The Bioethics Exam Doug Sipp Never Bothered to Take
1. What is the importance of "Helsinki" in bioethics?
A. It's a great place to buy swanky modern furniture
B. A great place to chat up blondes and ski
C. The site of a major World Medical Association bioethics panel
2. Based on Helsinki, doctors who responsibly use unproven care in attempt to help patients who have no other options are:
A. Criminals
B. Entrepreneurs
C. Good doctors
Now that you’ve seen Doug Sipp’s dodgy qualifications to be
a “unit leader” of a one man science policy unit at RIKEN, let’s explore what
this ex-trucker impersonating a bioethicist knows about bioethics. A
recurrent theme through Doug Sipp’s slag off's and interviews is that stem cell
clinics are evil mostly because they treat patients outside of clinical trials
or if a trial exists, because they charge patients. While Doug Sipp has exposed a few questionable clinics, he’s also gone after many that
seem to try hard to do things right. Case in point are his posts on the Regenerative Medicine Institute in Tijuana. Here he
lam basts a clinic with multiple clinical trials listed on the US National
Institutes of Health web-site www.clinicaltrials.gov
because they use unproven therapies and charge patients for medical care as part of the study. This would
of course mean that all of the major bioethical panels of the twentieth century
would surely frown upon this type of activity? Right? Wrong. Looks like Sipp
didn’t read these texts in the bioethics course he never took.
For this next info I have to thank one of my readers. Turns
out this blog on the real Doug Sipp is getting quite a bit of Internet play and
readers have been providing me with information. There are two major bioethical
panels that have been convened both internationally and in America. The international panel
was known as the “Declaration of Helsinki” and was convened by the World
Medical Association. The last update to the document occurred in 2008 in Doug’s
backyard, Soeul Korea. This panel produced a number of statements, but this one
applies to Sipp’s criticisms of clinics who treat patients with stem cells:
“35. In the treatment of a patient, where
proven interventions do not exist or have been ineffective, the physician,
after seeking expert advice, with informed consent from the patient or a
legally authorized representative, may use an unproven intervention if in the
physician's judgement it offers hope of saving life, re-establishing health or
alleviating suffering. Where possible, this intervention should be made the
object of research, designed to evaluate its safety and efficacy. In all cases,
new information should be recorded and, where appropriate, made publicly
available.”
So let’s break this down. The major
international bioethical document of the 20th century clearly
defines that when proven therapies don’t exist that will help a patient’s
disease, it’s OK for physicians to use unproven interventions. Isn’t that
Sipp’s point? That’s it’s “unethical” to use “unproven” interventions? Did Doug
skip this class…oh that’s right, Doug never enrolled in the class in the first
place!
If we apply this standard to the RMI clinic, the diseases
listed being treated are those without “proven interventions”. Sipp has not
exposed that proper informed consent of the patient is neglected, so no black
mark there. Finally, all that is required for the last piece is that the
physician’s judgement supports that the treatment offers “hope of saving life, re-establishing health
or alleviating suffering”. I’m sure if you ask these physicians they would believe that the
therapies they are offering have this hope of helping patients. In addition,
this group has made their treatment an object of research. So why is our
trucking supervisor who is playing a bioethicist attacking this clinic? Note
that there is nothing at all written about charging patients, which only
becomes inconvenient in a placebo trial, as who wants to pay money to get a
fake treatment?
What is interesting is that Doug loves
to pimp that only placebo controlled trials are acceptable for new therapies.
However, Helsinki is rather mixed on the use of placebos in research:
“32.
The benefits, risks, burdens and effectiveness of a new intervention must be
tested against those of the best current proven intervention, except in the
following circumstances:
·
The use
of placebo, or no treatment, is acceptable in studies where no current proven
intervention exists; or
·
Where
for compelling and scientifically sound methodological reasons the use of
placebo is necessary to determine the efficacy or safety of an intervention and
the patients who receive placebo or no treatment will not be subject to any
risk of serious or irreversible harm. Extreme
care must be taken to avoid abuse of this option.”
From the standpoint of Helsinki, the preferred method of research
is to test a new therapy against the standard therapy or a proven therapy. The
whole use of placebos in research is a bit of a side exception and can only be
used where no current proven therapy is available. In fact, the concerns of
Helsinki are opposite that of Sipp. They state that “extreme care” must be taken to avoid the abuse of placebos as their
use may harm patients.
So how did Sipp get these basic bioethical principles so
backward? How have the science news organisations who have listened to Sipp or
quoted Sipp failed to do even basic homework on whether what he’s saying was
accurate? For Sipp’s part, he just doesn’t know any better, basically
establishing a new bioethical standard that is the most likely to land him a
promotion and one that supports the financial interests of his bosses at RIKEN who
want to delay use of other types of stem cells until they can cash in on iPS
cells.
