Wednesday, 12 September 2012

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 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.