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QUALITY: Pain, its treatment and hope amongst the insanity

I won’t rant on about it, but the DOJ headed by theocratic fascist John Ashcroft has declared war on pain doctors. For much more take a look at the Pain Relief Network’s site. And the arrest, imprisonment and career destruction being meted out not just to “outlaw” doctors but those in the forefront of science on pain relief has a visceral effect on how pain is treated for patients across the board. For a gut-churning example of how much pain rational intelligent clinically-educated patients are forced to endure by the system, see this article on the treatment of “My Left Lung” by nurse and patient Richard Ferri.

But slowly the tide may be turning. In an article titled Must We Die In Pain? the radical commies at Forbes note that little progress has been made yet.

In 1995, a group of researchers funded by the Robert Wood Johnson Foundation published a shocking result in the Journal of the American Medical Association. At some of the nation’s top medical centers more than half of cancer patients passed away in serious, uncontrolled pain. But guidelines from the World Health Organization indicate that 85% to 90% of cancer patients could have their pain controlled by oral medications. It seemed like a solvable problem. The Wood Johnson Foundation and the Soros Foundation were among the groups that worked on trying to improve the care of the dying. (The Soros Foundation’s Project on Death in America spent $45 million on improving end-of-life care.) What do we have to show for it? Patients still die in pain. A recent study by Joan Teno at Brown University found that of patients in nursing homes with excruciating pain, 42% were still suffering after a second assessment.

But,(as certain politicians might say), hope is on the way. First, there is greater awareness among clinicians of this issue than there was some years ago, and the realization that pain patients are almost always not the same as recreational opiod addicts. In fact a relatively dispassionate reading of the data suggests that almost all deaths from Oxycontin abuse come in conjunction with other forms of substance abuse and have nothing to do with pain management patients. Second, there is better awareness among physicians of alternatives, especially for the dying:

Doctors don’t always know about alternatives to narcotics. Raymond Gaeta, director of the Stanford Pain Management Service points out that a whole host of treatments exist. One option is anti-epilepsy drugs such as Neurontin from Pfizer (Note: which as described elsewhere in TCHB is dramatically growing in use) and Topamax from Johnson & Johnson, which can ease the pain of nerves damaged by chemotherapy. When these medicines don’t work, there are local anesthetics, and drugs delivered directly into the spine by pumps such as those made by Medtronic. These pumps are expensive–costing some $10,000 per patient–but Gaeta thinks they’re worth it, even for patients who only have a month to live. Doctors also can simply surgically destroy nerves, preventing the patient from feeling any pain.

Third, much of the fuss about pain and the DEA and DOJ’s draconian assaults on pain doctors have to do with Oxycontin, and the ability of addicts to somehow break down its slow release mechanism to use it for a heroin-like high. At least one company, Pain Therapeutics, has two drugs in clinical trials designed to deliver Oxycontin-like pain relief without either the high or the addictive side effects. One is designed to reduce the addictive qualities of the opiate, and the other is designed to prevent abusers from breaking down the slow release mechanism. (Disclosure: I own stock in Pain Therapeutics. Do your own DD but obviously I think it’s a winner) Whether or not these drugs work, there is clearly a market for making a safe and effective, non-addictive pain killer, that will hopefully send Ashcroft’s goons into retirement–although hopefully he’ll beat them to it in January.

Finally the DEA and several consultants from academic medicine came up with some pain medication guidelines, that hopefully will make physicians more confident in their ability to use opiates without feat of arrest and professional suicide. Let’s hope that the “enforcement” side of the agency is kept on a shorter leash now that the “drug” side has created these guidelines.

POLICY: Apparently health care costs real money (and yes, more on CDHPs)

The NY Times has an article on the shocking fact that increasing health care costs actually cost actual money. Apparently it costs businesses so much in additional health care costs to hire new (especially older) workers that they are hiring fewer than they would if health care costs were lower. And of course instead they’re hiring contract workers and sending jobs overseas.

