In my background for the post last week on paying for Quality, I came across some of the more recent work by Michael Millenson, who wrote the great Demanding Medical Excellence. Millenson is not only a smart guy who tells a good story but he’s been a professional journalist for a major daily and a consultant for a major benefits firm. So his explanation of why the IOM’s To Err is Human report hit such a nerve is well worth reading. Partly it was the culmination of a slow groundswell of news and opinions from across the nation, both from reporters and consumers, and even a few doctors. But just as important was the fact that the IOM used human interest stories which were easy for journalists to latch onto and reproduce and also it was released on a slow news day. Scary but true, that’s how things get to be a big deal in America. You can read Millenson’s article Pushing the profession: how the news media turned patient safety into a priority here.
POLICY: Bush signs Medicare bill, declares victory, goes home
Well he went back to the White House anyway….
So the Medicare bill is signed into law, and Bush used the occasion to point out that a poor diabetic who couldn’t afford $6,000 in drugs and needles will now only need to be unable to afford $3,000. OK that’s a little cynical of me. If you click here and got to Chart 7, you’ll see that 43% of the Medicare population have incomes below $15,000 a year and this bill will help most of them….but it doesn’t give them everything for free. Click through to chart 9 in the same file, and you’ll see that 15% already have Medicaid and most of the rest have some variety of either employer or individual drug insurance. While this bill is good news for the 15% without any drug insurance, it’s neutral to bad for everyone else. That will be the political impact but probably not until people understand the bill in late 2005, which amazingly enough is after the next election.
And as usual when this White House announces financial data and gives human examples (and no I won’t give you a Krugman-esque diatribe here), the numbers Bush gave anticipated a best case scenario in the negotiations between the as yet unformed Medicare PBMs and the drug companies, expecting them to get a 20% price discount. We’ll see, but few serious observers are anticipating the PBMs to turn into Wal-mart any time soon.
INDUSTRY: HMA stock down 10%
Stock in Health Management Associates, a chain of mostly rural hospitals, was down 10% after a downgrade from UBS today. HMA’s stock has actually had a decent run up of over 40% since June, and with the Medicare bill favoring rural hospitals this might have been expected to continue. But the hint from UBS is that there are issues with billing, and of course that makes everyone think of Tenet and Columbia/HCA–of which HMA’s hospitals were a part before the now HCA spun them off as one result of their Medicare billing scandal.
In fact Don Johnson from the Businessword and I were having an email discussion about this last week and I presciently wrote this to him last Thursday:
meanwhile HMA is a logical winner, but I’m terrified of investing in hospital chains as they always get indicted for fraud or its equivalent eventually (e.g. NME, Columbia-HCA, Tenet)
So did I take every penny I had and short HMA on Friday? Of course not; curses, curses!
PHARMA: More on A-Z, Crestor, statins, heart disease . . .
And in a follow-up to Friday’s post about Crestor, I was alerted to this interview with Astra-Zeneca President David Brennan in which he claims that Crestor’s slower than forecast sales are due to an overabundance of free samples that they’d put into the market and expected (emphasis added by me) concerns about the drugs safety profile following the Baycol withdrawal. However, A-Z still believes that Crestor will get to be 20% of the statin market, and believe that their projections are on track. All of which leads the industry veteran who contributed to the post last week to comment:
"Talk about a non-denial denial of Crestor’s lagging sales, see the Reuters article below. I should think that if AZ’s U.S. president, David Brennan, disagreed with the Rx data or if there were any discrepancies in the performance measures, he would clearly make such points. Not only did he fail to refute the data in the interview, but he says they were expecting this slow uptake. "We knew going into this market, based on our market research, that because of Baycol safety on uptake would be an issue." Strange, but I don’t recall AZ ever mentioning anything like this before Labor Day!
