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Tuesday, July 10, 2007

Moving to WordPress Site

I am in the process of moving the blog over to a Bluehost server and shifting to WordPress -- starting fresh, you might say, but also using a new (sub)domain name:

Still in design mode there -- some things are a bit different, but most will transfer over....

More later....

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Tuesday, June 26, 2007

Spare part....

Well, here is a rather extended post that was not intended as such.

Friend Domonic and I are in the process of putting together a newsletter for the Public Administration Section of APSA (which is main reason why I have not been blogging of late), and while doing so I came to the (mistaken) realization that this was going to be a rather thin issue -- and one filled with more with obituaries than anything else. I tried some of my colleagues to see if they had anything of a controversial, Op-ed nature laying about that they wanted "out there", but I had no takers (after all, it is academic summer time and many folks are hard to reach). And so I thought it might be worthwhile to start a new feature for the newsletter about new ideas that might impact on the field -- and with that incentive I spent a day drawing up the following comments on two books that I have already blogged about here. In the meantime enough material emerged for the Newsletter to be consider now a bit too long -- and something had to give. So, applying the principle of "waste not, want not" (as if that has anything to do with it...), here is the comment that will not be found in the PA Section Newsletter:

Idea-log-ical {that is what we were planning to call the new feaure]

A bit of Pop Management [catchy title, eh?]

I am always on the look out for the latest book or article that falls within the broad domain covered by public administration, but over the years I have developed an aversion to those titles that make it onto the so-called "Management" shelves at the local mass market bookstore (typically Barnes and Noble or Borders). You know the kind of books I am talking about: The First Time Manager, How to Become a Successful Manager, 101 Biggest Mistakes Managers Make and How to Avoid Them, The Art of Managing People, The 21 Indispensable Qualities of a Leader: Becoming the Person Others Will Want to Follow, etc. Sure, there are some of those titles that may be worth reading for the PA academic, but I that I have been so put off by most of them that I typically wait until four or five of my colleagues mention the work in a positive way before I bother to use my Amazon One-Click to see what all the fuss is all about. Such instances are becoming rare indeed, but the titles of those that do make it onto my "read list" would be familiar to all: In Search of Excellence, Getting to Yes, The Gods of Management, almost anything by Peter Drucker, and (of course) Reinventing Government. I call the genre "Pop Management", and with those few exceptions (which often also disappoint) I am not a fan….

I bring this up because I am about to confess to having violated my own standard by picking up two recently published "Pop Management" books as they were released. In part this was because their titles and Amazon "blurbs" intrigued me. Also, at the time I was desperate to find a book or two that would not bore the hell out of my students in a "managing public organizations" course I was teaching this summer.

The books in question are The Starfish and the Spider and Everything is Miscellaneous. The first, by Ori Brafman and Rod A. Beckstrom, is an entertaining and quick read with little depth but one significant message: decentralized, leaderless organizations rule! The second, which turns out to be as much "Pop Metaphysics" as it is "Pop Management", is an entertaining read but with an even more significant message: disorder rules! Its author, philosopher David Weinberger, may have pulled off a rare scholarly coup by slipping a truly interesting work onto the Pop Management shelves of Barnes and Noble.

As the title of The Starfish and the Spider implies, the message is presented with a metaphoric hook that is pretty hard to ignore. The comparison they build on is striking. On the one hand you have the hierarchical, bureaucratized organization -- the spider which can be significantly incapacitated by pulling off any one of its legs, or completely done in by doing nasty things to its "head". On the other side are headless, regenerative entities -- the various forms of starfish which include some species that actually reproduce themselves when ripped apart. At the outset of the book, the contrast is used by the authors to explain historical phenomena that many have regarded as "strange but true" oddities; but as it turns out, what may have been idiosyncratic in the past may now be emerging as commonplace occurrences.

How, for example, do we explain the legendary endurance of the Apache nation in the face of European and (later) American efforts to conquer and subordinate the tribe. And in an era dominated by the transformation of social life through the corporatization and bureaucratization of everything, how do we explain the rise, success and proliferation of the non-corporate, non-bureaucratic model provided by Alcoholics Anonymous? Through these an similar examples, the book's authors demonstrate how the same starfish organizational logic found among Apaches and AA groups is at the heart of a number of "communities" that have emerged as strong challengers to those giant entities that have dominated their respective domains through traditional (spider-like) corporate forms. The examples are increasingly well known stories -- from Craigslist's challenge to newspaper advertising, to Wikipedia's challenge to Britannica, to the Napster/Kazaa/eMule challenge to the music industry giants.

