Categories

Category: Uncategorized

TECHNOLOGY/POLICY: Medpundit on Frist’s flight of fantasy

Over at Medpundit Sydney Smith takes a hillarious rip at Bill Frist’s vision for the IT interconnected health care future. And she’s wrong in one of her takeaway points and right in another. She’s wrong that IT and interconnected EMRs won’t benefit patients. Although they probably won’t help too much in the case of the heart attack that the mythical diabetic in Frist’s example has, they certainly will have a great impact on making sure that diabetics and other chronically ill patients actually get the routine care and routine bullying that they require to stay healthier. The same EMRs, if we are to suspend disbelief and belief that they will be interoperable and shared, will inform all clinicians about all the drugs a patient’s on, so they don’t have to rely on the list the elderly patient wrote on their arm (or just guessed at!). Of course the benefit to patients may not be a benefit to doctors–especially ones in small practices who don’t really have the ability to change their work processes. But surely Sydney’s not preoccupied by those concerns?

On the other hand, Syd is probably quite right that the perfect information about the health status of the individual will allow insurance companies to cherry-pick the best risks and discriminate against the sick. Of course the real joke is that Syd has in the past railed against government medicine (i.e. anything to do with Kerry) and is a firm conservative Republican. Yet the only way out of the insurance conundrum is to put every patient in the same risk pool. And that is something that Sydney apparently wouldn’t like because it’s called mandatory universal health care.

POLICY: More scenarios about the future of the system from The Industry Veteran

Yesterday I left you hanging with three scenarios as to the future of the system; muddling through; complete collapse leading to government takeover; and system self-reform. The Industry Veteran thinks that I’m on the right track but that I need to consider some other alternatives:

Your alternative scenarios for health care economics seem a bit too despondent to me. You’re quite right to say that the stakeholders in power will try to muddle along with the same bailing wire approaches, but that’s the way the American political economy works. Our system disdains national planning, preferring instead to let the market (i.e., the oligopoly capitalists) decide. That means things must approach the crash and burn stage before our power elite considers making substantive corrections. (Any time they do point to a distant crisis well in advance of its onset, e.g., Bush and Social Security, they’re usually trying to rig the system even more radically in their favor.) Throughout American history this predisposition has often placed progressives in the anomalous position of hoping for worse because that’s the only road to better. Now as far as your alternative scenarios, #3 is wish-upon-a-star thinking. Hope is not analysis and any expectation that the rational adults in health care manufacturing will act wisely by curtailing costs seems too far fetched to take seriously. More likely the earth would cease to revolve upon its axis, continents will crash into one another and the meek will inherit the earth. The question then becomes, what will cause muddling through to fail and turn the health care system into something approximating a nationally administered system? And when will this happen?

You’re probably correct in stating that health care emerges as a more acute crisis during recessions and, right now, the business cycle appears to be on an upswing. This means 2008 may not be a pivotal year for reorganizing health care. Again you’re correct to point out that the old moles of aging baby boomers (talkin’ ’bout my generation) and the ever escalating costs of new health care technology keep burrowing beneath the ground, making the soil ever more friable for fundamental change. What are some other factors at work here?

(1) I look for small employers and state-local governments to stagger beneath the inequitable, irrational weight of health care costs before the large companies do. Even though the top 500 usually maintain self-funded health insurance programs for their employees, health care also causes problems for them, not so much in terms of the absolute costs, but from the competitive disadvantage they suffer if they have to compete against Japanese or other foreign companies who don’t bear such a heavy a burden. I recently reviewed some of the debates over Social Security when Roosevelt proposed it during the 1930s. Auto moguls such as Knudsen at GM favored it because they felt confident of their ability to pass along the cost. Seventy years later automotives are a much more mature industry. Foreign competition constrains their ability to pass through the health care costs but I don’t look for them to take the lead in nationalizing health care. They’ll be around to play a supportive role. I also imagine that other businessmen clearly understand that the current system creates a forced transfer of income and wealth from themselves to health care manufacturers and they will no longer continue to permit it.

(2) The increasing stratification of health care into a two-tiered system represents too obvious a threat to the establishment’s managers. Just as the Vietnam war in the late 60s and early 70s caused students at elite universities to question some fundamental tenets of our entire political and economic system, stratified health care can disaffect wide swathes among the middle-aged and elderly. If social class works through a health care system to baldly determine life or death, too many people can ask too many, disruptive questions. We can see signs of this already from the fact that many elderly, sick people in the middle class must "spend themselves down" to Medicaid eligibility and the states are growing more stingy with these programs all the time.

(3) There is also the possibility, one to be fervently desired, that by 2008 popular discontent with the Iraq war and Bush’s overreach on gutting Social Security will provoke a pervading discontent with his entire program of crony capitalism and evangelical, social Darwinism. (I love your phrase, "theocratic fascism," but the last time I used it, my colleague in New York said, "High fallutin’ terms like that are why John Kerry lost.) If disenchantment with the reactionaries does come about, it’s entirely plausible that the next president, Democrat or Republican, may create a nationally administered health care program as a sort of less contentious sop to a broader, popular discontent. Nixon, after all, pushed the EPA partly as a distracting palliative to his Vietnam war.

In summary, 2008 may not be the year of reckoning, but as Bogart’s Rick said to Ilsa, "Maybe not today, maybe not tomorrow, but soon, and for the rest of your life."