Brennan then launched into what I can only consider a diversionary statement about sampling. "AstraZeneca distributed around 100,000 30-day "Reach for Crestor" free sample packs to doctors at the time of launch." This is certainly far short of the 500,000 we heard about earlier, but also suggests a faulty marketing plarelativeve to sampling distribution. If AZ has 3,000 reps promoting Crestor, the "Reach for Crestor" sample drop provides only 33 sample kits per rep. If we assume that each rep will drop one sample kit per physician, that means each rep is only sampling 20% of his/her call list (at an average of 150 physicians/rep). If AZ has 5,000 people on the street to promote Crestor, then they’ve given each rep only 20 sample packs. Each 4-wk pack is still for only one patient, no matter how many weeks worth of pills are in the sample. AZ would have been wiser to give out 400,000 1-week sample kits. The goal consists of getting as many patients as possible to start using the product, not to give a ton of free drugs to fewer patients!
Brennan goes on to say: "The amount of sampling in general, not just ‘Reach for Crestor’, has increased significantly with our launch. Not only our sampling, but the sampling of our competitors has gone up substantially." I knew someone here was born at night, but I didn’t think it was last night. What he described here is basic competitive marketing behavior. When a new product launches, it provides a wakeup call for existing competitors. They stiffen most of their "spokes on the marketing wheel."
Personally I’m taking a more sympathetic view. Brennan is a smart guy and he realizes that expectations here have gotten a little our of whack, and that the market needs to see the move to Crestor as evolution rather than revolution. It’s just a pity that A-Z didn’t try to prepare Wall Street for this before the Crestor launch. There will be a major DTC effort for Crestor next year, so we’ll see both what that does to sales and how Lipitor and Zocor respond.
Other statin news: Meanwhile theheart.org (reg req’d) reports on a British study which suggests that for patients with heart disease statins are harmful. The study’s author Dr Andrew Clark (University of Hull, UK) commented to heartwire:
"In heart failure, the fatter you are and the higher your cholesterol, the better off you will be. This raises the possibility that statins may be dangerous in these patients, but I couldn’t state that categorically. We need controlled trials to make such definite statements." But he is not treating his heart-failure patients with statins. "My recommendation at the moment is not to use statins in heart-failure patients. I have no evidence to believe that they are good and quite a lot of suspicious evidence that they are bad," he said.
Of course this is for patients who already have heart disease who are a very small share of the target market for statins.
Theheart.org also has a round up of the letters to the Lancet supporting and opposing its recent anti-Crestor stance.
FRIDAY FUNNY: Triumph
Totally off topic for health care, and not at all polite (YES THERE IS NAUGHTY LANGUAGE AND LOTS OF CRUDITY IN THIS) but Triumph the Insult Comic Dog’s "I keed" video is a hysterical spoof of the current music scene. Click here and then click on the video box to the left, but turn the volume down if your boss walks by!
QUALITY: Paying for medical excellence (and I do mean “paying”)
One of the best books on health care ever, second only to Paul Starr’s The Social Transformation of American Medicine is Michael Millenson’s Demanding Medical Excellence. In his tracing of the history of health care quality, Millenson demonstrated how organized medicine destroyed the burgeoning quality analysis movement early in the century, and how even as late as the mid-1990s, medical providers who became quality focused and more cost-effective found that they were losing money as a consequence. The problem then was that managed care payers weren’t sophisticated enough to pay based on quality and performance, so the old fee-for-service paradigm of do more, get more actually rewarded poor quality care. Millenson’s expectation was that over time as more aggressive payers realized that quality was synonymous with lower costs, pay for performance would replace fee-for-service. (For a contrary view see JD Kleinke’s Oxymorons, where JD decides that after preaching about the virtues of the market for all those years, better health care is just more expensive).
Well, now the New York Times is coming around to Millenson’s view. In an article called Hospitals Say They’re Penalized by Medicare for Improving Care, the Intermountain system in Utah claims that it’s providing great quality care, getting it right the first time and not having to redo procedures or transfer patients to higher intensity settings. As a consequence it is losing out on Medicare payments. Millenson’s book has a very complimentary section on Intermountain, and it’s no coincidence that Intermountain is among the most computerized health systems in the country and has been for years.
