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.

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

 
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.

 

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.

 

Leveraging social media by biopharma

Having just returned from the DIA Clinical Forum meeting in Lisbon, I was happy to see a notice within my LinkedIn account about a new posting by Daniel Ghinn of Creation Healthcare. This is not only a good overview of the Medical Informatics session at the DIA meeting but also makes reference to the recent DigiPharm Europe conference recently held in London. Daniel also delivered an insight packed presentation at the DIA meeting on the use of social media (e.g. Facebook, Twitter, Flickr) by pharmaceutical companies. In this presentation, Daniel cited work done by Johnson & Johnson, Pfizer and Boehringer-Ingelheim. Both are worth your time.

Can Frog Design figure out Healthcare?

If you have not heard of Frog Design, it's worth checking out what they have done over the years. I won't talk about that here and let you do the research. I promise, it will be fun!

But, I would like to get your opinion on what Frog Design and Microsoft are dreaming up to solve the ills of Healthcare with technology. Even Homer Simpson is in on the act (though not of his own free will). You can get a glimpse of that by clicking here to get to the video on the Forbes Video Network. It's less than 3 minutes long.

Do you like what you see? Are they on to something or are they nuts? Send me your comments and share them with my other readers.

I will hold back with my own opinions until I've heard from you.

Patient (Self)Recruitment

Notes from the 23^rd DIA CDM conference

Sometimes we tend to forget that everything we do is for the patient.

I was reminded of this when listening to a talk by Laura Esserman of the University of California Medical Center at San Francisco. Dr. Esserman described her clinical work in the area of breast cancer and the recognition that patients themselves could be the source for electronic health records (EHR). Once collected, these records could be used to match patients to clinical trials. In other words, the EHR becomes the source of data for patient recruitment.

2008: IT budgets to fall?

If the pundits are right, IT budgets will be smaller next year. Or, to put it more correctly, the percent increase for 2008 over 2007 will be less than the percent increase for 2007 over 2006. Are you still with me?

As an example, take the recent article by John Soat of Information Week, who cites two separate surveys involving CIOs. Both predict smaller budget increases for 2008. Mind you, this is across all industries and it's not clear what will happen in the Biopharma sector.

We can guess, however, that based on the somewhat dismal performance of most pharma and some biotech companies, CEOs will be looking for savings wherever they can be found. And that includes IT.

From my perspective, this is quite unfortunate since I am convinced that our industry has squandered countless opportunities to leverage information technologies to improve both day-to-day operations and improve the R&D pipeline. If you want examples, I'll give you several:

• document management and electronic publishing
• data management and exploration
• electronic data collection (EDC)
• clinical trial management
• master data management

Now, you may be saying: "Is this guy nuts? These are the areas where we have made the most progress!"

And no, I'm not nuts. These are great examples where lots of time and money have been wasted or investments underperformed. Despite glowing reports at DIA meetings and other venues, the reality is that we still don't know how to properly leverage IT.

I'll offer just a few reasons why our IT dollars/euros don't get us the returns we need:

1. Lack of resolve and leadership to change course;
2. Continued disconnect between the business community and the IT organization;
3. Missing or half-baked strategy for improving productivity;
4. Cowardly management disguised as management by consensus;
5. Focus on regulatory compliance rather than operating efficiency;
6. Failure to create a learning and innovative organization;
7. Over-reliance on selecting technology rather than setting strategy that drives technology.

So, it's possible that we don't actually need to increase the IT budget. Maybe it would be enough to just stop wasting it.

Pfizer: Irrational EXUBERAnce

The other shoe has dropped!

Pfizer has decided to stop selling Exubera, it's highly self-touted inhalable insulin product. As you have read here before, Exubera may be a technical breakthrough but it's also one without a proven benefit to the consumer. For whatever reason, management at both Nektar (the developer of the inhaler) and Pfizer got too enamored about the technology and chose to put their head in the sand about market demand and acceptance for such a product.

The consequences are devastating for both companies financially and highly damaging to their reputations as both researchers and marketers. On the financial front, Pfizer is taking a $2.8 billion pretax writedown. This, in light of blockbuster sales projections of $2 billion per year and an actual performance of just $12 million.