At the end of August, the Food and Drug Administration announced that it would be overseeing medical treatments utilizing stem cells. The agency is currently putting together rules that will govern the development of stem cell treatment, and it will be expanding its authority over businesses that the agency says sold unapproved treatments.
The commissioner of the agency released a statement that said, in part, “Our actions today should also be a warning to others who may be doing similar harm. We will take action to ensure Americans are not put at unnecessary risk.”
Stem cells have been used to replace skin, bone-marrow tissues and intestinal tissues. Scientists are currently studying whether or not stem cells can be used to grow replacement organs or treat various diseases. Research is currently experimental, but promising research has been shown in the treatment of Lou Gehrig’s disease among other conditions.
There are currently just over 550 clinics in the country that advertise treatments utilizing stem cells. Most of these, however, are not providing treatments that actually work. Because these businesses have been outed as offering treatments that have not been proven, it was widely discussed that perhaps the FDA should step in and assert its authority.
Operators of these clinics have argued that the FDA only has oversight of drugs, not a person’s own cells. Those who criticize the clinics say that there is potential harm to people purchasing treatments that are not proven effective. There have been some reports of injuries and death among customers of these clinics.
In some cases, clinics are facing lawsuits alleging fraudulent business practices. According to some of these lawsuits, prices for treatments have cost upwards of $15,000.
The FDA itself reports that it seized vials of smallpox vaccine from a center in San Diego. The vaccine was being used as part of a procedure that did not receive approval. The clinics in question were combining the smallpox vaccine with body fat and injecting the mixture into cancerous tumors. It is unknown how the company obtained the vaccine vials.
While many people have heard of stem cells, not everyone understands here they come from. There are several sources for these cells, including embryos, adult tissue, altered adult cells and amniotic fluid.
Embryonic Stem Cells: These stem cells are found in embryos that are between three and five days old. The stem cells can divide into more, or the can become a different type of cell in the developing fetus. This versatility allows the cells to be used in applications of regeneration.
Adult Stem Cells: Stem cells are found in adult tissues like fat and bone marrow. New evidence has shown that stem cells from bone marrow can be used to create heart muscle cells or bone cells. Clinical trials are taking place in people with heart disease and neurological issues.
Altered Adult Cells: Some scientists have been able to alter adult cells via genetic reprogramming. This has allowed scientists to use the cells in similar ways as embryonic stem cells. It is currently unknown whether or not this genetic altering will cause problems in humans.
Perinatal Stem Cell: Found in the umbilical cord and in amniotic fluid, these cells can change into those that are more specialized. Scientists are not currently aware of the full potential of these cells and more research is being conducted.
The use of stem cells is controversial, particularly in the use of embryonic stem cells. These cells are gathered from early-state embryos. Those used in research are gathered only from embryos that have been produced during in vitro fertilization and never implanted into a woman. Donors consent to the use of the stem cells.
Some people are opposed to this research, indicating that a “life is a life” and using embryos in such a way is akin to murder. Proponents of the research say that the embryo is still only a group of cells, not viable, and can contribute to the eradication of some diseases and the healing of others.
Others cite the actual dangers of stem cells themselves, especially since it is a highly experimental treatment. For instance, treatment from one clinic in Fort Lauderdale allegedly caused blindness in three women.
If you have been victimized by a center advertising stem cell treatments or misdiagnosed or mistreated by a medical professional in West Palm Beach, you have rights. Call our office today to schedule a free case evaluation. We will review the details of your incident and advise you of your legal options. Call now to speak with a member of our team.