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QUALITY: Hospitals remain dangerous, but talking about the issue makes them safer

I saw Michael Millenson doing Grand Rounds at UCSF last week. Michael, who has been mentioned in THCB a number of times, is a former journalist who has become something of a "bete noir" to organized medicine–or at least would be if they paid him any attention. While the AMA debates not offering care to trial lawyers, Millenson continues to point out the general "Silence" of leading medical organizations on the medical safety issue. The case he discussed at the UCSF Grand Rounds concerned a woman who’d had a double mastectomy for breast cancer that was later found to be a case of wrong identity on the pathology slides. The case was used by trial lawyers responding to Bush’s attacks on them over malpractice caps. Of course the AMA and its political allies have plenty of other human interest stories of counties where there are no obstetricians/brain surgeons/pediatricians because of the cost of malpractice insurance.

However, this fight between the lawyers and the doctors continues to miss the point, which is that we are a long way from achieving widespread use of evidence-based medicine. One little thing that might help is the "signing" of body parts by the surgeon prior to surgery, now as the Washington Post reports it is recommended as standard. I recall that before knee surgery in California at Stanford Hospitals in 1996 I wrote "Not This One" in marker pen on my healthy knee, and that got the admitting nurse very annoyed. At least the medical error debate is now in the open.

What’s not so in the open is the in-hospital infection issue. Millenson suggested last week that a nosocomial infection during on of Cheney’s heart procedures, or (my preference) perhaps during Ashcroft’s recent stay in hospital, would really put that issue on the front burner. (They could of course have a complete and full recovery afterwards!) Maybe not, but he found for me a really vicious example in the UK, where the medical safety debate has been even slower to develop than over here. This one concerns Claire Rayner, who is the British equivalent of Ann Landers. In this interview she hammers on the issue of infections caused by sloppy hygiene in hospitals. Take a read, And before you say it couldn’t happen here, be assured that it is happening here too — unless the IOM is making it all up.

Claire Rayner ascribes the problem to a decrease in standards of nursing care, directly associated with an increase in the number of less-well trained people dealing directly with patients. Interestingly enough Linda Aitken’s academic work has shown that there is a relationship in quality of care and outcomes based on the overall level of nurses’ education in a hospital staff. So Rayner may be on to something there. In any event, the more known about this issue, the better, and whatever Newt Gingrich and anyone named Kennedy say, IT is not a guaranteed standalone fix here. We need a system change.

TECHNOLOGY: Boston Scientific recalls stents

A while back THCB reported that there were some murmurs about problems with Boston Scientific’s Taxus stent. That followed earlier manufacturing problems with J&J’s Cypher stent. Now Boston Scientific has recalled about 200 stents with manufacturing defects.

This is probably a very minor hiccup in what has been a stellarly successful product launch. The Drug Eluting Stent (DES), which is on the way to being a $5bn market, has grown very fast to replace the bare-metal stent as a treatment of choice. This transition has helped over shadow research that showed that bare-metal stents (and the TCPA that accompanies them) were not as effective as by-pass surgery. Of course there are as yet no long term studies of the impact of re-stenosis from the new DES–but cardiologists and their suppliers have carried the day, and the drug-eluting stent (which incidentally is beginning to really negatively impact hospitals’ bottom lines) is the latest and greatest thing to hit interventional cardiology in ages. That’s a typical evolution of medical technology–put into mass use before it’s proved cost-effective compared to other treatment largely on implied promise. That’s the way health care works, and three decades of technology assessment work hasn’t changed it, and isn’t likely to soon. And minor manufacturing quality issues, if handled properly, won’t make any difference to that process.

TECHNOLOGY: Fuel Cells That Keep Going And Going…

A quickie for July 6th. I have been moving house (and office), had limited access to DSL and THCB has suffered a bit. Sorry, but the move is almost done (You must all come and visit!). My backlog is huge and there’s tons of interesting stuff coming!

