THCB

Categories

Above the Fold

PHARMA/POLICY: Was Plan B Crawford’s ‘Plan B’ for Commissioner?

Ex-FDAer Robert Steeves has this fascinating look at how Lester Crawford made it to the FDA Commissioner’s office despite being largely responsible for the FDA’s lack of activity and failed response to the COX-2 acopalypse. This is a re-print from FDAweb, which I would encourage you to  subscribe to (although it’s not cheap so it’s probably best if someone else is picking up the tab!)  Thanks to FDA Web publisher Jim Dickinson for permission.  As you might suspect with this Administration, it looks like political payoffs have triumphed over scientific integrity and commonsense

Looks like the true story of Lester
Crawford’s apparent triumph over conventional wisdom may be seeping out —
the only way most delicate information can get out of FDA. And it looks like a
good, old fashioned, political payoff. There are just too many “firsts” and too
many Plan B’s here to ignore.

Consider the emerging scenario as
follows:

In 2002, the White House considers Crawford for commissioner
and backs off for reasons never explained. Perhaps someone discovers that in
1985 the House Committee on Government Operations unanimously found that
then-CVM director Crawford “actually fostered the illegal marketing of
unapproved drugs,” failed to discourage the illegal use of drugs that tainted
the milk supply, failed to remove drugs from the market that had been proven
unsafe and approved drugs that his staff members suspected were carcinogenic.
Significantly, the committee found Crawford had disbanded an independent drug
safety group for humans within his Center because, as he then stated, “it is now
our job to approve drugs.” Internal reports warned that this move would
undermine safety concerns, hearings found.

Apparently concluding that Crawford could not be confirmed as FDA
commissioner in 2002, the White House instead names him deputy commissioner,
which many assume means de facto commissioner because popular wisdom is, and I
agree, that no nominee will be put up for confirmation to the top job. It makes
good sense — Senator Edward Kennedy,
the ranking Democrat on the Senate HELP Committee, has been threatening to
vigorously oppose any candidate with prior industry ties, and so placing
Crawford in a post not requiring confirmation avoids that obstacle without
changing substance. Anyway, FDA has no raging controversies and there are more
important issues facing the White House.

But FDA constituencies begin a steady drumbeat for a “permanent” FDA commissioner and
along comes Mark McClellan, a
physician with a business degree too, already serving in a presidentially
appointed and confirmed post, and he zips through the confirmation process but
sticks around for only 10 months before moving off to the Center for Medicare
and Medicaid Services. So, back to “Plan B” (leave Crawford as deputy and make
him the acting commissioner again.

Fast-forward to 2004 and the White House is looking at the potential of a
tough reelection race for the president, and there is unrest among the religious
and conservative base that Bush is not being sufficiently sensitive to their
concerns. Just when he needs least, Barr Laboratories provokes the
conservative/religious base with an NDA for an over-the-counter alleged
instant-abortion “morning after” pill, Plan B.

The nCDER review staff’s recommendation is favorable, the advisory committee agrees
23 to 4 and the decision gets kicked up a notch. CDER director Steven Galson “consults” with the Office of the Commissioner, FDA’s command center for political inputs. Why does
he do this, if as everyone later insists, the decision on Plan B is “purely
scientific” with no political considerations? He comes away from the
consultation and decides not to approve Plan B, saving the day for the White
House, intentionally or not.

To soften the blow for Barr, Galson suggests more “scientific” studies on the
“complex” question of how to assure that girls under 16 (not previously studied)
might handle Plan B and how to prevent them buying it if were available OTC.
Nobody but the religious far-right buys this subterfuge and political flak from
liberals gets into high gear as the election nears.

Meanwhile, the Vioxx withdrawal, the winter flu vaccine debacle,
whistleblower David Graham, and
associated pressures turn up even more heat on the White House for putting in a
permanent commissioner. Assessments on who the White House will nominate
universally discount him because he’s been the one in charge when the
controversies exploded, and because he has been passed over by the White House
before as being too provocative to the Kennedy crowd — notwithstanding the loyal
endorsement of his original champion, then HHS secretary and White House ally Tommy Thompson, or the rapidly
deteriorating situation at FDA under his management.

