The Board has gotten real quiet from the BSX supporters. First they downplayed the Hospital systems warning about the Taxus balloon sending someone to surgery. I believe they said it was a "Conspiracy" played out by J&J representatives. Then they did not comment on theheart.org article, and classified Trends in Medicine as a low level medical "magazine". Now the NY Times releases an article, and once again no comment. This is four different sources with no competitive alliance (one being a hospital system) all saying the same thing, there may be a serious malfunction with the Taxus problem. BSX folks, this is no "Conspiracy" this is reality.
I would agree that based upon what I have read there is a problem with the Taxus stent. I have not seen any article that had to do directly to any hospital chain in Texas. Based upon what I have read, no one has stated with clarity what the situations are! Based upon the NY Times article, it was 20 - 25 cases out of 70,000 stents used. I would at a minimum double that number for some cases do not get reported. I also believe the more serious the problem, the % of reporting go way up! So even if one devides the incidences by the total used, and even if you say there were 100, the it is less than three out of every 1000! Please go back and look at the posts last fall about the Cypher and SAT. I think the Cypher got a bad rap on that one, for the incidence was never greater than for bare metal stents. I never rushed to judgement on that one, nor will I on this one! Like in that case there were some serious problems reported, and with all devices there will be serious problems, thus the DFU's lists precautions. I can remember in my former life in a cath lab that we saw many problems, some product related, some related to off label use, and others operator error. However, I believe that based upon the statements included in the NY Times the FDA is investigating this issue as they should. But to date the numbers of incidences as per total usage is way below the 1%, in as reported it is .035%. So triple it and it is still not a significant number. I always keep my stock holdings diversified for any stock in the medical field can go down fast with problems. I still kie BSX, and believe it is undervalued as of right now. JMHO
<"But to date the numbers of incidences as per total usage is way below the 1%, in as reported it is .035%. So triple it and it is still not a significant number.">
What threshold of tolerance should exist for a problem such as this?
You are pointing out that it is substantially smaller than the risk of thrombosis, but thrombosis is an as yet unavoidable risk with ALL stents. Balloon adherence is an extremely rare occurence with anything other than Taxus, and is basically added onto the risk you would normally be asking a patient to undergo. How much AVOIDABLE risk is it reasonable to ask a patient to undergo? I don't have a number to offer you but can tell you the FDA's threshold will certainly be much less than 1%. How many cases of rhabdomyolysis were required for Baycol to be withdrawn? I don't know the answer off the top of my head, but it is probably one in tens of thousands or smaller.
This would be an interesting point to explore if others have any concrete examples to offer.
in your opinion, a small percentage of failures is OK? especially if the dead patient is not you or someone in your family? any failure due to product or manufacturing defects should be yanked until it gets fixed, which i think you will see soon.