The Laszlo Letter

Roche to implement Google Apps for 90,000 employees

You are probably aware by now that Roche has made a deal to roll out Google Apps on a global basis. This was reported by many news organizations and bloggers. One that is quite interesting, however, is on ZDNet since it generated quite a bit of heated discussion.

The rationale for this important move has to do with interoperability issues, or lack thereof, between the two solutions used previously by Roche and Genentech. This is stated by Roche CIO, Alan Hippe, on Google's Official Enterprise blog.

Reactions to the announcement focused on three issues:

1. Data Security

2. Data Privacy

3. Usability

In particular, comments pointed out security flaws in Google Apps, the probability that Google would inappropriately mine the Roche data/documents for their own purposes, and that users would get a much weaker set of email and MS Office-like functions.

These concerns may be real but also show that the commentators do not know how Roche operates. First, nothing at Roche is done in haste or without due diligence. The type of questions raised by those reacting to a press release would have already been studied to death by Roche staff and made available to senior management including risk, QA, procurement and legal staff. The decision would not have been made without Google agreeing to a detailed set of system requirements and the contract no doubt contains an equally strong Service Level Agreement (SLA). There would also be strict controls on privacy and security including what Google could or could not do with the data. Indeed, it is likely that the only thing Google will be able to do with Roche data is to provide appropriate technical support. And yes, it is also likely that an agreement is in place to govern how data moves (or not) between borders.

Then there is the rollout. Although I have worked quite closely with Roche IT on application implementations in the past, I am not privy to the way Google Apps will be rolled out. What I can predict is that it won't be done on a one-shot basis. One probable scenario (given what Dr. Hippe has stated) is for the email and calendaring functions to be rolled out first and even that in a phased manner to the 140 countries where Roche operates. It will probably start with the USA and Switzerland, then the UK, followed by the rest of Europe. Other regions would follow with double-bite countries like Japan going last.

You can then expect word processing, presentation and spreadsheet functions to follow. However, I would be willing to bet that other collaboration features (e.g. blogging, social networking) may come out before or in parallel with the more traditional office functions.

Although Roche and Google maintained radio silence on the current systems, it does not take a genious to see that Microsoft is in jeopardy at Roche. Given that this industry tends to follow the leader, Microsoft may suffer the fate of Blackberry in the biopharma sector. You may be elated or deflated by the prospect.

What's Wrong With EMRs

Short Rant

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.

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.

 

Hidden Gold Nuggets: Pfizer's Progress in Drug Development

I continue to be amazed by the number of great articles that do not get enough exposure. The key reason is that they are trapped in specific publications that you may never see or even know exist.

I was reminded of this again when opening my latest copy of 'Pharmaceutical Outsourcing' magazine. In this October 2010 issue I ran across an article by Chris Hilton of Pfizer, giving a great summary of the work being done by its Development Operations group.

As you may imagine, a significant part of the article focuses on Pfizer's growing and greater reliance on outsourcing. For example, the article states that in the past 5 to 7 years, the number of internal staff performing such functions like monitoring, data management and clinical programming has dropped from about 3,000 to 400 [no, this is not a typo].

At the same time, the number of external colleagues has gone up from roughly 100 to 2,400, most working for a group of 20 CRO's.

Doing some simple math got me to conclude that the total number of workers has stayed about the same. Of course, I don't know what is really going on here and one would need to ask the author what is behind the numbers. For example, are more studies being done by fewer people? Did the types of work being done change in any significant way? To what extent are technologies used affecting staffing?

Some other interesting facts (gold nuggets) noted in the article are:

• Year after year, the Last Patient Last Visit (LPLV) to Database Release time interval continues to drop
• The number of days from database lock to final CSR has dropped from 200 to 80 days.
• 1.2 databases are locked each day
• Reduction in cycle times ranging from 39% to >60% in several trial processes like Clinical Study Report completion and Protocol Development

 It is not my intention to review the whole article here. The best would be for you to read the whole thing and learn about other practices at Pfizer such as Functional Service Provider use, Reverse Auction Process, Continuous Improvement, Optimized Monitoring and Lean Six Sigma.

Read It! You won't be disappointed.

 

The High Cost of Swimming Upstream with IT Projects

Setting the scope of an IT project is possibly the most important factor affecting it's chance for success or failure. While most project do end up delivering some benefits, they rarely deliver everything that was hoped for.

Even when projects succeed, we may still be left clueless about unintended consequences. This is the main point of an article I recently wrote in the June issue of Pharmaceutical Executive Europe called "The High Cost of Swimming Upstream."

Just click on the title to see the article.

IMS Health - Sales Force Effectiveness with BI

My last post focused on the AstraZeneca "Zubillaga" affair. If you recall, Mr. Zubillaga was fired after his crass remarks about physicians offices were made public in the blogosphere.

What was not questioned by anyone, however, was whether what he said is actually true or not. In particular, can the following statement be taken at face value?

"The more times you are in [the doctors office], the more money goes in your pocket."

As a recent article by Chris Nickum of IMS Health nicely illustrates, making frequent calls on physicians does not necessarily translate into increased revenues.

It seems that working smarter (by using business intelligence) is better than working harder.

Industry News via Google - How to get...

You probably know how hard it is to keep up to date on topics relevant to your job. For the most part, we tend to rely on browsing (in print or on-line) our favorite publications. Sometimes, when we want to be more thorough, we conduct searches on the Internet or in on-line bibliographic or full text databases.

These are both good methods. What they don't provide, however, is a way to keep continuously up-to-date on the topic at hand.

For that, there is now a pretty good method combining Google searches and news feeds.

Here are the three key steps to get going:

On Application Systems Documentation

One of my recommendations to CIOs for 2007 was to focus on infrastructure rationalization and consolidation. With this post, I'd like to extend that concept to application systems documentation.

If you have ever implemented or maintained a new application within this industry, you know how expensive and time consuming it is to generate and maintain documentation. This is especially difficult when validated systems are involved.

Working on several of these in the past few months have made me painfully aware of the demands documentation places on an organization. That, in turn, led me to the conclusion that there are better ways of dealing with this necessary evil.

On Consulting and Consultants

I have been considering writing about Consulting and Consultants for quite some time but somehow never get around to doing it. Since I am a consultant, my wife would probably tell me that there must be some deep seated psychological reason holding me back. She may be right about that.

In any case, back in November 2006 I cut out an article from Optimize Magazine called The Advice Paradox. You guessed it, it talks about the need for hiring consultants and the somewhat likely result that you won't be quite happy with their performance.

So, here we are in February, 2007 and it's time for me to get over my writer's block and begin a journey on the consulting highway...

Time to Market in Dollars and Cents

In a previous post titled "I'm Going to Strangle Someone," I noted that it's time to stop beating a dead horse by citing that "For every day that is lost getting a drug to market, X million dollars are lost in daily sales."

I thought that no more needed to be said about this topic. Until today, that is, when I read an enlightening article in Specialty Pharma magazine by Joseph Bossart entitled "Estimating the value of time in biopharmaceutical development." Click HERE to download a PDF version of the entire issue.

It turns out that by modeling the potential sales and profits of a product over its marketable life span, it is possible to make an educated decision whether buying time through increased investment in R&D makes financial sense or not.