Robert Mittman wrote about fuel cells last year and Forbes followed up last week. Hopefully PDA Fuel Cells That Keep Going And Going… will mean that we won’t be searching around for that socket in the departure lounge in a hopeless attempt to keep that phone or laptop going all flight.

HEALTH PLANS: Wellpoint merger wandering through California

While the shareholders have approved the Anthem-Wellpoint merger, it looks like state insurance commissioner John Garamendi is likely to oppose it, causing a little embarrassment for a certain Governator. Meanwhile, the public hearing has been set for later next week.

Again, look for a deal with at least some of the money once headed to the pockets of Wellpoint executives instead ending up in the (bankrupt) state’s coffers.

INDUSTRY: Is nothing sacred? Cardinal admits sinning

OK, not really, but serious bad news at what has been one on the health care industry strongest performers and best run companies. Cardinal Health anounced that it would miss profit forecasts, and was being investigated by the SEC. The stock is off 25%. The Street.com has (for them) a balanced article including this juicy quote from one analyst: ‘Multiple investigations, lowered guidance and a hazy outlook on growth have shaken our thesis that CAH is a ‘buy and hold forever’ stock,’ Wieland concluded.". Of course regular THCB readers know what’s coming next. I bought a small amount of Cardinal stock on a slight dip as part of my "sensible" portfolio last month! Oh well, back to crazy biotech companies with no revenue–they’re clearly safer!

POLICY: One in five households struggle with medical debt

I’m moving today and tommorrow so dont expect much real thoughtful action here until next week. However, I’ll list a few bits and pieces you should keep up with.

As you’ll recall in my comparisons of Canadian and US healthcare systems (in my Oh Canada piece and elsewhere) the major issue for lower income Americans is their problems paying the bills associated with medical care. This is virtually unknown elsewhere in the civilized industrialized world. HSC has a new report out showing that 20 million families, which is about 20% of households, in the US have serious problems with medical bills, including having to choose between paying them and paying rent.

With a little more of this rhetoric, health care just might become a slightly more important issue for this election cycle. It’s more likely though that this will continue to build up until the dam bursts in the latter part of this decade, and we engage in a full-scale national debate a la 1992-4.

HOSPITALS: Pity poor ex-Tenet CEO Barbakow

Jeff Barbakow was the CEO in charge of Tenet at the time of their stock collapse following all the goings-on at their Redding, CA, facility and elsewhere. Although he cashed out nearly $111m in Tenet stock a few months before the scandal broke and the stock crashed, he apparently lost a fortune on Worldcom stock, when it went into bankruptcy–also after massive fraud. But proving that this is a great country, he’s suing to get his money back! At least Tenet hasn’t quite yet followed Worldcom in Chapter 11.

PHARMA: The Industry Veteran and friends blame (mostly) the doctors

So following Sunday’s NY Times article on bribes being paid for prescribing and my comments yesterday, the Industry Veteran let me in on some email exchanges going on round his electronic watercooler. You’ll note that he and his colleagues do not ascribe most of the blame to pharma:

    This morning a friend who teaches marketing at a local university e-mailed to me an article from yesterday’s NYTimes. The subject line of his e-mail read, "Just how stupid is Big Pharma anyway?" I am forwarding to you my reply to him. I think my reply will again tweak the noses of your physician readers who consider themselves healthcare’s good guys because I believe physicians hold equal or more blame for the system of pharma-to-prescriber payoffs now coming to light.

