Tuesday, October 12, 2010

Geron's futile fiddling finally approved

So the FDA has blinked, and the first patient has finally been injected with Geron's dubious nerve cells derived from IVF embryos. The race is on to see whether the immune suppressive drugs (required to induce tolerance of the foreign embryo's cells) or the still-risky cells themselves cause greater harm to these poor desperate individuals.

The media, true to form, sit at the feet of the embryo-cell masters, and accept uncritically whatever is spun at them. So, in the premier current affairs programme in Australia, the ABC AM radio show this morning, journalist Kim Landers reports:

“At a hospital in Atlanta, doctors have injected embryonic stem cells into a patient's damaged spinal cord.”

No, they have not. No ES cell (whether from IVF embryos or from cloning - and for that matter no iPS cell) can be put into a human being, because they form teratoma tumours in animals. For ‘authoritative confirmation’ of this fact, see the statement on the ISSCR web site (‘Top 10 Things to Know about Stem Cell Treatments’ at point 2):

“embryonic stem cells themselves cannot directly be used for therapies as they would likely cause tumors”.

Only adult stem cells can be put into humans, and have been in large numbers, because they alone are stable and safe in vivo.

Correct reporting would be that the Geron Corp ES cell trial in spine injury would NOT put a single ES cell into any patient; it merely uses ES cells (from IVF embryos) to generate “mature” (but genetically foreign) nerve progenitor cells for transplant. But here are the obvious questions:

o Since the same nerve cells could be readily generated from induced pluripotent stem cells ( iPS cells), with the huge advantage that they would exactly match the patient – and therefore not require immune suppressant drugs - why use embryos at all?

o Since scientists have already published trials using a patient’s own adult stem cells in spinal injury, with no tumours formed, and without requiring immune suppression drugs which the Geron study does require – why use embryos at all? [i]

Surely that is worth asking .

Kim Landers continues: “In phase one of this trial, doctors will establish only whether the treatment is safe to use. Geron will need to do more trials in the coming years to assess whether the treatment is effective in repairing spinal cord injuries.”

Correct, but not enough said to debunk the unjustified hype from Geron. There is still a concern that the “mature” stem cells in this trial may revert to ES cell status and cause tumours – that is why the FDA has for years equivocated over the proposal. In fact Geron has already said they will have to monitor the patients for 15 years to assess the danger.

The trial is only a Stage 1 test to see if tumours occur. It is not even pretending to be a ‘treatment’ – it is an uncertain experiment which has got even proponents of embryonic stem cell research worried that it could all be a rash miscalculation and backfire terribly.

Kim Landers: “In a statement, Geron's president and CEO, Thomas Okarma, describes this trial as a, quote, "milestone for the field of human embryonic stem cell based therapies".

Well he would say that… But what use is a milestone in a dead-end street? Cells from embryos are redundant in the era of direct reprogramming - iPS technology. ESCs cannot be used directly in humans, unlike ASCs; ESCs are foreign to the patient, unlike iPS cells, and are therefore of limited use even for research; iPS cells are easy to obtain, and ethically uncomplicated, whereas the Geron cells are only obtained from stripmining embryos.

Finally, for your entertainment, revisit the comical history of Geron announcing its ‘milestones’, usually corresponding to a temporary rise in their share price...

What an investment!

[i] Link to Adult Stem Cell Spinal Cord Trials:
http://www.nature.com/sc/journal/v47/n10/abs/sc200924a.html and http://www.ingentaconnect.com/content/cog/ct/2008/00000017/00000012/art00001?token=0057156e9168a7e442f20672148766c777b492b45427a63687627504541676249266d656c185ee1dce5572d and http://www.media.wayne.edu/2009/10/16/study-shows-adult-stem-cell-grafts-increased