The Laszlo Letter

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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

George

Friday, 06 January 2012 in 05 Industry Controversy, 70 Ethics and Compliance, 71 Public Relations, 73 Human Resources, 90 Diversions, 94 Random Thoughts | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: Astra Zeneca, biostatistics, clinical trials, data management, Elan, ethics, human resources, industry practices, jobs, Laszlo Letter, layoffs, pharmaceuticals, reduction in force, statistical programming, Survival guide

What's Wrong With EMRs

Short Rant

Cart-horse

The following is a quote from a recent article by Guy Boulton of the Milwaukee Journal Sentinel newspaper. Read it and weep.

Hundreds Of Physicians At ProHealth Care Hospitals Switching To EMR.

"In the next year, several hundred physicians who practice at ProHealth Care's hospitals in Waukesha and Oconomowoc will move from paper to electronic medical records [EMR], enabling them to improve the coordination and quality of care for patients." These "physicians will lease software that ProHealth uses at its hospitals and clinics." This "will allow the doctors to work from a single medical record on a central database, as opposed to each practice buying different software with little or no ability to share information."

Bold and italics above were inserted by me.

On the surface, one would be happy to read that more physicians and practices are finaly adopting EMR's. Unfortunately, the last sentence in the quote points to a serious problem with EMR adoption, namely the lack of data interchange standards. More specifically, the legislation that is busy throwing billions of tax dollars at healthcare providers for 'meaningful use' of EMRs does not also put a strict requirement on interoperability. Thus, we have hundreds of software companies and service providers who are competing for the EMR business but have little inclination or incentive to focus on the ubiquitous exchange of the data being collected. So, as more and more practices/hospitals implement EMR systems, the problem is going to snowball and the promise of electronic health records will not be met. 

Message to Obama and the Administration: A focus on data exchange standards should be the #1 priority for meaningful use. Throwing money at adoption is putting the cart before the horse. Change it now or wait for inevitable failure.

Sunday, 01 January 2012 in 05 Industry Controversy, 10 Innovation & Creativity, 20 Best Practices, 36 EMR/EHR, 40 Data and Content Mgmt. | Permalink | Comments (0) | TrackBack (0)

Reward Yourself. Make a Donation to Wikipedia

If you've connected Wikipedia at any time over the past two months, you know that they have been asking people to donate money so they can keep the site up and running. This is one of the few really useful web sites out there that don't rely at all on advertising.

So, today and tomorrow are the last two days when you can make a tax deductible contribution.

Click HERE to go to their site.

DO IT. You'll feel really good as soon as you click that payment button.

Happy New Year

George

Friday, 30 December 2011 in 90 Diversions | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: donation, Laszlo Letter, wikimedia, Wikipedia

Change of Direction for 2012

As you all know, the focus of this web site has been on leveraging information technology in the service of R&D. While there is plenty to talk about on this topic, I have been getting more and more frustrated with other aspects of our industry. Specifically, I am extremely upset and frustrated with politicians, pundits, corporate executives and (sometimes) mere employees who are actively undermining and possibly trying to destroy one of the most successful and useful industries on the planet. So, in 2012 you will be subjected to my opinions on any topic/issue that I feel may undermine the continued success of the biopharma sector. Of course, I will still talk about IT matters.

So, get ready!

As a line in one of my favorite movies goes: I'm mad as hell and I'm not going to take it anymore.

Tuesday, 20 December 2011 in 05 Industry Controversy, 70 Ethics and Compliance, 72 Regulatory Affairs | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: biotechnology, corporate responsibility, ethics, industry issues, Laszlo Letter, pharmaceuticals, politicians, pundits

Site Back Up - Sorry About That!

I only learned today that anyone trying to get here was being redirected to the BLOGBAR web site. After contacting my blog provider, TypePad, I was told that the problem is being caused by a widget that I used on this site. That widget was provided by Blogbar! So, I removed the Blogbar widget and we are now back in business.

A special thanks goes out to my good friend in Massachusets who brought this problem to my attention.