As in the best (and worst) of the Pop Management genre, the Brafman and Beckstrom highlight a small number of factors (conveniently summarized as the "five legs") that characterize starfish organizations: circles, catalysts, ideology, preexisting networks and champions.

While I would argue that most of Pop Management literature might easily be dismissed as repackaged hogwash, I believe the starfish "has legs" (sorry about that) for research as well as pedagogic reasons. Their assertions about (and for) starfish organizations are clearly useful, not only for students of management and organizations, but also for analysts who are trying to make sense the problems faced by the US military in past (e.g., Vietnam) as well as current (e.g., Iraq, war on terror) conflicts (here the lessons of the Apache example of decentralized resistance is all too clear). And if you read the book with the critical eye of a scholar, there are a number of interesting research questions begging for testing.

But before you think I have fallen head over heels for this work, let me point out some major and interesting flaws. First and foremost, I believe they were careless in their decision to highlight "de"-centralization as a defining feature of starfish organizations. As Daniel Elazar brilliantly pointed out in his studies of federalism and related forms of governance four decades ago, there is a big difference between de-centralization and non-centralization, for the decentralized entity implies or assumes the pre-existence of a centralized arrangement. Returning to the metaphor, to think of the starfish as decentralized would be to assume that it "devolved" from a creature that was more spider-like rather than "evolved" from ancestors that were more mushroom-like. In that sense, Elazar's idea of non-centralization is more appropriate, for most members of the starfish genus consists of five radically symmetric protrusions, each emerging from an central disc that seems little more than a shared core and can be regenerated by any of the radials that become detached. By using the term "decentralization", Brafman and Beckstorm create an analytic ambiguity that makes their discussion of so-called "hybrids" less relevant than they might hope.

A second flaw is related to their narrow use of the term "leaderless" in characterizing starfish organizations. The authors seem to view the role of leader in strictly hierarchical terms while at the same time devoting space to the role of "catalysts" and "champions". A good deal more insight would have emerged from this work had they been more knowledgeable about the various ways and means so-called leadership manifests itself in modern organizations.

Despite these flaws, I could not help but think about how valuable the "starfish frame" will be in moving forward the conversations and research now being conducted into emergent forms of governance. Just as "reinventing" tag provided some coherence to the growing body of work on cut-back management and neo-managerialism of the 1980s, the starfish metaphor can provide a popular face for our work on networks and the changing face of leadership.

Weinberger's Everything is Miscellaneous, in contrast, does not suffer from significant or uninformed flaws. The subject is "order", and although the book is written at the level of Pop Management, its lessons rise to the level of profundity. In a sense, Weinberger's miscellany complements the starfish thesis by stressing the effective demise of authority and essentialism. The search for order is (and in fact always has been) an increasingly hopeless endeavor, and the adoption of the "digital disorderliness" that now pervades our cultural, social, political and economic lives will ultimately change "everything" by making any form of categorization and classification arbitrary at best. Rather than see this as the basis for gloom and doom scenarios, Weinberger paints a positive picture of the what is emerging (and already had emerged in some arenas) form this seeming chaos.

At the heart of his argument is the idea of the "three orders or order". The first order is comprised of the things themselves, whether they be books or students or clients or any such material objects which we seek to perceive as an identifiable population. The second order are those ordering mechanisms we use to track the first order things -- from library card catalogues to course rosters to client numbering (e.g., issuing social security numbers). The third order of order replaces the physical (atom-based) reality with a digitized (bit-based) representation which cannot be associated with any particular space or time, and in fact can be associated with any and many perspectives depending on who is doing the perceiving.

The implications are truly revolutionary, and Weinberger's examples range from a visit to Staples to the recent debate over how to reclassify planets, with stops in between at libraries, Wikipedia and Google maps. Weinberger does not offer simplified formulae of how to make millions in the coming disorderliness, and to that extent his work actually fails as an example of Pop Management. Nevertheless, Everything is Miscellaneous is a reframing of the future that all managers will face, no matter what "sector" they operate in. To some extent, the picture he paints of a world dominated by the third order of order is just a "digitized" version of the information society addressed by Harlan Cleveland and Peter Drucker, but in a very real sense the future has caught up with us -- and the question is are we prepared?

I suspect we will hear a good deal more about starfish organizations and the new order of things over the coming years. My own sense is that as a scholarly field we in PA are probably better prepared than most to engage in the discussions that are likely to develop.

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Monday, June 18, 2007

Ignited memories....

A lecture point I made in tonight's class and associated news story had me thinking about growing up in Brooklyn this evening.

