The Laszlo Letter

Quotations from FDA CDER Head Janet Woodcock

Notes from the 23^rd DIA CDM conference

In the next few posts, it is my intention to share with you some of the information presented at the 23^rd DIA Clinical Data Management (CDM) conference. It is also my intention to give you some of my own thoughts about what I saw and heard.

The title of the conference was “Data Management in Transition: Putting the “e” in Data Management.” I am happy to report that the conference organizers did a great job keeping the majority of speakers focused on this topic. So, kudos are in order for Sue Dubman (Theravance), Kristin Neff (Boston Scientific), Paul Bleicher (Phase Forward), Shahla Farr (FDA), Rebecca Kush (CDISC), Denise DeRenzo Lacey (Waife & Associates), Johann Prove (Bayer Schering Pharma), Don Rosen (Rosen Consulting) and Steve Wilson (FDA.)

I could not think of a better approach to get things rolling than to simply convey several quotations from the talk given by the conference keynote speaker, Janet Woodcock MD, of FDA. As you may know, Dr. Woodcock was recently put in charge of CDER and she wasted no time telling us what she thought her division, and indeed all of FDA, should be doing.

These quotes nicely reinforce the tone of the CDM conference, one that was palpable if not always directly stated, namely that The time for change has arrived.

While I was initially tempted to put these quotes in context, I resisted that urge since they are as applicable to what we do in general as to the specific issues being discussed by Dr. Woodcock.

So, mull these over at your leisure and stay tuned for more about the meeting in future posts.

Quotations from Janet Woodcock

“current methods are not sustainable”

[there is] “almost a crisis in the United States to get clinical trials done”

“there is too much data being collected”

[we] “need to link EHR to clinical trials”

“we need to get out of the way we are doing things now”

The case for cocaine reimportation

One of the great benefits of blogging is the freedom to say anything you want. This also means that when you are not censored (i.e. edited) you can end up publishing something really dumb. I'm hoping that this post is not one of those. If it is, I'm sure you'll let me know.

The September 22, 2007 issue of The Economist showed a nice graph of retail cocaine prices (per gram) around the world. So you don't have to go there, here is the list as extracted by me:

• Australia - $250
• Japan - $240
• Norway - $155
• United States - $110
• Britain - $95
• France - $85
• Germany - $80
• Israel - $70
• Canada - $65
• Colombia - $3

These numbers gave me a few business ideas. Read on...

Forest Labs - Words of wisdom...

I'm pretty sure that reading corporate annual reports is not on the To Do list of too many people. It certainly is not on mine. However, I have made it a point to read the one from Forest Labs since it's CEO, Howard Solomon, normally has some interesting things to say. On that score, the 2007 report did not disappoint.

Take this concise quote, for example:

"If even peanuts can be fatal to some people, how can we expect all drugs to be safe for everybody?"

And, there is more...

AstraZeneca and Corporate Responsibility

In case you have not yet heard, Peter Rost recently broke a story about Mike Zubillaga of AstraZeneca (AZ), who was quoted in an internal newsletter saying the following:

"There is a big bucket of money sitting in every office. Every time you go in, you reach your hand in the bucket and grab a handful. The more times you are in, the more money goes in your pocket. Every time you make a call, you are looking to make more money."

Mr. Zubillaga, was regional sales director for oncology in the Mid-Atlantic region. He was fired by AZ soon after the newsletter was leaked to Peter Rost by an AZ employee.

AstraZeneca spokeswoman Kirsten Evraire, in a reply to inquiries by the Pharmalot web site, said the following:

"...Our company is disturbed by the content and particularly concerned about the impact the content of this unapproved newsletter may have on our employees and others. In addition, we are concerned that a manager in our sales organization used this vehicle to communicate messages that directly contravene our core values as a responsible pharmaceutical company.

Our investigation into the development and distribution of this newsletter continues, in an effort to determine whether our current policies and procedures regarding AstraZeneca communications are being adhered to by employees..."

So, once more we are back to the issue of corporate responsibility. In particular, we need to modify Ms. Evraire's comment by suggesting that they not only look into whether their policies and procedures are being adhered to but whether the policies and procedures themselves are sufficient.

Pharma Marketing: Leveraging Healthcare Bloggers

A New Controversy in the Making

J&J seems to have unwittingly given birth to a new controversy by hosting a dinner for healthcare bloggers in Manhattan. As Steve Palter MD noted on his blog, "the big pharma folks are exploring the blogosphere and testing the waters before they tread deeply.  Their goal was to explore the medical blogging environment and garner information to help them decide how to get involved."

Unfortunately for J&J, since bloggers are not known for keeping things secret, the blog traffic started to mushroom immediately after the event.

Mind you, there is no evidence that J&J wanted to keep things secret. (See, this is exactly how innuendo works! You say something in complete innocence or on purpose and make trouble for someone else.)

So, what's the controversy? Well, it's the same as big bad pharma inviting doctors to dinner and influencing (read: buying) their prescribing habits. In this case, the danger is getting bloggers to say nice things about the biopharma companies and/or their products.

The reaction from the bloggers, those invited or not, were predictable.

Drug Prices and the Big Mac Index

Is it just me or has media coverage of drug prices and reimportation from Canada cooled down in the past three months?

Perhaps our troubles in Iraq and the recent elections moved attention away from this key industry controversy. If so, let's hope it stays that way.

However, there is still a huge credibility problem for our industry that neither the drug companies or the PhRMA (or any other industry group around the world) has been able to blunt or reverse. I am not sure why very little change has taken place about the way we try to show the public that we're not an evil group of money grubbing capitalists.

So, here is one suggestion for reversing the bad reputation. Use the Economist magazine Big Mac Index to illustrate to the world why drug prices need to be different around the world.

The Big Max Index? What is that? Read on...

Productivity vs. Quality of Life

First, let me thank all of you for checking in on a regular basis while I'm on vacation.

I told you the last time that I am in a contemplative mood. So, today, I want to share with you a dilemma. Specifically, I am wrestling with the question whether there is a mutually exclusive relationship between productivity and quality of life.

Are Software Companies Hindering Productivity in Life Sciences?

I did not tell you about a thought provoking paragraph related to a perception of software vendors by Life Sciences companies in my last post. Here is the paragraph in its entirety:

"As [Mary Jo] Zaborowski [Senior Vice President and global head of global research informatics] of Roche points out, “The industry is not that large, and it creates an adverse situation for companies that create products.” The small size of this market can force vendors to generate revenue by using proprietary systems and requiring customers to purchase upgrades and add-ons. The proprietary aspects can impede the knowledge workflow in biotech and pharma. As a result, the informatics group at Roche often creates in-house solutions that make data available inside the company. For example, Roche writes its own code for mining data and then links that with products from vendors. “Ideally,” she says, “vendors should use open-source code, but they usually don’t.” More open-source products would greatly improve the possibilities of improved workflow across all biotech and pharma companies."

I think this view deserves discussion and I will attempt here to dissect what it says.

The Guidant Potboiler

While I think that Forbes typically does a better job covering the biopharm industry, Fortune also comes through with flying colors once in a while. The October 5th issue is a good example of that with an article called "The (Second) Worst Deal Ever."

Reminding me of many exciting encounters with books of the "who done it?" genre, the article by Shawn Tully recounts the fight for Guidant between J&J and Boston Scientific and the important role played by Abbott.

October - Just say KNOW to Prescription Drug Month

Even the best pharmaceutical marketer would be envious of this slogan.

I'll say no more. You be the judge.

Go here for more information about this campaign.