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BLOGGING: Christmas & Holiday blogging

I’m still in the UK and I may get to another post before Christmas, but then again I may not, and next week will be beyond spotty…there are a couple of articles in the queue but they may not make it out of the computer in time for 2005.

I will be writing my by now traditional end of year letter usually going out sometime next week, but that’s about personal charity and politics rather than health care, but I’ll put it up elsewhere on the web and link over to it from here.

In any event thanks for reading in 2004, and definitely check back in for 2005 on January 3rd (or the 4th if I haven’t recovered for the 3rd) and have a fun, and safe end of 2004. Happy christmas, holidays, channukah, kwanza, turkey day…..and here’s to Chelsea being top of the league on January 1! (That’s a clue as to where I’m spending December 26!)

PHARMA: Industry Veteran on Don Johnson’s ideas on saving Merck

Don Johnson at the BusinessWord blog had a long piece on how Merck might be turned around. I personally think that the cause is pretty hopeless, and that like many other once great companies, Merck will just have to accept its future shotgun marriage–although I think that the price needs to get a little cheaper before that happens. However, the Industry Veteran has a few ideas of his own about Don’s view of Merck, and as a Christmas treat to THCB readers, I serve them up for you, written in an open posting to Don:

Don–Your suggestions to Merck are provocative,  wholly unrealistic, but at least amusing.

 

 


 

I don’t know if your suggestions to Merck reflect the frustrations of a market ideologue when confronted with actual corporate behavior, or just indicate someone who wants to see good corporate citizenship from Big Pharma but doesn’t know beans about the industry. In either case your list contains some laudable goals but their prospects for adoption are remote. Below are my comments on a few items in your list.

 

 

 

* Appointing a glamorous, articulate physician as CEO may make casual observers feel better, temporarily, but unless the person also knows the pharmaceutical business very well, he won’t be able to address the structural problems and strategic deficiencies that have put Merck in its current predicament. The Merck Board appointed a person from outside the industry in 1994 when they picked Gilmartin and he took the company to its present condition. More precisely, he failed to initiate changes to an organization that his predecessor left in precarious circumstances. Merck’s arrogantly chauvinistic approach to R&D was the lengthened shadow of the previous CEO, Dr. Roy Vagelos. When Gilmartin arrived at Merck, its haughtiness and financial statements during the boom 90’s concealed some major problems. As an outsider to the industry Gilmartin felt obliged to leave the cultural legacy and strategic approaches in place. Instead he merely added his own affectations such as a crippling political correctness and the ascendancy of the legal department. Gilmartin also outsourced virtually all organizational planning to cronies at the Monitor Group. The result brings to mind a line from an Ernest Hemingway story. Someone asks how a particular character went broke. "Two ways," he was told. "First gradually, then all of a sudden."

 

 

 

* Single pricing for the entire world won’t work. Too many countries will execute compulsory licensing (i.e., break patents). I’m not talking about just poorer countries in Latin America, Africa or Asia, but western Europe as well. Here’s where your naivete sets in. Don’t you think Big Pharma and its lackeys among American trade emissaries have tried getting tough with other countries? The Bush administration recently tried it with what they thought would be a compliant government in Australia. After all, they’re conservatives, they supported his decision to invade Iraq and they were looking for us to lower quotas and tariffs on their agricultural products. All political segments in Australia held firm and the PM issued a stern rebuke to the Bushies. If we couldn’t squeeze the Aussies for a fairtrade agreement, you better believe it won’t work in other places.

 

 

 

* The idea of trading away some premium pricing in return for volume guarantees sounds appealing, but Big Pharma is against it because they fear it will open to door to a single buyer (or Single Payer, as it’s commonly called) relationship. Most of the world lives with that sort of a system and, in many cases, their health care outcomes are better than ours (the WHO rated the US as 37th in the world), but the bloody shirt of "Canadian-style health care" will be thrown in the face of anyone who pushes your suggestion.

 

 

 

* Raising the regulatory standards to both protect the public and impose competitive entry barriers sounds interesting (although the libertarian in me feels a minor twinge), but here you’re really outside the loop of plausibility. Try suggesting tougher approval standards to any of the R&D fiduciary officers in Big Pharma companies and tell me if your wrist chronometer records tenths of a second before you’re shown the door.