The lecture point was about how leadership changes -- especially sudden, unexpected ones -- can alter the structure and behavior of organizations. No big deal as a bullet on one of my powerpoint slides, but it begged for an example and there were two ready made ones in today's business news.

This AM's New York Times had a story about the leadership transition at HBO when its CEO resigned after getting caught in a bit of a scandal. The second story popped up in my email just as I was starting class as a NYT news alert: Terry Semel of Yahoo! had resigned as CEO of that company under pressure from shareholders unhappy with the company's stock value performance.

It was the Terry Semel story that got me thinking about having grown up in Brooklyn, specifically in the Brownsville section, and more specifically on Saratoga Avenue between Pitkin and Sutter. (The Wikipedia entry on Brownsville notes that among the notables who came out of the neighborhood were a range of folks from Aaron Copland and Alfred Kazin to John Gotti and Mike Tyson). According to family legend (and my own vague recollections), at some point in my very, very young years I accidentally set fire to some furniture in the Semel family apartment while Terry (and/or his older sister) were babysitting me. It wasn't a big fire -- I believe it involved some newspapers on a chair and my curiosity about the silvery looking gadget called a "Zippo" (again, my memory is very vague on such matter; hell, I can hardly recall what I ate for breakfast!).

Now Terry Semel is unlikely to recall the incident, although he is three years my senior and (again, if I recall) was punished as much as I was by our parents. But the news of his position shift (I believe he will now be chair of the Yahoo! board of directors) and the fact that I am back teaching and wandering in NY (if only for the summer) did trigger thoughts about how much things have changed over the past fifty years on the mundane level -- and yet how much remains the same for kids growing up in Brooklyn and other parts of New York.

This reflection continued as I took the subway and bus to the place I am staying in Manhattan. I was an early transit rider -- again, memories are vague, but I am pretty sure I was making my way around Brooklyn via bus and subway by age ten or so. Short trips to an aunt's house or to my grandparents' used clothing shop in East New York or to Hoyt Street where my parents worked for different stores. (For details I would have to rely on my older sister who seems to have better recall of my adventures as a kid than I do...). In many respects, for me the subway rides are as grimy and sweaty and noisy an experience now as then -- and as fascinating as a people-watching experience. I have been on many other subway systems since, but with the exceptions of Chicago and Boston, none come close to experience of New York, in both a positive and negative sense.

The same can be said for the bus rides, with one major change: the cell phone. As I took the last leg of my journey to the upper west side on the M86 Crosstown, I was struck by how many folks were using their phones, chattering away often as they entered the bus and throughout the entire ride until they got off at their stop. At least half the passengers on this relatively full bus ride were either on their cells, playing with the Treos or Blackberrys (including me, I might add); if you add the folks who were otherwise "plugged in" to their iPod or Bluetooth headsets, the figure would go to three quarters of the passengers. As self-involved temporary co-residents of the vehicle, the bus riders no longer engage in the awkward interactions that subway riders still experience because the phone signals cannot penetrate the underground tubes -- the avoidance of eye contact, the attempt to ignore the banter and noise made by others, the indifference to strange odors and screaming kids, etc. (all captured so well in the famous Seinfeld "The Subway" episode, although I have to admit I have never seen a naked man on any of my subway rides...).

So, despite Metrocards, refurbished subway cars, moderately improved buses (e.g., "articulated buses"), and all the other improvements that the New York Transit folks have brought on over the past half century, the NYC experience remains as fascinating for a 60-year old people-watcher such as myself as it did for the ten year old.

Thanks to Terry Semel for triggering all that....

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Sunday, June 17, 2007

Bacevich on JCS...

This morning's Boston Globe "Ideas" section (always a good read) leads with a piece by Andrew J. Bacevich on the need to reform -- or, better yet, get rid of -- the Joint Chiefs of Staff (JCS). It is, he argues, a failed institution that is beyond salvation.

Bacevich -- whose credentials to discuss this topic are professionally, academically (see here and here and here) and personally well established -- is focused on this particular institution, but what we have here is part of a more significant problematic: the unitary executive theory (UET). Bacevich contends that the failure of the JCS is partly due to design flaws that have not been resolvable via reform, and in part due to the mediocrity of those who rise to the level of JCS chair. (He does note Chairman Colin Powell to be the major exception, but his "success" in the position was a major reason for the mediocrity that has followed....) I think it pretty clear that the institutional context of the unitary executive theory is a more critical factor, for it defines and drives the logic of accountability and responsibility for the JCS and other agencies that were designed to have some degree of autonomy and detachment from the White House.

