Cases in Court
Cases in court for stem cell research are vast and cover a wide range of accusations. The cases have been set in motion at both the federal and state level. One of the most notable and recent cases was with the U.S. District Judge Ursula Ungaro of the Southern District of Florida who granted the motion for summary judgment against US Stem Cell Clinic LLC, of Weston, Florida, and US Stem Cell Inc., of Sunrise, Florida, and their Chief Scientific Officer Kristin Comella, Ph.D. (FDA, 2019)
This case is significant because it enters in territory of non-compliance and physician ethics because of harm being caused to patients. An issue that the U.S. Stem Cell Clinic was found guilty of was that it was dispensing their product by injection which is illegal through FDA regulations. U.S. Stem Cell Clinic was also guilty of contamination of their products which placed their patients in danger of infection.
U.S. Stem Cell Clinic was also in the news for the damage they caused to three patients in regards to vision, while two of the patients were blinded because a clinic affiliated with U.S. Stem Cell injected stem cells into their eyeballs. The clinic provided their own response in that they are exempt from oversight since the therapy was utilized with the patient’s own cells. The FDA dismissed the response under the fact that the clinic used and performed surgery with an illegal drug; which, Judge Ungaro agreed with and issued a ruling on June 3, 2019. (Hiltzik, 2019) This sanction is said to be garnered with support from researchers academically because there are concerns with these clinics that are making these promises regarding stem cell therapy, that they are doing so with little to no basis and undermining the integrity of legal research of stem cells.
Recommendations are necessary to create an action plan that can contribute to improving health outcomes and the safety of human life. Examples have been shown of court cases implicating this research and the effects of its procedure in patients that have been submitted to unregulated procedures. The importance of the review of actual regulations and laws is important to comply with the FDA policies and apply it to a facility and prevent that sanctions can occur in the future.
The FDA is even offering physicians new paths to the treatment and testing of stem cell therapies. The new process the FDA has introduced for clinics is the capacity to partner in clinical trials while also using a pool of patients which can increase time efficiency and also be cost-effective. This first recommendation by the FDA for a stem cell facility also benefits them because it allows them to provide oversight of one trial with multiple clinics involved.
The second recommendation that has been conveyed by the FDA is a 36-month grace period to be in compliance with FDA guidelines which would allow the facilities to continue to operate and test patients without having to do those costly and time-consuming clinical trials. (Levy, 2019) This grace period can be seen as an ethical implication because it allows for a clinic to operate outside mandated guidelines for up to three years, but it also allows for innovative and progressive research to be conducted with more allocation for funds and time.
The last recommendation entails the creation and application of the research committee which will provide oversight throughout the processes of research and therapy. The healthcare administrator will be briefed by the research committee to be made aware of any deficits or issues with meeting guidelines. The research committee will also present recommendations on a monthly, quarterly, and yearly basis to provide continued regulatory and legal compliance.
Changes in Law and Regulation
Medical advancements are often met with changes in laws and regulations to keep in compliance with local laws and regulations. Stem cells have been utilized in medicine for over 60 years since the 1950’s when the leukemia was treated with bone marrow transplants. (‘Timeline of major events in stem cell research policy’, 2016) United States Congress created the first major amendment in 1996 which banned any type of federal funding for research that included embryos. (‘Timeline of major events in stem cell research policy’, 2016)
Throughout the years different U.S. Presidents agreed and disagreed with the principle of stem cell research which resulted in prohibiting federal funding for human embryonic stem cell research by President George Bush in 2001 and the reversal of this prohibition by President Barack Obama in 2009. (‘Timeline of major events in stem cell research policy’, 2016) President Obama’s reversal of previous policies paved the way for the signing of the 21st Century Act which enforced timely regulatory review of regenerative therapies which included cell therapies enabled by stem cell therapy research. (‘Timeline of major events in stem cell research policy’, 2016)
The role of a healthcare administrator in the present dealing with stem cells will be different than an administrator of stem cells of the past because of all the changes in the legal aspect. There has been a more accepted approach to this treatment and research which has been seen from the lowest levels to the highest with our Presidents. As a healthcare administrator in the past federal and local guidelines prohibited the treatment or therapy for stem cells so the role was more inclined to monitor any illegal actions.
Healthcare administrators now have the role of providing health reform to facilities through meeting compliance standards and ensuring these facilities are maintaining standards while meeting goals and deadlines. Changes in law and regulations have drastically changed in the last ten years and seem to be headed to changing even more on a more detailed level in the next couple of years; with a focus on proving the benefits and basis of treatment using stem cells.
Action Plan Implementation
An action plan needs to be implemented for the implementation of the three recommendations along with facility policy and standard operating procedures (SOP). This action plan will allow for all facilities conducting stem cell therapy and research to be mandated under the same SOP while adhering to certain guidelines that will provide effective implementation. The process will include selecting leadership and staff members in key positions to ensure representation at all levels while allowing staff to have a voice in change.
An action plan needs to have the flexibility to define problems while creating opportunities so that future issues will be resolved in a timely manner. Another key aspect of an action plan is to have a test for effectiveness which can be used as a “trial” run for certain recommendations or changes in policy to measure how they work and if they are essential for continued growth. Certain measures in action plans coincide with multiple plans in place from successful companies like having targets or goals, recognition programs, timely individual and group evaluations, identified structure for communication (chain of command), and discussions involving all levels of staff for recommendations of changes. (“Ten Steps of Action Planning”, 2018)
Stem cell therapy is the future of innovative and radical change to how the treatment is applied to a broad range of diseases and injuries. As with any progressive and different idea, controversy can be found with the foundation and origin of the research or implementation. Through teamwork, understanding, and compliance this product can be effectively harnessed for extreme progress and acceptance across a multitude of skeptics. The assessment of stem cells is positive while also arising dilemma across the ethical landscape.
Ethical principles are being questioned with many choosing sides on what is perceived as right/wrong regarding stem cells and their origin. Changes in law and regulation have made this case even more complicated with governments and politicians creating and reversing policies affecting stem cells. Healthcare administrators are caught in the middle of this battle and need to comply with regulations and standards; while also maintaining ethical principles and meeting the goals to achieve success in the field of stem cell therapy.