Well it’s good to find out that the laws of economics are reported in the paper, so they must be true. In this case they are. Real wages in this country have barely budged upwards in the past 30 years. So what has gone up and been responsible for our increase in “wealth” over that time?

a) Working hours. Not only has the work year increased by about 10% over that time, but more importantly millions of women have entered the labor force and most families now need two incomes to keep going.

b) Productivity and technology: Which now means that you can buy a throwaway digital cameraphone that somehow you managed to get by without in 1973. It also means that a whole stack of stuff costs less (consumer goods) meaning that overall those real wages buy slightly more than they did, even though some things like education, housing and healthcare cost more.

c) Profits. Corporate profits have gone up faster than wages (especially in the last few years). The Marxists amongst us would note that this means that the share going to capital is rising faster than the share going to labor, particularly as stock ownership is still dramatically concentrated in the upper income groups.

d) Health care costs. Years ago I had a chart showing that the level of real wages was flat over 20 years while the increase in the healthcare cost part of total compensation went up over 200%. For a brief while in the mid-late 1990s the health care part of that equation settled down and real wages even went up a little. But now we are back in the old pattern. I don’t have the chart anymore, but if someone clamors hard enough I’ll figure out the numbers. Suffice it for now to say that health care costs are really eating into total compensation, and as HSC showed the other day, this is leading directly to fewer people getting health benefits at work.

So what to do about it? Kerry seems to care about the fact that health care costs are now getting through to consumers. Given that he barely mentioned this issue in years in the Senate, and now as the NYTimes says he’s raising it on every porch in middle America, methinks that his pollsters have told him that swing voters are feeling the pain. Bush doesn’t care and has no answers other than laughably and disingneuously saying that malpractice reform will solve the health care cost explosion, and promoting HSAs. Kerry’s solution is to basically make the government the insurer of last resort for catastrophic cases and force a pay-or-play solution on employers. Even if he wins (which I think now looks likely) and the Democrats retake the Senate (unlikely) the plan has little more than zero chance of becoming law this time around. It will however linger for the next time we have this serious national debate, which in my guess will be in the 2008-2012 time period.

Meanwhile, Karen Davis, radical commie and President of the Commonwealth Fund has made available the entire issue of Health Services Research that focused on CDHPs. THCB readers may remember that it had some surprising articles in it, not the least of which was health plan Humana’s research on its own internal CDHP which showed that it cost the employer (itself!) more than keeping its members in its standard plan. Davis has an excellent discussion of the research behind what the Canadians call user-fees (long version – short version) in which she points out that the RAND experiment back 25 years ago showed that increasing the actual cost of going to the doctor at point of service reduced services delivered to those patients. Of course you can read that two ways depending on whether or not you believe people use too few medical services or too many. But the key point that Davis makes is that the best way to improve quality (i.e. get the correct amount of services to patients) is to increase incentives to providers to do the right thing. She’s arguing for pay-for-performance, better use of IT, public reporting of cost and quality data, national EBM standards and a whole lot more spent on researching these issues at AHQR. And of course while she’s preaching to the choir as far as I’m concerned, it’s interesting to note that a version of these things appears in the Kerry plan too.

PHARMA: A great look at how a prescription drug gets marketed

Of all media sources you don’t usually expect in depth, balanced features from USA Today. But Tuesday’s USA Today has an excellent article by Julie Schmit on how Warner-Lambert (and now Pfizer’s) Neurontin went from being a minor epilepsy drug to a major CNS blockbuster. In 2004, the last year before it goes off patent, Neurontin will do over $3bn. Not Lipitor, but a pretty respectable number.

The answer is that Warner-Lambert promoted the off-label use of Neurontin from 1994, when it was introduced, to 2002, when it was given an additional approval for pain from shingles. The story:

Warner-Lambert’s offense was marketing Neurontin to doctors for purposes other than as a supplemental anti-seizure medication for epileptics. That was the only use approved by the Food and Drug Administration during Neurontin’s early years, when prosecutors say Warner-Lambert’s illegal marketing took place.