Wrong!!! Conventional wisdom forgets the “Plan B” political chit still
outstanding. When the president and the White House needed a “signal event” to
shore up the conservative base in the election campaign, who took the risk of
standing against the CDER drug review staff and the advisory committee’s
provocative recommendation — the first FDA head to do so that I can recall — and
save the day with the conservative base?
This is the scenario that is in the air. All the pieces make sense now and only if you
use all of these pieces. You do not have to have the political insights of a Karl Rove to put this together, but he might be a key witness in getting to the bottom of this.
When chairman Mike Enzi
reconvenes his Senate HELP Committee this week to examine the “unique and
confidential complexities” of Plan B, it ought be an open hearing, with sworn
witnesses.

What can be so secret about these machinations? To the extent that
there might be some trade secrets to protect, Barr CEO and chairman Bruce L. Downey — whose company surely has little to thank the Bush Administration for in this episode, given the profits lost by Plan B’s much-delayed launch — might waive any objections or
assertion of confidentiality, to permit the questions and explanations to be in
an open forum, especially if the witnesses risk perjury for false or misleading
statements. Mr. Downey has shown himself to be an innovative leader in the past
and he, too, might want to have this issue put to rest.
Is Plan B Crawford’s own “Plan B” route to the post that he lost in 2002 and that
conventional wisdom was sure he would otherwise have been denied? The Bush White
House values nothing higher than this kind of loyalty.

Neither science nor common sense can suggest any better explanation for this series of
decisions.

POLICY: Klepper on Porter

• 1

I’ve been in a healthy dialog with Brian Klepper and Pat Salber from the Center for Practical Health Reform in the last few weeks.  While I don’t agree with everything in their analysis, we have huge areas of common ground, and one part of that is in their view of Michael Porter’s thesis.  I wrote about this in THCB last year.  Here’s Brian Klepper’s response to Porter’s article.

A colleague recently commented on the similarities between CPHR’s work, and
Michael Porter’s and Elizabeth Teisberg’s recent Harvard Business Review article
on health care market competition. That led to the question of whether I had
contributed to their article. The question was passed to me, along with an
invitation to comment.
I rarely pass up such juicy invitations. Here’s
the short answer.

I did not contribute to the Porter/Teisberg piece. Michael
Porter is a well-established and highly respected thinker on markets. I have a
presentation with similar content he made a couple years ago; it’s clear he’s
been working on these health care concepts for a while.
But there’s more. When I read this new piece a few weeks ago, I had two thoughts.

One was that the article is a well thought through and accurate description of health
care’s two deepest problems: high fragmentation and a lack of systemic
management capability. In Porter’s and Teisberg’s zero-sum competition
framework, financial success is achieved more often through cost-shifting or
service reductions than efficiencies, and while organizations may benefit, the
larger enterprise rarely saves. In my work, I have described the same
circumstances, noting that in the highly fragmented HC marketplace, literally
thousands of organizations and millions of professionals pursue their
self-interests independent of their impacts on the whole. Fragmentation also
produces political gridlock that blocks change, because every potentially
positive reform gores somebody’s ox, and many groups have the power to kill any
proposal.

In the same vein, Porter/Teisberg talk in depth about the lack of the right
information in the right hands at the right time, and how that hinders the
ability of the health care marketplace to work properly and in everyone’s
interest. This, of course, restates the classic point made by the famous
economist Adam Smith, who said that markets can not work without perfect
information. CPHR has also relied on that point in its call for "standardized
management capability" in 4 areas: 1)universally compatible IT (which is the
predicate for systemic efficiencies), 2) standards (in the forms of
evidence-based medicine and management), 3) accountability/transparency at every
level of the system, and 4) technology assessment before innovations reach the
market and we begin to pay for them.

In
other words, my first thought was that Porter/Teisberg offer an insightful
explication of the system’s structural flaws. While they don’t really talk in
depth about current impacts, those flaws now appear to be effecting a
contraction in the health care economy that is unrelated to normal business
cycles.

