Thursday, March 24, 2011

OrbusNeich sues cardiologist over Genous stent data

I was reading through the internet news today. I came across this very upsetting piece of news at Heart.Org. I am very upset that a stent company is prepared to sue a clinician for reporting an unfavourable report on their stent, following a clinical trial. Orbus Niche is the company that manufactures the GENOUS stent, and the clinician being sued is one Dr Pavel Cerrinka of Masaryk Hospital, Czech Rep..
The clinical trial involved is called GENIUS - STEMI. It was a trial under Dr Pavel, which studied the use of the Genous stent in patients with STEMI. There were 100 patients enrolled and 50 received the Genous stent and 50, just cobalt chromium bare metal stents. The 30 days outcome was essentially the same. Dual anti-platelet therapy was used for 30 days. At 6 months there were 2x more MACE in the Genous group then the bare metal group. There were more TLRs and there were 3 stent thrombosis in the Genous arm. It is obvious that in this study, the Genous stent was not as good as the bare metal cobalt chromium stent.
With this news, Orbus Niche ( the maker of Genous ) was unhappy, and they decided to ask the trialist for an explanantion, and when the explanation was not to their liking, they sued the hospital and the principal investigator ( Dr Pavel ).
This is ridiculous. We are doing clinical trial to find out evidence of good effects and adverse effects. We cannot guarantee results. Otherwise, only positive results to the company will be reported, and negative results will be hidden. We will never know, which one is bad. I hope that this is a one off, bad manners in Orbus Niche company. Unable to come to terms that they have a stent which is not what they think it is. I must say that looking at the graphics and theorectical basis, the Genous stent, with the concept of EPC ( Endothelial Progenitor cell ) capture, is a very attracting concept. I never used it because, I was very concerned ( and I told Orbus Niche top guns too ), that when you switch on the capture you also turn on many other reactions that are not easy to predict. Along the pathway, the EPC capture, interacting with the monoclonal anti-bodies on the stent, turns on a whole series of reaction, some through the C34 ligand, and all hell can break loose. Having just returned from CIT 2011, Beijing, I asked my overseas colleagues ( corridor talk, which are usually acurrate ), their view of the Genous stent. They just told me simply, don't touch it. I am sure that Orbus Niche is not happy with that. But if that is the truth, the people to gain are the patients, and I am sure that Orbus Niche is here for the patients, or are they?
As far as I know, so far so bad for Orbus Niche. Their TRIA-1 study also showed poor results. As I always say, Genous is the only stent that performed poorer than Taxus in a control trial ( TRIAS-1 ). All other DES beat Taxus, or is non-inferior to Taxus.
Orbus Niche is not the only company doing this. earlier in 2007, NMT medical ( the maker of the LA appendage closure device for treatment of migraine ), sued Dr Peter Wilmshurst of the Royal Shrewsbury Hospital, UK, for comments he made about the device used in the MIST ( Migraine Intervention with STARFlex Technology ) trial.
I hope that these are not attempts by the " big boys" to muzzled the medical community. It is certainly a bad trend. When viewed with the fact that many interventionists are being sued in the USA, it makes one wonder whether there are too many lawyers in the US with nothing much to do, and doctors are easy meat.
In life we do have to accept our failures when it happens, go back to the drawing board, work out what is wrong, and get it right. Bashing doctors, is not going to help.

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