The Justice Department says that’s what Warner-Lambert did from shortly after introducing Neurontin in 1994 until 2000. Prosecutors alleged that Warner-Lambert lied to doctors about the drug’s effectiveness, paid doctors to allow a sales representative to sit in on sessions with patients and paid doctors, some up to $250,000, to unethically talk up Neurontin to other doctors. In fact, the list of ailments that Warner-Lambert claimed Neurontin alleviated was so long — covering pain, headaches, bipolar disorder, attention-deficit disorder, alcohol detoxification — that some Warner-Lambert employees dubbed it the “snake oil” list, government documents say.

The strategy worked. In 2002, 94% of Neurontin’s sales were for off-label uses, up from 40% in 1995, the government estimates, citing company documents and independent market research. Wall Street firm Lehman Bros. estimates that 90% of Neurontin sales are currently off-label

So Pfizer, having got Neurontin as a side dish to what it really wanted (Lipitor) when it bought Warner-Lambert, inherited the good and the bad with it. By 2002 the horse had left the barn and Neurontin was being prescribed for virtually anything that doctors and patients felt it might work for. Now that’s not necessarily a bad thing, and its very common. As PhRMA likes to point out, the FDA tends to be over cautious, but the same drug works differently for different people, and if a drug is doing some people some good who’s to blame them for using it and doctors for prescribing it. As one quoted patient says: “If it doesn’t work, then why do I feel better?”.

But that’s exactly the same argument made for medical marijuana. And while DOJ is massively over-zealous in enforcing its perception of the law in that case (at great cost to patients and society), fining Pfizer $430m for violating marketing practices over 8 years (although the admission is only up to 1996 not 2002) on a drug which is probably dropping more than $2 billion to the bottom line this year is not exactly vigorous retribution. But that is the typical state of play. It’s how the pharma business has worked for a long time and it’s unlikely to change any time soon, even if the DOJ chief’s name in February 2005 is Spitzer.

PHARMA: Is this the best they’ve got?

So after Marcia Angell rips the pharma industry a new one in the LA Times last week, the official comeback from Alan Homer, President of PhRMA is nothing short of pathetic. Is this really all that big pharma feels it needs to respond to? Go after her credibility (as Atlas did in THCB last week). Go after her facts, if you can. Or do something positive. Try to explain how drugs have reduced other health care costs over the years, and how they’ve improved life expectancy and that we have to pay for that. But apparently the only thing that Holmer can come up with is that his mom had fewer side-effects on a me-too? That absolutely justifies the sixth statin on the market to rise in price by 15% each year.

I don’t know if they can’t do any better or if they just don’t care what people think of them. Maybe the tobacco companies’ place at the bottom of the reputation list isn’t safe after all.

QUALITY: The VA, Managed Care and care management

Navigate your way over to DB’s Medical Rants to read Robert Centor on the VA doing better than managed care plans in a study of care for diabetics. Here’s the AP Version and the study abstract. Essentially back in 1998-9 the VA’s diabetics got statistically better quality care than a matched selection of patients in managed care plans. This tends to make me believe that there’s still not that much care-management going on in the general “commercial” population.

Now the “managed care” population is not a homogeneous blob. You can’t tell which plans these patients were in from the article, but some were in Hawaii and Northern California (where Kaiser is 50% & 30% of the whole market respectively) while others were in Indiana, which basically never had any managed care. So my suspicion is that the rates of care is a factor more of the delivery environment than the type of insurance coverage. But nonetheless, hats off to the VA for this care. (Right, that’s enough praise for that evil socialized medicine….)

However, some of the uglier traits of “Managed Care” (such as utilization review and physician hassling) which were dying out in the late 1990s (the time analyzed in the study) are apparently making a slight comeback, according to this recent HSC report in Health Affairs. There’s even the odd case of care denial that makes me fell that we’re back in 1996, such as Cigna recently doing a flip-flop after denying payment for an experimental procedure. I’m almost expecting $93m judgments against Healthnet with Mailk Hassan making cameo appearances in stretch limos and Time magazine.

I just get the vague sense (based only on anecdotal observation) that the DSM/care management trend is becoming slightly more important again for health plans. But it’s nowhere near as important as getting rid of the bad risks up front, as Aetna has shown its shareholders. Is there a real trend towards care management from health plans? Or is it just medical directors talking shop over at the DM Forum? Comments on a postcard please!

