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QUALITY: Wennberg’s Dartmouth team shows enormous variation even in the “best hospitals”

More just astonishing research from Wennberg and his team. The latest study shows that whatever the US News and World Report’s ranking of a hospital, some top centers do lots more to a patient close to the end of life than others. In other words the immense practice variation that Wennberg unveiled in the early 1970s continues, even within the elite hospitals in the nation.

And the differences within this elite group are very large. To get a quick summary look at the this AP story. For example, at Mt Sinai in New York LOS was twice that of the Mayo Clinic, while at Cedars-Sinai in Los Angeles, sick patients stayed in the ICU three times as long as at the Mass General in Boston. There’s much more in the full article in Health Affairs. Something is clearly wrong when the best medicine in America is so different from the best medicine in America.

Another article from part of the same Dartmouth group (led by Elliott Fisher, and including Jack’s son David Wennberg) looks at the impact of ICU services in those same elite hospitals on patient outcomes, and it comes up with this pretty stunning conclusion:

Major U.S. AMCs differ dramatically in the overall intensity of services they provide to similar patients. The increased intensity does not appear to be associated with higher quality of care or to result in better survival. Patients in the higher-intensity hospitals simply spend more time in the hospital and intensive care unit (ICU); have more frequent physician visits (especially in the inpatient setting); have more specialists involved in their care; and receive more imaging services, diagnostic testing, and minor (but not major) procedures. The similar results achieved with markedly different levels of resource inputs imply large differences in the longitudinal efficiency of chronic disease care across these hospitals.

Given that they are handing out Nobel prizes at this time of year, is there a more important body of work in economics that has yet to be recognized? In case you wondered, here’s a list of Nobel prize winners in Economics and even though his formal training wasn’t in economics, I think Wennberg would fit right in with this group.

PHARMA: Marcia Angell rips big Pharma a new one

So Marcia Angell’s talk at the commonwealth Club was all that I expected. She is witty and charming and she really laid into big Pharma. Big pharma to her has no redeeming qualities. Everything they do is wrong and all they do is run biased clinical trials, and pay off the doctors (majority) and the politicians (minorly). A review of her book in the NEJM(BTW you can go to BugmeNot to break into these password protected sites, shh!!) from a Canadian Medical Association doc echoes her points, even though rational people (i.e. me) think that she was a little over the top.

I hope that there is a middle ground. Drugs save huge amounts of other health care costs and they do keep people alive who would otherwise be dead. If you read on in the review you get to this passage.

Angell’s concluding chapter, the least convincing one in an otherwise fascinating and penetrating book, contains the solutions, all of them predictable (and probably unattainable): control me-too drugs, re-empower the FDA, oversee Big Pharma’s clinical research, curb patent length and abuse, keep Big Pharma out of medical education, make company financial statements transparent (so we can tell what the costs of research really are, as distinct from marketing), and impose price controls or guidelines. Granted, the problems are so prevalent and the corporate tentacles so entwined with our way of being that it is hard to see what else to recommend.

But perhaps Angell is right. We must change the way we manage research and the development and distribution of new drugs. Not only are health and health care at risk, but so are the research enterprise and the reputations of universities and governments. The integrity of scientific research is too important to be left to the invisible hand of the marketplace.

The problem is that this logically leads to the idea that the only solution is heavy government regulation or even the total nationalization of the pharma business. Realistically, that’s not going to happen. So if you go to that extreme, all you can expect from pharma is a circling of the wagons and an attempt to keep paying off their servants in Congress and the Administration.

There needs to be a middle way, and I gave some ideas earlier this week about what that looks like. I don’t think Angell’s approach will get us there, even if 90% of what she says is true.

HOSPITALS: A southern hospitals CEO roundtable, with UPDATE

“Tennessee, Tennessee, there ain’t no place I’d rather be” sang the Greatful Dead back in the day. Why that bunch of stoned hippies wanted to go 1,500 miles away from the good stuff from Humboldt I’ll never know, but Knoxville, Tennessee is a very typical second-tier American town with typical hospital issues. And what are those issues? Well the Knoxville News Senitnel had a CEO Roundtable to tell y’all.