Since the Bush Administration has taken UET to a level well beyond those of previous administrations, it is all too easy to fall into the trap that the situation will improve on January 20, 2009. But the UET is not a manifestation of partisan differences -- it has been as strongly supported by scholars on the liberal left (see here for JSTOR-access article by Lawrence Lessig and Cass Sunstein) as defended by neocons (e.g. John Yoo). The popular consensus the UET is a necessary aspect of the modern US administrative state has been impossible to break, and the logic of American politics does not make one hopeful for a change in the near or long term future (imagine a presidential candidate running on a platform of "I will do less and defer to Congress more!"; the last president to take that position explicitly, I believe, was Grover Cleveland). But as long as UET dominates our "governmentality", none of the changes advocated for the JCS or other parts of our national security complex (Bacevich advocates advisers drawn from retired military officers) will work.

Central to the problem is a view of accountability that relies on hierarchical governance models that have been central to popular administrative thought in the US for well over a century, and even longer if you broaden your perspective to the modern state. But let's not get into that here -- a post should not be book length....

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Thursday, June 14, 2007

Mintz(berg)-ing his words....

If you are teaching a course on organizations (as I am), it is all but impossible to avoid using the work of Henry Mintzberg. Starting with his groundbreaking attempt in the early 1970s to study what managers really do and his comprehensive textbook treatment of organization structure in the 1980s,(e.g., here and here) through his extensive critique of strategic planning in the 1990s (e.g., here and here) (see cv here), Mintzberg is on track to become as important a "guru" in management and organization studies as the late Peter Drucker. The difference is that while Drucker has been treated as Buddha-like, a fount of wisdom whose every word was (and is still) to be taken as authoritative, Mintzberg is perceived as a brash critic who has used his intellectual pulpit to take on the management powers-that-be.

In Mintzberg's case it is a reputation well earned -- and one he continues to savor.

And thank goodness for that.

Examples are found at his personal web site where he provides links to an interview in which he questions the value of an MBA education, a published commentary in the major Canadian medical journal where he goes after the outrageous pricing practices of pharmaceutical companies (and calls for price regulation), and an unpublished essay on the coming economic "collapse of 2008" that will result from the superficial and dangerous effort to maximize productivity.

Brlliant stuff....

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Tuesday, June 12, 2007

Sweating bullets of chili joy...

I am continuing my “busman’s holiday” in New York City, and at the moment I am sitting at Señor Swanky's (no kidding) Mexican café on Columbus Avenue off 85th Street eating some surprising good southwestern chili. It is a rare find on the east coast – you can find so-called chili, but nothing in substance or "heat" to match what those of us from the southwest have come to expect. Typically the eastern attempts are watered down or not quite as “hot” as they ought to be – but I have been sweating bullets of chili joy from the first spoonful. Very nice! With a bottle of Corona and tortilla chips, I am good for the rest of the day….
Randi was down here for the weekend but has now trekked back to work, and I am spending most of my time enjoying the open schedule during the day that allows me to do some catching up as well as prepping my course at Baruch.

On Sunday we had traveled to the New Jersey town of
Sparta for a party held at another terrific restaurant – a very out-of-the—way place called Zoes By The Lake that serves French cuisine. We went there for a special occasion, but ordered off the dinner menu and found it to be as good as anything in the Boston-New York area we've eaten. Tough to get to, but if you are in the Delaware Water Gap region along I-80 really worth the stop. To make things better, and as noted in the name, it is located right on a small lake, adding to the great atmosphere.

Besides the food, hanging around Manhattan has reminded me why I like to visit here for extended periods, especially during the late spring, early summer and early fall. Sitting in cafes, watching the VERY DIVERSE mix of people, listening to sounds ranging from car horns to horse hoofs (I am staying at a home located outside the horse path in Central Park) – all extremely satisfying and actually exciting. I guess when you are born in New York you retain that sense of belonging despite having lived elsewhere (and I have lived many elsewheres).

The Corona is almost done in and I will shift my locale to a coffee shop to work on that “catching up” stuff…

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Sunday, June 10, 2007

NYC Subway Saga....

This is the second week of my summer teaching adventure -- a "gig" at Baruch College that involves five weekly commutes to and from New York. Last week (the first) went so well that I was quickly lulled into the belief that things are really quite different (improved, that is) in public transport services in Boston, New York City and in between.

That judgment was challenged yesterday by the folks of the New York City subway system.

This was going to be (and still is) a special commute not only because it began on Saturday (I would normally head in on Mondays), but also because spouse Randi joined me so we can have an anniversary day dinner in Manhattan last night (39 years!) and then attend a family gathering in New Jersey today (an aunt is celebrating her 90th birthday at a restaurant operated by one of her grandkids... should be nice).

