What's Wrong With EMRs
IT Trends for 2012 by SAFE-BioPharma

2012 - A Survival Guide

The following first appeared on the Pharmaceutical Users Software Exchange (PhUSE) Facebook page. 

Happy New Year to you.  I am saying ‘to you’ deliberately since I’d like this post to be read as if we were good friends having a chat in a cafe over a cup of coffee. I realize though that by the time you finish reading this you may not want to be my friend. Let’s see what happens.

First, I want you to know that I consider you a professional; someone really good at what you do. So, I’m not going to dwell on that except to say that you may need to be a bit more open to learning new things so you can survive the hard times ahead. More about that later...

As I write this post, Astra Zeneca has announced another round of layoffs, this time affecting over 1,200 employees. Most of these will be in Sales. Don’t let that make you complacent. While the industry has finally figured out that you can’t have nearly as many reps as there are physicians, they may have also determined that all other professions are fair game too. That means you!

So, how will you survive and thrive? Good question. Let’s come back to that later as well...

I’d like to share with you a cautionary tale. A few years ago, I was helping Elan implement a new clinical data management system. As always, my team had the chance to work with some really bright programmers and statisticians. This did not mean that all of them were enthused about the solution that was selected. You could say that we had the typical bell curve; a few people who were really enthusiastic, a large number who would go along without complaint, and a few others who were silently or vocally opposed.

Anyway, no matter what you believed, the marching orders were clear and you were expected to help implement the new system and the processes that went with it. We had lots of planning meetings and everyone had important tasks that had to be completed on schedule. And did I mention that everyone still had to do their regular jobs! Then, one bright sunny morning we came to the office only to find out that six of the team members were let go the previous day. Not only that, but the entire project was scrapped. We packed our bags and went home.

On the plane back to New York, I had the chance to reflect on what happened. First, I felt bad for all of those who were let go. I then made myself feel a bit better by rationalizing. Specifically, I thought that some of these people probably hated what they were doing or loathed the company they worked for but were afraid to make a move. Now they had no choice and would most likely land on their feet.

Then I thought about the naysayers who were also fired, those who had to be dragged kicking and screaming to adopt the new system we were trying to implement. How ironic, I thought. Whatever job they got next, they would need to go along with whatever system and processes are already in place. They would need to work with whatever cards they were dealt.

So, there are a few important lessons wrapped up in this cautionary tale. The most important one is that you have to keep things in perspective. It’s important to have principles and convictions but you also need to be critical of yourself and not just of others. For example, is it possible that you may be wrong about the new system? Is the real reason for objecting your fear of the unknown or having to learn something new? Would you be protesting as loudly if you knew that you will be out the door the next morning? And finally, why can’t you think of the new system and processes as if you were showing up at a new job with a different company the next day?

Oh, this reminds me. Did I tell you about the conversation I had the other day with my friend Audi. I know, I know, it sounds like the car but it’s a real Arabic name. She came to the United States from Syria and is still struggling to understand our ways. Anyway, we somehow got into a conversation about God. She wanted to know if I believed in God. I told her that it’s not something I think about. But she would not let it go at that saying “Just think about the universe and all the things that exist? It could not just have come from nothing?”  So I gave it another try. I said “Audi, it’s pretty simple for me. We humans are pretty limited. We have trouble thinking outside of ourselves. And besides, it’s arrogant for us to even think that we could know who God is? See, I just humanized God without even thinking!  Is God a ‘who’?  It’s only because we have a big brain and self awareness that allows us to even think about God. And what do we accomplish anyway? It makes no difference whether I believe in God or not. It won’t change anything.” I don’t think I convinced her.

Then I smiled and said: “Audi, did I ever tell you the joke about husbands and wives? The one about big and small decisions?  It’s pretty simple. Wives let their husbands make the big decisions like ‘how we can solve the deficit problem or world hunger’.  Wives make the small decisions like ‘where we’re going to live, where our children go to school and what we’ll do for our summer vacation.’” She laughed at that.

So we have another important lesson. Try not to think or worry about things over which you have no control. Focus on things that you can influence or control. Maybe that is how we’ll all make it through 2012 unscathed!

I know, it’s easier said than done. You come to work every day and do what is expected.  Come to think of it, you’ve been pretty lucky in Biostatistics. All of your customers think of you as a black box. They send in the raw materials and you give them a finished product. They have no idea how you do it and I don’t even think they care. It’s nice that you have control.

