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PHARMA: Merck knew more than it let on about Vioxx

A group of emails from within Merck show that the scientists were questioning the data and the marketing people were telling the sales reps to obfuscate. This is really ugly stuff. Taken on its own the views from the scientists aren’t too bad, as they state the actual truth — that good drugs have side effects. But the trial lawyers will not care about that and Merck’s stock is down another 10% today. And you can just imagine the courtroom scene where the plaintiff’s attorney reads management’s instructions to the sales reps to “dodge” questions from doctors about the safety record of Vioxx versus its competitors.

Merck’s long-term is looking bleaker and bleaker. Even though Arcoxia, its new Cox-2 may make it through the FDA — it got a go slow but positive letter last week — the combination of the settlement for Vioxx and the fractured trust with doctors and patients really spells the end of Merck’s reign as the most trusted of the “scientific” pharmaceutical companies that it enjoyed when Vagelos was the CEO. Expect some other pharma to come after Merck within a few months, but perhaps after it’s got a little cheaper.

POLITICS: After today, it may be over

The rumors I hear are that no-one will concede tonight and that the whole thing will go to appeal in Ohio, Florida and who knows where else. Four years ago a done-nothing Governor, who’s only promise was to govern from the middle and not get a blow-job in the Oval Office, “won” election by getting fewer votes than the other guy. Love him or hate him, it’s hard to imagine that after governing the way he has, with the contention that his Administration has created at home and abroad that the numbers for Bush in advance of the next election look exactly the same as they did on election night 2002.

But that apparently is the way it is. God Bless America.

POLITICS: It’s a dead heat

If anyone tells you they know who’s going to win the election, they’re lying. I reported that Harris said it was a dead heat a few weeks back, and not much has happened to change that view. You all know who you want to win. I know who I want, and I’ll report back on Wednesday on what we know, if we know the final answer then.

UPDATE: Apparently, this is not true and there is a certain outome. ESPN reports that for the last 16 elections since they moved from Boston in 1933 when the Washington Redskins win their last home game before the election, the incumbent’s party wins. When they lose, the incumbent’s party loses. Well on Sunday, the ‘Skins lost. Sorry, Bush!

POLICY/POLITICS: Prop 72, sorry couldn’t stop myself!

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So I tried to not say any more about Prop 72 and the analysis from the Harvard economist Anna Sinaiko that poo-poohed my theory about labor costs versus profits. But as I never heard back from her, I might as well print what I wrote here after she said this in reply to my earlier letter:

Let me begin with Matthew Holt’s letter, in which he questions: Can we finance health insurance by tapping into (“all-time high”) corporate profits? It has long been recognized in labor and health economics that firms regard the cost to employ a worker as the sum of cash wages and fringe benefits, and offset higher costs of health insurance with lower wages. While in the short term this may be difficult, over the long term, wage reductions are likely to be a consequence of an employer mandate such as SB 2.

Here’s what I wrote to her in reply, as yet not hearing back from her.

By claiming that economics tells us something — in this case “firms regard the cost to employ a worker as the sum of cash wages and fringe benefits, and offset higher costs of health insurance with lower wages” — you appear to mean “economic theory” tells us something. You appear to be saying that the theory says that overall gross labor costs are necessarily static and any change in one part of labor costs will be compensated within those labor costs, either by lower wages or lower employment. Those of us who think of economics as a pretty imperfect science would be interested to know how you reconcile the UK experience with the introduction of a minimum wage with your economic theory? Wages/labor costs there went up and unemployment stayed the same (in fact dipped).

Assuming that no miracles occurred, and that the total amount of revenue in those firms stayed constant, something else MUST have gone down. Unless Adam Smith has changed his text since I went to college “Economic theory” says that there are only four elements in the cost of production: Land, labor, capital, and “enterprise”. You have effectively said that a change in the cost of one of these is self-regulating and that the others cannot change. That is patent rubbish, as the “cost” (or share of revenue) of all 4 elements changes constantly in any market. Or maybe you have created a new “economic theory”. If that’s not what you are saying you need to restate your argument, and answer my criticism properly.

And you never answered my final question. If this all washes out within labor costs and they stay constant, why are corporations (who care only about the “enterprise” or profit part of the equation) so dead set against SB1? I’ll answer it for you. They are not economists and they–like labor unions–live in the real world where these types of battles over distribution of revenue happen all the time because there actually IS something at stake.

