Researcher Blows Lid on Unapproved Drug & Ignored FDA Warning at NY Presbyterian & Weill Cornell

Researcher Blows Lid on Unapproved Drug & Ignored FDA Warning at NY Presbyterian & Weill Cornell

Edited by: TJVNews.com

In the intricate world of healthcare, trust and transparency are vital pillars upon which the entire system stands. Patients trust medical institutions to provide them with the best and safest treatment options available. Doctors, in turn, rely on medical institutions to offer products and equipment that meet stringent safety and efficacy standards. However, a recent incident involving an unapproved medical product with serious manufacturing concerns has cast a shadow over the normally pristine reputation of New York’s renowned medical institutions, NewYork-Presbyterian and Weill Cornell Medicine, as was reported in the New York Times on Thursday.

The report delves into the perplexing case of how an unapproved medical product, BioBurst Fluid, managed to find its way into the inventory of these respected institutions.

The fluid, derived from umbilical cord blood, was not approved for such procedures, the agency cautioned, and its Idaho manufacturer had been cited for possible contamination problems and inadequate screening of donors, making the product potentially unsafe, the NYT reported.

Hospitals, like any other organizations, have a formal process for approving the use of products on patients. This process often involves a committee of experts who thoroughly vet requests from doctors before these products are integrated into the hospital’s inventory, according to the NYT report.

In the case of NewYork-Presbyterian and Weill Cornell Medicine, spokeswomen from both institutions have remained tight-lipped about how and when products are approved.

Before the FDA’s advisory, approximately 40 patients at the hospital had received treatment with BioBurst Fluid, overseen by Dr. Roger Härtl, a senior surgeon and professor at Weill Cornell, and a physician for the New York Giants. These surgeries were documented in a draft study, co-authored by Dr. Pravesh Gadjradj, the visiting researcher, which aimed to track the fluid’s effectiveness in fusing delicate bones, the NYT report said.

The revelation prompted Dr. Gadjradj to approach Dr. Härtl, expressing his concern about the fluid’s safety. In a complaint filed with the hospital, Dr. Gadjradj alleged that Dr. Härtl had asked him to delete the research file on the project and never discuss it again. The NYT report indicated that he further asserted that Dr. Härtl had not informed the patients and had instead chosen to “cover it up.”

In an interview, Dr. Gadjradj disclosed that this conversation took place in the spring of the previous year. Despite his persistent worries about the patients’ well-being and his belief that they had not been informed of the potential risks, his complaint did not yield any significant actions, as was noted in the NYT report. This situation highlights the complex ethical dilemma faced by clinicians in such circumstances.

“Maybe all of these patients don’t have any adverse effects, but maybe they do,” he said. “We don’t know. That’s a terrible thing.” Because of privacy protections, Dr. Gadjradj said, he would not disclose the names of the patients or contact them himself, according to the NYT report.

FDA warning letters do not mandate the notification of patients about a product’s potential problems, creating an ethical quandary for healthcare professionals, the NYT report said.  While there may not be a formal requirement, many medical ethics experts argue that there is a moral obligation to inform patients, especially when it concerns new or untested treatments.

Hank Greely, a law professor at Stanford and director of its Center for Law and the Biosciences, emphasized the importance of transparency. The NYT reported that he stated that the ethical approach would be to inform patients about known risks. However, concerns about reputation, lawsuits, and patient dissatisfaction often deter doctors and hospitals from taking this course of action.

What is perhaps more astonishing is the fact that, despite the controversy surrounding BioBurst Fluid, doctors at several other hospitals have reported using Burst’s products and have expressed their surprise at the FDA’s warning, as was indicated in the NYT report.  As was reported by the NYT, Dr. Faheem A. Sandhu, a spine surgeon at MedStar Georgetown University Hospital, revealed that he learned about BioBurst Fluid through a company sales representative around 2017. Dr. Sandhu was under the impression that the product was FDA-approved and, like many other healthcare professionals, simply considered himself “just another customer.”

Dr. Sandhu disclosed that he had used the product on over 50 patients and had witnessed favorable results with no apparent problems. The NYT report suggested that this reveals the complexity of the situation, as it suggests that healthcare professionals may have unknowingly put their patients at risk due to a lack of transparency and information regarding the product’s approval status.

Umbilical cord blood products, like BioBurst, have FDA approval for treating disorders affecting blood production. However, the NYT report said that their use in spine surgeries, as in the case of BioBurst Fluid, is an entirely different matter. This highlights a regulatory gap that needs to be addressed to protect patient safety.

The manufacturer of BioBurst Fluid, Burst Biologics, is a small biotechnology company that had shipped its product to hospitals and clinics across the country. According to the NYT report, Burst Biologics claimed that the fluid could potentially stimulate bone regeneration, positioning itself in the burgeoning field of regenerative medicine.