But I differ with Drs. Porter and Teisberg on how we can effect
the changes that are so essential to improving competitiveness and fortifying
market stability. They offer a range of solutions, some of which mirror the
ideas our group has settled on (e.g., Transparency, A Minimum List of Coverage
Benefits), and others that are far more specific to certain industry sectors
(e.g., Simplified Billing, Non-Discriminatory Insurance Underwriting). In any
case, the authors appear to believe that once market players recognize the harm
caused by current dynamics, they will migrate to their solutions (or variations
on them). This, in turn, will improve competitiveness and bring the system back
to homeostasis. To me, this betrays two basic misunderstandings: one relates to
the trajectory of the current crisis, and the other to how power
works.

As a practical matter, we have come to believe that corporations
are the primary influencers of change in 21st Century America, and that health
care’s solutions lie at the convergence of the special and public interests. As
long as the system remains "normal" and unchanged, the traditional reform ideals
that Drs. Porter and Teisberg call for will be systematically blocked. For
example, employers will likely not buy into universal coverage if they believe
they’ll have to pay for it and if the cost continues to spiral up at seven times
general inflation. Health plans, physicians and hospitals will not likely agree
to transparency and performance accountability, for good and not-so-good reasons
associated with liability, exposure and profitability.

So if we want overcome gridlock and galvanize disparate interests toward a common vision of
change, a common value proposition is necessary. We must find something that
everyone, independent of perspective or special interest, can agree on and buy
into. And that agreement must be on something so powerful (and almost certainly,
alarming), that organizations will be willing to compromise their current
circumstances to achieve it.

We believe that value proposition is this. We are now witnessing a series of linked, rapidly intensifying economic phenomena that threaten the industry and the national economy. Porter and
Teisberg’s zero sum competition has generated a cost explosion that has driven
premium, where all cost converges, beyond a threshold of affordability for an
increasing percentage of individual, corporate and governmental purchasers.
(There’s lots of very compelling evidence for this, which I’ll be glad to
forward if anyone’s interested.) The shrinking commitment to coverage has
translated to an erosion of premium (masked by premium inflation), which in turn
constitutes a reduction in the total funds available to buy health care products
and services. This economic contraction could ultimately result in market
instability, the most feared of all market states, because in an environment of
significantly reduced resources and increasing demand, commerce grinds to a
halt. And that’s the thing that nobody wants to happen. Nobody wants health care
and its associated commerce to become immobilized.

And if health care,
the economy’s largest sector with 1 dollar in 7 and 1 job in 11, is disrupted,
then the chaos will almost certainly cascade to the larger US economy.

In recent months, CPHR has had many discussions with influential organizations
throughout health care and the broader business sector that have become
increasingly aware of the threat to corporate interests represented by impending
health care market instability. They have bought into the common value
proposition that instability must be averted, and they have agreed that our (and
to a large degree, Porter’s and Teisberg’s) principle set – informed
decision-making, universal basic coverage, and health care liability reform –
represents a narrowly defined set of structural (rather than philosophical)
principles that everyone in the system can abide, if they recognize that the
alternative is market instability.

In other words, the impetus for health care reform, in our view, is common self-interested buy-in by the nation’s most influential groups to the very severe threat posed by the economic implications
of current system flaws. The task then becomes mobilizing and positioning to
effect optimally positive change at the moment when the environment becomes
receptive to it.

To me, understanding health care’s current problems and
identifying solutions is not the hard part of the problem. Lots of people
seasoned in the industry have done this: The Institute of Medicine, Paul
Ellwood’s Jackson Hole Group, Dr. George Lundberg, the National Coalition on
Health Care (in the report they released last week), and so on. The harder part
is effecting change in a highly fragmented environment dominated by opposing
powerful interests. In my view, Dr. Porter and Teisberg handled the first part
very well but glossed over the latter part. Once CPHR became convinced that its
principles for change were refined and correct, we focused hardest on the latter
part, because that is the key to effectiveness, to the translation from idea to
action.

One last point. Drs. Porter and Teisberg really call for reform
that is based entirely on market-based solutions. They don’t frame their
solutions in terms of regulatory changes that can guide accelerated solutions
toward, for example, national standards (e.g., for IT compatibility, publicly
available performance information, minimum coverage) or rules of redress (in the
case of medical malpractice). In other words, they believe that organizations
will, on their own, execute programming that will be sufficient to resolve our
current problems and save the system.