Traveling on weekends in the Northeast Corridor is not as convenient schedule-wise as during the week, especially for folks like us who begin our treks in the suburbs along the MBTACommuter Rail line. The Amtrak Regional we took left Back Bay Station at 150PM, and to play it safe that meant taking Commuter Rail train at 1030 into Boston. In hindsight we could have done that better, but as it was we more than a couple of hours to kill in Boston which we used to good effect by wandering around the malls in the Back Bay area (bags and all). The Amtrak ride was fine -- no real hangups and we were into Penn Station at 545PM.

And that is where it became a problem and this saga begins.

To get to the place we were staying on the upper west side we would usually have two or three choices. Randi wanted to take Broadway-7th Avenue line 1-2-3 trains, but I insisted on the 8th Avenue local C train that would put us several blocks closer to our destination.

By a little after 6PM, each of us with bags on our back as well as moderate size carry-ons in our arms, climbs the steps to where the Uptown C train is supposed to stop -- and there are signs on every post saying that for that day the C will run on the A-train (express) tracks, which means now schlepping ourselves and bags up and down some more steps. OK -- not too much of an inconvenience.

Standing on that express train platform, we kept watching as several E trains (they go to Queens) pulled in and out of the local platform. Nothing was happening on the express tracks -- nothing, not a C or an A. No announcements were made (even though you can hardly figure out what they are saying when they do make one -- the acoustics are terrible in those old stations). No one was around to give information or direct people one way or the other. By 630PM we did what others were starting doing -- moving back over to the local line where at least there was some train to catch heading in the right direction. Along the way I saw a transit employee slouching comfortably against the token booth outside the gates and asked about announcements, and she essentially shrugged but made no effort to be helpful or informative -- she hardly moved. (Ah, just like the old days of "I don't give a damn about customers" service..." -- not a good omen for Mr. Bloomberg's legacy).

As we approach the steps to the local line platform there is rumbling and dozens of folks who had been standing patiently on the express platform made a mad rush (literally) over to the local line. With bags on back we just walked, and still made it up there in time to see that it was indeed an A train that had stopped unannounced on the local track; and now it became evident that if we had any hope of catching a C train it was on this platform.

I situated us by the middle car stop location so I could at least speak with the so-called conductor (on NY subway trains it is a person who sits in a cubicle and opens and closes the doors). The first says all he knows is that there are many trains following him, so wait it out. Another A train follows, and another, and when a third comes in quick succession I ask if there are any Cs running and she says no -- but that her A train is supposedly to make all local stops (which would do the trick for us since that would put us at 86th Street and Central Park West).

We stay on through three or four stops and at 59th Street (Columbus Circle) we hear that same conductor announce that this was to be an express train that would have its next stop at 125th Street. We jump off the train and there stands (finally!) a transit employee giving directions. He tells us to either go to 125th and then take a local C back downtown to 86th (if we wanted to assume that the locals are running from 125th in that direction; but how could there be locals at that end if none are making them uptown?). Otherwise, he says, take the M10 bus uptown using the free transfer allowed on the Metrocard (NY allows for free transfers for two hours -- it was 7PM so we were still good for another 45 minutes....) Where is the M10 stop? Somewhere in the street, he tells me. (I don't think he was trying to be a smartass on purpose -- he just didn't know the answer...)

Up the steps we go and then I make the mistake of asking the person in the token booth about bus stops. "Where do you want to go?" (the standard response; they never answer a direct questions like "where is the M10 bus stop?"). "86th Street," I respond. "Take the 1-2-3 trains right over there" -- and she points to another train platform within seeing distance and lets us back in the platform area through a service gate. We go there and it is obvious that trains have not been running regularly here as well -- lots of people with that impatient "Where the hell is that train" air about them....

We decide to escape and take our chances above ground, and as soon as we emerge we are standing at the M10 bus stop. Sweaty, tired, a bit pissed, we wait as several non-M10 buses pass by -- and then finally the M10.

Now, a brief description of NYC street layouts. As you head north-south in Manhattan all streets (well, there are exceptions here and there, mainly along Broadway) are .5 miles in length -- 20 blocks to the mile. Which means that standing at 59th, we were only 1.5 miles from our destination. Should be a quick trip, right? Not really.

When M10 came, we boarded, and along the way we made stops to pick up and drop off people requiring special access (that is, the driver had to get out and operate the access equipment in the rear of the bus); in addition, we made most station stops as well as at about three-fourths of the traffic lights (which are also, I should note, located at each intersection -- each .5 miles -- along the route). In other words, it was not a quick mile and a half.

