That’s where I’d go to cry…

A few months ago, I underwent surprise heart surgery to repair my mitral valve (it was leaking in a major way). I have the explanation that I give to people that ask about it down pat. I vainly make sure they know it wasn’t a heart attack, that I don’t have clogged arteries, that it was a genetic defect, that in all other ways I’m completely healthy, that it wasn’t my fault. I am not shy about it when they ask.

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And ask they do. “How are you feeling?” “What happened?” “Do you have any restrictions?”  And comment. “We really missed you”. “It is so good to have you back”. “My husband had something very similar; feel free to call him if you have any questions”. (I never did). “You look great”. “I’m so impressed at how quickly you’re recovering”. “You do a 5k every day? That’s great!” “Wow, I didn’t expect to see you back at the boxing gym so soon”.  “You’re coaching soccer again! That’s great!” “How are you feeling?” The support and good sentiments have been overwhelming. People at work, people on facebook, neighbors, friends, family. They all let me know how much they care and I really appreciate all of it. But that’s not what I wanted to share just now.

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My wife, Susan, has been a rock during all of this. She really kept it all together: watched over me while I was in the hospital, kept the kids grounded, waited for me during during my diagnostic and repair surgeries, and took care of me when I got home. And while having surgery (and particularly cardiac surgery) is a scarey thing, I think it is much worse for the significant others than for the actual patient. This was brought home to me when during a post surgery checkup at the hospital, I noted a bank of windows along a corridor that I hadn’t noticed before and commented on them to Sue (who had driven me and accompanied me to the appointment). She looked sadly at me and told me, “Yeah, that’s where I’d go to cry”. I looked at her, a little bit startled.

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She had to see me with heart monitors, oxygen masks, eKG leads, tubes, tubes, and more tubes all coming out of me. She had to watch them prep me for procedures. She had to wait while I was in surgery. For. Six. Hours.  She had to go home and explain to preteen children what was going on without unduly scaring them. She had to keep it all together for them. She had to contemplate the prospect that she might be planning a funeral shortly. She had to spend time beating herself up with guilt over symptoms that neither of us noticed in the moment, but suddenly remembered in retrospect.  After I was home,  she had to help me into and out of the shower, get things for me,  drive me places, help me on the stairs, see me in my weakened state. She spent a lot of time blaming herself for something that wasn’t her fault.

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So she saved most of her crying for that lonely hospital corridor.

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Like me, she gets a lot of questions, but unlike me, the questions she gets usually aren’t about how she’s doing. They’re about me, about how I’m doing. “How’s Tim?” “I saw Tim’s picture on Facebook, he looks great!” “Is Tim doing ok?” “Is he back to work yet?” “We were so happy to hear about his recovery” “How’s Tim?”Don’t get me wrong, there were those who made sure she was ok. Joanne took care of the kids. Michelle took care of Sue and stayed with her during the surgery. And Tara made sure the family was fed. I can never thank them enough. The medical team at Saddleback Memorial were also great, both in their care of me and in their sensitivity to Sue. There were others who were looking out for her, but for the most part, it has been all about me.

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So, I offer up these thoughts and observations to thank my wife for going through it all for me (Love you, sweets!), to thank those who looked after her, and to highlight in a small way how much harder it can be for those who wait, for those who need a place to cry.
~TJK
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Hear Hear, Apple! Hear Hear, Google!

In a move of solidarity, Google supports Apple in its fight against the US government to provide a “back door” into the popular iPhone…a move that would allow the government to hack  all of Apple’s customers.

#privacy #nobackdoor

~TJK

http://finance.yahoo.com/news/heres-googles-ceo-just-said-000854021.html

Here’s what Google’s CEO just said about Apple’s battle with the FBI

The radical plan to destroy time zones – The Washington Post

I would love this. “What time is it on Earth?” #UTC https://www.washingtonpost.com/news/worldviews/wp/2016/02/12/the-radical-plan-to-destroy-time-zones-2/?tid=sm_fb
~TJK

Continental to Cancel Flights to Avoid Fines

As a business traveler, this is troubling news:

http://news.yahoo.com/s/ap/20100309/ap_on_bi_ge/us_continental_airlines_cancellations

Due to the government’s knee-jerk reaction, the cost of travel will be rising sharply. Now, I hate getting trapped on the plane too, but the cost of these fine (and the costs associated with avoiding them) *will* be passed on to consumers….as will difficulty in getting where we’re going. Sounds like a great idea, doesn’t it?

