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PHARMA: Follow up to the Pipeline Post

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.

QUALITY QUICKIE: Follow up to Kentucky nurse dismissals

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..

PHARMA: The pipeline needs filling

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.

QUALITY QUICKIE: Kentucky hospital dismisses 14 nurses

I am deeply puzzled by this one.  Apparently patients on respirators sometimes try to pull their tubes out of their throats in a panic, and administering such patients Diprivan immediately calms them and potentially saves their lives. A hospital in Louisville, Kentucky has  fired 14 nurses for giving the sedative to patients on respirators without a doctor’s order.  Now I am not an expert on clinical procedures so take everything I say as opinions held very gently, but…..

a) Wouldn’t there or shouldn’t there typically be a standing order from the doctor as to what a nurse should do if a patient starts trying to pull their respirator out?
b) If (at least) 14 nurses were routinely doing this, it is definitely a system problem.  Should not the hospital have been educating the nurses about the rules before they fired them, as they apparently are doing now for those not fired? Has anyone in the hospital management been fired for allowing so much to go wrong on their watch?
c) Is it realistic for nurses to know these rules? On Saturday I watched a baseball play-off game where a hitter being paid over $4 million a year failed to score the winning run because he mis-interpreted a rule.  Yet he’s in the game I’m watching as I type this on Monday night!
d) A nurses’ association is trying to unionize this hospital.  Were those nurses fired purely for the sedative offence or were they involved in union activities?
e) Who creates the Kentucky Board of Nursing standards? Am I suspicious, or might a core of doctors be involved here. Don’t forget that several states restrict midwives from delivering babies, and even prosecute them, when in most other countries they are a core part of the labor and delivery system*, and there is very credible evidence that using midwives for routine births is safer than using OBGYNs.  Those rules came from the political power of organized medicine. Is something similar going on here regarding the ability of nurses to encroach on anesthetists turf?

I don’t know the answers to this issue.  But this mass firing looks like a symptom of a wider disease at this and probably other hospitals.  If you have comments, please email me and I’ll follow up later.

*For example, while the United States has 35,000 obstetricians and about 5,000 midwives, Great Britain has 32,000 midwives and fewer than 1,000 consultant obstetricians.

QUALITY QUICKIE: Managed care works in California (according to Managed Care)

While the managed care industry generally has more or less given up the concept of trying to manage the way physicians practice, it’s not quite so in California. The CCHRI, a mostly payer/provider funded group, albeit with representation from organized medicine, reported late last week that both clinical performance indicators and member satisfaction are getting better.

How come the connection between managed care and quality is still alive in California, after a combination of physician and consumer outrage beat managed care to death with a stick in the rest of the USA? Well, like everything else it’s mostly an accident of history.  California has big medical groups.  They tend to have the management structures in place that allow them (even if they haven’t always) to both measure their physicians’ clinical performance and work to actively change their behavior.  Outside the left coast physicians still tend to practice in smaller groups and the groups that do exist tend to be smaller, looser or affiliated with a clinical teaching practice (and therefore be unmanageable!).

So how did California get that way?  Well, by dint of historical accident, it had the Kaiser Permanente organization. Because of the inherent price advantage Kaiser’s pre-paid (or capitated) plan had over the traditional insurance companies, in the late 1970s and early 1980s Blue Cross went actively looking for physician organizations that looked something like the Permanente Group on which to base their incipient HMO, the forerunner of HealthNet.  They found several groups mostly in southern California.  Of course they were historical accidents too.  One, Friendly Hills, was a group of family docs who’d covered for each other on call and gradually developed closer business links.  Another, Mullikin, was (I was once told) a haven for gay doctors who couldn’t find other places to practice. By the mid-1990s these groups and their ability to deliver high quality population-based care in a heavily internally-managed environment was well known in the industry. I spent many a session frightening East Coast hospital management teams with the specter of what would happen to their  occupancy rates if those crazy Californians brought their "bed-days per thousand" rates to their town. It even got the attention of the east coast medical intelligensia. Unfortunately both the greed aggressive business tactics of the health plans and the greed incompetence of the Medpartners organization which bought the vast majority of these groups had driven them into chaos and bankruptcy by the late 1990s.

It appears that the medical groups are recovering from that era of chaos and are now getting back onto the "good" managed care track.  With employers paying more and health plans not being under the financial gun they were in the mid-1990s, the CCHRI report shows that there’s potential within California for real improvement in those population clinical improvement measures that we were all talking about 10 years ago.

POLICY: Pay or Play in California signed into law

In what may be one of his last acts in office depending on how tomorrow’s recall vote goes, yesterday Gray Davis signed SB2. I’ve written more extensively about what SB2 is and more importantly what it isn’t in this post. Essentially it’s a play or pay mandate for businesses with more than 20 workers who don’t provide health insurance.  If the business has more than 200 employees it will also have to provide insurance to the families of the workers. Most importantly it won’t take effect for more than two years or more than 3 years for smaller businesses (20-200 employees), and it doesn’t impact businesses under 20 employees at all and business between 20-50 employees will get a tax credit to cover (some of) the costs of the insurance they have to buy.