By the time we got off at 88th Street we were exhausted but at least more relaxed as we walked to our destination. A fast hello to our hosts (who were on their way out the door) and we headed off to a nice anniversary meal at a nice Turkish restaurant at 85th and Columbus -- and soon forgot about the previous three hours of transit torture in NYC.

Ah, New York!

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Friday, June 08, 2007

Confessions of a gillyspitkin!

Among the many things I am, I can now add the label "gillyspitkin"!

Starting on May 23 I began injecting lizard spit into my stomach twice daily -- once when I get up and then just before dinner.

"Lizard spit" is the term used by the blogosphere's "Byetta" community -- folks like me with Type 2 diabetes who have shifted from one medication to another over the years in an effort to avoid having to take insulin. It is called lizard spit because the basic "chemical" in exenatide (its generic name) is derived from the saliva of the Gila Monster. And so folks who take Byeta call themselves "gillyspitkins.

With all the news about Avandia, Actos, etc -- and with the growing numbers of folks suffering from this malady -- one ought to be a bit anxious about taking this new drug. There are, after all, side effects to consider.

There is, for example, the possibility of nausea and other "gastrointestinal" issues, but none have proven widespread or serious.

And since it is typically taken in conjunction with other meds intended to lower glucose levels (in my case, glipizide, a sulfonylurea class drug), there is the possibility of a hypoglycemic episode. (I had one last night when I took the injection too late -- that was a bummer....)

But then there is the most notable of side effects -- weight loss!

Yes, list among the side effects is the fact that in clinical trials those who took Byetta recorded a 2.3 kg weight loss over 26 weeks -- not much, in deed, except for the fact that almost every other type of diabetes medication generates weight gain -- or at least bloating (I can confirm all that!). What's more, most folks in the blogosphere report more substantial weight loss (others note the weight loss varies). This is a side effect that in fact works to make the diabetic healthier!

Which leads to the question: in what way is Byetta like Viagra?

For those who do not know the story of sildenafil (the generic name for Viagra), it was originally developed as a medication for treatment of hypertension and forms of angina (the legend is that it was actually being developed to stimulate hair growth). In any case, the participants in the field studies reported involuntary penile erections, and eventually the drug was patented to deal with male erectile dysfunction. The rest is history. (Which raises another question: do they prescribe Viagra for hypertension?)

Exendatide's weight loss capacity may end up doing the same for Byetta, although it is sure to retain it diabetes control purposes as well. There are reports of non-diabetics seeking prescriptions for the drug (see NYT article), and given it high safety scores (at least for now) we may have a real, honest-to-goodness way to counter obesity through medication.

The injection process is not that bad -- best place to insert the needle is in the flabby part of the stomach right above the waist (the "love handles"), although upper arm and thigh are also possible injection sites. The key to Byetta's effectiveness is timing -- you must eat within one hour of the injection, and never take it after eating. There is also a temperature factor, but as long as it is kept refrigerated before its first use -- and otherwise generally at room temperature -- all is a "go".

There does not seem to be a serious downside to this medication, although some bloggers report its effectiveness degenerates over time. Thus far, however, it has earned a reputation as a "monster drug" reflecting its derivation as well as its success for many....

We will see....

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Thursday, June 07, 2007

Acting on Actos....

At yesterday's House hearings on the ongoing "Avandia affair", the FDA commisisoner announced that stronger warning labels had been ordered for Avandia (see yesterday's post) and Actos (generically, pioglitazone). These are two of three drugs under the class of thiazolidinediones (we are really now regretting falling asleep in our high school chemistry class), the third being troglitazone which was taken off the market in 2000 for its link to increased risk of hepatitis.

Hmmmm. While I was rather gleeful that I had not really been taking Avandia all that long, I had been on Actos for quite awhile prior to the switch to Byetta (again, more on that later) and it was a bit of a surprise to hear that they are concerned enough about Actos to order the enhanced warnings as well.

As I recalled, back when it was first put on my list of medications, the studies were indicating that Actos actually reduced the risk of heart attacks -- and I believe that was the motivation for my GP prescribing it since I had already been through a cardio event. Looking it up on the web, I found that early study highlighted in a number of news stories -- back in 2005.

But in the interim, another meta-analysis of several studies was published indicating otherwise -- this time concluding that Actos may not only be riskier than the 2005 study indicated and may not be that effective in achieving the kind of blood glucose control that it was designed for. My sense is that the combination of the Avandia scandal and the relatively close "family" relationship between Actos and Avandia led them to extend the cautionary warnings to Actos.