No prizes for guessing them, and they are a fair reflection of the state of the nation’s hospitals.

A. We need more money from the government and everyone else.
B. We have too many uninsured patients and they won’t go away.
C. We can’t get enough nurses and other staff.
D. This new IT is very expensive and no one will let us charge for it.
E. We like our gentlemanly southern ways and we really hope that no specialty hospitals comes to town to break up all this gentility. Cos then we’d get mad.
F. And if you build too many new hospitals too quickly and can’t fill them, you’re going to lose money

UPDATE: Hope Morrison from the Appalachia Alumni blog informs me that I am “unaware that there’s a Humboldt in Tennessee. I know because I spent about half of my formative years a stone’s throw away from there, in Jackson.” Of course with the Dead that might well have been a “stoner’s” throw away.

Which reminds me… Ian McLagan, keyboard player of legendary English bands The Small Faces and The Faces and later perennial sidesman with The Rolling Stones tells that the story of when he was offered him a gig touring with the Dead at $300K a year. He was excited as he was down on his financial luck and he asked for a tape as he didn’t know their stuff. He told the interviewer: “it was such a pity. I couldn’t play with them because I thought their music was bloody awful!”

PHARMA: Reimportation, corporate villains and the likely outcomes

So it’s become apparent to THCB readers and anyone else following the reimportation issue that Pharma is, as the Christian Science Monitor puts it, the new corporate villain. And it isn’t playing its hand very well. The one person in big pharma who has gone off the reservation is the Pfizer exec Peter Rost. Here’s his very positive review of Marcia Angell’s book on Amazon. (BTW before they start I can dispel the rumors–Peter Rost is not The Industry Veteran!). But Pfizer’s lawyers have already visited Rost in a way that really didn’t show much subtlety.

To be fair, those attacking the pharma industry are also being a little over-aggressive. Marcia Angell was on a NPR radio show last week in which she attacked the pharma business over the creation of me-too drugs. (The drug discussion is about 5 minutes into the show here). Rost makes a cameo appearance and a flack from PhRMA also defends their touch position. The show is well worth a listen, but it’s worth trying to distinguish among the “me-toos” that Angell is attacking.

There are “me-toos” that are second to market for whatever reason, but usually because of the research process (e.g. Crestor developed later in the race after Lipitor). It may or may not be OK to have another statin on the market, but that type of competition in development is the American way. Furthermore, as the Vioxx mess shows, not all “me-toos” have identical clinical effects (or at least Pfizer is hoping like hell that that’s true!)

The thing that Angell should be going after is the set of other “me-tooisms”, such as

While much of this bad behavior is in the past, it doesn’t exactly help that DCI, a lobbying group for pharmaceutical companies (and by the way the publisher of the supposedly academically neutral Tech Central Station) was reported by The Hill a few days back to be “offering healthcare consultants almost $4,000 each to find senior citizens who are willing to speak out in favor of the Medicare drug discount card and write letters to Congress thanking members for saving them money on pharmaceuticals.” So I think it’s helpful to try to distinguish between the bad behavior and the market failure. My problem with Angell is that she sees no good in the industry at all, and that leads to the industry just circling the wagons and saying “screw you” to other approaches.

However, there are some vague signs that calmer heads may be able to prevail, even if they aren’t close to doing so yet. Most of this really bad behavior on the pharma industry’s part is in the past. Meanwhile, an interesting but very small survey being conducted on the Pharma-Marketing List-Serv suggests that a big section of that pharma audience realizes that reimportation is a) inevitable and b) not likely to be that harmful. Last week the NEJM had an article that more or less agreed with the CBOs analysis that reimportation won’t have that big an impact on prices. The author, Richard Frank a Harvard health economist, argues that:

The Congressional Budget Office has also suggested that direct negotiations would have a “negligible effect on federal spending.” But direct government negotiation may realize savings on brand-name drugs that have little competition — cases in which prescription-drug plans would be unable to negotiate lower prices by taking advantage of competition among similar products for positions on drug formularies. Paying VA prices for the drugs used by Medicare beneficiaries would benefit the federal budget. Of course, lower prices would also affect the revenues of pharmaceutical companies. For drugs that are unique, prescription-drug plans will have little ability to negotiate prices. Thus, higher prices would most likely be paid for the most innovative products. Yet it would not be politically acceptable simply to let the industry name its price. Thus, at a minimum, some direct price negotiation by the government is likely to occur regardless of which candidate is elected.

He goes on to suggest that as a consequence of re-importation prices will lower here and increase sharply in Europe, but that we’ll get to a place where we can have a rational discussion about how to fund the research for innovative products.

So is it too much to see if we calmer heads can start that conversation, as after the election it’ll have to happen anyway? Well tonight I’m going to see Angell talk live, so I can report back as to whether there is any middle ground. I actually have a spare ticket, so if any locals are looking for a hot date, let me know quick. (You think I jest? I actually took a date to see my colleague Paul Saffo once. It was pretty much our last date!)

POLITICS: Real survey companies know that it’s a tie

So after the debate on Thursday, which didn’t feature health care, it looks like the Presidential election is back in a tie. Newsweek has Princeton Survey Research’s post-debate poll with Kerry leaving 47-45%, with a 4% margin of error. When Nader is taken out Kerry’s lead increases slightly. This is similar to the Harris poll that was released a couple of weeks back.

Now Bush may be feeling like the SF Giants on Saturday (who lost the NL West by giving up 7 runs in the bottom of the 9th) but in truth he was never as likely to win in a cruise as some pollsters have suggested. Worst offender here was Gallup which does the CNN/USA Today poll and has been consistently showing the Republicans doing better than most other pollsters. Gallup frankly (speaking as an ex-pollster myself) in the past few years has done its business some harm by not moving into Internet polling and now is engendering severe doubts about its political polling methodology (Having a former CEO who is an evangelical Christian when 8 out 10 evangelicals are on Bush’s side doesn’t exactly help their PR whether or not it has any influence over their methodology. By the way, Humphrey Taylor, chairman of the Harris Poll, has never taken US citizenship after 30 years of being here because he’s never wanted the possibility of his voting to impact his polling in any way). Speaking as someone who has commissioned polling from both Harris (and later worked there) and Princeton, and who also has looked at a lot of other polling organizations, I know that I’d tend to be more comfortable with them (and with Field in California) than most others. All Gallup really has left is the most famous name.

But what this all means is that the election is still as close as its been all along. So that means that turnout is the key and there are signs that the Democrats have done better in registering new voters. That of course doesn’t mean that they’ll get them to vote. However, anyone in health care assuming a straight Republican win should do some quick scenario planning about what happens if Kerry gets in. Particularly as the MMA gives the FDA (i.e. the Administration) the right to allow the importation of pharmaceuticals with no further Congressional action. When that was passed last year it looked fairly safe for the pharma business for some time. Right now they need to be thinking about plan B. (Of course I don’t think reimportation would be too dramatic and I have some ideas for Plan B that don’t lead immediately to Marxism).

PHARMA: Everything you ever wanted to know about Vioxx but were too afraid to ask

So it may be that the doyen of American drug companies when I entered the business may be falling into a death spiral. Merck’s withdrawal of Vioxx from the market combined with its major statin Zocor going off patent in 2006 may relegate it to the second tier of international pharmas, falling well behind Pfizer, GSK and the new Aventis/Sanofi. The new Aventis/Sanofi combo has its anti-smoking anti-fat pill Acomplia coming out in a couple of years, which may end up being the biggest selling Rx product of all time.

