Mundy Morning Quarterback

Alicia Mundy’s story, “FDA Outlays for Morale-Boosting Draw Fire From Lawmakers” (Wall Street Journal, January 8, 2009) is slanted and sloppy journalism.  Aside from the petty attack on Dr. Janet Woodcock (the globally respected CDER director), Ms. Mundy failed to accurately report her story.  It’s not the first case in respect to either issue.

First some background.

In October of 2007, the FDA announced the award of a two-year, $1.5 million contract to the Center for Professional Development (CPD) to assist with the transformation of FDA's Center for Drug Evaluation and Research (CDER), with a particular focus on steps to improve workplace leadership, empower staff, and establish more effective business practices.

The contract was part of the FDA’s ongoing response to a report issued in 2006 by the Institute of Medicine (IOM). Under the contract, CPD will help in the development of practical strategies, including training, tools, and processes that will strengthen CDER’s organizational effectiveness and reaffirm its mission of advancing and protecting the public health.

(The IOM report, “The Future of Drug Safety — Promoting and Protecting the Health of the Public,” identified workplace culture issues in CDER and recommended participation of external management consultants to develop a comprehensive strategy to address them.)

According to the FDA’s own press release (issued in October 4, 2007) “Over the past year, CDER carefully evaluated options and developed a scope of work to solicit the best outside experts to assist in transforming the workplace environment. The entire workforce of about 2,300 in CDER will be included in the workplace transformation effort. CPD will work with CDER’s senior management team and a cross-sectional working group of CDER employees to assess the center’s organizational culture, identify characteristics and a vision for CDER’s desired culture, and develop a plan for implementation and follow-up.”

There was no media coverage and no comment from any member of Congress.

Then, in December of 2008, 14 months after the FDA press release, two members of the House Energy and Commerce Committee Representatives John Shimkus (R, IL) and Joe Barton (R, TX), sent a letter to FDA Commissioner von Eschenbach demanding to know what was going on. Shimkus and Barton wrote, "We are very concerned about the lack of any justifiable metrics for measuring contract success.”

Which brings us to Ms. Mundy’s article in the Wall Street Journal.  Here’s how she began her story, “At a recent retreat for Food and Drug Administration employees, a slide show likened the agency's top drug regulator, Janet Woodcock, to "visionary leaders" such as Golda Meir and Gandhi.”

Mundy quotes Representative Shimkus; “To remove managers for two days to discuss this morale problem, instead of putting food and drug safety first, is ridiculous.”

(It should be noted that Representative Shimkus had no comment about the IOM report when it was released, or about the FDA’s October 2007 press release.  Why did it take him 14 months to break a sweat? This is particularly surprising since his legislative director at the time, Maureen “Mo” Zilly, worked closely with the House Energy and Commerce Committee on FDA issues. Ms. Zilly has since left the employ of Mr. Shimkus to become a lobbyist for Varian Medical Systems as director of federal affairs.)

Mundy also finds space for a quote from Representative Barton, "It's a cinch that if I spent a nickel of taxpayers' money to rank myself with [Sam] Houston and [Stephen F.] Austin, I'd have some explaining to do after the laughter died down."

(Fortunately it is unlikely that Mr. Barton will find himself in that situation.)

What Ms. Mundy did not find room for was the rather lengthy interview she did with Dr. John Jenkins, the FDA’s well-respected director of the Office of New Drugs. His quotes were restricted to defending the “Gandhi” slide and the FDA’s decision to work with a company that also has pharmaceutical industry clients ("I think it's quite silly to bring that up as a point.”)

Why truncate what Dr. Jenkins had to say?  Could it be because he had things to say that didn’t fit into Ms. Mundy’s well-known and well-demonstrated anti-Woodcock, anti-FDA agenda?

As it turns out, that’s exactly the case. Here are all of the questions and answers (taken from a verbatim transcript of Ms. Mundy’s complete interview with Dr. Jenkins) that present a much more balanced and insightful view of the situation under discussion.  It also shows just how “selective reporting” can miss the real story.

DR. JOHN JENKINS:  Hi, Alicia.  How are you?

ALICIA:  I’m fine.  I’m sorry to trouble you.  I’m doing a story on the workplace culture and communications contract.

DR. JENKINS:  Okay.

