So I spent part of yesterday at the HIT meeting west in San Francisco.  The most amusing session has Molly Coye  pretending that she’s the governor, and apart from the wisecracks about steroids and occasionally forgetting that she’s supposed to be pretending to be a Republican, there is some serious discussion of how information exchange between systems in California might work. This is the creation of the RHIO (regional health information network) to get to that mythical state of  inter-operability.

The CMA rep (Jack Lewin) believes that his members–all those poor solo surgeons struggling by on $200K plus a year–can’t afford EMRs or any inter-operability and shouldn’t be given an unfunded mandate to get on it.  In fact he thinks that if a RHIO made health plans better off due to the elimination of duplicate testing, then they should be taxed $25 per head to pay for all this.  I don’t think that Arnie Milstein (Med Director of PBGH) representing the employers. They are not too interested in paying any more than "their fair share". On the other hand Bob Margolis (CEO Health partners, the second biggest group in California with 1,000 docs) thinks that the state and Federal government should just piggy back off the private efforts.  In other words let Health Partners connect to Kaiser and hope everyone else can hang on. No reason for those two to slant it to their advantage, is there?

Well at least they are all talking about business models and there does seem to be some agreement that there is money to be saved, at least if anyone’s information was available when they showed up in the Emergency room. So that may be a place to start, as it appears to be in Indianapolis, but while (as Jeff Rose says) at the end of the day people want to do a good job, waiting for that to happen may take a long long time if no one’s funding the inter-operability. In fact in Santa Barbara there are, after all that time and money from the CHCF, only 50 odd doctors are on the system.

David Lansky (Foundation for Accountability) on behalf of consumers pointed out that the industry is getting $10,000 a year from each consumer and yet it hasn’t got enough money, wants more….and the industry is having the meeting about moving the consumer’s data around without telling the consumer about it! (The only funny line so far!). He wants consumers to get a seat at the table, and wants the product to serve the public more than the industry.  Plus he wants privacy and auditability, and for the info gathered to used for report cards, quality and who to go to–in other words accountability! And he warns that if industry does this without the consumer, then the consumer will torpedo it later (shades of the backlash against managed care).

So how to move things ahead? Jeff Flick from CMS likes demos, like the small and hard to find (unless you know how to spell it) DOQ-IT program. He also likes putting up data for consumers — Medicare has done it for nursing homes and home health. Their comparative data is changing behavior and being accessed by consumers, but at the moment they don’t have the data for the rest of the system, especially doctors.  In the end though he thinks that a successful RHIO will allow access to that data —  another good reason for providers to resist it.

Jeff Fickenhaser (ex WebMD now CSC) says that to get RHIOs to work you need a) organization — all sides at the table inc payers and providers, b) leadership, c) clear sense of where the money will come in and where the value is created, and d) the data has has to be transparent.

It all sounds very like a CHIN meeting in the mid-1990s  I hope it has a better outcome, but I still see no reason why it will. There doesn’t seem to be any common ground and there doesn’t seem to be any money or business reason to do it. And that’s not my idea, it’s what David Brailer himself said at the last HIT conference out here.

BONUS : Great quote from Arnie Milstein"My aim is to change the direction of begging"

(That is begging from medical directors and quality people having to beg physicians to get involved to the other way around because the market is going to punish them if they don’t)

I’ll be at the HIT West conference later today hopefully with a little live blogging if things go well.  But meanwhile two articles over the weekend persuaded me that plus ca change plus c’est la meme chose in the wacky world of American health care.

15 years ago I wrote a thesis on the spread of laproscopic cholestectomy (gall bladder removal), which replaced both the conventional surgical method and a sound wave machines called a lithotripter to blast the gallstone. Lithotripsy didn’t actually work in that the gallstones tended to reform later.  Lap choles did work, and were self-evidently better than laparoptomy (surgical dissection and removal).  But in the case of a new surgical technique or procedure, there is no clinical trial required before it hits the market. Lap chole was popularized by a Tennessee surgeon called Eddie Jo Rickett.  In his heyday in the late 1980s, he was teaching other surgeons how to do it 50 week for a couple of grand a time.  He made so much money that (if I recall rightly) he quit surgery and became a country and western singer. Of course everyone had converted over to lap choles without any big clinical trial, just as lots of hospitals had bought million dollar lithotripters who’s main use a couple of years later was as a doorstop. Meanwhile the quick spread of lap choles also produced some real horror stories.

