April 7, 2010:
May 26, 2015:
They just published the results of Phase III clinical trials of a herpes simplex-1 genetically modified to kill cancers, specifically, advanced melanoma.
The GMO virus has a name now: T-VEC.
And instead of looking at 50 patients who all got the virus, this study was a group of 436 patients , randomly assigned 2:1 to a treatment (T-VEC) group, or GM-CSF only group (the immunostimulatory molecule the virus also delivers). GM-CSF only is not a placebo arm-- There was already some suggestion that it could be beneficial, getting more antigen-presenting cells around to convince cytotoxic T-cells to do their job killing the cancer.
The question was really 'Is this GMO virus that does stuff and delivers GM-CSF better than GM-CSF alone?'
They look at lots of stats in this paper, but the outcomes that mean the most to people suffering from cancer are 1) side-effect profile, and 2) how this treatment effects your odds of survival.
1-- The side-effect profile of this therapy is, like before, pretty damn awesome. For those of us who have watched loved ones suffer through surgery, radiation, chemo, the side-effects of T-VEC are, again, a walk in the park:
Frequently occurring AEs (adverse events) with T-VEC were flu-like symptoms (including fatigue, chills, and pyrexia). The only grade 3 or 4 AE occurring in ≥ 2% of T-VEC–treated patients was cellulitis; there were no treatment-related deaths. In the context of toxicity reported for some other melanoma therapies, the low rate of grade 3 or 4 AEs with T-VEC is notable, particularly when considering combined immunotherapy approaches.
2-- While some patients responded *very* well to this treatment, it is *NOT* a magic, guaranteed cure. In the final time-point (about 4 years or so), 189 of the 295 patients in the treatment arm died. That is ~64%. Not a magic cure. But, they could use these rates to predict how long, statistically, a person diagnosed with Stage III/Stave IV melanoma could expect to survive, given this treatment:
- 12 months: 74% (74 out of 100 patients who get this treatment are alive one year later).
- 24 months: 50%
- 36 months: 39%
- 48 months: 33%
While these arent 100%, they are an improvement over the GM-CSF only. The earlier the patient is treated, the better. And, if the patients never had 'systematic treatment' (chemo), results were better too.
GMO HSV-1 makes sense as a first-line therapy (Diagnosed-->GMO HSV-1), not as a 'last resort'. All the more so when you compare the side-effect profiles of this treatment, vs old school approaches.
Perfect cure-all for melanoma? Nope.
Absolutely amazing viral technology that has the potential to save some lives while minimizing suffering? Yup.
I love the future.
Did they say anything about what stage were the patients' melanoma?
In each group, ~30% were Stage IIIb or c, and ~70% were Stave IV.
Woot! This is so awesome! I'm sure they're already working on the differences between the patients who had 4 year survival and the ones who didn't to either improve the T-VEC or target patients who are more likely to respond to the treatment (or both).
thats so cool!
OK, but what does this have to do with Agribusiness?
They don't want to use GMOs like this and create a crop for 10 million hectares in Idaho and make a profit off it.
Agribusiness aren't against EU rules because this GMO product would have to be labelled as GMO product, but because corn, wheat, or whatever, coming from the USA have to be labelled as GMO, when NONE OF THEM have this change (or any like it) in it.
So, yes, like Stem Cell research, GMO is another method of getting a medical product that we would be otherwise unable to get at this time.
But we don't want Stem Cell research to take on a massive business role such that all our food is produced with stem cells from foetuses (aborted or not).
And we don't want GMOs to do that either.
Because it's completely unnecessary and has absolutely no way of containing the problem if the hopeful wishes of the proponents turn out to have been... overoptimistic.
i think I may have an illustration of the problem here.
The push for GMOs in bulk food production is like taking DDT and spraying it over every field where mosquitoes breed to get rid of malaria.
It's a good idea to get rid of malaria and killing mosquitoes is a known way of doing so.
Defenders of GMO foods and detractors of "anti-GMO" proponents are both looking at it like the defenders of the *abuse* of DDT as an insecticide to spray everywhere.
Banning GMOs is no more being demanded than DDT is banned by the WHO.
I hope that helps.