 

 

 

*  Now here’s where you really start operating in  fantasyland.  "Produce and sell drugs that will win in their classes and get rid of product lines that aren’t number one in their classes in cost effectiveness, safety and efficacy. Price accordingly. Call off the detail dogs, who aren’t trusted by physicians and, according to recent research, may be less profitable than conventional wisdom suggests." The Jack Welch stuff won’t work in pharmaceuticals because, unlike most of GE’s operating divisions, product development is extremely long and precarious. That’s why Pharma has developed an economic model where a competitor can hold fifth-place in ACE-inhibitor market share or fourth place in the statin class and still make a ton of money. If wishes were fishes…

 

 

 

* Now this idea of getting tough with the product liability trial lawyers seems clever: NOT. I wonder why someone else didn’t think of that. Actually someone did — it was the tobacco companies and you may remember how well it worked out for them. Given the number of Pharma researchers and investigator-physicians who feed information to Public Citizen, to plaintiffs’ attorneys and media reporters, how long do you think it will be before someone comes up with incriminating documents and makes the fen-phen damages look like chump change?

* You make some suggestions that do appeal to my libertarian side because their objective consists of evening up the asymmetry of information that exists between the Pharma manufacturers on one side and practicing physicians and patients on the other. It’s actually amusing when you advise Merck to sponsor a  "prime-time consumer-oriented health and medicine talk show on MSNBC or CNBC. Allow physicians and consumers to ask questions and comment on blogs and message boards. No holds barred. Docs will watch and learn". That will be must-see TV when pigs fly. Some of your other suggestions actually seem biblical: Merck should cut its marketing budget and drug prices in half, help institutional buyers reduce inappropriate uses of expensive drugs and put easy-to-comprehend product comparisons on the Internet. And the last shall be as first and the meek shall inherit the earth.

My own suggestions to the Merck board are substantially more modest, less apocalytptic, but more likely to deal with the world as it is.

* Hire one of the usual suspects from outside the company as the next CEO. The Dutchman who ran Warner-Lambert and Don Hayden at BMS are two likely candidates. Have the new guy bring in his own R&D man and together they should go up and down the halls of MRI, West Point and Upper Gwynedd the way the Russians went through Berlin: house to house carnage, taking no prisoners, looting, pillaging, raping and humiliating along the way. Ooo, Ooo, "the delicate flowers" in R&D, as Richard Sykes once called them, may be offended and leave. Tell them not to let the door hit them in the ass. Confiscate their notes, hold on to the intellectual property rights, and after the security marshalls lead them out the door, hire other scientists to replace them. In case you hadn’t noticed, it’s buyer’s market out there.

* Eject from business departments the ignoramus, Ivy League MBAs who know nothing about the industry but feel they can comprehend the universe with spreadsheets. These people are holdovers from Vagelos’s era, abetted in politically correct fashion by Gilmartin and David Anstice. And while we’re at it, stop the kickback arrangements with outside suppliers that has made Merck’s self-righteous hypocrisy well known inside the industry years before Vioxx.

Hey, that’s just for starters. For anything more specific, Merck will have to pay. Of course the idea of Merck paying me to tell them that they’re such dumbf—s is also in the realm of biblical prophecy.

 

PHARMA: Don Johnson on how to save Merck

I’m not sure Merck is salvageable. My assumption is that its sales force is worth something, as is Fossamax, and that a shotgun marriage with another pharma with a better pipeline is in the offing. But Don Johnson from The Business Word gives Merck a gazillion dollars worth of consulting on how to make the turnaround, and seems to be doing it for free! An excellent analysis from a savvy business observer. Someone in New Jersey should be reading and getting Don on a plane at a high fee. I’m not sure anything can work to save Merck as it faces post-Vioxx and Zocor going off patent, but many of his ideas are well worth thinking about.

POLICY: Medicare dis-Advantaged?

A couple of weeks back I suggested that the Medicare CCIP (disease management) demonstration projects were designed at least in part to get private health plans (and the DSM companies that contract with them) involved in the wider management of Medicare FFS patients. The Oliver Stones amongst us think that this is part of a logical attempt by the Administration and its Congressional allies (perhaps I should just start calling them "the Government") to fast-forward the privatization of Medicare. Now a somewhat renegade ex-CMS employee, Robert Berenson of the Urban Institute, has a paper in Health Affairs that accurately recounts the history and likely future of the other larger part of the privatizing Medicare equation.

Berenson shows that, essentially, private plans are being bribed back into Medicare Advantage (the new name for Medicare plus Choice, nee Medicare Risk) with payments that equate to roughly 108% of the equivalent per capita cost of a senior in traditional Medicare. In addition Medicare is introducing regional private PPOs even though:

The traditional Medicare program has enough market power to impose administrative prices on providers at rates that are generally lower than those of commercial PPOs. Medicare beneficiaries already enjoy broader freedom of choice, with limits on balance-billing, than in most PPOs. In other words, the main virtues of the PPO model in commercial markets are not applicable to Medicare, which itself functions in many ways like a PPO.

In addition to the private PPOs, and the improved terms for the private Medicare Advantage plans, the new Part D which will be run by a different set of private actors, the PBMs. And of course many of the most expensive and sickest Medicare patients will be in the CCIP programs which will be expanded if they prove successful, and have been set up to give at the least a very good chance of success. So when private sector Medicare has shown little skill at implementing cost control in the past, why is it being encouraged so much now? Part of this is the ideological preference of the Republicans to see the market work and the government fail. But there’s more than that going on.

