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October, 2006: The SCOT trial is advertising
an alternative treatment for Scleroderma sufferers.
It is currently being offered in many states, and
patients are running to find out about it. Before
you do, there are some facts you should know before
considering this trial.
In 2004, investigators in the SCOT trial published
Phase I outcomes showing a 30% mortality rate*.
Since then there have been no additional Phase I
data published by them to inform patients or
rheumatologists of the Phase I outcomes.
There is real concern since the SCOT trial uses
Total Body Irradiation as part of their protocol.
It is not easily noticed in the description of
the protocol in their pamphlet, but it is a major
part of the procedure. They claim they are
shielding the lungs and the kidneys,due to the
learning curve from recent data, but radiation,
by virtue of its definition, goes where it wants.
Total body irradiation makes Scleroderma worse.
The "T" cells, are already over activated by
Scleroderma.
To reduce the high mortality rate, The SCOT
trial has considerably narrowed the qualification
process to enter their trial. If you have lung
disease,watermelon stomach, are takings certain drugs
for your treatment to this point, and other
situations, you most likely will be rejected
as a candidate. This skews the data, masking the
danger of the radiation to anyone who undergoes the
treatment, even further.
What is most disturbing is that patients--rejected
or not--are not being told that another trial exists.
In fact,in many cases they are being told that the
only other way to get a transplant is to go to Europe.
The SCOT people know this is not true.
There is another trial called ASSIST,
which does not use total body irradiation and is safe
for patients with lung involvement and other forms
of the disease. Patients cannot make an informed
decision with only partial information. A protocol
called ASTIS, similar to ASSIST is used widely in
Europe, with very good results, including a zero
mortality rate.
Let's look at the facts: The ASSIST trial does not use
Total Body Irradiation and has a zero* mortality rate.
The SCOT trial does use TBI, and as of 2004 with no
current data, has a 30% mortality rate*. It could be
higher. We do not know. This information is being
withheld from the patients. I researched the latest
SCOT data, and could not find any mortality rates listed
from 2004 on.They have also removed the 2004
publication from the Internet.
If you are approached about the viability
as a potential candidate to the SCOT trial, ask
about the mortality rate. Ask about the dangers
of radiation. Persist until you have answers with
which you are comfortable. Ask your doctors about
the ASSIST trial. You will probably get a negative
response from them. This may be due to ignorance or
because they have chosen to be part of the SCOT
program. Persist. Do not do anything until you are
satisfied with the information you receive. It is
YOUR LIFE. You are entitled to all the information
there is.
Many revered medical institutions all over the
country are turning away from the SCOT trial
because of its radiation danger. Consider looking
at the ASSIST trial.
There is a real controversy here. Nevertheless,
ethically, professionally, responsibly, morally,
the patients need to be made aware of the potential
hazards and all the options open to them so that
they can make informed decisions for themselves. The
onlyway one can do that is to study BOTH protocols side
by side. This is not about money or egos. It is about
the safety of patients.
* In November I was taken to task by a doctor from the
SCOT trial for my information. He told me my information
was innaccurate, and misleading. He told me I had to point
out that ASSIST had one death. So, to be fair, I am stating
that information. It was nearly 5 years ago, it was
disease related, but there does not seem to be evidence
that it was transplant related. I have since rechecked
my information. My reporting is correct. SCOT has since
published data stating their mortality rate is 23%.
One has to conclude that this is related to the narrow
inclusion requirement.
I told the SCOT doctor that if he wished,I would put the
SCOT protocol and testimonials on the site, in a further
effort to be fair. My excluding their information has
not been fair.
To date, I have received no protocol or testimonal.
The offer still stands.
I can be contacted for
more information at: advocate at this address.
* * * * * * * * *
A clinical trial is a study of how well a protocol
performs on a certain part of the population before
it is released into the public at large. These trials
come in many forms. But people are needed to help
researchers get this information out to the public.
This is where you come in. You can go to
www.clinicaltrials.gov, put in your diagnosis,
and a screen will come up listing the different trials
for that disease. You can read about many different
protocols for your specific disease and the hospital
and group of doctors who are performing that procedure.
There could be more than one procedure. There was
in my case. It did matter in my situation which trial
I used since I have pulmonary involvement. Your physician
should be able to help you decide on the best trial
according to your condition.
Some of the trials have already been approved by the
FDA. For other diseases, the trials are not yet open.
You will have to keep trying and keep looking in
some cases. This is not to cause frustration to you,
but to give you hope. You can take this information
to your doctor and then you can make decisions together.
You will find that the more informed you are, the more
likely your doctor will be to consider the information.
The clinical trial may not be for you. The stem cell
transplant may not be for you. But you must be your own
advocate. You must trust your inner feelings and if you
think this is right for you, you should go for it.
It is ultimately your decision, it is your body. If
you do not make the call, you will never know.
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