The nine-month composite rates of DEATH from cardiac causes or myocardial infarction (4.7 percent and 4.3 percent, respectively) and stent thrombosis (0.6 percent and 0.8 percent, respectively) were similar in the group that received a paclitaxel-eluting stent and the group that received a bare-metal stent.
Sure the FDA doesn't approve medical devices that would be harmful to the patient...remember that AAA device? Or how about that last stent that was coated by BSC, gold wasn't it. Great preliminary data, however, a year later it was pulled from the market with a 50% MACE rate. Last time they picked the wrong coating. This time, they picked the wrong drug. It is that simple.
I will not disagree that there is still much to be known. By the way, did I notice a change of attitude, from an attack to a discussion mode, I hope so! I believe the FDA does exactly what you said. However I believe they, and their analysts, really can read data, and do the best they can. I think there is so much still to learn on both. Let us not be smug my friend, for they are both in a learning period. When dealing with drugs, versus mechanical, some effects will not be seen until a later time, like drug resistance.
Actually, the FDA has released dozens of products that later proved to be unsafe or produced unanticipated or produced unfortuante outcomes. Heart valves, PTCA devices (Probe), IUD devices, AAA devices, lots of drugs etc. etc. Approval is not an endorsement. FDA approval is simply clearance to market based on the manufacturers data which could be flawed, insufficient, poorly done or misleading or as in some cases simply did not reveal the unanticipated events that later crop up. The lack of human stent over lap data is one example where the product may be used in applications not sufficiently studied. TAXUS 5 is not finished yet and the product is potentially getting approved before this data is available. Much yet to know and prove...very much.
I actually believe that this is a fundamental question that many posters do not understand. The FDA looks at all of the documentation, and where they have questions they want proof (evidence) that the issue is understood, and tested. Prior to the Nov. panal this board was full of individuals who stated the panal will be the death of Taxus, versus what actually happened. It tells me BSX has done due deligence, and the results are good! Is one better than the other, I tend to say it has not yet been proven, and in the end I would bet that each may prove to be better than the other in certain patient sub-sets. The one thing that I do laugh at is for someone to imply that either one of them do not work, they both have demonstrated that DES is here to stay.
You must think that the FDA is composed of fools. Do you really FDA would release an implantable device and fail to ask the most basic questions. The FDA is by nature the most conservative of organizations. That is why both JNJ and BSX were using their DES in Europe about a year before the US. The FDA is not going to release something until they are very sure that there will be no problems. Of course there have been mistakes but there is getting to be a history here.
You are charging some pretty serious things here. You had better be more careful about what you are saying...
BSX and JNJ has something that works and that is what the trials are about. TAXUS has been proven safe and effective VS a bare metal stent. Get over it. And you better start working harder at your JNJ sales job or your GDT counterpart will eat your lunch and you will be out there looking for a job.
You must be missing something...first of all, do you think Boston Scientific is going to provide the raw data for any of their trials? In fact they will not even tell the cardiologist if his patient that is returning with restenosis got a DES or Bare making subsequent treatment for patients in the TAXUS 4 trial complete guess work. Is this in the patients interest? Hardly...This is not how J & J managed it. They unblinded the data because they were not afraid of people seeing the actual results. Boston is going to hide it for 5 (five) years. By then they hope they will have something that works.
I must be missing something. Having worked in one of the major core labs for over 20 years, prior to retiring, I have seen the raw data, and then the spin of the data. To date I see JNJ spinning, not BSX. TLR and angiographic f/u have no direct relationship. I would like to see how you come up with a 43% angiographic f/u? In the submission, BSX planned 732 patients for f/u, and of those 732 patients they had a f/u that was reported in the nine month data of I believe 74% (could have been 76% but close). JNJ is spinning that data due to the fact that an amended protocal was added to allow more patients into the study to look at stents longer than 20mm in length. I do not believe one should even compare the data from one study to the other due to the fact that each study had different endpoints, and protocals that very few individuals understand. Two examples, in Sirius they could pre-dil prior to choosing to randomize, that alone raises procedual success, and second both studies had different endpoints, Sirius an angiographic endpoint, Taxus a clinical endpoint of TVR. What I find amazing is the denial of the results. Both studies had great results, both showed safety and efficacy. I will say that I believe that the Reality trial will provide valuable information, only if JNJ allows the raw data to be released from the core lab. I do not believe that just because it is a JNJ trial that it will be unfair. The docs will randomize, and submit info to the core lab. JNJ will get the results, and if they do not choose to release the core results the study will get questioned. If they do, then we will get a very good study, and a lot will be learned. I do know this, that anyone who thinks they know the results of the Realty trial today does not understand trials, and that could also be said of the Taxus V trial. The results are not known. The one number that BSX for sure can hang their hat on today is that 3.0 TLR! That number is no spin. I also do not like angiographic f/u results for I am not a strong believer of binary restonosis and its relationship to clinical outcomes, but that is JMO!