And so after that non-reply here comes the real proof. Today’s NY Times has an article about WalMart and how it basically offers fewer health benefits than its competitors and as an aside many more of its employees wind up on public assistance of various sorts for their health care needs. Walmart is more profitable than its nearest competitor Costco because of that, and Wall Street notices:

Wal-Mart says that 23 percent of its employees are not eligible for coverage, but that it covers 58 percent of those who are. That compares with an insured rate of 96 percent of eligible full-time or part-time employees of Costco Wholesale, the discount retailer that is Wal-Mart’s closest competitor nationwide. Costco employees – most of whom are not represented by a union – become eligible for health insurance after three months working full time, or six months part time. At Wal-Mart, which has no union employees, many who work full time must wait six months to become eligible. Part-time workers are not eligible for at least two years. Because of turnover, some employees never work long enough to become eligible.

If there is any place where Wal-Mart’s labor costs find support, it is Wall Street, where Costco has taken a drubbing from analysts who say its labor costs are too high. Costco’s pretax profit margin is only 2.7 percent of revenue, less than half Wal-Mart’s margin of 5.5 percent.

But I guess Sinaiko’s economic theory doesn’t cover Bentonville AK and Wall Street or Sacramento and Athens medicaid payments, so she must be right, and labor costs have no impact on profit margins.

INTERNATIONAL: US primary care looks poor in comparison to other nations

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Not two weeks ago Bush yet again trotted his dad’s old line about the American health care system being the best in the world. A little earlier this fall Robert Centor at DB’s Medical Rants said that primary care in the US “trumped that in the UK”. I posted my objections to both Bush and to Dr Bob on TCHB before, but I didn’t have a lot of proof in terms of hard data.

Well I do now.

Health Affairs has published the latest Commonwealth Fund report, (survey research was conducted by my ex-colleague Kinga Zapert and her group at Harris Interactive), on primary care in 5 English speaking countries. Here’s the Press Release and here’s the whole article. Essentially on every measure, apart from peventative screening, on an absolute basis American primary care performed as badly as anywhere else and usually worse than everyone else. And of course it costs a whole lot more, both absolutely and in terms of out of pocket costs.

For example only 37% of Americans had a more than 5-year relationship with their primary care doctor, and 20% had no primary care doctor. Everywhere else more than 50% have a five year-plus relationship.

Here’s a look at timely access to care:

The majority of adults in New Zealand and Australia said that they received appointments the same day the last time they were sick and needed medical attention. In contrast, only one-third or less of Canadian or U.S. adults reported such rapid access. Canadian and U.S. adults also reported long waits, with 20-25 percent waiting at least six days to get an appointment when sick, a waiting time rare in Australia or New Zealand.

Telephone help lines provide a potential source for primary care access after hours. In the United Kingdom, NHS Direct operates a twenty-four-hour telephone nurse advice and information service. When respondents were asked about any use of such assistance in the past two years, help lines were used most frequently in Canada and the United Kingdom, followed by the United States.

And then again costs really impact use of care, especially for the poor:

U.S. adults were the most likely to say that they did not see a doctor when sick, did not get recommended tests or follow-up care, or went without prescription medications because of costs in the past year. New Zealand rates of not seeing a doctor rivaled U.S. rates and were significantly higher than rates in the other three countries. The United Kingdom and Canada stand out for having negligible cost-related access problems. Australia stands midway between the country extremes. Lower-income adults’ access to care was particularly sensitive to costs, with problems again the most acute in the United States.

And American primary care looks pretty bad regarding test results and patient communication — a result I suspect of poor care coordination here:

8-15 percent of patients said that they were given incorrect test results or had experienced delays in being notified about abnormal results. Test error rates were highest in Canada, New Zealand, and the United States…..The study reveals missed opportunities to identify patients’ preferences or concerns, to communicate well, or to engage patients in care decisions. On each of these measures, U.S. adults were significantly less likely to score their doctors highly and the most likely among the five countries to report concerns.

