Equipping People To Make Sense Of What They Are Told
Stem Cell Therapy
Neural stem cells are currently being investigated as potential therapies for neuro-degenerative
diseases, stroke, and trauma. However, concerns have been raised over the safety
of this experimental therapeutic approach.
In February 2009, the journal PloS Medicine published an article detailing a case
study of a 13-year-old boy who had developed a brain tumour as a result of a stem
cell treatment.
Between 2001 and 2004 the boy received three separate fetal stem cell transplants.
During 2005 he developed headaches, and was found to have a brain tumour which was
found not to have originated from the boys own cells, but from the fetal stem cells.
The evidence was that none of the tumour cells carried the genetic mutation that
causes ataxia telangiectasia. In addition, the tumour cells were a mix of men and
woman, indicating the tumour actually originated from two separate donors.
At the time he developed the brain tumour, the boy still had typical symptoms of
ataxia telangiectasia.
Ataxia-telangiectasia is a rare, childhood neurological disorder that causes degeneration
in the part of the brain that controls motor movements and speech. Its most unusual
symptom is an acute sensitivity to ionizing radiation, such as X-rays or gamma-rays.
The first signs of the disease, which include delayed development of motor skills,
poor balance, and slurred speech, usually occur during the first decade of life.
In the 1950s and 60s it was already generally accepted that cervical cancer could
be prevented by treating women who were found to have precancerous cells called Carcinoma
In Situ (CIS). The methods at the time to treat women with CIS usually involved either
a hysterectomy, the surgical removal of the uterus, or a cone biopsy which could
cause bleeding and fertility problems.
Professor Herbert Green, a health professional in Auckland, New Zealand, hypothesized
that CIS was not a precursor to cervical cancer, which was contrary to scientific
consensus, and embarked on a study to prove his theory and show that women could
be spared the negative effects of treatment. He primarily elected to leave untreated
identified cases of CIS in young women (under 35), as his main objective was to preserve
fertility. The women were never informed they were in a study, never told they had
treatment options, and in some cases never were told they had CIS.
The study ran from 1955-1976. During that time 131 women tested positive for CIS,
of which 22% developed invasive cancer and some died as a result. Only 1.5% of women
with normal pap smears developed cervical cancer.
The study continued despite evidence that the health professional's theory that CIS
did not lead to cancer was wrong.
Several regulatory guidelines outlined in both the Nuremberg Code and Helsinki Declaration
were ignored. people were not properly informed, there was no effort to minimize
harm to the people, and scientific evidence, both indicating that CIS did lead to
cancer and that the lack of treatment was harmful was ignored.
Could it happen again? - Letter from New Zealand - PubMed -Internet Page
Thalidomide
Developed and marketed the as a sedative. In animal testing of thalidomide, researchers
were unable to find a dose high enough to kill animals. It was therefore thought
that thalidomide would not cause fatal overdoses in humans, and it was deemed safe.
The drug was rushed into market in countries throughout Europe, and in Australia,
and Canada. In many countries the drug was considered so safe it was sold over the
counter, and in some it was also given to pregnant women as a remedy for morning
sickness.
Chemie Gruenenthal, however, neglected to perform a well-designed, controlled clinical
trial before widespread distribution as a sedative, and despite differences in how
humans and animals react to thalidomide, relied primarily on the animal tests to
indicate safety.
Around 1960 health professionals began noticing that some people who had used thalidomide
developed polyneuritis, numbness in the hands and feet, caused by permanent nerve
damage. At around the same time, physicians began noticing a dramatic increase in
the normally rare birth defect phocomelia, in which the legs and/or arms are severely
malformed or missing. Many such children were also born with severe defects to the
bowel that often proved fatal.
The sudden increase in a rare birth defect was found to be directly linked to thalidomide
use. It was found that a single dose of this "safe" drug during a critical period
in pregnancy was enough to cause birth defects. Following the revelation of these
severe side effects, thalidomide was taken off the world market through 1961 and
1962.
Thalidomide was never marketed in the United States because the U.S. foodstuffs and
Drug Administration (FDA) deemed there was not enough evidence indicating the drug
was in fact safe. Except for a few experimental test cases, the United States was
largely spared.
The drug ‘Thalidomide’ was mainly prescribed to pregnant women for morning sickness
in the late 50s and early 60s. Instead the drug caused severe deformities in babies
with missing limbs. Some thalidomiders were also born with internal deformities.
It’s estimated that over 3,500 babies died before their first birthday. Thalidomide
was invented in 1954 at the Grünenthal Labs in Germany by the inventors Dr. W. Kunz
(chemical synthesis) and Dr. H. Keller (pharmacological description of sedative properties).