I am typically pretty skeptical about administrative reforms promoted by members of Congress whenever something like this FDA story breaks - usually they are mere symbolic gestures that prove costly and unwise in the long term regardless of the impression they give that the problems are being solved. But watching this all play out at the FDA, I am now sympathetic to the idea (currently on the table in Congress) to create and/or empower a separate entity to deal with drug safety while leaving drug approval to the FDA. The mixture of the functional roles within the FDA clearly raises issues of accountability in the truest sense of that term, for there are distinct and contrasting interests to be served within this regulatory process.

Putting the two (approval and safety) in the same agency under one commissioner makes sense only to the extent that there is an agreement upfront as to which trumps the other. Up until this Avandia episode (and there have been others that have come to the surface), the recent "agreement" gave priority to the approval process over safety concerns. This is probably an artifact of both a move from the right to deregulate and pressure from the left to speed up the approval process in light of the HIV/AIDS epidemic. The resulting state of affairs altered a more cautious "safety first" perspective fostered by the infamous Thalidomide tragedy of the late 1950s and the congressional hearings and legislation that followed.

With that in mind, and given the uncertainties of any one specific study as well as the power of the pharmaceutical industry, it may be best to spin off the safety unit into an autonomous agency where the sense of administrative responsibility is clearer and less subject to overrulings and reprimands for doing their job. It is interesting that the folks heading the agency do not regard it as a structural issues, but rather one of improving communication with the public. Either they don't get it or I don't get it.....

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Wednesday, June 06, 2007

Glaxo's pain, my gain....

The postings on this blog have typically been mostly about my obsession with two things -- accountability and life in general (that pretty much covers it, I guess).

Well, as it happens this AM's New York Times has a story that brings together both my personal and scholarly obsessions.

The story is about various issues surrounding testing for the drug Avandia, a medication prescribed for folks like me with Type 2 diabetes.

At the heart of the controversy (no pun intended) is the online publication on May 21 of a metaanalysis study indicating Avandia (generically rosiglitazone) was associated with a 43% increase in the risk of heart attacks by its users in the study groups (that is, their "risk ratio" as study participants was 1.43). This generated all sorts of reactions. The FDA issued a warning and had to respond to many questions about what it knew, when it knew it, and why it did not take action earlier. Many of the reported several million who take the drug were told to consult their physicians (that certainly must have tied up the phone lines) and there were reports that a good many of those patients involved in an ongoing study being conducted by Avandia's manufacturer, GlaxoSmithKline (GSK), were withdrawing. Of course a congressional hearing was called for today (not the first time for the FDA), and that has brought the controversy up a level or two....

In addition to posting all sorts of information on its Avandia web site and elsewhere, GSK took out large adverts in major papers on Tuesday expressing its confidence in Avandia and its commitment to the safety of the drug, and later in the day a preliminary analysis of the ongoing study was published online which highlighted that (thus far) fewer people in the Avandia group had died from cardiovascular problems than among the non-Avandia taking group (btw, they were on a regimen of other medications).

According to the Times article, the New England Journal of Medicine published three "editorials" (here and here and here) along with this more favorable piece, one noting that the number of cardiovascular events (not merely deaths) was actually slightly more among the Avandia group. (It is noted that none of the numbers rise to the level of statistical significance and thus nothing is proven one way or the other to this point; the study -- if they can keep folks from fleeing -- still has another year to go...).

Adding fuel to the controversy is the claim by an FDA supervisor (noted in the Times article) that she was overruled and rebuked for issuing a recommendation last year that the warning label on Avandia ought to be strengthened in light of what her office's analysis of the available research. Quoted directly in the Times, she is also going to appear before the Senate committee today.

Obviously this stuff has accountability issues written all over it, and I would be more gleeful if it wasn't for the fact that I was into my second month of Avandia on May 21 when the story first broke....

My attempt to live with Type 2 started a decade ago when I was first diagnosed, and like the millions of others who have the same "late onset" version I have been through a variety of regimens to control this malady. I was doing pretty well in terms of controlling the symptoms until a few months ago when I began to feel that things were not quite right (as documented in some of my earlier "personal" posts). Finally I asked my GP, and he set me up with an endocrinologist who, in February, started to get me back on track.

First thing she suggested was a switch in medication -- initially to Glocuphage (metformin), a medication I recall having taken years ago which (I was soon reminded) did not quite agree with my digestive system. Another switch followed -- to Avandia as it turns out, although at the time she thought it probably won't do the trick given my indications of problems. But given the next possible option -- Byetta, which would have to be injected twice a day -- she thought we would see how this worked.