TJK

Defending Pharma

As all of the discussion on Healthcare reform comes to a head, I think it warrants some comments from me regarding “The Greed of Pharma”.  Let me start by saying that Pharma is a for-profit business like any other.

I think it is important to note that neither pharma (nor the insurance industry for that matter) has particularly high profitability (ROE %’s). The following industries have a higher ROE % (Return on Equity rating) than Pharma (21 of them, and in the order listed). Cigarettes has nearly triple Pharma’s profitibility (and the US Gov is a de facto share holder); Aerospace has double. So why would Pharma be expected to foot the healthcare bill (and squeal like a pig -to paraphrase Congressman Marion Berry of Arkansas) when there are so many other more deserving candidates?

 

Cigarettes

Aerospace/Defense – Major Diversified

Information & Delivery Services

Diversified Computer Systems

Cleaning Products

Beverages – Wineries & Distillers

Processed & Packaged Goods

Auto Parts Stores

Education & Training Services

Application Software

Personal Services

Food Wholesale

Industrial Metals & Minerals

Restaurants

Gas Utilities

Management Services

Personal Products

Personal Computers

Agricultural Chemicals

Diversified Communication

Electronics Stores

 

~TJK

SQA Abstract – Impact of eSystems, etc.

I’ve submitted this abstract to the SQA for their annual meeting in April and am really hoping it is accepted. A very similar one that I posted last year was not….but this year, it seems that this sort of stuff is on their “hot topic” list. Fingers crossed.

~TJK

The Impact of Electronic Systems, eHRs, and eData on Clinical Research

Although the use of electronic data in the pharmaceutical industry is by no means a new phenomenon, its impact has evolved over time. Technology has revolutionized our lives in many ways; in the way we access information, in our entertainment, in the way we do business, and in the way we interact. This technological revolution has had very pronounced impacts on the GxP industries: eRecords, eData, eSignatures, Data Processing, Data Mining and the Regulatory Standards associated with them.

These impacts have been most apparent in the cGMP and GLP areas and there is a fair level of comfort with eData and Validation in those areas. Increasingly however, the impact of eData and the need for controls around its use can be seen in the GCP area. Due to its large reliance on external sources of data, Clinical Research has some unique challenges. This session will cover:

I. Technology in Pharma and Validation Overview: a discussion of these concepts (which are widely felt to be cGMP artifacts) and relating them to the GCP area through analogies.

II. Centralized GCP Technology: The use of centralized eData and eSystems, primarily on the “sponsor side” has some unique challenges due to very short timelines and the external nature of clinical data inputs. Also the challenges of study-specific validation activities will be addressed.

III. De-Centralized GCP Technology – “Technology at the Clinic”: The advent of electronic Health Records (eHRs) has had a profound impact on Clinical Research and the way in which source data is handled, however the adoption of eHRs has been uneven, piecemeal, and largely independent of any research concerns . Resultantly, source data at clinical sites varies widely in format, from purely paper systems through purely electronic integrated source systems. However, a large and growing number of sites use a hybrid paper/electronic model with various sources of data, scans of source destroyed by hospital systems, paper notes, dictated notes, email notifications, and central sponsor data collection systems. Some ideas on how to address various hybrid source data scenarios will be presented.

Level: Basic Validation, Intermediate Clinical
Key Words: GCP, Electronic Data, Hybrid Source, Validation

Fundamentals of Quality

I’ve gotten some questions of late that have had me thinking about the core of what I do; fundamental questions as to what it is and why. This is a good thing and I feel that now is a good time to till this fertile soil and see what can be learned (or remembered).

Over the next few weeks, I plan to explore these ideas in a series of posts. I’m planning on submitting an abstract or two to the SQA conference and this will be a good stepping-off point to get that effort underway. I plan to present on a subfield in which I am working very heavily in my current role; Clinical System Validation. That is, Computer System Validation for the Clinical (GCP) arena within the greater pharma landscape (pharma, medical devices, and related industries).

In any case, its been too long since I’ve added some really good content here. Keep your fingers crossed that I’ll be able to put up something useful, interesting, or both.

~TJK