Twenty percent of people living with Congestive Heart Failure die within
twelve months of diagnosis. Research clinics across the nation believe stem
cells could offer a solution in the future. Unfortunately, for every research
clinic striving for the greater good, there are companies falsely offering
cures for financial benefits. These faulty clinics call for extreme regulation
in the field of regenerative medicine and, therefore, inhibit stem cell
research. The Food and Drug Administration prolong the process of approving
regenerative research due to invalid stem cell companies. Though the FDA
protects patients with new regulations, the administration also delays the
advancements of proper clinical trials. The Food and Drug Administration’s
deficiencies prove that regenerative medicine needs a new method of regulation
that ensures safety for patients as well as progress in stem cell research.
Regenerative medicine aims to recreate living, functional tissue to
repair the human body. Whether fighting a deadly disease, treating a genetic
disorder, or combating a painful deformity, regenerative medicine depends on
the future of stem cells. These undifferentiated cells hold the ability to mold
into nearly any other cell. With mild medical manipulation, scientists hope
stem cells will cure many diseases and deformities by replacing the damaged
cells. Though regulation for any medical process is necessary, can too much
regulation prevent advancement?
In 2010, the Food and Drug Administration won the right to regulate stem
cell therapy. Since their legal success, the FDA has only approved one
regenerative medicine company, Hemacord. Hemacord provides patients stem cells
from umbilical cords, peripheral blood cells, and bone marrow to treat blood
related diseases. In other words, the FDA approved bone marrow transplants.
Scientists first conducted bone marrow transplants in the 1960’s and have
successfully treated diseases such as leukemia since. Will we have to wait
nearly fifty years for the FDA to approve every new regenerative procedure?
With the rate that medical science discovers new potential cures,
waiting for FDA approval seems counterproductive. Yes, every new process needs
regulation to ensure purity and safety, but shouldn’t there be a faster way to
regulate new treatments? Science deemed bone marrow transplants effective long
before the FDA gave their seal of approval. The FDA claims patients should not
undergo any stem cell therapy that does not have approval because the
treatments do not exist. Yet, just because a clinical trial does not have FDA approval,
as a treatment does not mean the trials are ineffective.
The idea that stem cell therapy acts as a drug gave the FDA the right to
regulate regenerative companies. However, the medical community and drug
industry continue to argue over whether or not the alteration of stem cells
defines the procedures as drugs. The FDA claimed that a stem cell could only
have “minimal manipulation” before considered a drug. Unfortunately, “minimal
manipulation” lacks a concrete definition. The broad term causes mass amounts
of arguments as doctors and scientists perceive minimal manipulation
differently than the FDA. Therefore, whose definition do we trust: the FDA or
the scientists that created these procedures? The gap of knowledge between
medical stem cell specialists and the FDA currently prohibits further
regenerative medicine advancements. The FDA should have control only when a
sound definition of “minimal manipulation” arises. Until then, clinical stem
cell trials should not take the fall for the FDA’s lack of understanding.
This lack of understanding may derive from the Food and Drug
Administration’s lack of focus on the positive progress of stem cells. The
FDA’s recent media celebrity revolves around their battle to shut down all
companies promoting illegal stem cell therapies. These companies target
terminally ill patients and offer them untested stem cell treatments with the
promise of a cure. One company promised a treatment for an eleven-year-old
boy’s cerebral palsy. Tested by Duke University research lab, the stem cells
provided to the boy were either defective or dead. Upon further investigation,
the doctor providing the stem cells and promoting false treatment lost his
license years before moving to Ecuador to sell sham stem cells. Regrettably,
many more companies offering similar false treatments remain. These clinics
advertise treatments to incurable diseases and claim FDA approval. According to
Duke University’s scientific stem cell officer Joanne Kurtzberg, applying
defective or dead stem cells into another human can be fatal, causing a stroke
or brain inflammation. Therefore, FDA intervention is imperative. However, the
FDA does little to differentiate the clinics aiming for economic gains and
regenerative companies that intend to cure the world’s largest problems. The
negative media coverage of these clinics hinders the reputation of regenerative
medicine. With control over stem cell clinics, the FDA should not only abolish
faulty companies, but also promote successful procedures as well.
Recently, the Department of Neurosciences of City of Hope discovered a
groundbreaking new correlation between stem cells and inoperable brain tumors.
Doctors diagnose nearly 23,000 Americans a year with glioblastomas, an
extremely aggressive malignant brain tumor. With an average survival rate of 15
months, over half of the patients die soon after diagnosis. Miraculously, City
of Hope’s Dr. Karen Aboody provides a clinical trial that strives to treat
these once terminal tumors. Before this trial, doctors considered chemotherapy
dangerous and ineffective on glioblastomas. Backed by the National Cancer
Institute, Aboody’s trial injects chemically manipulated stem cells into a
patient’s brain, which then attach to the tumor. The patient then takes a
specific drug that reacts with the enzymes in the stem cells, providing an
effective form of chemotherapy on the cancer. This trial is far from FDA
approval, but has shown positive results thus far. While two patients
undergoing treatment lived seven months longer than originally expected, one
man still lives today, three years after treatment.
Aboody’s trial targets similar patients as faulty stem cell companies,
terminally ill patients with nothing to lose. Furthermore, Aboody’s treatment
does not yet have FDA approval and still needs far more testing before
considered a proven cure. So, how do patients differentiate between positive
trials like the City of Hope’s and falsely advertised stem cell companies?
First of all, everyone should heavily research any clinical trial before
agreeing to a medical procedure. However, many of these patients hold an
unstable emotional state due to their fatal diagnosis and will try anything,
regardless of the dangerous side effects. As the FDA works tirelessly to shut
down harmful clinics, regenerative medicine needs another form of regulation
that encourages the work of pioneering stem cell research.
The field of medicine is growing at a faster rate than ever as
scientists seek to find cures for the world’s most troublesome diseases and
disorders. Currently, thousands of medical clinics provide trials that offer
hope in the future of curing cancer, heart disease, diabetes, genetic
disorders, and more. While every medical procedure must be heavily monitored
and proven before offered to patients, the field of regenerative field of
medicine must create a faster and more successful method of regulation. Until
the knowledge gap between scientists and regulators diminishes, the Food and
Drug Administration should not hold sole power over stem cell research. The
regenerative medical field encompasses the potential to attain great
accomplishments through stem cell research. In a generation plagued by cancers
and incurable disease, do we have time to delay prospective solutions?
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