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TECHNOLOGY: Tim Oren’s analysis of Sili valley development

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As  healthcare person connected to Silicon Valley by geography and osmosis, I’m always amazed why I don’t quite "get it" and hence why I’m not driving a Porsche, owning 6 houses and lying on the beach like some folks I know.  Tim Oren is a self-confessed Silicon Valley old fart Gray Beard, who really gets technology and writes the excellent Due Diligence blog. (I’ve argued with him about health care and he’s the only guy in the Bay Area who voted for Arnie but don’t let that put you off!). Tim’s recent post about how tech innovations come out of nowhere, "You never know where you’re going till you get there" is wonderful, and I just had to quote this line here:

    I served on the program committee for ACM Hypertext ’91 in San Antonio. We hold the distinction of relegating a certain prototype by a Mr. Tim Berners-Lee into the poster and demo track, since (as I recall the discussion), it didn’t present much theoretical novelty, and the user interface sucked. Well, it did.

Those of my health care readers who don’t know what this is referring to must subject themselves to the public ridiculing of asking me! But go read Tim’s article.

QUALITY QUICKIE: Another study on medical errors

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AHRQ, the Agency for Healthcare Research and Quality has put out another study on medical errors This one has a slightly different methodology than the IOM’s 1999 "To Err is Human" study. The researchers estimated that the study’s findings mean about 32,600 deaths result from various specifically defined medically-caused injuries in the U.S. each year.

The IOM’s estimates are of 44,000 to 98,000 deaths.  Some of the difference is due to the AHRQ’s methodology and choice of data set. (Here’s the abstract).  Their data set was much larger than those used by the IOM, and was based on administrative and billing data but didn’t include chart review.  The IOM study was based mostly on various other studies that included chart review.  In addition the new data focuses on "injuries" resulting from specific procedures and as far as I can tell doesn’t include adverse drug reactions, so the actual number of total deaths is likely to be much higher.

It’s also worth noticing that the attempts to find the truth in what’s really going on are hampered by the age of the data, and the type of data collected. But the direction in which all the data points is very clear. It’s dangerous in that big white building, and going into hospital can be very hazardous for your health.  Thankfully, from all anecdotal evidence I’m hearing about/seeing, providers are getting the message and are working on getting the CPOE systems, drug databases and workflow systems into the hands of clinicians.  Hopefully, this will mean that those error or "injury" rates will start coming down.

On a childish aside, if you check out AHRQ’s URL you’ll notice it used to be called the The Agency for Health Policy and Research. Think about that for a moment.  Shouldn’t research come before policy, you say?  Well they were going to name it that way until someone noticed it’s acronym would be AH-CRaP).

PHARMA: The orphan blockbuster costs $800m

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Forbes is pumping out a lot of interesting articles on the pharma market these days.  In an article called The Diagnosis For Medical Diagnostics they raise the issue of pairing diagnostics with drugs.  The basic problem is that as drug development becomes more specialized, genetic-based diagnostic testing pinpoints who the drugs will work for.  So the drugs will be more likely to work in those patients and have better results. This is a good thing! 

However, if we know who the drugs will work for, we’ll also know that the same drug won’t work so well for other patients. It’s likely therefore that newer drugs will only work for a smaller share of patients with any particular condition. For the drug to be profitable either the it must cost more per patient or less to develop.  The CEO of Genta quoted in the article doesn’t believe that the cost of drug development–the $800m in the title–is going to come down, which means that their drugs (and presumably many others) are going to cost significantly more per patient than currently available less effective drugs.  And as Jane Sarasohn Kahn mentioned in this recent post, "It’s not clear really who will be willing to pay for innovation". Given that patients are gong to want these new drugs, this leaves both the pharma cos and the rest of us with a big problem–particularly if Medicare is going to pay for drugs (uncertain, but likely) and seniors are going to vote (damn certain!).

PHARMA: Follow up to the Pipeline Post

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Health care expert and all-round wonderful person Jane Sarasohn-Kahn of Think-Health has some added thoughts about what’s likely to be happening inside the pharma industry to deal with the "pipeline problem" discussed in this recent post. Jane suggests you keep your eye on three related developments:

    1.  A lot more co-marketing agreements between pharmas (a la Bayer and GSK’s venture into Levitra, Viagra’s competitor for the moment)

    2.  Pharmas are looking to biotech for new formulations, but they’re also looking to smaller pharmas too for licensing deals.  This will be important over the next few years.  Obviously, biotech will be important in the longer term, but the juries are still out on so many very expensive drugs. We will be hitting the wall on who is going to pay for those expensive bio drugs, and I anticipate that will be a big area of contention.  It’s not clear really who will be willing to pay for innovation.