Monitoring my blood sugar carefully, I noticed that the numbers with Avandia were actually up about fifty notches initially, although things started to settle down over a couple of weeks time. Still, she thought the Byetta was definitely now the best option -- so we set an appointment for May 22 when she would brief me on how to take this new medication.

Thus, while others were dialing in to their doctors to get off Avandia after the May 21 news reports hit, I was already set to do so the next day for entirely unrelated reasons. I began the Byetta regimen on May 23 (which relates to another story about weight loss that I will post at some point) and moved to the sidelines as observer of the tribulations surrounding Avandia.

But while my personal connection with the Avandia episode is over, my scholarly interest is deepened by recnet events. What a great case study for insights into our complex system of accountability -- formal and informal, official and unofficial, scientific and political. Great stuff, and a further confirmation that accountability is not merely something we aspire to in governance, but is actually a fundamental (and I would argue, defining) characteristic of modern governance in all its forms (i.e., public, private, social, etc).

So while personally I am relieved to be off Avandia, professionally I am thrilled that its widespread use is stirring such consternation. Mixed emotions, indeed!

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Re-birth, New York City style...

More about my Tuesday in New York.

After a bit of a rest and reading, I took off on my major errand for the day -- to get a copy of my birth certificate.

I was dreading having to do this, but the fact is I have misplaced my passport and cannot find my birth certificate among the piles of papers and boxes that I call my office. (More than likely the passport will eventually be found right next to the birth certificate....)

Looking up the relevant information on the web, I saw that I had many options (internet, fax, mail-in, etc.) for obtaining the copy -- most involving $30 plus handling stuff and two weeks or more; or $45-60 for expedited processing which would take a week. Lots of options, and a good deal of work downloading and filling out forms, scanning other documents related to proving who I am, etc.

But then I saw one option that said "walk in service", and when I read the details it all seemed so simple. As someone born in a borough of the City of New York (I was born in Brooklyn, officially Kings County) after 1910 all I had to do was go to 125 Worth Street, Room 133, pay $15, show my driver's license, and voila, I'd have a copy of my birth certificate.

And of course I imagined that the reality would be a lot worse. I would go there, stand on a long line, fill out lots of forms, wait hours to get to the right window where they would take my money and tell me to come back in a few hours or tomorrow to pick up the official copy....

Oh, me of little faith -- oh, me who teaches about this stuff, and tries to explain to students (with fingers crossed) that bureaucracy is really getting better, and that all that BS about inefficiency and incompetence is just myth (if you think I am kidding, read what I write in chapter 12 of the American Government textbook....).

Well, I guess I had it coming -- it really was a smooth and efficient process. In fact, the biggest problem I had was figuring out how to get to 125 Worth Street (despite good directions from a knowledgeable source).

The web site for the New York City Department of Health and Mental Hygiene (the keeper of such records for the City) did recommend the best hours to be early morning and between 3 and 4:30 in the afternoon, so I timed my errand to reach the office at 3 (I always factor in getting lost...). I was already convinced things were not going to go well when I got to the front door of 125 Worth Street and saw a sign that said this was not a public entrance -- and I should enter from the side street. "Here we go," I thought, and proceeded to take the Centre Street entrance which, as it turns out, put me two or three steps from Room 133 once I got passed the security check point. Peering into the room I saw a line and, once again, thought things were not going to go smoothly.

First hurdle is a women sitting at a desk who asked what kind of business you had there (they deal with marriage certificates, newborn birth certificates, name change documentation, etc.). She handed me a form which was pretty simple -- name, mother's maiden name, father's name, place of birth, etc. Hmmm - all too simple.

Then I get on the line which was not quite as long as it seemed from the doorway. Three or four of six windows were handling folks, and so it did not take long to move up. Surely, I thought, this is probably just the first stop -- hand in the form and go to room 1334, I thought; pay your $15 there and and go somewhere else to wait, or come back later, or....whatever.

And so I get to the window, hand over my form, show my Massachusetts driver's license, hand over $15 when requested, watch as the women behind the window scribbles some things on the form (and on the money as well -- that was strange), and waited for the other shoe to drop.

But what she did was reach under the shelf to her side where a printer had been working its magic and -- voila, indeed! -- a really quite official looking copy of my birth certificate was slipped into my hands along with an envelop to put it in and a receipt. That's it.... Next!

The transaction at the window took no more than three minutes, tops! And when you calculate another ten minutes (tops!) waiting on line... Well, all I can say is that I was impressed, and bravo to the folks at Room 133 at 125 Worth Street near City Hall.

But before I get to carried away I remember that I now to deal with the ten weeks (that is the rumor) it takes to get my new passport....


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