The Rapid Movement Of Medicine

As modern medicine continues barreling forward in an ever-advancing world, doctors are continually discovering new ways to treat disability and disease. Surgeons now routinely use high-definition cameras to perform new methods of minimally invasive surgery, the development of the artificial heart has prolonged the lives of thousands of heart disease victims, and genetic engineering is on the brink of a becoming a mainstream technology that could ultimately shift the course of human evolution. As a testament to the success of scientific and medical research over the last one hundred years, these three cutting-edge advancements are merely scratching the surface of medical innovation.

More recently, in the last twenty-five years, the field of stem cell biology has proven to be one of the biggest breakthroughs in medicine and healthcare of our time. Stem cells stand to allow us to truly manipulate our own biology by reproducing our own worn-out tissues and organs and using the powers that are held within the cellular mechanisms of our bodies for healing and repair.

For several decades now, doctors and scientists have been conducting research on stem cells and their functionality with the goal of introducing new forms of treatment. This global initiative to apply stem cell science to treat disease has created a new clinical discipline often referred to as “stem cell therapy” by physicians and the public. Stem cell therapy involves the introduction (commonly by injection) of adult stem cells into various areas of the body for regenerative and reparative purposes, and researchers are quickly approaching a refined treatment that will be approved by the Food and Drug Administration (FDA) and widely adopted by the field of medicine.

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However, over the last two to three years, the process of integrating stem cell therapy safely and legitimately into mainstream medicine has been threatened by an epidemic of widespread malpractice and consumer fraud throughout the United States.

Patients across the nation are currently being “treated” with stem cell therapies in unsafe clinical settings that have not yet been approved by government standards, leaving the power of the FDA in question and the safety of the public at risk. In addition, many of the practitioners administering these treatments are not licensed physicians and have zero personal experience in stem cell research. In fact, the majority of the centers dispensing these unapproved products are made up of chiropractors and naturopaths who are preying on a vulnerable public desperate for a “miracle cure,” charging outrageous out-of-pocket fees for each injection. As a nation that holds pride in its advanced medical capabilities as well as one that seeks to protect the well-being of its citizens, it is crucial that we hit the pause button on these premature stem cell treatments until we can ensure that they are safe and effective for those receiving them.

As with any other form of treatment or medicine that is intended to be distributed to the American public, it is required by law that stem cell therapy is screened for safety and effectiveness by the FDA before it becomes available for practice by medical practitioners. Because stem cell therapy is still relatively young in the field of medical treatment, with the exception of blood disorders such as leukemia, the FDA has yet to officially approve it in any form based on their official reviews of clinical trials (controlled tests on humans). As of right now, the FDA has forbidden the practice of stem cell therapy on members of the public until it has been proven safe by the due process for approval and distribution. However, despite these precautionary regulations, hundreds of “stem cell clinics” have opened across the nation and currently remain in operation, declaring themselves legitimate providers of stem cell therapy and making claims for its effectiveness that have yet to be evaluated by the FDA.

To understand how these rogue stem cell clinics might have come to exist and prosper, it is important to understand the history of stem cell research and the evolution of public opinion on stem cells as a form of therapy. Since the first successful bone marrow transplantation in a two-year-old boy in 1968 (Halme & Kessler, 2006), the medicinal properties of stem cells have grasped the attention of the public. This particular infant child received a bone marrow transplant, donated by his biological sister, which healed him of Wiskott-Aldrich syndrome, a severe blood disease characterized by eczema, reduced ability to form blood clots, and a slew of other symptoms. As this was a critical breakthrough in medicine, word of the successful procedure reached the media and it quickly became public knowledge that stem cells had extraordinary capabilities, could be extracted from bone marrow and could be implanted into patients in need of healing. In turn, this created great demand from the public for scientists to bring stem cell therapies to the mainstream medical market. Populations of affected patients were enthusiastic about the potential for a new form of treatment for their previously hard-to-treat diseases.

However, this process was held back greatly in the following years by numerous technical and ethical issues. Initially, stem cells were thought to only be present in the bone marrow with the sole function of replenishing the blood . Today, we know that stem cells are ubiquitous in the human body and are responsible for repair and regeneration of not only the blood but all types of solid organs and tissues as well. So, early on, scientists were restrained by a fundamental lack of knowledge in the field. Soon after, in the 1980s, the discovery of embryonic stem cells sparked a new debate over their potential for use in a medical capacity. At the center of these debates was the ethical dilemma around obtaining functional stem cells at the expense of a human life (a living embryo). Additionally, embryonic stem cells were found to be highly volatile with great potential to form cancerous tumors, and because of these obstacles, the use of embryonic stem cells in medicine was put on hold.

