EMA Fails to Follow Legislation and Its Own Policy, page-14

PleaseDYOR - Please do some research before stating "Approval teams only seem to be interested in harm caused by products not net benefit".

Primum non nocere (i.e., First do no harm) is a mandate in modern medical ethics (Thomas Inman, 1820-1876).

To list the medications that have caused (and still do cause) harm is too long to list on this forum. Birth defects, nerve damage, kidney and liver damage, brain damage, etc......... are some examples of the harm caused to patients. Just recently a large US surgical implants provider had to issue a recall of thousands of implants. Of course, TIS isn't there yet where they have to make provisions for recall.
That's why the work of approval teams is important and the question of net-(medical and not monetary) benefit should always come secondary.

As far as I am concerned I do not want my wife/children/myself become casualties of medication. The application of VG is for venous ulcers, the (limited informal) study group comprised some 50 mostly elderly persons, there was no 'standard of care' comparison - in short: that's just not good enough for public release.   
hvalfisken voiced a concern regarding vitronectin as the delivery device. Surely, he/she did not pull it out of thin air. Do a google on 'vitronectin safety concerns' - I am sure you can put a positive spin on the results.


Sorry, but I must ask the question: Are you in any way involved with QUT/TIS (apart from being a SH).