Former CMS administrator Tom Scully argued that one main purpose for creating an extensive network of PPOs in Medicare would be to decrease the market power of the traditional program yet to replace it with nongovernmental insurers, which themselves might have sizable market power. In his view, private monopsony payers would be unencumbered by the political interests and regulatory requirements that arguably restrict the flexibility of the traditional Medicare program to act decisively to reduce spending and to respond to market-specific factors related to quality and access.

In other words, if Medicare is going to be reformed–and yes I agree it needs to be–the Administration believes that the government itself can’t do it. It’s just too political, and the interested parties will resist any significant reform or price cuts. Those interested parties are of course largely America’s providers who have indeed grown fat at the Medicare trough over the last 40 years. Instead the Administration’s hope is to hand it off to a gang of private enforcers who they hope will be as successful with reducing cost in Medicare as they were for their private employer clients in the mid-1990s.

There are of course several potential pitfalls with this approach. First, in order to increase the numbers in Medicare Advantage from the current 12% to a percentage where their weight of numbers might have some impact, the bribes paid to the private plans are (and need to be) rather substantial. In order for the program as a whole to be reformed by the private plans rather than directly by CMS, many, many more seniors have to be tempted into Medicare Advantage. However, although some good policies like real risk adjustment and competitive bidding have been included in the legislation and are due to be implemented in the next couple of years, the current way that they’ve been set up doesn’t really encourage plans to cut costs–rather it will likely result in them pricing to a benchmark that CMS sets. Of course that benchmark and indeed all payments from CMS are vulnerable themselves to yet more political interference. And if the amount of the bribes start going in a direction that the private plans don’t like, well we’ve seen this movie before in 1999-2002 when lots of plans took their ball back and went home.

Secondly, the biggest likely interference will arrive should the so-called conservatives in the Congress remember that being a conservative is supposed to be about reducing government spending. The argument which goes that "we have to increase Medicare spending now in order to put a structure of enough private plans in place so that they can cut spending at some unspecified future date", may not hold much water if Congress ever decides to look at the deficit seriously. Of course if you really want to cut Medicare spending and you can muster the political will to do it, doing it by reducing the amount you pay providers in the traditional program is the most effective way. After all it worked pretty well in 1998-2001. And if you grow the private plan side, instead of having a group of voracious cost cutters, you may just end up with a group of Mr Ten-Percents in the middle who also need to be taken care of politically and will have more power to ensure that they are. It can’t have escaped everyone’s notice that health insurers actually have done better financially in times of big cost increases rather than when they were slashing and burning provider rates.

Finally there are two other sleeper issues with Medicare that shouldn’t be forgotten. One is Teddy Kennedy’s overriding concern that increasing Medicare privatization combined with the (admittedly limited) means-testing for Part D introduced in the MMA will lead to a de-facto defined contribution mindset. He foresees Medicare eventually paying a flat rate voucher for seniors’ membership of plans, and as that amount is cut over time, you’ll see a distinction between the class of private plan for different Medicare recipients, based on whether they can afford bigger premiums out of pocket. Kennedy’s eventual fear is that the "contribution" eventually becomes regarded as a kind of welfare payment. And we all know how the public feels about cutting back on welfare. There are certainly influential Republicans (Grover Norquist is one who wants to "drown government in a bath tub") who regard that as a legitimate end-game.

The other issue is one that Ross at the sadly quiet again Public Health Press has raised many times. Hidden in the MMA legislation is a provision that if Medicare premiums for Part B no longer cover 50% of Part B costs (and that money has to come from the general taxation) benefits/payments will be cut until the premiums do cover 50%. In other words there’s a self-limiting mechanism built in which will likely mean that seniors will end up paying more to get less.

If I had to make a tenuous forecast, my suspicion is that the payments to Medicare private plans end up getting reduced sometime in the near enough future that they never obtain the critical mass that Scully and others want them to get to enable them to reform the system. I believe that the future of Medicare is a fairly straight fight between providers and taxpayers, with an increasingly aggressive CMS pushing P4P and attempting to reduce regional spending variation using the fee-schedule as its main weapon. But trying to privatize this process to stop it being political, well that just sounds un-American to me! Anytime the tax payer is forking over several hundred billion dollars, the process will indeed remain political.