The Veteran’s reply to his friend:

    ‘In this case I don’t think it’s a matter of stupidity as much as systemic incentives and culture. Whenever fiduciary gatekeepers (e.g., healthcare professionals) are inserted into a market system, there will always be an enormous temptation to influence their decision-making. It’s the same with company purchasing agents and government contract committees. From the NYTimes article, one might as easily admonish physicians as the pharma companies. If you were to speak with the marketing and sales people who develop these payoff programs, I’m sure they’d all say that the docs expect it and that if their company were to opt out the payoff system, their competitors would get all the business.I’d make the argument that over the past 40 years, the development of physicians’ unbridled avarice represents a bigger change than any supposed penchant for corruption on the part of Big Pharma. After years of attending scores of brand team meetings at all the Big Pharma companies, I’d go so far as to say that in most cases where baldfaced, baksheesh programs are developed, the driving force is usually one or more of the physicians in the room. As a curbstone assessment of their underlying psychology, I suspect that they typically seek to impress other team member with their machismo and their marketing acumen. Their payoff initiatives represent an attempt by arrogant ignoramuses to figuratively say, "What’s so tough about this marketing stuff? Hell, I’m not just a clinical nerd. I’ll show you marketing."’

A little later the Veteran copied some more correspondence into THCB

    I wanted a reality check on the reply that I sent to my academic friend this morning. After sending it you (i.e THCB) I also forwarded it to an acquaintance who has worked for 20+ years in the industry. Unlike my dangerously subversive political views, his are hard core, Reagan-Bush right wing. He is, however, scrupulously honest and empirically open-minded. I pass along to you his comments in anticipation of the fusillade from the medical practitioners of negotiable virtue.

    "I agree with your message back to _____: the $$ demands of MDs are just amazing. And having been in marketing most of my career (launched two products and Director of Marketing for a biotech company), I can tell you that most of the time pharma is in reactive mode. Those who are strong enough can resist the demands* of the purveyors of the Hippocratic Oath, but it is difficult for the very reason you mentioned: at some point, you know you’ll get left in the competitive dust. And one of the biggest jokes is biotech. Many, if not most of their top honchos are ex-academic researchers. In my experience the majority of them are not at all cognizant (nor do they care) about such trivialities as FDA guidelines or anything that they believe applies only to the dirty, big pharma companies. In their way of thinking, biotech is much too cerebral and pure to be lumped in with the pharma industry."

    *Just look at how the cost per patient of legit clinical trials has zoomed the past 10-12 years; clinical investigators will take on any trial if the price is right.

INTERNATIONAL: Canada’s Liberal Party Loses Majority

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So after all the fuss about Canada possibly changing political horses, the election result shows that the Liberal Party got much more of the vote (37%) than the conservatives (29%). Due to the way Canada’s parliamentary system works (and because of the gains by the Quebec nationalists), PM Martin will have to form a coalition government. But the impact on the health care system will likely be neglible, as both sides more or less want to keep it as it is and both have promised to spend more money on it.

PHARMA: Hands – cookie jar – once more a connection

If you missed this over the weekend, the New York Times reports on yet another example of very dubious marketing practices by certain pharma manufacturers. This time the charges are that Schering (more or less) paid doctors to prescribe drugs. Anyone watching the health care system for any length of time is used to this. It’s rare that it’s this overt, although it was when Caremark was paying for infusion referrals back in the early 1990s, but sweetening the route to ensuring the right drug ends up written on the prescription pad has always been a big part of pharma’s marketing approach. While there are some limits that since the late 1990s are supposed to be placed on what the local marketing teams can do, the pressure remains on to make the physicians happy, whether it be via Dine and Dashes, free goodies, consulting agreements, or simply having a rep show up that the doctor will enjoy meeting (and I’m not spelling that out for you!).

The NYT suggests that this will only get worse as more and more of the pharma dollar gets spent by the government, and hence more and more of this bad behavior will be punished by Federal fines. As it’s been an accepted cost of doing business by the pharmas for a long time, and as the government really hasn’t got the option of giving them the "death penalty" (i.e. banning them from the Federal marketplace), expect this cycle–bad behavior, then punishment, then official reform, then more local level bad behavior, more punishment, more reform, new bad behaviors, etc–to continue.

By the way, if (as reported in the article) anyone out there wants to send me a consulting agreement accompanied by a large check with a blank schedule of works to be performed at some unspecified time in the future, they will find that I have few fewer ethical qualms in accepting it than the anonymous physician interviewed by the NY Times!