The US did better than other nations on some preventative screening measures like pap smears and checking for high blood pressure, which the study attributes to the pressure brought on providers via the NCQA’s HEDIS measures. But otherwise there’s a really clear question. What are we getting for all the extra money that we’re spending? In fact the authors come straight out with it in the discussion phase when they write:

Across multiple dimensions of care, the United States stands out for its relatively poor performance. With the exception of preventive measures, the U.S. primary care system ranked either last or significantly lower than the leaders on almost all dimensions of patient-centered care: access, coordination, and physician-patient experiences. These findings stand in stark contrast to U.S. spending rates that outstrip those of the rest of the world. The performance in other countries indicates that it is possible to do better. However, moving to a higher-performing health care system is likely to require system redesign and innovative policies.

It’s of course no secret where the extra money goes in the US system, where we lead the league in excessive care of the virtually dead, or as THCB contributor Dave Moskowitz said yesterday “For 70% of healthcare dollars to be spent in the last 12 month’s of a patient’s life means that it is spent on surgery and ICU care that is futile but expensive”. And of course the recent Dartmouth studies showed that the variation in ICU and end of life care and costs both between states and between leading hospitals in different parts of the US varies by a factor of 3! Not to mention Uwe Reinhardt’s point that we pay higher prices for the same amount of medical services delivered here.

In other words, buyers here(and by that I mean the big employers and the Federal government) have got to start changing the way they regulate the system and how they pay for care. It makes no sense for us to continually defend the way we’ve been doing things when the indicators are that everyone else can essentially do better spending less money. And saying it can’t be done, or Bush denying that there is anything wrong, reminds me of American auto execs in the 1970s poo-poohing the threat from Toyata. The alternative, of course is more of the same and the rest of the economy picking up the tab, at considerable social cost.

Meanwhile, the foreigners are trying to get further ahead. Here’s a webcast from Kiasernetwork of the study’s lead author Cathy Schoen ripping the US system, and a somewhat smug–and every right to be–UK health minister explaining how the government there is working to add improvements to the system (and no that doesn’t mean introducing more cost-sharing, which seems to be our only idea here).

Finally, the study also used the three part Harris question that you’ve seen me reference before. The question asks people to put their views on the whole system into three buckets which are in favor of a) minor tinkering, b) fundamental reform, and c) complete rebuilding. Most people end up in the middle bucket, of course, but the number of Americans looking for complete rebuilding is way higher than anyone else’s, and is now back up to 33%. In fact another Blendon study conducted more recently found that it was at 36%. Immediately before the 1992 election that number was at 42%. My forecast is that as cost shifting continues and as the uninsured rate rises, that number will climb here back to near the 40% mark, and a big debate will ensue.

POLICY: One more time around on the VA issue, by Dave Moskowitz

This may be the last word for now on the idea of using the VA for the uninsured, raised by Dave Moskowitz last week. Let me try to put this in a little context. We’re not likely to have a universal health insurance scheme come out of the next Congress. As I write about elsewhere, the proponents of this year’s version of healthcare reform (California’s Prop 72) which I support because it’s better than nothing, come straight out and say that incremental change is all that we can expect. While I don’t approve, I don’t disagree. So Dave’s idea is an incremental change that’s worth considering and also not to far away from Bush’s idea of spending more money on community health clinics for the poor. I did though have a couple of concerns before I appointed Dave to run the much revamped VA. He replies here (and you may notice him getting into the somewhat cynical but jocular spirit of THCB):

You asked two more questions, which I’d now like to reply to:

Is Congress ready to come up with $100 B for healthcare? Perhaps Congress has grown amnesiac since the 1994 Contract On America. They are spending, after all, our taxpayer money. According to the Constitution, they’re supposed to be working for us, not the other way around. Congress has already spent $180bn for the War in Iraq, and have just been asked by the Administration for another $70bn, bringing the total to $250 B, a project which enjoys less than 50% popularity with their constituents. So it would be only reasonable, in a representational democracy, for them to spend $100 B of our money annually on a need near and dear to 70% of Americans. I understand that using the government to help the people has fallen out of favor as a political concept since Reagan took office in 1980, but perhaps the people will gently remind their elected representatives who’s paying their salary and why.