We are less optimistic. Our argument would be that, at its heart, public policy should serve two important
purposes. First, it should protect the public from the overreaching grasp of
special interests (e.g., Enron). Second, in times of crisis, it should
facilitate a course correction that can save the system. Left to its own
devices, there is little evidence that the health care marketplace has the
organizational capability to effect enterprise-wide change that can avert market
instability. While new programs and tools (e.g., Disease Management,
Claims-Based Population-Level Management Tools, Patient-Decision Support Tools)
have the capacity to vastly improve our operations and effect savings, the
adjustments necessary to save America’s market-based health system require rapid
and pervasive implementation. This is one of those cases when the market simply
can’t do the job by itself. We need policy adjustment too.

BLOGS: THCB sells out!

• 3

Well not exactly, but I have taken a first tippy-toe in the commercial water by putting Google Ads down in the left column. No idea how it’ll play out but maybe I’ll cover some of my costs. Because of the nature of the program I have no control over the ads in it. Let me know what you think, and of course I’ll be reviewing it to see how it goes.  If you are interested in advertising/sponsoring the site, please let me know. (But I’m not expecting to get rich off this!)

Meanwhile, all of the back posts moved over from the old site have now been indexed into their correct category (doing that was a mind-numbing but  necessary task!).  So you should be able to see all the posts in a category that you’re interested in by clicking on the category in the left hand column.

HEALTH PLANS: Kaiser/Gadfly update, Fri, with early afternoon UPDATE

• 1

So today brings a couple of new wrinkles to the KP story.  First, following the initial meeting with the Judge after KP looked for an injunction asking the Gadfly take down the site which allegedly holds the 140 patients’ data, according to her version of events, the Gadfly voluntarily acceded to a request from the Judge to take the site down while the case was being decided.
Nonetheless, the Department of Managed Healthcare, which has basically been acting as a lap-dog to for-profit health plans since  Arnie became Governor, decided to intervene by issuing a press release this evening  giving the Gadfly 15 days to take the site down. Given that a judge will be ruling on this within seven days you’d think that the DMHC would have better things to do with its time, like ignoring the potential damage to the state by the local Blue’s licensee becoming part of a major monopoly and having its executives becoming gazillionaires in the process–luckily insurance Commissioner Garamendi was at least partially awake to that last year, even if he too was easily bought off in the end.

Still while the grandstanding by the DMHC is not particularly impressive,  in the press release they also seem to be stating that they are also investigating to see whether KP was guilty of posting this information before the Gadfly did. If they really are dong that, then this whole incident still has the possibility of hurting KP legally and reputation-wise, and it at the least gives the Gadlfy another venue in which to make her feelings about Kaiser known.  Although it’s probably at this stage pointless for me to say this again, KP would have been much better off if it had calmly and quietly dealt with the Gadfly’s complaints about her firing.

So what happened there?  Well there’s no sure way to know.  The Gadfly has put the long explanation of her version on her web-site. It appears that she got caught in a political infight between two managers, and then in attempting to get out of that problem, made a misstep which somehow signaled to their manager that KP would be better off getting rid of her, despite her work performance, which apparently seems to have been good.  But KP is known for being pretty political internally so I’m inclined to believe that there were things going on that were beyond the Gadlfy’s control. I’m also personally a believer in a greater level of trust and honesty being shown between employer and employee, and having seen a copy of the final termination letter from HR at KP, it’s clear that they at the least acknowledge that her version of events didn’t  square with that of her managers’. Now she was within her probationary period, and California is an
at-will employment state which means that anyone can be fired for any
reason at any time, but you’d hope two things.

One, that KP would have the decency to get to the bottom of this, including having a fair internal review process. Two, realizing that this firing put the Gadfly’s life into a tailspin and made her a KP enemy for life, you’d hope that KP would look to find a sensible way to settle the problem rather than ignoring her efforts and seeing her get all the more desperate and dangerous to their public reputation (not to mention having her dump the cost of her health problems on the goodwill of non-Kaiser providers and the taxpayer).

