Polyheme & Dialysis

Any of you heard of it? Have any of you on dialysis tried it?

More Information
http://www.northfieldlabs.com/polyheme.html

Gus, I don’t believe this product is FDA approved or on the market yet. In fact, they haven’t even completed safety/efficacy trials (the first step). Plus, the way that the company is doing the trials has drawn them a lot of ethical fire: they’re using it on emergency victims without their consent (no need to match blood types in the field is meant to be the advantage; that plus no shortage of the stuff if they produce it) and then even when they’re transported to the hospital and real blood is available, they’re not switching them back to it. What I read in a local news story is that 2 people in the Polyheme group had heart attacks, while no-one in the real blood group did…

Here’s a link on ethical issues with the study: http://ethics.ucsd.edu/journal/2005/august.html.

So, it may end up being a good product, but it’s already controversial.

I know about that, its the reason I asked here…

What they’re doing to the public, without telling them or asking for permision is very serious.

If it happened to me I would have probably joined a class action suit… :twisted:

…anyway, check this out…if the patient is dying and can’t talk…they can do whatever they want? Seems so…

http://irb.ucsd.edu/notices/polyheme/FAQs.htm#safe

The Federal Office for Human Research Protection is still battling this study, saying it’s unethical. There’s a new (yesterday) AP wire story about it:
http://hosted.ap.org/dynamic/stories/B/BLOOD_SUBSTITUTE?SITE=CAOAK&SECTION=HOME&TEMPLATE=DEFAULT
It’s hard to get people to participate in legitimate research when folks like this abuse the protections that were put in place to prevent harm to research subjects.

There was a study of cystic fibrosis that was at least partly done in Madison, WI, where babies were tested at birth for the CF gene–without their parents’ knowledge or permission, and the parents were not told the results. Some of these parents went on to have another child who also had CF before they found out the truth. This type of research abuse should not happen.