Why separate but unequal in healthcare when it no longer applies in education? Au contraire, gentle blog-meister. Separate but unequal is no longer supposed to apply in PUBLIC education, but Brown vs. Board of Education of Topeka, KS never struck down the inherent separateness (and demonstrated inequality) between public and private schooling. In the US, roughly 85% of education is public, open to all comers, and 15% is private. We’re all aware of public school districts where daily survival is the most one can pray for, let alone a college-prep education. And we’re all aware of the training ground set up by the power elite that includes prep schools like St. Paul’s, St. Alban’s, and Andover. After all, the Presidential candidates for the past four years have come only from those three high schools. Waterloo is still being fought on the rugby fields of Eton, so to speak. (Ed’s diversionary note: They don’t actually play rugby at Eton; they play this weird sport instead and the correct quote is “playing fields”. Anyway Rugby wasn’t invented till decades after Waterloo! End of history and English elitist culture lesson!) So separate and unequal is in no way un-American.

It’s actually as American and as much a pillar of capitalism as apple pie (not to intimate that the pillars of capitalism are grounded in less than cement). It’s seen, for example, in airplane travel (Business Class vs. Coach), ground transportation (luxury SUV vs. public transportation), housing (4-star hotels vs. economy motels; gated mansions vs. trailer-parks), food (fresh T-bone steaks vs. frozen bulk hamburger), medicines (branded vs. generic), etc., etc., etc. People get what they pay for. The goal of government is to ensure that the cheapest commodity is at least non-toxic. In government as in medicine: primum non nocere (first, do no harm). In the case of healthcare, I’ll let you in on a very well-kept secret: the cheaper public system is very likely to yield better patient outcomes than the more expensive, private alternative.

Here’s why: Modern health plans started with the Blue Cross/Blue Shield plans set up in the 1920’s by surgeons to make sure they got paid for the operations they did. Healthcare reimbursement has kept its close ties to the hospital ever since. For 70% of healthcare dollars to be spent in the last 12 month’s of a patient’s life means that it is spent on surgery and ICU care that is futile but expensive. An excellent example of how the system works is the recent decision by CMS to pay for lung volume-reduction surgery (essentially, popping emphysematous blebs) the week after a study in the New England Journal of Medicine showed that it was useless. Only in America!

Genomics makes it possible (finally!) to prevent diseases from occurring, or at least not to be ambushed by them, as we all currently are. Genomics makes it possible to keep people healthier and out of the hospital. The current hospital-based system, which represents the medical establishment in every country, with its research institutes and medical schools, will not go quietly, as the TB sanitaria did in the 1950’s when streptomycin was discovered. But the dynamism of capitalism will save the private sector. In order to regain market share, the hospital-based system will be forced to adopt preventive molecular medicine. Patient outcomes will begin to improve in the private sector, too. There will be aggressive marketing, encouraging patients to stay with their fancy, branded private sector health plans. If the tobacco and ammunitions industries can survive despite their effect on the public health, then the private healthcare system will do fine, too. But we need both players, because the government by itself simply cannot pay for healthcare at the current level, let alone with double-digit inflation. Healthcare would have to be rationed, as in Canada and the UK.

This is politically unacceptable. Americans like the notion that anybody who can afford a liver transplant can get one, and Mickey Mantle can get two in a week. If the private sector folded, the $100 B annual price tag for 45 million currently uninsured Americans would balloon up to $600 B a year for all 270 million Americans. Getting this Congress to spend an extra $600 B a year on health for the nation will be infinitely harder than getting them to spend six times less. So by all means, let’s keep both systems. But if you happen to find yourself, for a time, in the public sector healthcare system, don’t be upset–you may actually be getting better care!

While I think he’s hit the nail on the head with his analysis of the wasted money spent on end of life care — and the Dartmouth crowd agree — I’m still not quite sure if I follow all Dave’s logic. Surely if Congress is going to spend a lot more on health care for all Americans, private sources (that is employers and individuals) will spend less. However, the idea that health plans have to compete on outcomes is something I like the idea of, even if its mostly fantasy for the near-future. I’ll see if this idea crops up elsewhere, but hopefully this has added something to the debate.