ALICIA: I wanted to get your view based on what I’ve seen of your slides on what you think the workplace culture is right now?  Do you think the morale is that low?  Do you think there is, you know, you seem to be addressing the issues – is it that bad or does the FDA just attract a lot of criticism, you know?  Are there really this many serious concerns about science versus popularity and drug approval?  Or is that, you know, is that something that’s been kind of blown out of proportion?  And that seems to be part of what your – the slides that I saw on equal voice or your part of equal voice were getting at, and that’s basically what I wanted to ask you about.

DR. JENKINS:  My presentation at the summit was about a process improvement effort that we’ve had ongoing in the Center now for about four years about how to further improve the way we do our review work to ensure that we’re making certain that all the disciplines involved in the review of applications are engaged, they’re part of the team and they’re heard and that their voices are heard.

So the effort we had underway for the review process improvement team pre-dated any of the cultural contract work and as the slides in my presentation note, they overlap and are essentially the same concept. 

We want to have a review process where everyone is bringing their scientific input to the table, they’re sharing their perspectives, they’re a member of the review team, their voice is heard.  They get feedback on their recommendations and opinions and in situations where their recommendations and opinions are not the direction that the decision makers on the application feel is appropriate, they get that feedback and know why their recommendations are not the ones that are carrying the decision making process.

So the review process, the 21^st century review process that I talked about in my presentation is, I think, a real day-to-day manifestation of the cultural values of equal voice that we’re trying to ensure that everyone understands across the entire Center. 

One of the comments I made at my presentation that I make it frequently internally in discussions with staff is that consensus is not our goal when we’re reviewing an application, and that takes some people by surprise because most of the time, we actually do reach consensus, but it can’t be the goal because if consensus is the goal, I think, it places a subtle pressure onto any member of the team who might have a differing viewpoint to conform to the majority view and actually our decisions are the strongest when we hear all those dissenting views and they’re discussed among the team and the decision maker, explains why they agree with one position and they don’t agree with another.

So while consensus is often the outcome, consensus is not the goal in our review process and I think my presentation at the summit was to show that this whole concept of equal voice was not something new, it’s something that has been part of our process for many years and we’re taking it to the next level to make sure that it’s really understood clearly by all members of the Center and all members of the management team.

ALICIA:  What do you mean by taking it to the next level?

DR. JENKINS:  Well, we’re trying to make sure that everyone in the Center understands the concepts of equal voice, what their role is in the review process.  One of the important concepts of equal voice is about it relates to the discipline, not the individual because we need to hear from a particular discipline about their recommendations for an action on application and there’s a process within that discipline for any differences of opinion among the reviewers and the managers to be resolved.

So we’re trying to make very clear that this is the culture that we expect to operate within the Center, you know, going back to the IOM report on drug safety, one of their recommendations that we undertake this type of an effort to reiterate these issues.  I think they’ve always occurred and the vast majority of the interactions internally within the Center.  This is our attempt to try to ensure that they occur with all interactions on review issues within the Center.

ALICIA:  I don’t mean to necessarily go down this path, but since this was the focus of your presentation, you know, I know you’re saying that this goes back four years, but the IOM report, you know, they came to a pretty strong conclusion, I guess, that if this process has been underway at the Agency, it didn’t seem to be producing much because they were very critical of CDER’s review process and I think they called it at one point an obstacle to the FDA.

So they hadn’t – when I looked through the report, they didn’t seem to focus on an ongoing process or, you know, an earlier process to try and make sure that there were equal voices getting, you know, getting heard.

DR. JENKINS:  I don’t think you’re understanding the distinction between the program that we’ve had underway for several years to deal with improvements and how we manage the review of applications, which is the 21^st century review process that I discussed at the summit and the work has been in progress now for several years, from the IOM report which was heavily focused on post-marketing safety issues.  The 21^st century review process is primarily focused on pre-approval review of applications.  The IOM report was much more heavily focused on addressing post-approval safety issues, but they all dovetail together in the concept that I described earlier that we want to make sure that every voice is heard, every voice is respected.  It doesn’t mean that every voice carries the day on what the decision will be, but we want to make sure that we have a culture where people feel free to express their opinion and support it with scientific data and the ability to justify how they reach that conclusion.

So I think there are parallel issues, but they overlap significantly.  I don’t think the IOM report had much, if anything, to do with review process improvement efforts that I am describing.