QUALITY: Is pre-chemo testing the future? by Harvey Frey MD

Careful readers of this blog will have noted that along with reporting about the change in reimbursement for cancer drugs (and to get the real scoop on that you should see JD Klienke’s excellent article in Health Affairs), there’s also been a trend generally in favor of chemo-sensitivity testing before chemotherapy–largely considered a fringe activity by mainstream oncologists. Then this week the NEJM had an article generally in favor of pre-chemo testing. Did the appearance of this article mean that oncologists were moving the way of the pre-chemo testing radicals or did I as the dumb layman misunderstand it? I asked Dr Harvey Frey, who has written for laymen on this subject for THCB before but has generally not been in favor of it, what he thought.

I think you’ve got it right.

Now oncologists guess at prognosis and probable effective treatment based on how a cancer looks under the microscope, how extensive it is when found, and some blood tests. But even within the groups they’ve determined that way, there are still huge variations in actual patient response and survival rates. Since they never know who needs the treatments for sure, many patients are treated who might not need the treatment, and some get ineffective treatments before finding an effective one, and since the treatments are not innocuous, that’s bad.

They first tried doing sensitivity testing by growing cancer cells with different chemotherapeutic agents. For a variety of reasons, that never was very helpful. For years they have thought that, if only they could determine the actual genes responsible for cancer, they could break down the large heterogeneous groups into smaller groups with better defined responses, and spare many patients any treatment at all.

This study is a start toward that end, but still a small step. The technique doesn’t require that they try to grow the cells, but can be done on regular biopsies as obtained now. But so far all it’s shown is a correlation between their test and survival. They haven’t yet shown that they can predict response to hormones or chemotherapy. But there’s every reason to hope that they will ultimately be able to make such predictions, at least with better accuracy than we can now.

THCB UPDATE

Sadly, no posts from Matthew over the next few days. He’s on his way back to the UK for the holidays and having laptop problems, so his latest series of missives will be delayed.

BLOGS: Italics for anyone?

For some strange reason Blogger would not publish for hours today.  And then when it did, everything became italicized…..sorry! (Unless you like it that way!)

PHARMA: Fee-based distribution

Pharma wholesalers used to make their mark-up on tiny price changes. Like a Walmart, they’d buy now, sell later and pay their suppliers even later. As the suppliers were the hugely profitable pharma companies who made huge margins on each product, they weren’t too bothered about their downstream distributors making money by financial manipulation.  Add to the equation that prices were going up 10% a year, distributors were making even more just by holding inventory. But it was always a low margin business. The big three (Cardinal, McKesson, and AmerisourceBergen) have vast revenues but relatively tiny profits.  In 2003 Cardinal made $1.5 billion in profit, on $51bn in revenues. Not bad, but its biggest upstream supplier, Pfizer, made $11bn on $32bn in revenue.

Now distributors are having problems with their old model (in part because drug prices aren’t going up as fast). They are now trying to move to a fee-for-service model for distribution.  Here’s an interesting report as to whether that’s going to work. The answer seems to be, maybe.

HOSPITALS/POLICY: Matt Quinn on California staffing ratios contention

Last week our beloved Governor must have thought that he’s wondered into a John Leslie movie. 3,000 nurses protested his visit to a women’s conference (no less), and he told his audience that "I kick their butts" and that nurses–the most trusted people in the health care system–were "special interests". Oh and by the way this was at a conference in which CEOs who contributed to Schwarzeneger’s campaign were allowed to actively promote their own companies. While I resisted the temptation to use the headline Arnie takes on 3,000 Nurses,   Matt Quinn doesn’t want this to slip by THCB:

Don’t think that you’ve covered the Governator’s decision to repeal CA’s mandatory nurse staffing ratios. The reality is that most hospitals can’t (consistently) meet them . . .  which speaks to the acuity of the nursing crisis in this country (and especially CA).

While I certainly believe that most hospitals can do a much better job of allocating nursing resources (and some are using "bidding technology" to do so), there simply not enough nurses being produced . . . or staying in the profession.

Instead of encouraging hospitals to fight (and spend more money on bonuses, etc.) to recruit away nurses from other organizations in their areas by mandating ratios, it makes sense to increase the supply of nurses. There are lots of ways that the state and federal governments can make this happen . . . if it’s a priority. Arnold so far doesn’t seem to feel that this is a priority.

While Linda Aitken and others have done great research on correlating staffing with mortality, complications, etc., there remains too little effort in giving individual healthcare organizations the tools that they need to effectively (and empirically) balance staffing with quality, safety, satisfaction, and cost. "Standard" nurse to patient ratios represent too blunt a tool for this.

Ask any nurse (or hospital risk manager) and you’ll find that staffing is at least a contributing factor to the vast majority of medical errors / mistakes. Hurried people make mistakes . . . and can’t provide patients with the care and compassion that they deserve. Hurried and overworked people are also unhappy. While I applaud the (currently under funded by highly emphasized) efforts to implement IT as a solution to patient safety, having enough nurses (or clinical workers) should rank as high or higher…

There have been some pretty good articles about this in the Sacramento Bee of late.

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