According to the Dartmouth Atlas, Utah certainly has lower rates of surgery than Colorado next door. Of course you don’t really know the incidence of disease behind this variation. This led to the great comment at a meeting I was at from Larry Weed: "You don’t know whether to move to Denver to get your problem taken care of properly or go to Salt Lake City to avoid unnecessary surgery." My pretty strong hunch is that you’re better off in Utah (even if it’s murder getting a drink there unless you know where to go).
The Times then suggests that getting Medicare to "pay for performance" is the answer, as suggested by the Jackson Hole veterans in Health Affairs, although I was somewhat disparaging about the concept’s prognosis yesterday. Apparently Tom Scully thinks it’s a good idea, and the Times says he is:
quick to agree that the payment system needs to be fixed. "It’s one of the fundamental problems Medicare faces,"
Of course the minor problem is that years of data suggests that the for-profit hospital sector that Scully represented during the 1990s is the worst offender in terms of doing too many procedures that are medically dubious and of low quality; our buddies at Tenet being among the worst examples. I bet you all a nickel each that when Scully is back in the private sector he’ll be making sure that his clients don’t have to worry about Medicare forcing them to really change their ways–that is unless those Mormons can come up with some serious cash for lobbying.
INDUSTRY/POLICY: It’s 1990 again, and the autos want a solution for health care
Back in 1990 when I first got into this health care policy stuff a guy called Walter Maher was going around saying that we needed a government single payer system. Nothing too unusual in that other than Maher was head of public policy at Chrysler. He was saying it because Chrysler and the other autos, with their unionized and older work-force and pensioners, were locked into paying very high health care costs. When they did the math they noticed that a Canadian-style single payer system paid for out of general taxation would be cheaper for them. Of course during the 1992-4 debate on the subject, the rest of Corporate America took Chrysler out to the woodshed and little was heard from Maher after that. And of course managed care was going to fix it all, and the market was going to work. By then anyway the 90s boom was on and the Japanese competition was running into trouble and Detroit (aided by some little known tariffs on Japanese light trucks) was making a fortune out of minivans and SUVs (which are trucks not cars, really!), and saving a fortune by sending jobs to Mexico.
However, there’s to be a sequel to the movie, given that the autos are not seeing the boom days continue, but health care premiums are. Like all good sequels, we’re now going to see a rehash of the first movie. This time it’s Ford stepping up to the plate, and putting a senior executive in charge of solving their health care cost crisis. Listen to the complaint from Ford:
The automaker spends about $1,200 on employee and retiree health care for every vehicle it builds, a huge cost that private employers don’t bear in countries with government-funded medical care.
That was written last week, whereas in 1990 you would have read this:
"Health care adds $700 to the price of every American-made automobile,” stated Walter Maher, spokesman for Chrysler Corporation, at meetings of National Small Business United and the National Health Forum. Besides, the existence of the uninsured is an "offense to his social conscience.” His solution: let the government pay the bill, while placing tough controls on expenditures.
I don’t know why Ford is bothering to have its own investigation. Surely Chrysler can send over the draft of Maher’s old speeches. All they have to do is double the numbers and the job’s done.
PHARMA: More on Crestor and Astra-Zeneca
One of the great fun things about doing this blog is meeting people via email who have interesting insights. Of course sometimes I feel like an investigative journalist as I can’t always reveal my sources. That’s the case with the Crestor issue which I’ve blogged on for a while most recently yesterday, when I suggested that it might be time to short Astra-Zeneca. Well today in my email box popped this gem from a pharma industry veteran:
I’ve noticed some people are placing bets down on AZ stock but I’ve also seen that for the past several weeks, AZ has been buying 200,000-300,000 shares of its own stock every day. Looks to me as if McKillop and his CFO have been propping themselves up on the ropes with their left hand while trying to parry the jabs with their right.
