Sunday, September 30, 2007

This is how it went that night.

Since a recent posting concerning the deteriorating health of my mother, there have been further developments. She passed away last month. It is the scene of her final moments that I wish to describe.

I talked about the probably medication errors that brought her to the hospital. Now, we used a different medication to help end her life.

I was called to the hospital by my three siblings, who had been there a while. They wanted to increase her morphine drip, knowing that the increase would likely be the end of her already labored respiration. But they waited for me to arrive first. When I got there, she was on her side, and each breath made her face look like a fish gasping fon land. Her eyes were open, but not seeing. There was no one else in the room. Since my sister is a nurse in that hospital, she could control the rate of the iv drip.

I was rather alarmed. I wanted to better understand what was happening. I know that my sister wanted Mom to be out of pain, but were we killing her?

I spoke up, and asked that question. Everyone was distressed, but we could still have a conversation about what was going on. My sister asked me what I wanted to do, which was difficult to answer. She wasn't being flippant - there she was, in possession of much greater knowledge about the situation than I could hope to have, but she really wanted my opinion. I asked, what was she really dying from - would she be dying anyway, and were we just hastening a process with the morphine, while sparing her pain. She was bleeding internally, and there was no way to access the bleed without invasive surgery, which we had declined to do, since she would not survive the procedure with her co-morbidities.

Sister went ahead and increased the morphine, and within a few minutes, the very loud labored breathing quieted down. Her eyes remained open. I positioned myself seated by her head, my nurse sister to my left. She was talking to Mom constantly, giving reassuring statements which were likely not heard. My other sister and brother were on the other side. Over the course of several minutes, her respiration continued to drop, as well as her heartbeat. Sister mentioned that when her heart rate dripped below 60, her pacemaker would attempt to kick in. It did, creating a short spike on the monitor, but it didn't last. Her vitals continued to drop quickly from there, and then she just stopped all motion. Her eyes remained open, and the rest of the time we were in the room, and we said goodbye, I considered closing her eyes, but did not.

One bizarre moment was yet to occur. We had to get the attending ICU physician to declare her death, so we called the floor nurses to get the doc. It was about 2 am. I watched him stumble toward the room, he walked in, banging his shoulder on the partly open glass door, walked past the four of us, peered over her, turned around and said "well, she's at peace" to nobody in particular. He stumbled out, banging his other shoulder on the same door. No acknowledgement of any of us. Nothing like "Hi, I'm doctor whoever, I'm sorry for your loss.

JMK (nee H) 1928-2007

Tuesday, September 25, 2007

Social Media Marketing

A new term for me, courtesy of a vendor who will be carrying out this function for my company within a few weeks. It means blog monitoring, in short, both the posts (like this one) that write about your company or product, as well as the feedback the blog postings generate (like all three of mine). I was aware of activity at my company that scrutinized sites like WebMD and the major disease sites like the various Cancer societies, but now we're talking about a bigger rabbit hole.

We'll be jumping into it headfirst, looking for postings for one of our asthma products. Google and Technorati keyword searches, board tracker software, etc.

An anonymous screen name is not enough to warrant action normally for an adverse event report. That's just not a valid, identifiable patient or reporter. But we've made exceptions in the past if the poster describes a serious adverse event that we have a particular interest in for that product.

I'm a little unsure about the value add for this kind of activity. Last Spring, our pro-active monitoring of Cafe Pharma revealed a very embarrassing post by a named individual in our sales force, that compared physician visits by sales reps to grabbing money from a cookie jar. It still made it to Peter Rost's blog, but we did fast damage control by being aware of it that much sooner. Pharma Blogosphere has information about posing as consumers on blogs, but we've never reached that point, and I doubt we will, considering the scowling glances that our legal folks brought to the table, simply at the mention of monitoring sites.

Recent experience is very interesting. For another, more controversial product, we uncovered artificial blogging activity that was an attempt to create business for law firms. One poster would write "I started taking this medicine, and this terrible thing happened!" and the response would be "That happened to me too! I just got a $100,000 settlement for it though. Check it out!" and the whole thing was an elaborate fake. There would be a banner at the bottom for Dewey, Screwum and Howe law offices. We managed to take action, but my readers will be aware that we were (and still are) awash in legal cases.

Speaking of which, I just participated in a review of a regulatory document for a legally challenged product that was hardly a joy to read, as it was all about patient deaths. As I alluded to in a previous post, there are concerns that the legal case overload will throw off our ability to detect genuine safety signals. If our spontaneous caseload normally equals x% of the background "noise" for a condition or event, but the case load for one particular issue skyrockets and clogs our database, our statistical analysis must be reconfigured to handle that, or else a separate analysis is undertaken to discount those legal cases. The latter is what we've actually done. So for this document, the discussion of legal cases was made separate from the rest.

A special shout-out to those of you who let me know you've added my blog to your Google Reader accounts. Let me know if you got this.