ALICIA:  Well, I don’t think it had to do with the review process improvement efforts, but I think there are definitely parts of it that had to do with the new drug approval process in general and, again, concern that science, you know, does not always – science is not always the deciding factor and decision making.

DR. JENKINS:  My take on the IOM report was that they were interested in ensuring that all the perspectives were being incorporated in the decision making and that’s exactly what we’re doing through reiterating the equal voices principles that, you know, ultimately, there has to be someone who makes a decision in a regulatory organization.  We are not a democracy internally in how we can reach a decision making process.  Someone is charged and responsible with making hundreds, if not thousands of regulatory decisions each week, month and year.  We want to make sure that those decisions are informed by all the perspectives and all the data and all the viewpoints, but it doesn’t mean that each individual viewpoint will always be the one that leads to the Agency action.

As I said earlier, we think that our actions are the strongest when they’ve been informed by all those different perspectives, and that’s what equal voice is about.  It’s what the 21^st century review process is emphasizing about teamwork and mutual accountability of the members of the team, sharing information, speaking openly, being able to defend your scientific position and not simply state an opinion, but not be able to support it.

That’s my perspective on what we’re trying to achieve, and I think we’re very much in line with trying to achieve the goals that the IOM report set out for us.

ALICIA:  When I look through the slides, there were a lot of, in general, from the conference.  I didn’t see any, what didn’t – a presentation by anyone who might have, not necessarily taken issue with your perspective, but who might have raised the idea that there were times when significant and serious difference of opinions were – it’s not just that they weren’t included in the final decision making, but were actively suppressed and I didn’t see that necessarily addressed in any of the slides or anything that would have, you know, spoken to your issues. 

Is there anything here that I’m missing?

DR. JENKINS:  Well, I don’t know what the packets of slides you have available to you are, but the presentations were designed to lay out the goals of the meeting and the concepts that we were trying to achieve and some examples and some case studies. 

There was plenty of opportunity during the two days of the meeting for discussion and dialogue to occur and opportunities for the 475 or so people who were there who were all managers within the Center to raise any concerns that they might have about whether these principles have always been applied or will they always be applied in the future.

So I think there was plenty of opportunity for that discussion to occur.  There was a lot of discussion amongst the tables where people were seated.  There was a lot of time spent having them interact with one another.  They were purposely seated in a way that we maximized the mixture of the staff so that they weren’t just people who normally would sit together.  They were a cross-section of the Center at each table.

So I think there was plenty of time for discussion about any concerns people might have about, you know, these principles and how they might be applied. 

ALICIA:  Okay.  One thing that I wanted to ask, well, actually, after your presentation, you know, I don’t want to put you in an awkward situation.

DR. JENKINS:  Reaction exactly to what, again?

ALICIA:  There was a slide, it was visionary leaders and as I’ve seen it and as it has been explained to me by five or six participants, basically, you know, it seemed to suggest that Dr. Woodcock is in with – vision is on the same plane with Gandhi’s or Barack Obama’s or Margaret Thatcher’s or Golda Meir’s as a visionary leader and, you know, there were a number of people who called me, I guess, within a couple of days after the conference to express a little bit of shock about that and that’s why I had requested to find out the context of that slide and what, you know, I guess what FDA officials think of it.

DR. JENKINS:  Well, my take on the slide was that, in part, it was there to inject some humor into the proceedings and as I recall at the meeting when the slide came up, there was laughter in the room because there was some humor associated with that. 

The talk – when that slide was used was one where it was talking about leadership and leading through a change process and that’s what we’re trying to do as the senior management team of the Center is lead through a change process and it was an example of thinking about visionary leaders and how they went about accomplishing their goals.

Now, I don’t think anyone was trying to imply that Dr. Woodcock is on the same level of world leader as Gandhi or Barack Obama.  They were pointing out that within the context of the job that she is responsible for doing; many people view her as being a visionary leader.  And so I think people pointing that out as an issue for a two day conference that was focused on trying to improve the culture of the Center and how we work together in equal voice, to my mind, is really a distraction from the important issues that occurred over two days.

Dr. Woodcock is the one who had the vision to bring this meeting together.  We took two days away from very busy schedules for 475 managers from across the Center to come together and it emphasized how important she and the senior management team for the Center view this effort.  It’s in direct response to what was recommended by the IOM report.