Merck’s Vioxx had certainly had its problems. Today’s New York Times article details the very recent history of Vioxx. As THCB noted back in August, a Kaiser study suggested that there were instances of heart attack and stroke among Vioxx patients, though not for Pfizer’s Celebrex. Once Merck’s own clinical study (which was trying to extend the indication to stomach polyps) showed the same thing, the company in consult with the FDA and no doubt its legal staff and investment bankers decided to take the enormous step and bite the bullet.

Not since the withdrawal of Baycol has there been such as tizzy in big pharma land, and Vioxx was not a 5th in class drug like Baycol. However, the Cox-2’s are a interesting case where a drug that has a benefit for some patients was probably being used too widely anyway. The Cox-2s are no more effective at reducing pain but were introduced and marketed as being better for those 30-40% of NSAID and ibuprofen users who had stomach pain. Express Scripts has shown in its studies that many if not most of those using Cox-2s were not suffering that stomach pain in advance and should have been on a cheaper drug first. Another Expresss Scripts study showed that over half of older Cox-2 patients were taking aspirin anyway, which meant that they were still probably getting the pain relief and also stomach problems of aspirin, probably negating the value of the Cox-2 in the first place–if the Cox-2’s even worked for those stomach problems in the first place (and there’s some evidence that Celebrex doesn’t). As a PBM, Express Scripts of course wants its customers to take OTC ibuprofen and an OTC PPI for their associated stomach problems. And of course there are plenty of alternatives beyond the aspiring/PPI combination. Even the NY Times Editorial page weighs in on overuse of Cox-2s. All this of course will make the already delayed FDA approval of Merck’s delayed replacement for Vioxx, Arcoxia, and Prexige from Novartis, much trickier.

Longer term this is all very grim for Merck. Below (purloined from the Times and IMS) is a list of 2003’s top Rx sellers (by $$) in the US. Note that Merck has only Zocor, Fosamax and Vioxx on the list. (The list says that it has Nexium too, but of course that’s Astra-Zeneca’s).

  1. Lipitor, $6.8 billion, cholesterol,Pfizer Inc
  2. Zocor, $4.4 billion, cholesterol, Merck & Co.
  3. Prevacid, $4.0 billion, heartburn, TAP Pharmaceutical Products Inc.
  4. Procrit, $3.3 billion, anemia, Johnson & Johnson
  5. Zyprexa, $3.2 billion, mental illness, Eli Lilly & Co.
  6. Epogen, $3.1 billion, anemia, Amgen Inc
  7. Nexium, $3.1 billion, heartburn, Merck & Co.
  8. Zoloft, $2.9 billion, depression, Pfizer Inc.
  9. Celebrex, $2.6 billion, arthritis, Pfizer Inc.
  10. Neurontin, $2.4 billion, epilepsy, Pfizer Inc.
  11. Advair Diskus, $2.3 billion, asthma,GlaxoSmithKline PLC
  12. Plavix, $2.2 billion, blood clots,Bristol-Myers Squibb Co.
  13. Norvasc, $2.2 billion, high blood pressure, Pfizer Inc.
  14. Effexor XR, $2.1 billion, depression, Wyeth
  15. Pravachol, $2.0 billion, cholesterol, Bristol-Myers Squibb Co.
  16. Risperdal, $2.0 billion, mental illness, Johnson & Johnson
  17. Oxycontin, $1.9 billion, pain, Perdue Pharma
  18. Fosamax, $1.8 billion, osteoporosis, Merck & Co.
  19. Protonix, $1.8 billion, gastrointestinal reflux disease, Wyeth
  20. Vioxx, $1.8 billion, arthritis, Merck & Co.

So soon they’ll only have Fosamax on the list. Forbes has a hard hitting article suggesting that both the CEO Gilmartin’s days are numbered and that Merck itself will become a takeover target. For a company that was the leading pharma company in the world in the early to mid-1990s, that would be a mighty fall.

Of course, if this can happen in as big a market in Cox-2s, can it be long before there’s more analysis of the biggest market of all, the statins, to see if any share Baycol and now Vioxx’s fate? There are already (as reported by Medpundit) some dissident physicians questioning their value.