Regenerative medicine, which aims to replace or restore damaged cells through gene and stem cell therapies, has gained significant attention from regulators. However, the FDA’s inspection of Burst Biologics in 2021 revealed serious problems, including breaches in sterile manufacturing, inadequate donor screening, and a lack of proper approval for BioBurst Fluid, the report added.

In February 2022, the FDA issued a public warning about Burst Biologics, leading to the recall of the two products, BioBurst Fluid and BioBurst Rejuv. Subsequently, the company’s founder declared bankruptcy, and the company’s equipment was sold at auction, as was reported by the NYT. Notably, Burst’s recall did not include a process for notifying patients about the potential risks they faced.

The troubling history of Burst Biologics extends back several years. Interviews with former employees revealed serious issues within the company, including subpar laboratory practices, inadequate safety protocols, and a retaliatory work environment, according to the NYT report. Some employees also had concerns about the regulatory status of BioBurst Fluid and BioBurst Rejuv, believing that these products should be subject to more stringent FDA standards.

In 2017, some employees alerted management and regulators about product safety, lab conditions, and regulatory requirements. However, regulatory action was slow to materialize. As was indicated in the NYT report, Burst Biologics continued to expand its presence while cultivating ties with doctors across the country, further raising concerns about the safety of BioBurst Fluid and BioBurst Rejuv.

Dr. Härtl, the physician overseeing the use of BioBurst Fluid at Weill Cornell, declined interviews, the NYT reported, but provided written responses. He acknowledged using the fluid between 2019 and 2021 as an alternative in minimally invasive spine surgeries. However, he did not directly address questions regarding patient notification or concerns about the product’s safety.

In the absence of responses from Dr. Härtl, the hospital, and Burst Biologics, it remains unclear how the product found its way into the hospital’s inventory without proper approval, as was noted in the NYT report. Spokeswomen for NewYork-Presbyterian and Weill Cornell Medicine did not provide insights into their product approval processes, deepening the mystery.

Financial considerations also play a significant role in this narrative. Some patients had their BioBurst Fluid treatment covered by insurance, a process that typically costs thousands of dollars, the NYT report said. This raises questions about the financial interests that may have influenced decisions regarding the use of unapproved products.

Dr. Sandhu’s revelation highlights the crucial need for doctors to have access to accurate and up-to-date information about the products they use. Had he been aware of the regulatory concerns surrounding BioBurst Fluid, he claims he would not have used it and would have informed his patients accordingly, as was reported by the NYT. This raises an essential point: the responsibility of healthcare institutions to provide their staff with comprehensive information regarding the products they offer and the potential risks associated with them.

Although he had experience with clinical research on spine surgery, Dr. Gadjradj  arrived in New York with no prior knowledge of Burst’s products. The NYT report said that initially, he enjoyed a good working relationship with Dr. Härtl, his mentor at Weill Cornell. However, a clash over the Burst research soon soured their professional connection.

Dr. Gadjradj said it was the hospital’s lack of transparency with patients that was most troubling to him.

“They can’t ring the bell if something goes wrong,” said Dr. Gadjradj, who completed his tenure with Dr. Härtl at the end of June and returned home to the Netherlands with plans to finish a residency in neurosurgery, the NYT reported. “We don’t know because we just discharged them like nothing happened.”

Dr. Gadjradj’s primary concern was not just the unapproved product itself but the hospital’s lack of transparency with patients, according to the NYT. He expressed dismay over the fact that patients were discharged without being informed of the potential risks associated with their treatment. This revelation exposes a severe flaw in the healthcare system, as transparency is not only an ethical obligation but a fundamental aspect of patient safety, the report suggested.

The use of unapproved medical products in healthcare settings raises several issues and concerns:

Patient Safety: The foremost concern is patient safety. Unapproved products may not have undergone rigorous testing and evaluation, potentially exposing patients to unknown risks and complications. Transparency about a product’s approval status is essential for patients to make informed decisions about their healthcare.

Professional Trust: Healthcare professionals, like Dr. Sandhu, may unknowingly use unapproved products, eroding their trust in the institutions they work for. Trust is a cornerstone of the doctor-patient relationship, and any breach of that trust can have far-reaching consequences.

Financial Implications: Patients and healthcare institutions may face financial consequences when using unapproved products, especially if insurance coverage is involved. This can lead to disputes and legal ramifications.

Regulatory Oversight: The incident also highlights potential gaps in regulatory oversight. How an unapproved product found its way into these respected medical institutions without detection raises questions about the effectiveness of the regulatory framework.

Transparency and Accountability: Hospitals must prioritize transparency and accountability when it comes to product approval and patient communication. Patients have a right to know the risks associated with their treatments, and healthcare professionals must be equipped with accurate information to make informed decisions.

The case of BioBurst Fluid serves as a stark reminder of the critical importance of transparency, accountability, and regulatory oversight within the healthcare industry. It is imperative that medical institutions prioritize the safety and well-being of their patients above all else.