So we can expect:
a) a hell of a fight in the next two years by California’s business lobby (in particular the fast-food industry)  to overturn the law in the courts and by referendum
b) a lot of consultants emerging explaining how to restructure your business into several businesses with less than 50 or 20 employees each (depending on how that tax credit works out)
c) (when the law takes effect) some combination of job losses/higher prices for consumers as we see in Hawaii —  all dwarfed by the real driver of the employment market in California which is the national economic state of high-tech, entertainment and the defense industry.
d) gradual acceptance of that fact that that’s a cost of doing business here which the vast majority of employers were paying anyway (OK some editorial in that comment from me!)
e) more legislation to reduce medical care costs (as there is no cost control in SB2).

Of course the major issue behind all this is that 75% of the uninsured in America are full-time workers (and their families)  in low wage industries. Most of them work in businesses too small to be affected by this law, so it will only get some 1 million of California’s 7 million into insurance.

Friday Funny

So I’m a very messy guy who’s insensitive to what’s happening around me and likes using the TV remote control — a massive P rather than a J on the Myers-Briggs scale. I have had several girlfriends who are extreme Ps, i.e. total neat freaks, who somehow have found this a problem.  Medical Rants today explains that it’s not that I’m a slob, it’s my brain’s fault!

PBMs: The very, very begining of the end for PBMs?

You may remember my post somewhat facetiously titled The End of Managed Care. The concept was that managed care plans had stopped trying to manage physician behavior and had given up in the face of aggressive class action lawsuits from doctors who wanted to get paid more quickly and objected to being "down-coded".

Well the lawyer behind that suit is turning his sights on the PBMs on behalf of some smaller pharmacies. The new suit filed today alleges that the PBMs are forcing patients to use their mail-order services instead of the local pharmacies (which seems likely but probably not illegal to me) and are forcing unfair contracts upon small pharmacies (which if your definition of "unfair" means "using your buying power to extract lower prices" also seems likely but not illegal). Still, worth watching this space and seeing if yet more legal antics for the PBMs actually has any effect on their business. As someone who completely underestimated the impact of the backlash against managed care, I’m loathe to say that this seemingly hopeless suit will have no impact on PBMs.

QUALITY QUICKIE: Practice Variation by Race

Researchers in John Wennberg’s shop at Dartmouth have come out with another stunning analysis of practice variation published in the new England Journal of Medicine (NEJM). This time it’s not region that makes a difference, but race of the patient. Essentially the article says that you are much less likely to receive a common type of knee surgery if you are black or hispanic than if you are white.

We’ve know for a long time that outcomes and health status are impacted by race and socio-economic status (SES).  For instance black males in Harlem have much lower life expectancy than average.  Similarly, despite the 50 years of Universal Health Insurance and care from the National Health Service in the UK, SES or "class" level there has a marked impact on health status and outcomes. In fact variation in employment status within the same SES, also has a large impact (and not surprisingly it’s better to be at the top than the bottom), as shown in the classic British Whitehall Study. And of course we also know that access to care for those without insurance is worse in the US than for those with insurance.

However, I believe that this is the first example in the US showing that access to a specific type of care for those in the same insurance category is very different.  I don’t know why black seniors in the US have knee surgery at half the rate of white seniors.  I suspect both patient demand, and physician culture have something to do with it.  I also don’t know which rate of knee surgery is better.–especially as last year the NEJM published a study that said that in the case of osteoarthritis, knee arthoscopy was no better than placebo. But it is clear that race and presumably other social factors influence the treatment that is given to patients with similar conditions for no good reason.

(Alerted to this by California Healthline)

THE INDUSTRY: Price Discrimination lives–Only the poor pay full price in U.S. healthcare system

In an article on CBS Marketwatch, titled Only the poor pay full price, Michael Collins points out from a business point of view, the crazy pricing scheme in the U.S. healthcare "system". I had a similar experience last year when I had knee surgery.  I bargained heavily with my surgeon who wouldn’t take managed care contracts.  For the facility charge, the bill I saw was $20,000 but the facility only collected around $8,000.  Meanwhile a surgeon billed me over $100 for a second opinion, but the PPO only paid $43. I remember this back in 1990 in Alain Enthoven’s class.  Several hospital representatives in the class used to complain about being forced to give managed care plans "discounts".  Enthoven called hospital billing a "fiction".

Collins makes the obvious point that if you do not have insurance, you will be charged the full price.  The provider may not expect to get their money, but if you have any assets, the hospital/clinic will come after you for the money–and you’ll be paying at the full rate, which no insurer pays. 

In fact it may be worse.  If you do have insurance and you pay 20% of the fee, your insurer may make you pay them 20% of the full fee, while they get the negotiated discount that my classmates complained about.  Several Blues plans had plenty of legal problems when they were caught doing this practice in the mid-1990s, including Trigon (Virginia) which in essence was forced to pay large fines several times over in order for the state Attorney-General to allow it to turn for-profit. (I can’t find a reference to this but it was a big deal before they could get their S1 registration out in 1996).

Transparent pricing would appear to help everyone.  But for historical reasons (the need for cross-subsidizaton within providers from rich to poorly insured patients) it hasn’t emerged. Now for business reasons, no one wants to reveal their "deal". This is as true for hospital and physician care, as it is for drug rebates, and it gives the lie to health care being a "free" market.


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