BLOGS: Off-topic, THCB predicts future! Craigslist….

A few weeks back I suggested that eBay or Knight-Ridder may be concerned about the way Craigslist is eating small ads. Last Friday eBay bought 25% of Craigslist. So my “prediction” was in some ways correct. Interesting deal though. Craigslist is basically an anarcho-syndaclist commune posing as a small privately-held company, and they have made only a very little attempt to cash in on their success (the only charges are for job ads in SF, and NYC). So in a sense it’s a success story of the old Internet strategy of “get the eyeballs then ramp up the prices,” without ramping up the prices much–although my sources there tell me that they get so swamped with New York apartment brokers that they might be next ones to get a bill! The deal came about because a partner and minority owner no longer working there wanted to cash out, and rather than get a new minority owner who they didn’t like, the management team basically steered the deal to the (hopefully well-behaved!) eBay. BTW Happy birthday Jim, and thanks Susan.

PHARMA: More on the ethics of reimportation and all that, with new contributor Atlas and a cameo from The Veteran

Well the radical communist moderate social democrat nature of this blog has been somewhat shattered by recent contributors, and this post continues that trend. Mark McClellan (the ex-FDA commissioner and now CMS head), Cato and more radical wingnuts libertarian think tanks like the Institute for Policy Innovation (founded by ex-House GOP leader Dick Armey and funded by corporations, the Scaife family and the rest of Hillary’s VRWC) continue to think that the problem is that drugs in the rest of the world are too cheap. IPI’s latest press-release claims that prices in Canada ought to be 82% of the US level but in fact they’re only 59%. So they think of course that Canadians should voluntarily increase their payments by some 35%. I assume the IPI also thinks that WalMart should start paying its suppliers a ton more every year, or is using your purchasing power only OK if you’re in the private sector? For that matter I don’t think WalMart lets its suppliers get away without innovating, but they certainly don’t let them raise prices to do it!

While espousing the same general view, new THCB contributor Atlas turns his rather entertaining guns on the motivations of Marcia Angell and her colleagues at the New England Journal:

Marcia is no angel when it comes to this. She and fellow traveler Arnold Relman have been biting the hand that fed them for years. The NEJM, unofficial voice of Man’s Best Medical School (Harvard) and Man’s Best Hospital (Mass. Gen.)(reference: Samuel Shem, House of God) is perhaps the only paid subscription medical journal with a circulation of 130,000 plus physicians. However it has for many years accepted pharmaceutical advertising support. Yet somehow it has managed to maintain Brahmin-like integrity and the respect of physicians worldwide. So it is for many of the physicians condemned by Angell. If not, why publish them? Shills don’t make it through peer review. If the pharma companies don’t subsidize these studies, who will? The government, of course. Talk about mega conflict of interest! What incentive will a weasly, rationing American National Health Service as Angell and Relman and fellow Brahmin Kerry advocate have to publish objective research about costly new therapies? and how will NEJM keep its sub price affordable when the only ads they get are PSA’s from their new patron, Uncle Sam?

Ah, the road to serfdom is paved with fool’s gold, and Ms. Angell and Mr. Relman are skipping along it hand and hand, off to meet the Wizard in the worker’s paradise. Wait until they meet the man behind the curtain. He will make Big Pharma look like Dicken’s old Fezziwig compared to Uncle Scrooge

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Now Atlas points out a very big dilemma–how can journals remain objective while taking money from those they are reviewing. Really only Consumer Reports (with its no advertising, subscription only model) can claim that level of objectivity. Funnily enough the issue is one that I found in an email sent to me from The Industry Veteran late in 2003 (hitherto unpublished in THCB). Concerning the then controversy about Crestor and The Lancet, and in response to a suggestion that the Lancet was attacking A-Z’s Crestor purely on the desire to cuddle up to Pfizer The Veteran wrote:

I don’t for one minute think that the Lancet’s editors are impervious to the pressures of their publishers, and Reed-Elsevier’s business ethics are similar to Tony Soprano’s. Saying that, it remains a fact that only a fool would believe an unscrupulous company always takes the rotten course of action. If the editors are mere henchmen for a corrupt publisher, then I have to question why a company with so many business entities dependent upon the promotional spending of pharmaceutical manufacturers would go out of its way to antagonize a drug maker with an announced $1 billion promotional budget for its Crestor launch. Prestige journals such as Lancet and the New England Journal, and thought leaders in academic medicine, earn their money in the manner of whores by going to bed with every big spender they can. Reed-Elsevier can squeeze more ad pages out of Pfizer for Lipitor and Caduet (as well as Merck/Schering for Zocor-Zetia) in the event of a lavish Crestor splash rather than in the absence of one. Of course Noam Chomsky (and David Hume way before him) is correct in pointing out that the media manufacture consent. That just means we have to rely on diverse outlets and know how to read them instead of thinking reflexively and without context.

The careful TCHB reader may notice a strange confluence between Atlas’ and The Industry Veteran‘s views on medical journals. I assure you that these are two very different people but it warms the cockles of my heart to see that cynicism is very much alive on the right as well as on the left!

QUALITY QUICKIE: Seniors on the wrong drugs–Medicare & doctors on the wrong incentive plan

Two amazing articles in the NY Times in recent days show that–as John Mattison from Kaiser told me in 1996–although we know what to do we don’t know how to do it. First off a study of a PBM’s database containing all prescriptions written in 1999 for 765,423 patients over 65 found that 21 percent of the patients had at least one drug on a list of drugs potentially dangerous for seniors, and that half those prescriptions were for drugs considered to have the potential for serious adverse effects. (Here’s the California Healthline link with more details).Then we come to Thursday’s NY Times article about the long-term failure of what appeared to be a successful disease management project in Washington state–again because the incentives were in the wrong place. I think that the way Medicare (and other insurers) set up their incentives is mostly to blame. But The Industry Veteran has a more familiar foe in his sights:

Now believe it or not, fixing this isn’t that hard. In the bad old days of HMOs–the early 1990s–Friendly Hills medical group and others in southern California would get all their senior patients into a brown bag lunch, tell them to bring all the pills they were on, and then pharmacists would basically go around the getting the patients off all the drugs they shouldn’t have been on at all or ones that counteracted each other. And this was prior to computerized pharmacy records! Why hasn’t this spread (other than Caremark/Medpartners buying and destroying Friendly Hills in the mid-1990s)? Well Medicare doesn’t reward that activity, but it does reward the multiple visits to doctors to get multiple scripts. And even though doctors know that this is both bad medicine and a safety risk, there’s been no national movement to do much about it.

The subdued, temperate mice in healthcare analysis (I think he means me!–Ed) consider me entirely too hostile because I refer to physicians as Mafiosi and whores, but here’s an article from Wednesday’s NY Times that should elicit temperate responses only from corpses and theocratic fascists. Written by Gina Kolata, a groupie for anything in a lab coat, the article discusses a pilot program, called a "shared care plan," that Medicare ran in Washington state among people with concomitant diabetes and CHF. The program has two components: greater access to medical records via IT and the use of non-physician, clinical care specialists.

To paraphrase the gist of the article, physicians, patients and their families have access to a patient’s computerized medical records. This allows patients to note changes in their reactions to medications. Every physician in the geographic area can access the updated medical records. Then the clinical care specialists serve as personal assistants to severely ill patients, going with them to doctors’ offices, being available by cellphone to answer questions, and teaching them to manage their diseases. The program has reduced doctor visits and medical complications. Patients with diabetes have lower glucose levels, those with congestive heart failure have remained stable instead of getting worse, and third-party payers such as Medicare save money. Therein lies the rub. Participating in the program costs each doctor in the group $500 a month over four years for the electronic medical record system while other innovations, such as group office visits and e-mailing with patients, receive poor reimbursement, if any. As a result, physicians say they will refuse to participate in the program after the pilot ends.

Hell, we don’t need John Kerry to replace George Bush, we need Harry Truman to draft these Mafiosi physicians into the Army. Then they’ll comply!

