenly stop working and fluid and uremic toxins build up in the body, is one of many complications affecting COVID-19 patients.”

At the time of publication, Regiocit was in the training portion of the FDA agreement. Next, pharmacies will begin purchasing the bags and making them available for use. Dr. Tolwani and Baxter anticipate the first patients will be using the solution by the end of September or the first part of October 2020.

Looking to the future, Dr. Tolwani wants to continue sharing her expertise through curriculum creation, training, speaking engagements, and mentoring. Even those who are not her formal mentees, or may not even be physicians, can learn from her positive attitude. Whether you work in the school, at the bench, bedside, or anywhere else, Tolwani advises people to remember, some of the simplest ideas can have the most significant impact.