Friday, 16 September 2011 | Permalink | Comments (0) | TrackBack (0)

Civil War 2.0 - The 'Haves' vs. the 'Have-nots'

Until now, I have refrained from stating my political and societal views on this site. There is, however, a disturbing trend gaining steam in the United States (and to a lesser extent in the rest of the developed world) that all of us should be aware of and (through careful consideration) guide our actions as citizens of this great country.

The trend I am speaking of is the expanding chasm between the economic upper class and those in the middle or lower classes. I was reminded of this again through an article by Joseph Stiglitz in the May issue of Vanity Fair. The title of the article was "Of the 1%, by the 1%, for the 1%" and was neatly buried on page 126. Even the editors of Vanity Fair felt that Rob Lowe, Golman Sachs and the Royal Wedding deserved more attention.

The title of the article is both catchy and correct. When 1% of the population is pulling in 1/4 of total income every year and has 40% of the total wealth of the country, you know that something is out of balance. You could argue that this is OK as long as the rest of the populace is also benefiting from an upward income and wealth trend. Unfortunately just the opposite is the case and has been so for years.

Although most of us working in the biopharmaceutical industry have been quite fortunate to make a comfortable middle class living, the trend is not headed in the right direction for us either. Witness the latest headline on the on-line CBS Interactive Business Network (BNET): "Teva Merger: Cephalon CEO Gets $5M for 3 Months’ Work; Staff Gets Layoffs."

In the latter article, we learn exactly what the headline says (i.e. CEO walks away with $5 million) and what is also implied (i.e. that layoffs are expected to save $500 million within 3 years). Although Teva is a first rate company and certainly better run than Cephalon, the layoffs from the merger are inevitable. Personally, I am not upset about the $5 million payoff even if Cephalon's President is getting it after only 4 months on the job. After all, we all would love to be in his position. Unfortunately, those getting laid off are in for a great deal of anxiety given current market conditions.

Disclaimer: I have personally done work for Teva in the past and completed a small engagement for them just this year.

 As for the Stiglitz article, what cought my eye was the following penultimate paragraph:

"Alexis de Tocqueville once described what he saw as a chief part of the peculiar genius of American society—something he called “self-interest properly understood.” The last two words were the key. Everyone possesses self-interest in a narrow sense: I want what’s good for me right now! Self-interest “properly understood” is different. It means appreciating that paying attention to everyone else’s self-interest—in other words, the common welfare—is in fact a precondition for one’s own ultimate well-being. Tocqueville was not suggesting that there was anything noble or idealistic about this outlook—in fact, he was suggesting the opposite. It was a mark of American pragmatism. Those canny Americans understood a basic fact: looking out for the other guy isn’t just good for the soul—it’s good for business."

In short, it is natural as one gets richer and richer to have less and less empathy for your fellow man. The rationalisation goes something like this: "I worked hard to become successful. If the guy next door could not do the same, that's his problem." It is thus up to our government to recognize that hubris and arrogance must be held in check using legislative means and via social programs that adequately balance capitalism with the social good.

Given the current political climate I fear that not much progress will be made on this front in the coming years. And certainly not if Obama is defeated in 2012. So take heed, just as we now clearly know that our first Civil War was an economic vs. human rights issue pitting north versus south, if the gap between the rich and not-so rich widens further, our next Civil War will be a lot messier and will pit the 'haves' vs. the 'have-nots.'

Friday, 06 May 2011 in 05 Industry Controversy, 70 Ethics and Compliance, 73 Human Resources, 74 Legal and Government Relations, 90 Diversions, 94 Random Thoughts | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: balance of power, capitalism, Cephalon, civil war, empathy, hubris, Inequality, Laszlo Letter, merger, personal income, poverty, social good, social welfare, society, Teva, Toqueville, wealth

Briefly Noted: IT articles in Contract Pharma

In case you are not a regular reader of Contract Pharma, I wanted to make you aware of three articles that appear in the March 2011 issue:

The first reviews the current market for Laboratory Information Systems (LIS) and their Electronic Lab Notebook cousins. The ability to share data via standard data models is discussed. The impact of outsourcing on LIS is also covered.