Meanwhile certain wags have pointed out that as a non-natural born citizen I can’t be Preznit and appoint Dave as head of the VA. Even if the Constitution was changed and I could be, I might find a tough opponent in a certain ex-steroid using body-builder. The Guvernator is raising my ire this week by both opposing Prop 72 (which given his business connections I’d expect) and much more so by toadying up to the most appalling union in America, the California Correctional Peace Officers Association, in opposing Prop 66 — the much needed amendment to the nutty three strikes law. You may recall that in the recall race Arnie said he was opposed to special interests. The prison guards have been the most egregious and aggressive special interest group in this state for over a decade. Good one, Guv.

POLITICS: My (almost) last word on Prop 72

I’m much more disgusted with both sides on the prop 72 debate than I was before this past week. I went to a “debate” on it at the Commonweatlh Club on Monday and then heard (and phoned into) an NPR show on it this morning. (The show wasn’t my finest hour, but then I matched the general level of debate and I’m on about 10 mins before the end of the show).

The opposition was the Allan Zaremberg from the American Chamber (at the debate) and a school board member Gabriella Holt (on the radio) representing public sector employers. The chamber of commerce’s major objection — and I am not making this up — was that the 20% of premium that Prop 72 would force the employee to pay (capped at 5% of income) would take away their choice to buy other things with that money! In other words the poor little poor minimum wage employee doesn’t want health insurance, otherwise he’d be buying it himself already! Obviously the Chamber hasn’t noticed how bitterly hotel and grocery workers in this state are fighting to maintain their health benefits, nor have they noticed how much employees in polls always favor health benefits over cash, nor have they noticed how shitty the individual insurance market is. This argument really reminded me of a southern lady I once sat next to on my first trip to the USA. I asked her about being in the south during the Civil Rights movement. The first thing she said to me was, “well I’ll tell ya one thing–the blacks didn’t want it!”.

My namesake from the public employer representative didn’t seem to realize that she was being a shill for the fast food companies and Walmart, which exposed its true colors by dumping $500,000 into the No on 72 campaign today. (I have a sneaking feeling that she’s a single payer advocate). She kept on claiming that the demands of 72 would increase labor costs for school districts, and therefore lead to lay-offs. I think she meant that there are some employees who do not get health benefits from school districts (my guess is that they are the lowest paid employees like the janitors), and that by covering them they’d run out of cash. However, even if that is right for a school district it certainly isn’t the case for other employers — especially the fast food chains and the Walmarts who cannot move their stores out of state, but would be forced to pay more in labor costs and TA-DA reduce their profits in consequence. That’s why they are opposing 72, and it doesn’t take a rocket scientist to figure out that they’d rather have the taxpayer take care of their employees than do it themselves. Worse, particularly in Walmart’s case, it’s forcing its competitors here (Albertsons, Safeway, etc) into the same behavior, which will force even more costs onto the taxpayer in the future in the absence of 72. This is a straight fight between allocation of revenue to labor versus corporate profit for immobile service businesses, whatever a certain Harvard PhD student might think.

The advocate of Prop 72 was the ex-head of the CMA and the AMA, Richard Corlin, and he wasn’t exactly a whole lot better. He delighted in consistently saying that he didn’t want government regulation, and that this was a tiny incremental solution that only worked for a few people (1 in 6 of the uninsured). He’s right but that’s not a good thing! As per usual you can expect organized medicine to protect its own arse first, and to only move very modestly in the direction of helping the people it serves.

So why am I for Prop 72?

1) It levels the playing field between big firms that can’t move (notably Walmart and the other grocery stores) preventing an ugly race to the bottom

2) The additional cost will start motivating large and medium sized business to finally get on the right side of this issue, pushing them to look for a universal solution that includes real cost containment and real universal coverage.

3) At the margin, as a value judgment, 1 million poor working people getting coverage is better than Walmart and McDonald’s shareholders getting slightly bigger dividends.

Meanwhile, polls have this Prop dominated by the undecideds.

Postscript: I have replied privately to the non-reply to my point by the Anna Sinaiko, the author of the Health Affairs article, and as she’s just a doctoral student I’ll give her a little while to respond to my attack on her dismal science. Of course if I don’t hear from her soon, there may just be one more little article on this topic before Tuesday. And it wont be pretty.