    3.  We can’t switch too many more drugs to OTC as allergy and GI were the low hanging fruit here.  We’ll get a bit more savings out of switches, but then you get into another category of drugs that really does require professional input — depression/mental health, migraine, anti-infectives (gotta watch out for resistance there and over-indulging the paeds population whose mothers aren’t patient enough when it comes to ‘watchful waiting’ over ear infections), cancer, HIV/AIDS, etc.

TECHNOLOGY: Follow up to Wireless Vulnerability

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I’ve been having a background email conversation with Lisa Williams who covers many medical blogs as part of her blog Learning the Lessons Of Nixon and kindly refers back to me. (Lisa does seem to think this is a blog just about scandals in health care. I keep trying to tell people that this is an objective blog about the entire health industry, but they’ll call it the way they see it, and there have been a few naughties lately!). Regarding my post on Wi-Fi security, Lisa writes:

    I was at a healthcare facility — a hospital which will remain unnamed — and found an unsecured wireless LAN by accident. It should be noted, however, that access to a LAN emphatically does not mean that you can get access to patient records.  Each system which does something for users — an email system, a database containng records, a billing system — may be connected to a network, but just because you’re on that network doesn’t mean it’s any easier for you to get into that system if you are not authorized to be there.  It’s sort of like houses on a road: Just because you can get on a street where there are houses doesn’t mean that you can automatically let yourself in to any house. It’s worse, even, because being on a computer network won’t give you the same cues that a system with data is nearby, the way your eyes will if you are walking down a street that there is a house nearby — you won’t know if there’s a door or where it is, or if you get there, how to open it. The example you gave regarding your own LAN only shows how unsecure consumer software is; most people don’t bother to have a password when they boot up their machine, and so, when connected to a network, that machine is wide open.  But almost any program in a work setting requires logon.  So, by all means, secure your network, but the best security is always provided at the "house" level rather than at the "road" level.

    It’s worth noting that workers in many healthcare settings do have Windows laptops that aren’t much (or any) different than what you or I have at home.  Would those contain personal information on a patient? What about email?  Sure.  I suspect the "big" systems that are central to containing registries of health data require *at least* password authentication, and have other forms of security.  The problem is securing PCs.  My husband works for a company that lets you configure hundreds of PCs over a network simultaneously.  Who are the biggest new customers? Hospital chains and HMOs.  Sure, they probably use it to install the latest virus patch, but I wouldn’t be surprised to have someone use it to say, Okay, everybody’s PC that we own here is going to have X security software and settings, period.   

    If the individual PCs aren’t secure, then wireless does increase the risk, because walking around with an ethernet cable looking for a jack in a hospital or doctor’s office is gonna attract some attention!  And sitting there with a wifi device isn’t.

I’d only add that the Laptop PC security management problem Lisa brings up will be expanded by the numerous PDAs and smartphones that will be making their way into clinicians’ hands in the next few years.

TECHNOLOGY: A surgeon as a futurist?

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Speaking as an ex-real and current hack futurist, this title disturbs me.  However, jumbled up in this interview with ex-Yale surgeon Richard Satava are a bunch of very interesting concepts. He discusses the potential impact of smart dust, radio-tagging (RFID) and remote telemetry, xenotransplantation, nano-technology and organ regeneration on the future of human health.  If after reading it you fell like someone threw a bucket of science-fiction technology water all over you, I recommend that you hop over to Robert Mittman’s Technology Foresight columns on the iHealthbeat site, which give you more measured and controlled sips of each concept. (You need to register but it’s free and there’s a wealth of stuff there–thanks Wellpoint!)

In particular take a look at the articles on smart dust, RFID, and nanotechnology.  Robert is a professional forecaster (rather than just playing one on Yale Medicine News) and delivers a more rational explanation of the pace of change within each technology sector–not that Satava’s vision isn’t a lot of fun.

QUALITY QUICKIE: Follow up to Kentucky nurse dismissals

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A cardiologist wrote to me about my post concerning the nurses fired for administering drugs without physician approval. The response suggests that there should have been standing orders, which sounds logical to me:

    In regards to intubated patients, 1) almost all ventilated patients have standing orders for either Diprivan, Versed, or Ativan; 2) these sedating medications are held prior to extubating patients; 3) in my experience, (for what it’s worth), patients who extubate themselves usually stay off the vent, either because they were ready to be extubated, or because they would rather die than be re-intubated. I don’t know why those nurses were disciplined. If they willfully ignored the MD’s order, they should be fired (unless the MD was grossly incompetent). If said MD did not given standing orders for Diprivan, etc, s/he deserves to be paged throughout the night.  . . . One other possibility:  the physicians were so incompetent, the nurses took it upon themselves to initiate sedation orders. But again, if standing orders were present, this would not be a violation..