The second covers the importance of standards for data sharing. This time it's not about CDISC but the need for similar standards in the manufacturing and supply chain arena. Reference is made to the Pistoia Alliance;

The third discusses IT investments in the areas of drug discovery, drug development, supply chain and manufacturing and sales/marketing. Special focus is placed on the role of IT when operations are outsourced.

Wednesday, 16 March 2011 in 40 Data and Content Mgmt., 50 Lab Information Management, 55 RFID, 65 Application Hosting, 80 Outsourcing & Offshoring, 99 Vendors | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: Contract Pharma, data models, data standards, development, discovery, GBI Research, GeoMetrick Enterprises, Kalorama, lab notebooks, laboratory information systems, Laszlo Letter, LIMS, LIS, manufacturing, marketing, Pistoia Alliance, sales, supply chain

R&D - The need for accountability. Pfizer weighs in again.

Pfizerlogo 
Matthew Herper of Forbes magazine wrote a review of a press conference held by Ian Read, the new CEO of Pfizer. Of interest to me was the following paragraph:

"One of the main goals of the changes is to try and prevent any repeat of Pfizer’s disastrous investment in Exubera, the inhaled insulin, which the company spent years developing before it hit the market and bombed. Without accountability, Read says, projects were handed off from one team to the next without demands that they actually be ready. 'You get the transfer from one stage to the next stage, always investing in hope rather than strong clarity of signals and clarity of medicine and clarity of mechanism.'"

While I continue to fault Pfizer for their lack of imagination when it comes to R&D, this statement is right on.

Some of you may have read my point of view on the Exubera debacle on this web site. Mr. Read seems to understand that once a project takes on a life of its own within the R&D pipeline it is nearly impossible to stop it.

Why is this the case? Because pharmaceutical firms have gotten so specialized and compartmentilized that people are simply completing the work assigned to them without seeing the big picture. It seems that even Lifecycle Teams are not able to complete a holistic review of a drug candidate. The stakeholders are simply focusing on getting their part of the work done right and on time and are rewarded for doing so. If the incentives are not based on team success then the chances of getting a compound on the market are significantly reduced. This is where the idea of accountability comes in and was highlighted by Mr. Read.

Now, Mr. Read's observation is not original. We have heard many times about the need to "fail early." Unfortunately, the acceptance of failure and the possibility of being rewarded for it has not really become a visceral behavior at most companies. Perhaps Mr. Read will take steps that will make this happen at Pfizer. If that happens others are sure to follow.

 

Friday, 04 February 2011 in 05 Industry Controversy, 10 Innovation & Creativity, 30 CxO Corner, 33 Discovery, 35 Clinical Trials, 45 Sales & Marketing, 71 Public Relations | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: drug pipeline, Forbes, Ian Read, Laszlo Letter, lifecycle team, Matthew Herper, Pfizer, R&D

R&D - No longer untouchable! Pfizer gets the ball rolling.

Pfizerlogo 
The other shoe has dropped.

For many years now we have seen pharmaceutical and biotech companies lay off lots of people. With every layoff, however, we have seen a stated commitment to keep R&D untouchable. NO MORE!

The world's largest company, Pfizer, has kicked a small snowball down the mountain. It will now turn into an avalanche. Given that our industry has a herd mentality, the Pfizer action will now give every large and medium size pharma firm the excuse to jump on the bandwagon. It's unfortunate and deplorable. Management has a lack of imagination as made evident by other stated intentions like a new focus on drug targets that are more profitable. Now, if everyone just pays attention to what's more profitable, then how exactly will they all profit? Warning bells should be going off in the minds of employees and investors alike when statements like this are made.

Pity the countless staff at Pfizer's Sandwich, UK facility who will either have to relocate (at best) or lose their jobs (at worst). What will they do next? What will this move mean to the entire economy of the region? 

Is this the only way this industry can save itself? Something is wrong with this picture.

R&D is dead! Long live R&D.