As you know as a subdued temperate mouse I’m a sucker for those nice doctors but on the other hand, doing demonstrably the wrong thing because it pays better doesn’t appear in in the version of the Hippocratic oath I remember. So this is a clear case where Congress needs to step up, and in a bi-partisan fashion institute both pay-for-performance for Medicare to get us away from the FFS treadmill and hold hearings to shame the AMA and the rest of the "Mafiosi" into doing the right thing, right away. It’s been long enough.

BLOGS: Happy 1st Birthday to THCB and Hi to Genny

One year ago today I started THCB not knowing what to expect. The first post was about What’s wrong with Medicare and it still rings true one year, and one massive political fight which resulted in the MMA, later. In fact yesterday’s article in the NY Times about the failure of a "successful" Medicare disease management experiment in Washington state confirms my very first post’s contention that financial incentives in Medicare are set up the wrong way. More on that tomorrow.All these improvements are the work of Genny Pham-Kanter, who is THCB’s first ever blogmeister. Genny is a very talented PhD candidate in Economics and Sociology at the University of Chicago, who just to make sure that she’s really overqualified also has graduate degrees from both Cambridge and Harvard. As she gets the site under control you’ll also be seeing posts from her, and she’ll be taking over some of the back and forth with contributors. So please make her feel welcome!

I’ve enjoyed writing the blog and most especially have enjoyed meeting via email (and in real life in some cases) a whole group of new collaborators and sparring partners. Thanks for reading, thanks for emailing, and thanks to everyone who contributed. I’m looking forward to another year.

And in that new year I hope THCB will continue to improve. You may have noticed a big improvement in the layout in recent days, and there’s more to come in making the site more user-friendly and easier to navigate. Included in these improvements, and coming soon (at long last) will be a topic index which will make it much easier to find particular posts, or all posts under a certain heading. If you have any suggestions please email me.

PHARMA: A riposte to my crack about pharma, software and auto R&D, by Terry Nugent

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Terry Nugent, who’s a frequent contributor to the Pharma-Marketing list serv was not too impressed by my recent post about Cato and how pharma companies might have to live in a world where their margins were much smaller but they still had to do real research: He writes:

Ironically, Cato has hoisted the industry on the Republican free trade petard. However, there are a few caveats to your comparison to the high tech and auto industries. In the case of the former, copyright protection is a powerful moat to competition (e.g., Microsoft: there’s no generic Windows to separate Bill Gates from our $50 billion). In the latter instance, what’s missing is profits (as evidenced by the dismal PE ratios of auto stocks). The automobile business market is almost as unsustainable as the airlines’.

Unrestricted reimportation has some substantial downsides, including the inevitable counterfeiting that has already come to light to an extent that surprised even industry friends and allies. The pharmaceutical industry is probably the best generator of the high wage, high tech jobs its critics claim to champion, which reimportation will in effect outsource.

Profit diminution will inevitably reduce investment capital in what is a notoriously risky business. Already, pharma PE ratios are lower than their historical levels due to shortened patent windows, litigation exposure, and a clear and growing public policy hostility that amazingly lumps the cure with the cause by putting big pharma in the same docket as big tobacco, hounded by the dogs of demagoguery and the trial bar.

Prices may go down, but at what price to our progeny, much less ourselves? Our unborn children will be the ones to suffer from the absence of undiscovered drugs, aborted by the shortsighted "savings" that are the price of populist politicians’ purchase of power.

Believe it or not I’m not entirely unsympathetic to the pharmas on this issue. They live in an odd industry, where production costs are low and market entry is relatively cheap once the IP is known and exposed (unlike autos), installed bases don’t count for much (unlike operating systems) and where they do only have a few years to make the huge profits before those revenues go away (a la Claritin whose demise almost destroyed Schering Plough). But over the last decade the bigger pharmas via mergers have become more like other corporations that have the diversity to survive the disappearance of one product line or another. And their profitability is such that it can’t go up much more, and their sales and marketing expenses can certainly come down. And like it or lump it that will have to happen, lest they provoke that excessive demagoguery that Terry fears or worse that intervention from populist politicians.

And I tried to promise Terry that I wouldn’t mention the fact that the auto manufacturer’s profits would be much higher if they were paying Canadian prices for their employees’ drugs. But I failed!

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