POLICY/HEALTH PLANS/PROVIDERS: Michael Porter sinking into the healthcare quagmire

So the nice folks at Harvard Business School publishing invited me to attend the Michael Porter virtual seminar, and very interesting it was too. Porter says that the overall problem is that we haven’t defined health care as the delivery of value to patients. We need to get innovation within the system at the patient level. That’s what he said in his article published back in June (here’s an interview about it as the whole article is sub only), backed up with the version of the article presented in his talk. Most of his criticisms of the system are very familiar to THCB readers. And we mostly agree about what’s wrong.

There was also some new research from Porter’s team discussed in the seminar, which is about how to get “there” from “here”. For example, Porter believes that there is little benefit in broad provider networks, but instead providers they should try to be excellent and unique regionally and nationally. Porter also suggests that providers should consider one bill (as a patient I applaud this!) and organize around one practice area for each disease state. In order to get this team unity potentially hospitals should hire physicians and put them all on salary. In any event providers need to organize themselves surrounding the patient practice areas and move away from procedural functional areas as they are now organized. In addition providers should separate diagnosis and treatment into different functions (Ed note: Isn’t that what managed care tried to do with outside review? Maybe, but with very limited success). What Porter was leading up to is that providers need to be distinctive and have a market niche or brand strategy that’s comparable to other businesses in other industries. He then proceeded to give several examples of providers that have made big improvements by adopting some of these innovative business methodologies.

Porter continually stressed that the local versus regional/national axis is a really important one for providers to focus on, and that excellent providers should expand regionally and manage care on a much wider level. Interesting idea and the branding impact may have some impact, but how can it be a major trend when health care is produced and consumed locally, mostly because people want their services delivered locally? Incidentally, the reason for horizontal hospital mergers was to amass local monopsony power versus strong regional payers. Any hospital backing out of that for some mythical value creation strategy is looking at economic suicide given the current incentives in the market. It’s the Sutter Healths of the world using their market clout to jack up fees and revenue who are doing well!

On the insurance side, Porter believes that health plans should stay independent from providers and should stay in market–he thinks they can “add value”. But not by extending the managed care network control model, which he believes has failed. He thinks health plans will provide value in 3 areas –providing information, helping support consumers and efficient claims processors. But he notes that patients don’t trust their health plans, and that was the political reason for managed care network model’s failure. But the reason health plans went away from the narrow network model is because their customers (plans and employers) asked them to, and were prepared to pay more (the increases of the last 5 years) for those wider networks. And the last 5 years have been very profitable for plans that have gone back to the old ways of picking their risks very carefully.

In my interpretation Porter gave a fascinating lecture about how health care providers might have changed had Enthoven-style managed competition become a dominant force in American health care. Unfortunately for political reasons managed competition didn’t become that force and without the financial incentives, providers didn’t have to change what they did. What Porter says is, thankfully, more coherent than Reggie Herzlinger’s notions about a consumerized system, but everything he says about provider innovation being possible Alain Enthoven said 15 years ago. These include single prices and bills for a lifecycle of care, which sounds a lot like capitation or defined costs for DSM to me! Porter says that health plans need common information protocols, as there are no common standards, and people need to be able to understand the choices they make based on good information. All standard stuff I heard in Enthoven’s lectures in 1990 (and he’d been saying them for more than a decade by then).

But it’s where Enthoven went next was important. He said that to get to the type of innovation Porter wants you’d need a) a significant change to the incentives in the system brought about by tighter (or more accurately) very different regulation of health plan behavior and the insurance market, and b) that consumers needed help from intermediaries to understand what they were buying because it’s too hard for them to figure out the differences based purely on price without understanding outcomes.