Or is it? The company as a whole is in big trouble? Do you know why? It’s probably pretty complex. Maybe you need to understand that better. I guess I’m suggesting that as an employee you have a responsibility not only to do your job but to think about the success of your fellow employees and that of the company as a whole. You know, if you don’t care about them, why should they care about you?

For example, you know that the cost of R&D is astronomical and always going up. Yet, the chance of success with any candidate is going down. So, what can you do to get that R&D buck to go further? Just think about it?

OK, I’ll give you an example. SAS is pretty useful to your job but it’s also very expensive. On the other hand, there is R which may be just as good and perhaps even better at some things. And did I mention that it costs a fraction of the big gorilla?

I know, I know, you have a ton of people who are SAS experts (including you). But if you know that you can save your company a lot of money by switching, why aren’t you doing it and doing it faster? Aren’t you smart enough to make it successful and yourself more valuable in the marketplace? Would you rather risk losing your job so that management can hire someone who knows R better than you? Which is better: Having your friend in the next cubicle keep his job or have some employee at SAS Institute eat as many M&M’s as they want? It’s partly up to you, you know.

Sorry, I got carried away there. Sometimes I get emotional about this stuff. But you have to understand. It’s a dog eat dog world out there and you can’t just stand by as an observer anymore. You have to be active to save yourself and stay ahead of the competition.

You know what the enemy is? Time! The clock is ticking for this entire industry and we are still doing our jobs in slow motion. We used to call this the “Fat and Happy Syndrome.” I have a variation on this that I shamelessly call Laszlo’s Law. This states that change in the biopharma industry takes the same amount of time as drug discovery and development. In other words, we’ve come to accept that it takes 8-12 years to get a product to market and thus, it must take equally long to get anything else done too. Read it and weep!

Since I’m an IT guy, I will give you two examples of this.

Q: How long did it take for Documentum to be accepted and widely used for regulated document management?

A: About 8-12 years

Q: How long did it take for EDC to be used more widely than hard copy CRF’s?

A: About 8-12 years

And yes, you can do something about this. Just look around you, observe and ask questions. Why, for example, is it taking so long to adopt R? Why do we have 3-5 year transition plans from one system to another? Why can’t I get my hands on the clinical data from study X in 3 minutes rather than 3 months? Why can’t I have my EDC system be reconciled with my AE system in real time? Why do I have to re-run 20 programs to modify single footer? Why isn’t it possible to (insert your own question here)?

If you can ask these questions and derive solutions from them, you have all the ammunition you need to take your case to management. No topic/issue should be off limits. If you don’t do something about it, who will? Rest assured, someone will and you may not like the outcome. Proactive beats reactive anytime.

Speaking of Management, you may not know this but you also have the responsibility to keep them honest.

Want to save more money and perhaps some jobs? Look into your company’s travel policies. Is it OK for employees to spend $80 for dinner when their colleagues are being laid off? Can you stand it sitting in coach flying from New York to Frankfurt at $1,000 rather than $3,500 in business class? Are you taking advantage just because you can? How about some self direction? Be proactive and fly coach even if the policy says otherwise. Then let everyone know that you did it and why. Better yet, ask Management to review and revise the whole travel program. Ask them to build in some incentives (Read $$$ and €€€) to get T&E costs as low as possible.

OK, you don’t think that’s important enough? Well, how about this? Do you know if your company and its employees are following corporate governance policies? Did you know that those are even posted on the company web site? How about the ethical guidelines?

Did you hear about that giant company that just paid close to $1 billion to settle an illegal marketing scheme? No admittance of guilt of course. Was it your company? Were you outraged? Here you are doing your job and know that your fellow colleagues are also doing their best. How is it possible that a few misfits are making you into a villain in the eyes of the public? Aren’t you working in healthcare because it actually makes life better for mankind?

Oops. There I go again. But yes, stuff like this happens because someone was only interested in the bottom line. A game, if you will, where you gamble that you’ll make inordinately more than what it will cost you to settle. It’s not only money this time. The reputation of your company and the industry is at stake.

So, yes, it’s up to you to keep your own company honest. To protect it from itself.  That means that you need to understand how it’s governed and evaluate for yourself whether its policies actually work. If not, you need to bring up the issue with the powers that be. Perhaps not alone but with your fellow employees.

 By the way, did you hear that some of the Novartis employees and a local union actually staged a public protest about the layoffs at their Nyon facility? That’s in Switzerland. Amazing!

Happy New Year



Surviving 2012 Guide

Great Article!

It has some really useful information!

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