POLICY: Interesting book out on Soc Sec, Titles 18 & 19

Liberal historian Mark Santow has written a book about Social Security, Medicare and Medicaid with his fiscal conservative dad, Leonard. I haven’t got through much of it, and it’s a 100 pager, not a 3 pager, but well worth looking at for you wonks. Here’s the link to the explanation, and here’s the full PDF. The full title is Renewing the “Promise of American Life”: Social Security, Medicare, Medicaid And Beyond.

TECHNOLOGY: Stent Wars

The NY Times looks at the ongoing battle between J&J’s Cordis and Boston Scientific’s drug-eluting stents. Since Boston Sci has recovered from its recall problems over the summer it has been really cranking out the numbers. It’s Taxus stent sold over $600m last quarter, comfortably besting Cordis’ Cypher and putting it on course to become the best selling medical device of all time–recall that if it gets to a $1 billion quarter, only 3 drugs sell more than that in the US. Cardiologists like Taxus because it’s easier to put in and apparently the problems with early openings are behind it. However, there are some indications that Cypher might actually have better outcomes.The main issue in stents is the restenosis rate, or in English, when you put the stent in, how long does it take for the blood vessel to become blocked again? It’s been a progression as first balloon angioplasty was used, then a bare metal stent and now a drug-eluting stent. But it appears that the restenosis rate for Cypher is better than that of Taxus.

The results of some early studies comparing the two stents were reported last month at a major conference in Washington of cardiologists who perform stent procedures. The studies included one in Korea comparing Taxus and Cypher with a control group that received a bare metal stent that was not coated with any drug. The trial focused on patients with longer blockages, or lesions, in their vessels than the average patient who receives a stent, and had a high proportion of patients with diabetes or other diseases that can lead to complications. While both drug-coated stents achieved far better results than the bare metal control group, various measures showed that Cypher patients had a third to a half as much regrowth of lesions as Taxus patients. And while the number of patients who suffered such extensive reblockage that they needed a second procedure was too small to produce significant results, those data also clearly favored Cypher.

It’s unclear what “far better results than the bare metal control group” means but I’d be very interested in the long term outcomes of this type of study. Recall that last year a Stanford group compared the long term results of those who had bare metal stents with those who had a CABG, and over a 10 year period the CABG group had much better outcomes at a much lower cost. So if the restenois rate for the DES doesn’t stay good in the longer term, they too might be a failure in health services research terms while being a huge market success. As with any technology assessment the attitude of the physicians on the ground is far more important than that of the academic wonks looking at longitudinal data sets. Meanwhile an earlier article in the NY Times questioned whether any of these surgeries–including CABGs–aimed at keeping arteries functioning were a good idea.

Researchers are also finding that plaque, and heart attack risk, can change very quickly — within a month, according to a recent study — by something as simple as intense cholesterol lowering. “The results are now snowballing,” said Dr. Peter Libby of Harvard Medical School. “The disease is more mutable than we had thought.”The changing picture of what works to prevent heart attacks, and why, emerged only after years of research that was initially met with disbelief. In 1999, Dr. Waters of the University of California got a similar reaction to his study of patients who had been referred for angioplasty, although they did not have severe symptoms like chest pain. The patients were randomly assigned to angioplasty followed by a doctor’s usual care, or to aggressive cholesterol-lowering drugs but no angioplasty. The patients whose cholesterol was aggressively lowered had fewer heart attacks and fewer hospitalizations for sudden onset of chest pain.

But really that’s what Dean Ornish has proved for years. With aggressive enough diet exercise and behavior changes, heart disease can be relatively quickly reversed. So does that spell the end for stents and CABGs and a trip to the breadline for cardiologists, cardio-thoracic surgeons and their suppliers? Well probably not. The level of change required to avoid surgery is pretty extreme. I gave a talk to Ornish’s group a while back and had the lunch they provided. I had to break out for a cookie run in the afternoon after the no-fat no-sugar experience was too much for my delicate constitution. In general Americans like this type of intervention over changing their lifestyle.

Their new stents, coated with drugs to prevent scar tissue from growing back in the immediate area, are increasingly popular among cardiologists, and sales are exploding. But there is not yet any evidence that they change the course of heart disease.”It’s really not about preventing heart attacks per se,” said Paul LaViolette, a senior vice president at Boston Scientific, a stent manufacturer. “The obvious purpose of the procedure is palliation and symptom relief. It’s a quality-of-life gain.”

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