Thursday, 03 February 2011 | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: clinical research, drug discovery, job cuts, Laszlo Letter, layoffs, Pfizer, pipeline, plant closure, R&D, RIF

Are clinical trial results all wrong?

And what to do about it if it's true.

One would not normally consult the New Yorker magazine about the scientific method, but a recent article in that publication makes it necessary that we do just that.

In short, this article concludes that most of the controlled clinical trials that have been performed and used to get medical treatments on the market had (and will continue to have) false results.

Now, read that again and let it sink in!

Since we have learned to be paranoid about the integrity of what we do in this industry, it would be natural to think that this claim must be based on evidence that the studies have been rigged. This is not the case. Rather, the various individuals cited in the article claim that it's simply human nature that leads us to reach the results that we wish to reach and that we actually use the scientific method to help us get there.

Now, it's not my objective to summarize or rehash what's in this article. You are perfectly capable of doing that yourself. Rather, I want to share with you my ideas on the ramifications of the core finding of the article. Let me repeat those here in my own words:

  1. It is nearly impossible to come up with a truly objective scientific study design;
  2. It is human nature to (unknowingly) design the study to prove what we wish to prove;
  3. We use scientific tools and techniques to fool ourselves that we are being objective;
  4. We do this all with good intentions (most of the time); and
  5. Other scientists reproduce the false results for the same reasons (see 1 - 4)

If we take all of this at face value, we would need to ask why we continue to design and run controlled clinical trials. Of course, we know that this is what the regulators (i.e. FDA, EMEA) want. Since the regulators are not necessarily smarter than the sponsor's scientific staff or, for that matter, the experts that they call on to pass judgment on marketing submissions, we need to conclude that everyone pretty much has deep faith in the current and accepted methods we use to carry out these trials. Based on this article, we thus need to also conclude that all of these people are wrong!

At this point, you may ask yourself "What is this guy talking about? He must be an idiot!" If you think this, it means that you have not yet read the article (see link above.)

Personally, I found this article to be quite disturbing. After reading it, I could have done one of two things: 1. Put my head in the sand and pretend that I never read it; or 2. Bring it to your attention to give the claims more visibility and lead to its evaluation by our industry as a whole.

Now for the good news:

If we can accept the hypothesis and the evidence presented that it's inevitable that the results of clinical trials are normally false, we can move on to a few ideas that may help get past this problem. Here are the ones that I have formulated:

  1. Continue to design and execute controlled trials but strictly limit the number of them required to gain marketing authorization;
  2. For the trials that remain, focus primarily on safety and less so on efficacy;
  3. Allow for adaptive study design for Phase II and III studies;
  4. Provide marketing authorization earlier for the claimed indication;
  5. Require rigorous follow-up of the actual patient population receiving the treatment including the analysis and reporting of pooled data;
  6. Require the reporting of outcomes to show both safety and efficacy in the actual patient population;
  7. Over time, allow outcomes from different treatments to determine whether a drug stays on the market and/or ascertain its cost/benefit value to society

Does any of this sound familiar? The answer is yes. It's just that we now have even more reason to do it.

 

Tuesday, 14 December 2010 in 05 Industry Controversy, 10 Innovation & Creativity, 20 Best Practices, 35 Clinical Trials, 40 Data and Content Mgmt. | Permalink | Comments (2) | TrackBack (0)

Technorati Tags: clinical trials, comic habitiation, empiricism, John Ioannidis, Jonah Lehrer, Jonathan Schooler, Joseph Banks Rhine, Laszlo Letter, Scientific method, selective reporting, verbal overshadowing

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Recent Posts

  • 2012 - A Survival Guide
  • What's Wrong With EMRs
  • Reward Yourself. Make a Donation to Wikipedia
  • Change of Direction for 2012
  • Site Back Up - Sorry About That!
  • Civil War 2.0 - The 'Haves' vs. the 'Have-nots'
  • Briefly Noted: IT articles in Contract Pharma
  • R&D - The need for accountability. Pfizer weighs in again.
  • R&D - No longer untouchable! Pfizer gets the ball rolling.
  • Are clinical trial results all wrong?

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