There’s even a bizarre twist that, according to the Gadly in order to get Kaiser’s attention, she tried to post some other Kaiser documents — not apparently the ones in dispute in this round of the story — on eBay. Although apparently nothing ever came of it,

Quite where all this goes I don’t know, but I suspect that the downside for the Gadfly is modest, as she’s clearly at the bottom and at the end of her rope and so has nothing to lose. The outcome for KP is probably modest too, but there’s a wildcard that this whole affair may become a bigger distraction than they’d like, and even that some genuine complaints are raised over their handling of patient data which might even result in penalties.

Somehow you have to feel that this could have been headed off at the pass if the Gadfly had been given a different assignment within Kaiser, or even a half-decent exit interview.

UPDATE: Over on her Corporate Ethics site the Gadfly details her problems with the DMHC which she claims failed to interview a doctor involved in her complaint about care she received when she was a Kaiser member and closed the complaint, and also that the DMHC seems to believe that she put the original site up.  She has continually stressed that she found the data online several months after she left Kaiser and never had access to it when she was there. The original site was taken down several days after this story was first featured in THCB in September 2004, but the Gadfly’s mirror stayed up. I cannot believe that the Gadfly was sneaky enough to steal the documents, stick the original site up, and then mirror it and take it down.  Much more likely, KP found out about the original error by their staff or consultants via the THCB posting and took it down themselves. (I have several Kaiser contacts and I know some of them read THCB). Obviously mistakes happen, and given the complexity of finding the patient data in those diagrams (I looked quite hard and I never saw any!) and the relatively few people who paid this any attention till this week, it seems like relatively little harm was done.  But KP should be trying to blame the original breach on the Gadfly if it’s not her fault. 

And as I’ve said for the nth time, there had to be better ways of dealing with this….

 

PHYSICIANS/QUALITY: Now it’s smoking too many old doctors kills you, by The Industry Veteran

• 3

A recent study instead of looking at specialists versus generalists showed that there’s a strong correlation that the older physicians get — and the further away from medical school — the worse the outcomes for their patients. While you may see this as an inevitability or a trick of the data, The Industry Veteran suggests that there are more malevolent factors at work:

My clients are blithely perceiving this news as confirmation of the admonition from Marketing 101 that they should segment physicians by age in addition to their usual criteria of specialty, Rx writing volume, current product preferences and so forth.  By contrast I perceive the news in a more dour fashion, taking it as further confirmation of the medical profession’s malevolence. Organized medicine’s failure to institute and enforce rigorous standards of continuing medical education is a menace to public health. Their failure reflects all pernicious elements of the guild mentality and the sense of entitlement that we perpetually see in physicians. Once they have completed that residency, they are as regents of the kingdom, set loose upon a defenseless public.  The fact that the profession exempts its practitioners from self-funded CME requirements virtually invites some of the worst excesses of pharmaceutical and other manufacturers. The companies provide continuing education programs that just happen to serve as promotional platforms for their respective products.  The added incentive of these company sponsored programs also providing mini-vacations for physicians and their families/mistresses is a mere incidental. Perhaps George Bernard Shaw used a bit of hyperbole in saying that every profession is a conspiracy against the public, but his language is a strict, empirical description of reality in medicine.

HEALTH PLANS: Kaiser Gadfly update

For those of you following along at home….

Today Kaiser sought an injunction against the Gadlfy asking her to take down the web site that supposedly contains the confidential information.  The Gadfly has just emailed me telling me that the judge did not grant that order, but instead set a hearing for next week.

POLICY/PHYSICIANS: Smoking too many specialists will kill you

• 1

Health Affairs is out with one of its fun articles looking at the physician labor force. Here’s the press release which basically explains that on a county level  and controlling for a bunch of other confounding variables (like race, income, etc), places with more specialists have higher mortality rates than those that have relatively more primary care doctors.  Here’s the full article from Johns Hopkins’ workforce specialist Barbara Starfield.