TECHNOLOGY: Dump the stent, have a by-pass

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You may recall that when I wrote about the market for drug-coated stents, I made an off-hand remark about a Canadian health services researcher who told me that stents were a waste of money because, from a health services research point of view, you get more bang for your buck by just doing angio. Well it appears that some health services researchers–who are even smarter than the Canadians, because they’re at Stanford–have gone even further and concluded that drug-coated stent or not, bypass surgery is more cost-effective than angio! (Full disclosure: I went through the Stanford HSR program & I studied under/with three of the report’s authors. I don’t know anything about this research, but I do know that they are a hell of a lot smarter than I am).

The researchers built a complex computer model based on a study done 10 years ago comparing angioplasty with cardiac bypasss surgery. They built in corrections that made the data look as though today’s rate of stent use was used at that time, and adjusted for the improved impact of today’s stents.  They then looked at the outcomes and costs of follow-up treatment over the next five years. It turns out  that the five year cost was about the same and that quality of life was actually better for those who’d had the bypass.  In fact the advantages by the ten year mark were considerable.  Here’s a detailed press release explaining the study’s methods and conclusions.

Even more direct is what the authors say in the abstract:

    "Primary stent use cost an additional $189,000 per QALY* gained compared with a strategy that reserved stent use for treatment of suboptimal balloon angioplasty results" and they conclude that "Bypass surgery results in better outcomes than angioplasty in patients with multivessel disease, and at a lower cost".

Traditionally in this country, we’ve ignored health services research as it often tells us that less care is better care, but less care means less money to those in the industry and those supplying it. Here’s a case where something that costs a little more up-front and has its own constituency (bypass surgery) saves money and improves outcomes over the long-run compared to its more recently developed rival. If this was paid for by insurance companies that expected their members to be in another plan within two years, they’d be right to go for the cheaper option.  But in this case the majority of people undergoing these procedures are in one insurance plan called Medicare, paid for by you and me. And if they’re not in Medicare when they undergo the procedure, they will be soon enough when the added costs from recurring blockages that follow angio often require another procedure. So it’s not unreasonable to expect that the folks at CMS are reading this study too and may start taking a long look the use of stents. Prepare for this study to be widely ignored by the stent industry who right now I’m sure are working on their own research to refute it. $5 billion will not go quietly into the night.

*QALY is Quality Adjusted Life Year–a measure of life expectancy that takes into account the patient’s health, so that a year lived in good health is valued more highly than one lived with serious health conditions restricting activities of daily living or requiring significant medical care.

PHARMA: The pipeline needs filling

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There’s been substantial worry in the pharma business about the future of the pipeline–and rightfully so.  More than any other business, pharma companies tend to rely on one huge hit, and the spin-offs from it, rather than a steady stream of new products. The recent round of consolidation in which Glaxo and Pfizer got much, much bigger was in part an attempt to diversify their portfolios by acquiring other blockbusters, and also an attempt to make the overall corporation less vulnerable to the patent expiry of others.  As I wrote about a while back, the specter of Claritin’s disappearance removing billions in revenue off Schering Plough’s income statement haunts all pharma CEOs’ nightmares.

So how does the potential pipeline look for the latter part of this decade, when many of today’s blockbusters come off patent? Well according to a Datamonitor study quoted in this Forbes article, Pfizer has 5 potential biggies with a guestimated revenue of up to $5 billion in 2008.  GlaxoSmithKline (GSK) has only one with estimated revenues of only $700 million. Pfizer’s 2001 sales in the US were $17 billion, whereas GSK’s were $15 billion.  So it appears that GSK is more likely to be doing what it can to find more ways to fill its pipeline. Expect more activity in both big pharma M&A and looking to biotech to fill the pipelines from the big players in the next year or so.

For a good general report on the pharma industry from (believe it or not) the CMS, click here.

TECHNOLOGY: Wireless vulnerability

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According to AIS’ Business News wireless networks can create major HIPAA vulnerabilities.  This seems obvious but if the network is not secure and doesn’t require authentication, anyone within range can get on the network and with a tiny amount of knowledge get into other computers on the network.  Of course that’s a huge security vulnerability. That’s well known. 

Let me give you an example not in health care but very close to a home I know well–mine.  I have wireless LAN in my office on the ground floor. To get onto my network you need to know an authentication code, so it’s very secure.  But upstairs in my house, while my LAN doesn’t go up through the floor, I can pick up no less than 4 other networks in my apartment building, for which you do not need an authentication code to get on.  Last night I was watching the baseball and (I guess illegally) using one of those networks to post on my blog.  I then shut off Explorer and email and was working on a word document (while Oakland decided that it was time for a Red Sox/Cubs world series). I then got a call from my neighbor.   My computer was still active on his wireless LAN, he had found it on his network and had found out who I was by poking around in my files, called me up and asked to get off his network!  So as an amateur "wardriver" my computer was vulnerable too.

So given the number of people who like me use other people’s LANs in an unregistered/illegal way, how many clinicians are exposing patient information without knowing it?