So I really think it’s a distraction for someone to focus on that one slide, which I think was intended to inject a little humor into the proceedings, but was also there to make a point that everyone within their capacity at their job can be a visionary leader.

So it was not to suggest that Dr. Woodcock is on the same plain of a visionary leader as a world leader like Gandhi, but I think was making the point that every one of us in our job can be a visionary leader to effect change.

ALICIA:  Okay. I’m just curious, you know, were your slides put together by the company or did you do your slides?

DR. JENKINS:  Well, I think it’s important to look back at the preparation for the two day summit in general.  The contractor, CPD, was an important partner in helping us put together this program and supporting, preparing for the program.  There was a steering committee within the Center of senior managers within the Center that worked very closely with the contractor to develop the agenda, the plan for the meeting, the logistics, et cetera, as part of the process for developing the meeting, the steering committee working with the senior management team of the Center developed the agenda presentations and then working with the contractor, we developed the slides that would support those presentations.

So in the case of my slides that I used, the initial draft of the slides was prepared by the contractor based on the discussions that they had had with the steering committee and discussions that the contractor had had with me about what I thought we should cover.  The contractor shared the draft of the slides with me and we had several meetings over the course of several weeks where we had adjusted slides, I edited the messages, et cetera.

So at the end of the day while I did not physically generate the slides, the message that was on the slide and the content on the slides were mine. 

            ALICIA:  Okay.  All right. 

            DR. JENKINS:  I admit very readily that some of the graphics that were on the slide, I’m not capable of producing in a PowerPoint program.

            ALICIA:  And a graphic artist –

            DR. JENKINS:  I was very happy to have a contractor who could generate those concentric circles and other flow charts and the diagrams because I can’t do that.

            ALICIA:  I’ll tell you, some of them were impressive.  Some of them were definitely state-of-the-art PowerPoint stuff, anyway.

            You know, I guess the big issue is that at least for some veteran FDA employees, they feel that there has not been that much of a serious, ongoing effort with equal voices and the conference did not, you know, did not get at the key issues of how to get dissenting opinions over science and safety heard versus, you know, a general theme of improving culture with skill workshops on using better choices of language and vocabulary and behavior, which I guess on its face seems like something that people should know anyway.

            DR. JENKINS:  Well, you know, I would disagree strongly with those comments and those assertions.  That’s not the meeting I attended for two days last month and it was not the meeting that was the goal that we put together.  Again, I would point out that we took this issue so seriously that we took 475 people away from their busy jobs off site for a two day meeting to discuss the culture that we want to make sure that everyone understands that we’re trying to achieve in the Center for decision making and how we work together as a group. 

            As part of the meeting, there was a survey done about the value of the meeting to the participants and the majority of the respondents to that survey were favorable.  There were some who were not so favorable, but the vast majority of the people who attended the meeting were favorable. 

            Another component of the cultural contract that I would point to is the contractor helped us do a cultural survey, probably about a year ago to help us get a baseline understanding of what is the culture and the status of that culture in the Center as a snapshot and that survey results were very positive for the most part.  They pointed out areas where we needed to improve and we could do a better job, but the vast majority of the respondents to that survey were very positive about working in CDER, the importance of their work, the value that they felt that they added to the system.

            So I would just very strongly disagree with the people that you have been talking to about the focus of the meeting, the value of the meeting. 

            I saw a lot of people very engaged for two days, two very long days and I saw people at the very end still very engaged, very enthusiastic about the fact that they were getting to meet that they normally don’t get to meet and talk to and to share perspectives.

            So I think it was a very positive meeting.
    

Indeed. An excellent interview with an important FDA official who rarely engages in lengthy conversations with the media.  What possible reason could there have been to waste such an open and honest and timely and relevant interview?

Could it be because it justified the agency’s decision to hold the workshop?  Could it be because it makes Janet Woodcock look like the superstar she is?  Or could it be something else? Inquiring minds want to know.

One thing’s for sure, it is unlikely that anyone will be creating a PowerPoint slide comparing Alicia Mundy to Edward R. Murrow any time soon.

And to quote the great journalist himself, “To be persuasive, we must be believable; to be believable we must be credible; to be credible, we must be truthful.”

Amen.