A decade further on not much has changed.  Today’s trendiest surgery is bariatric bypass (or stomach shrinking).  You might think this is pretty rare but there were over 150,000 done last year in the US including weather man Al Roker. However, just like lap choles and anything else that’s spreading fast, there’s not really any good trial data that shows it’s an effective treatment in the real world.  This fascinating and long article in the St Louis Post-Dispatch shows that like lap-chole and laser eye surgery, bariatric surgery has become a cash cow for some hospitals, and a stampede of surgeons learning the technique has massively increased its use.  Of course the backlash is starting and patients including former proponents of the surgery are starting to come forward with a litany of complaints, and many professionals and facilities are either getting out of the business or are starting to offer repairs on the shoddy work that’s being done. The article starts with this grim story:

She dropped from 302 pounds to 126 after her gastric bypass surgery in 2001. Since then, she’s become a strong advocate for other patients,
providing encouragement and advice to hundreds who have had weight-loss
operations. She arranges visits to the hospital rooms of people just
undergoing the surgery. From her home in Cincinnati, she runs a support
group called "Midwest Losers." Her work was honored with an award last
October at a national surgery trade show. But she’s paid a price to be thin: Five surgeries in four years for
related problems, including two hernias and three small bowel
obstructions. She was just diagnosed with a crippling vitamin
deficiency.She’s 41 now. She wonders how much more her body can take. "I’m second-guessing everything right now," Pierce said recently. "Is this what I have to look forward to the rest of my life?"

The point is of course that these surgeries spread in an uncontrolled fashion.  While there’s been plenty of criticism of the FDA, there just is no equivalent body demanding a clinical trial of surgical procedures, and any government agency that even dares to suggest such a thing needs to be wary of the fate of the AHCPR which fell foul of some Texas back surgeons in the mid 1990s and damn nearly was killed off by the surgeons’ friends in the newly Republican Congress.

The only time that surgery tends to get a clinical trial is if Medicare does one (which is rare) or if it involves a medical device regulated by the FDA. That’s just happened in the case of the drug eluting stents (DES).  A new study shows that the DES (Taxus from Boston Scientific and Cypher from J&J’s Cordis unit) both are much more effective than bare metal stents. (Incidentally both stents worked equally well and a new one from Medtronic coming on the market next year did just as well too. In any other industry you might expect a price war, but here don’t hold your breath)!
So at least there’s some good news that the trial proves these things are helpful.  But let’s consider two things.

1)  Virtually anyone who needed a stent was already getting a DES. Even despite the manufacturing problems both major stents have had and an entire recall of the Taxus stent last year, their use has been growing like crazy and they are the dominant treatment of choice for early stage heart blockages.  All this happened well before any clinical trial results came out. So what was the point of the trial? I guess it was like phase IV post market surveillance in the drug world.  But if the results had been bad, would it really have stopped Taxus and Cypher in their tracks? I doubt it.  Why? See reason number two.

2) Because the trial is comparing DES to a treatment that is known to be pretty useless.  The Bare Metal Stents have a high degree of re-occlusion. In other words the arteries they are placed in clog up again anyway. In late 2003 a Stanford study showed that that stents were less cost-effective than traditional by-passes. So the real challenge for the DES is to prove that over time they are more cost-effective than CABGs.  Do you expect to see that clinical trial any time soon? Nope, neither do I.

So 15 years on from the lap chole and lithotripsy story, we still don’t have anything like the clinical controls over new types of surgery that the FDA imposes over drugs.  And you may have noticed that some grumpy people have been complaining that the clinical trial and surveillance system for drugs is too lax!