Fast forward to the early 2000s. Through their research, scientists learned that there are alternative varieties of “adult stem cells” that can be extracted from an organism (human, dog, etc.) and harnessed to replenish blood cells or generate tissue for bone, fat, or muscle. With the ethical dilemma of the embryonic stem cell eliminated, adult stem cell therapy was well on its way to becoming a reality . Over the next decade, scientists began working with the FDA, conducting studies in animals and taking the first steps in the long and expensive process for approval and distribution. Unfortunately, while legitimate physicians and scientists were taking their novel stem cell discoveries through the regulatory pathway, a few unlikely practitioners decided that they didn’t want to wait for FDA approval. Inspired by the idea of pocketing thousands of dollars per treatment, this is where the illegitimate practitioners entered the scene.

For the practitioners who opened up the first stem cell therapy clinics and began distributing unapproved treatments, this was a no-brainer from a business perspective. There was a great opportunity presented in an extremely profitable market. In their opinion, stem cells had been well-studied and well-tested for decades. The public had long been aware of the fact that stem cells promise to be the next paradigm shift in medicine and were simply waiting for the first clinic to offer them. Not wanting to waste any time and potentially miss the opportunity to build a fortune, proprietors kickstarted their new business ideas and suddenly clinics were flooding the nation, each promising to offer the newest technology in stem cell therapy. The FDA was caught off guard by this blatant disregard for their authority and lacks the necessary bandwidth to physically visit each new clinic and shut them down. In addition, doctors and scientists were also blindsided, as opportunistic businessmen began turning incredible profits off of their decades of painstaking research.

Not only did this seem morally wrong, but also exceptionally unsafe as thousands of people began participating in stem cell treatments that had not been conclusively studied by experts. Fast forward to 2018 and this is the situation: for-profit unapproved stem cell clinics now thrive throughout the US and a divide has formed with regard to the current practice of stem cell therapy. There are two opponents: the rogue clinicians backed by their vulnerable patients desperate for a miracle cure and the legitimate medical community—backed by the FDA and the global scientific community. A simple Google search for locally available stem cell treatments will reveal that these rogue clinicians often have little to no background in legitimate stem cell science nor regenerative medicine yet make major claims about the safety and effectiveness of their methods.

They claim that their practices are safe because they use their patient’s own cells and a majority of their patients report a perceived sense of healing—the latter being their strongest and most commonly used point of argument. Unfortunately, many of the therapies currently in use have shown to be no better than placebo in controlled studies by the scientific community. “But if the treatment is working for some people, then what’s the issue?” One might say. The legitimate medical community has a number of credible responses to this question. Doctors and scientists believe that stem cells show great promise and they remain highly aware of a multitude of clinical therapies that are very close to becoming reality through the traditional regulatory pathway (FDA approval).

However, the medical community also understands that there are many things about the mechanisms of stem cells that are not fully understood and that may need to be tested further and clarified before stem cells can be used for treatment. Doctors have yet to determine which variety of stem cells is most effective for each affliction. Definitive instructions have yet to be established for dosage and frequency. Most importantly, there is great potential for harm if stem cells are used incorrectly or without proper training and supervision, and sadly, this has already become evident in the United States and other regions of the globe. In one instance, US Stem Cells, Inc. a clinic in Sunrise, Florida, left three women completely blind after injecting stem cells into their eyeballs in an attempt to cure their ensuing blindness.

To make matters worse, the nurse practitioner (not a doctor) performing the procedure treated both eyes at the same time, something no legitimately qualified physician would do in the same operation. In another instance, a man had an unapproved stem cell procedure performed where the cells were injected directly into his spinal cord, which soon after caused the growth of a cancerous tumor due to the genetic instability and unsafe handling of the stem cells. As of May 2018, the FDA began taking action to address some of this dangerous behavior by filing complaints against two illegitimate stem cell clinics, one of them being US Stem Cells, the clinic that blinded three women in Florida, and California Stem Cell Treatment Inc. was the other (Scutti, 2018). The aim was ultimately to ban the clinics from administering unapproved