There are also some follow up articles with commentary. One by David Goodman, another of those socialist reprobates at the Dartmouth School who’ve been causing trouble in this arena for a long time, asks that given that we test the health impacts of every drug on the market extensively based on studies, why don’t we similarly seem to care in any empirical way about the health impacts of our structuring of the physician workforce? To be fair he does point out some limitations of the county-based study (e.g.. in California, Los Angeles county is huge, Placer County is not), but overall he thinks that COGME and others backing physician (and specialist) workforce expansion should do more to justify themselves.

The group from the Robert Graham Center in Washington DC point out the relatively obvious–specialists make (and generate) more money for themselves and the economy, and therefore you can argue that the creation of a specialist is better for overall economic growth than that of a generalist. I think their tongue is firmly wedged in their cheek, but surely a bright economist in the THCB reader corps can remind us of the "products versus services" argument from Econ 101–after all as it said in the Hitchhikers Guide to the Galaxy, the telephone sanitizers aren’t that productively useful no matter how much they get paid. (Until of course the civilization dies out from a disease caught off a dirty telephone)

Finally Edward Salsberg is director of the Center for Physicians Workforce
Studies at the Association of American
Medical Colleges. In other words he represents the
status quo of the current residency and training environment. He
thinks that any number of factors but not necessarily an "excess" of
specialists are to blame for this mortality differential, and that we should reorganize the system to better integrate PCPs and specialists. Somehow I suspect that by "reform" he doesn’t mean getting rid of specialists or reducing the residency places provided for them and the money the taxpayer provides to the AAMC members for those places!

Let’s all be real for a moment. Every doctor with a quarter of a
brain who is going through the hassle of med school and residency
realizes that for a couple more years in fellowship they can double or
triple their salary if they reject pediatrics and general practice and
head to orthopedic surgery or diagnostic radiology. Even with the
downturn in some specialist’s income in some parts of the country in
the 1990s that’s still the case as this list  shows. So the demand for those residency
slots is high.

Furthermore because specialists can create their own demand (see
Fuchs et al ad nauseam for this) and we have in a system where payers
are prepared to stick in 15% more money each year apparently ad infinitum, there’s no real incentive for
the specialists themselves to limit their own numbers. And of course
the government is paying, and paying alot, to subsidize those
residency slots (at least $22,350 per slot per year), and the US government will almost always do what its
interest groups, in this case medical schools, AMCs and their students, want.
In other countries, the money available for specialty care is centrally
limited, and so the specialists are happy that their supply is limited,
so they and the government are happy to keep those specialist residency
slots down.

The current Administration is unwilling to take on the AMA, or the specialty societies over physician income, or the AAMC over residency slots, or today’s medical students and their families who want their son to be the highly-paid sub-specialist. And it would also be unwise for the Administration to take them on directly given that it has no real reason to care much about the overall state of the physician workforce compared to the myriad other things wrong with the health care system that it blithely ignores. So the top down approach of limiting residency slots is not going to happen.

So I’m left with two questions. First, does this have any minor impact on the whole pay for performance notion?  And can Medicare start thinking about this "impact of specialty mix on outcome measure" as something that far down the road it might think of "rewarding", in order to have a very, very long term impact on specialty mix. Second, if the answer is no, as I’m sure it is, why does Health Affairs keep on pissing into the wind by printing this stuff, if no one is going to take a blind bit of notice!

 

 

HEALTH PLANS: Kaiser patient data release spat update

• 2

Sigh.  Well KP, an organization that (I repeat) I have much respect for, is not taking my advice in the tawdry little business of whether they or the Gadfly released patient data onto the Internet. If you go to the Gadfly’s website you’ll see both that she has received a notice from Kaiser’s lawyers about an impending court date which presumably will order her to take her mirror site down (something that should please Kaiser), and has requests from two more journalists for interviews (something that probably won’t please Kaiser).

Can calmer heads prevail here? Are there any on either side?

BLOGS/QUALITY: More ego surfing–me on DM in Pharma Executive

Just in case you missed it, Pharmaceutical Executive interviewed me about a whole range of stuff. Out of that they chose some allegedly wise words I had about Disease Management and EMRs in a feature in the February issue. Interestingly enough they were a little dubious about my statements (that didn’t make it into print) about the coming reduction in the salesforce workforce, and that was a couple of weeks before Pfizer said it was canning 30% of its salesforce.

 

assetto corsa mods