Epsteins discussion/slides on the Gilenya deaths is worth a listen. For those that did not hear it, I've cut and pasted the transcript below.
<<What I want to do now before I move on is try to put the Gilenya story and to give you a little bit more perspective, given what we've seen in the press of late. You've all heard about the recent death of a patient that died less than 24 hours after she took her first dose of Gilenya. She went through her normal -- the normal 6-hour observation period. There was no ECG taken. And it was really uneventful and unfortunately, she passed away during the evening and we do not yet have a detailed autopsy report.
That event triggered the health authorities around the world to begin discussions with us about the product and the label and to look at overall benefit risk for the product. What I want to do now is be fully transparent with you and give you a complete overview of MS patients that have ever died after having taken Gilenya. The overview covers more than 30,000 patients who've been treated since 2003 in both clinical trials and in the post-marketing setting. And I want to emphasize that it's very unusual, perhaps unprecedented for a company to disclose all cause of mortality in this therapeutic area. So as a result, I'll show you the numbers now and we'll talk our way through those.
When we compare our data overall with the background rate of overall death as well as cardiovascular death in comparable population, we see no imbalances whatsoever. Also when we look at our controlled clinical trials, which are covering thousands of patients over several years, we see the rate of death is not elevated when compared to placebo. Since 2003, there have been a total of 31 MS deaths. 11, which is the number you see in the press are mentioned in the EMA's press release of January 19. These are patients that were in Gilenya from between 2 weeks to 3 years with the exception of that one U.S. case, which I already mentioned to you.
In addition, for full transparency, there were 20 cases not mentioned in the EMA's press release, bringing the total number to 31 and as you can see here, a number of these patients that have been off Gilenya for quite some time, some as long as 3 years. There are also people that passed away because of traffic accidents, suicide and the like. We are confident that Gilenya has a strong benefit risk profile and we believe this brand will continue to provide significant growth to our company. But as I said as a result, the regulatory authorities have started reviews both in Europe and in the U.S. In the interim, the EMA has asked that the patients who go through that 6-hour screening also have continuous ECG monitoring. The French have taken a more aggressive approach. The FDA's ongoing safety review, you can read off the chart, has told us that there are no interim recommendations at beyond the current label at this point in time. And I think over the next couple of weeks to months, we'll get more clarity after any changes that are required.>>
The slide indicated that of the 11 deaths being investigated by the EU 3 were due to cardiac disease. Additionally, the woman who died in the US was reported to be 59 years old and had recently had surgery.
Based on this color the situation may not be as dire as the initial media headlines suggested. I worry that there are entities out there that might influence media to slow Gilenya uptake before competitors release their own oral MS drugs. I'm looking forward to the review committee sort the risks out.
FL