In any case I don’t think that some investor activity is indicative of how Crestor and Exanta will perform competitively. My own hunch is that if (a major "if") no ADR reports surface of rhabdo for Crestor and liver toxicity for Exanta, both products will eventually do well. I define "well" for these products in more modest terms, however, something closer to $1b-$1.5B rather than $3B for Exanta and $2.5B for Crestor.
I honestly feel that these Big Pharma companies do substantial harm to themselves by over-inflating the market prospects for their new drugs. A couple of years ago I closely assessed for clients the development progress of Bristol-Myers Squibb’s Vanlev. They touted that thing as likely to revolutionize hypertension care and as a $5B drug. Merck similarly blared the sirens for its Substance P antagonist and its PPAR, both of which they just abandoned. In terms of marketing strategy this early hyping makes little sense. The companies do it mainly because it gives a short term boost to the stock and the compensation of senior managers is closely tied to stock appreciation. By the time reality hits, when the stock price tumbles and ordinary blokes lose their jobs, these boardroom Tony Sopranos are off looting some other venture.
There’s clearly a lot in that last paragraph. Pharma execs in general benefit from actions that happened before they got to the top. Not that they don’t have huge challenges, but they benefit (or not) from bets made years before which either turn into blockbusters (or don’t). Similarly the PhRMA’s decision to go for Medicare reform will end up profiting the pharmas in the short and medium term, but will likely open them up to price controls in the next decade or so. Of course by that stage the executives behind today’s deals will be happily in retirement.
PHARMA/PBM: Three tier formularies work
In a New England Journal of Medicine article called The Effect of Incentive-Based Formularies on Prescription-Drug Utilization and Spending a team from Harvard found that three-tier formularies work. Three tier formularies are what PBMs and health plans introduced in response to rising drug uilization and prices in the late 1990s. In essence the PBM puts generics, and the branded drugs for which it has negotiated the best rebates, into the cheap first and second tiers ($5 or $10 co-pays) and charges huge co-pays for the others. Amazingly enough this means that people switch. In this study:
Among the enrollees who were initially taking tier-3 statins, more enrollees in the intervention group than in the comparison group switched to tier-1 or tier-2 medications (49 percent vs. 17 percent, P<0.001) or stopped taking statins entirely (21 percent vs. 11 percent, P=0.04).
While the only press article I could find on this in the Boston Globe, plays up the fear that patients will stop taking their drugs, my guess is that some of those people would have given up anyway. The key stat is that half the people switched. Presumably switching to another statin doesn’t make much difference on health. Medpundit has some interesting things to say about the clinical impacts of this switching (and, Sydney, we agree in this case!)
This is what Ian Morrison calls "the Ross Perot effect"–you can move people around for $10. (Apparently in 1992 Ross Perot spent $10 for each vote he got). Actually it’s a little more than $10 in this case, but it shows that therapeutic substitution based on money is very powerful.
My sense is that this shows that the power of the PBM has been underused. The PBMs have been mostly the handmaiden of the pharmas. For their health plans and employer clients they have in general been unwilling to really move people away from branded drugs, unable to get too many of their clients to move to very aggressive formularies, and unable to get doctors to prescribe according to the formulary. However, this study shows that the opportunity to move people between products is very real, and with Medicare formularies on the way (in the new PBM-managed formularies) they may become even more important.
PHARMA: Lipitor v Crestor
Forbes is running a wacky poll to see if people think that Crestor can take on Lipitor. Lipitor should hit $9 billion in sales this year. Early indications are that Crestor is struggling but the poll results show some support for Crestor. Meanwhile Astra-Zeneca’s stock value shows that Wall Street is certainly anticipating big things from Crestor. It’s within a couple of bucks of its all time high, and has well outstripped Pfizer’s in the last 2 years. If I ran a billion dollar hedge fund I’d buy Pfizer and short A-Z against it….but I don’t
. But these guys do and they went short of A-Z a couple of weeks ago with a price target of $40. In fairness to A-Z not much has happened since!