In the recent case brought up on appeal, U.S.A. vs Regenerative Sciences LLC, the Appellate Court re-examined the issue of whether federal laws regulating the manufacture and labeling of drugs and biological products were violated by a company that produced a mixture of stem cells and antibiotic doxycycline. In an earlier ruling, the District Court held that Regenerative Sciences LLC did violate these laws, and the Appellate Court affirmed the lower court’s judgment. This case received a lot of publicity due to the ethical issues surrounding stem cell research and resulting impacts to stakeholders affected by the outcome. The case presents interesting questions involving the stem cell research controversy, because it is a little different from the typical controversy involving this type of research. In this case, the stem cells come from the patients’ own bone marrow, as compared to coming from embryos. Since the treatment procedure involves a mixture of the patients’ own stem cell substance, the typical ethical issues are slightly different.
The main stakeholders impacted by the case are the appellants, who are the doctors involved in the research and who also are the majority shareholders of Regenerative Sciences LLC. In addition, the laboratory director for Regenerative Sciences is also a main stakeholder involved in the substance mixture, called Regenexx Procedure. Regenerative Sciences LLC is the owner of the procedure and holds an exclusive license to a clinic involved in the treatment of the procedure. Thus, the appellants all stand to gain financially as a result of the success and exclusive license of the treatment procedure. If the court determines that the federal laws were violated, the appellants will be unable to continue with their treatment procedure and will lose out on the financial gains and future monetary gains based on the procedure. The potential patients will also be impacted, because they stand to lose out on the Regenexx Procedure which would benefit them. Future patients in a wide range of areas will be affected, as the treatment is recommended for osteoarthritis, non-healing bone fractures, chronic bulging lumbar discs, and soft tissue injuries.
Although this case does not involve the typical kind of stem cell research that usually causes ethical issues, it still does raise some ethical concern. Typically stem cell research raises ethical concerns because it requires the destruction of a human embryo. Pro-life supporters have argued against stem cell research for this reason. Other arguments against stem cell research have been that stem cell research currently has few practical applications. In this case, the stem cell research involved does not come from a human embryo and it does have a practical application. Here, patients’ stem cells from their own bone marrow are used to treat bone, muscle, joint and tendon pain. The treatment procedure is intended to repair the patient’s degenerated or injured area, so it is more than just research without a current valuable application. Furthermore, the stem cells come from the patient’s own body, so there is nothing or anyone else that is harmed or involved in the procedure other than the patient’s own body.
The ethical concerns raised by this case do not involve the stem cell research involved. The ethical issue presented does not involve whether the procedure used to administer the treatment is safe; rather, the ethical issue involves whether the mixture of the stem cells and the antibiotic fluid is safe in itself. The court held that the Regenexx Procedure involved a drug which is regulated by the FDA, not the “practice of medicine,” which is what the company argued. The Appellate Court held that Regenerative Sciences LLC misbranded its mixture consisting of stem cells and antibiotic doxycycline, which is a drug under the federal regulations. The process involves so many steps, so that the treatment procedure is not merely a simple extraction from a patient’s bone marrow. The Regenexx Procedure consists of stem cells taken from bone marrow being placed into a solution which causes them to divide and proliferate. The question then becomes whether this mixture is a drug and biological product. This mixture is then used to treat the patient. The case poses more of an ethical question of whether the appellants knew that their treatment procedure consisted of something more than the “practice of medicine.” The ethical question involves whether the treatment was a drug instead of a medical procedure. Thus, it poses a smaller and different ethical dilemma than that usually associated with stem cell research.
I do not think that the case was initiated because of an ethical dilemma, rather I believe that the case was initiated based on the violation of the federal regulations. The regulation of drugs is a serious issue, and the FDA should be the ruling authority on whether or not certain drugs are safe for humankind. If a certain procedure is considered a drug, then I think that all relevant federal regulations should apply to keep the population safe. In this case, the Regenexx Procedure really consisted of a mixture of substances instead of an actual treatment procedure. It is in the court’s interest to enforce federal laws and regulations, and if a company is violating these regulations they should be stopped. I think that the court ruled correctly in this case, because the mixture of stem cells and antibiotic doxycycline used in the treatment does consist of a drug rather than just the practice of medicine. As a result, I do not think that the case really poses an ethical dilemma. There are ethical questions, but those mainly involve whether the appellants in good faith believed their procedure was just the practice of medicine instead of a new drug. Finally, future cases in this area of stem cell research will shed more light on the issue.
United States of America v. Regenerative Sciences, LLC. 1:10-cv-01327. U.S. Court of Appeals.