In this lecture Porter never got to these points. He managed to talk for 45 minutes about how providers should change behavior without mentioning incentives. I asked a question about why he felt that the system might change in the absence of Medicare or any other big payer pushing a change in incentives. As part of the question I mentioned that the changes he wanted were the same ones that Enthoven’s managed competition would have brought into fruition. Porter was pretty dismissive of managed competition and Enthoven, saying that there was no such thing as competition that could be “managed”, but here he’s just wrong. Any market is bounded by regulation and market players are acting out their rational incentives within that regulatory framework. If the government uses regulation and subsidies to change the market, in one way or another it’s “managing” competition. And governments do this in every market either by deliberate action or by inaction.

Health care is a prime example. The incentives are wrong because the regulation allows them to be. For instance, Porter’s patient-centered value delivery sounds very like disease management to me. So why has DSM failed? Mostly because health plans and payers have competed to get rid of patients from their plans who need that DSM, and because providers haven’t been rewarded based on patient outcomes. The reason that providers are rewarded the wrong way is due to the historical fee-for-service system that was set up by insurers and adopted by government. And that system is still the basis for healthcare incentives. Unless Porter has repealed the laws of economics providers will still, more or less, follow the money.

In the rest of his answer to my question, Porter said that although Medicare is important, we don’t need it to change for the system to adopt his principles. He still thinks that we could have dramatic improvements in care cost and quality and providers can do well doing it, in the absence of policy change (although he grants that it would be helpful). He believes that providers are driving this change, and are integrating their care around practice areas. One of his prime examples (mentioned several times in his talk) was Intermountain Health Care. You’ll get no argument from me that they are doing great work. Unfortunately historically very few organizations have been copying them. Intermountain had the luxury of a wealthy benefactor–the Mormon Church–insulating it from market incentives and helping it get set up to do the right things, such as comprehensive care management, reducing medical errors, and cutting waste by getting procedures right the first time. More importantly they have been leaving money on the table by doing that!! Their quality guru, Brent James said so himself on the front page of the NY Times last year, and Michael Millenson wrote much more on the providers who “got quality too early” to their own fiscal detriment in his book “Demanding Medical Excellence”.

Porter thinks that we don’t need to wait for public policy, although some of the changes he advocates are sensible like a move to a defined benefit package along the FEBHP lines (something again from Enthoven c. 1985). But Porter said loud and clear that everyone in health care should move in the direction he advocates even without regulatory change and would do better financially by doing so. While they might follow his lead, it is extremely unlikely whether the typical provider or plan would benefit from doing so.

Instead of looking at the big-name outliers and assuming that they’re the ones who are going to do well, Porter needs to realize that it’s the mass of American physicians and hospitals who are going to have to change for the overall patient experience to change, and they have no incentives to do so. When, as Wennberg shows us, providers in Florida are practicing on patients at three times the rate as those in Minnesota, there’s a reason for it. They get something like three times the money!

There are ways out of this, and to be fair Porter mentions them in his paper, even if he belittled them in his talk. Putting Medicare into a Pay for Performance mode is one important element, Changing regulations governing the insurance system so that health plans are rewarded for better handling of the treatment of sick patients is another. But HSAs and Association Health Plans are pushing incentives in the opposite direction, and the Medicare P4P movement is very, very nascent. Porter seems to think that the system can change itself. As the old joke about the light bulb and the psychiatrists goes, the system has to want to change. And right now it doesn’t. And there’s $1.5 trillion worth of political influence to stop the reforms needed to make it change.

I think looking back in 10 years Porter’s ideas may share Enthoven’s fate. He’ll be wondering why no one paid attention given that the solutions were so obvious. Unfortunately this is typical of a really bright person entering health care from another perspective and being totally bewildered by the ferocity of the political reaction they’ll get. Porter comes from the rarefied air of international business, but this also happened to Enthoven even though he was one of Macnamara’s whiz kids at Defense Dept in the 1960s.

For now Porter will raise some fuss on the conference circuit, and these ideas may be fad of the month at hospitals, just as integrated delivery systems were 10 years ago. But unless he wants to go to Washington and explain how public and private payers need to change their incentive structures and get the lawmakers to agree over the interests of their campaign contributors, few of the provider-specific innovations that we all agree are needed to promote value in health care will survive in the current market.

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