POLICY: Health costs and the road to Armageddon

Since I wrote about the Center for Practical Health Reform and their intention to head off a perceived collapse in private sector health insurance at the pass,
a little more attention has been focused on the whole issue. How bad is
the current cost crisis and how long can the rest of the economy go on
pushing money into it?
  The press is flowing in two flavors. First, we can’t afford the costs. Second, we’re going to pay more for more cool technology.Here’s the word from the Detroit insurers that fund their health care programs by selling cars on the side (sorry for stealing Uwe’s line): 

Health
care costs are moving front and center as the single biggest factor
impacting corporate profits and U.S. companies’ inability to compete
globally……Health expenditures rose from $1.3 trillion in 2000 to
$1.7 trillion in 2003. The health sector consumed 15.3 percent of the
nation’s gross domestic product in 2003, up from 13.3 percent in just
three years. Industry observers say the problem is bigger even than in
the 1980s, before managed care came on the scene and curbed increases
for a little more than a decade before costs started spiraling again.

Those
who pay for health care — businesses, government and individuals —
are becoming more vocal about the need to bring costs in line. But
that’s about where the agreement begins and ends.

Some rather astute observers of the system think that it can’t take much more of this. My old boss Ian Morrison and his colleagues at Harris have been suggesting that the 2008 election is about the time when this issue will get national attention.  THCB regular The Industry Veteran seems to agree:

I’ve
said it for a long time; at a certain point the top 500 (non-Pharma)
corporations will no longer be able to pass along the exorbitant health
care costs and at that point, they will pose the biggest threat to Big
Pharma. It may not come now because, as this article makes plain, some
of the big companies are pursuing diversions such as
pay-for-performance, evidence-based medicine and so forth. I give it
until about 2008 for the big companies to recognize that IT and efforts
to rationalize providers wonÂ’t adequately control costs. At that
point, if our old buddy John Dingell is still around, he may emerge as
a co-grandfather of a national health care system.

The
folks at the Center for Practical Health Reform want to get the whole
of the industry together to get past their differences, essentially so
that the health care industry as a whole can keep manufacturing an
affordable product for their customers. The problem is that the pace of
the technology change that is the major reason for driving these costs
up is not slowing, it’s speeding up. Just this weekend here’s one
article about
new scanning technologies, and another about defibrillators.
Clearly there are incentives to do too many scans, and clearly there
are going to be even more incentives to put defibrillators in even more
people now that it’s been approved for virtually anyone with any heart
condition (such as a pulse). So the system will produce more services
connected to those devices. (And perhaps these scans and devices will
save other costs down the road–but that’s a separate argument we don’t
yet want to have).

But
the point is that as these costs get added onto the system, government
will more or less keep paying just as it always has over the last 30
years. Although employers are starting to eject themselves from the
system, enough of them will keep paying that disaster will not
immediately strike. In no event will there be a huge flow of money out
of the system. Why do I have some confidence in saying this?

Health
care costs are highly related to recessions, and the relative
difference in health costs to overall GDP growth causes alot of fuss.
And it does have a big impact. In the early 1970s we had Nixon’s plan
for universal care and price controls (My, how have those Republicans
changed!). In the early 1980s we had DRGs for Medicare inpatient care,
and in the 1990s we had managed care. Each of those was a reaction to
the high level of health care costs coming out of a recession as this
chart shows.

NEWS/BLOGGING: FierceHealthcare is back

After a one month hiatus, the daily digest newsletter FierceHealthcare is back. There were lots of nice things said about it during its absence and it’s going to be slightly refocusing on the processes building the 21st century health care system. And if I say so myself it’s pretty good–OK I’m the editor so I’m biased! But the price is unbeatable. If you don’t already get it, you can sign up here.

PHARMA: FDA stonewalls FOIA requests. by Blunter

Veteran FDA observer Blunter is back with more accusations about the FDA’s unwillingness to let the public know what it knows.

When I last blogged about the utter incompetence and disarray in the FDA establishment, I emphasized the "transparency" and "culture"” there. If any further proof is needed, look at the Public Citizen FOIA complaint for information on parecoxib. (Copy of the complaint is with the FDAWebView article, 1/25) (Ed’s Note: It isn’t available elsewhere on the web but I have seen a copy of it). Here we have the HHS Secretary Nominee saying the White House is looking at new candidates for the FDA Commissioner post, with the issue of Vioxx and similar drugs raising the question of "what did you know and when did you know it," amid the spectacle of supposed protectors of our health groping for their hindsides and unable to find it with both hands.

You will recall, I stated in my previous post:

For sure, more funding which would be effectively applied will be needed but unlikely to do much good so long as the current management and culture is allowed to continue.

Presently, outsiders who want or need information on FDA decisions, and the like, are channeled through a Freedom of Information process which takes two years or more just to get around to the request, and then some more time and redactions to get the info out, if indeed any is released. It has been long-standing, recognized management incompetence, worse in the Center for Drug Regulation than anywhere else (probably in the whole government). There is no transparency in what FDA is acting on, or ability for any one to compare in real time other similar data, by scientists or others, who may have data of their own or seek to learn from the existing records FDA has passed upon. And when it comes to other than medical and scientific data, the likelihood of getting anything at all to look at several years down the road is even more remote.

And there has been no effort in the last near decade to do anything about it, like introduce management or data submission processes to make the system workable. Human clinical data and drug experience (appropriately clad to protect patient privacy) is a public resource, not a trade secret, for example. But you’d never know it at FDA.

Last October, the Health Research Group of Public Citizen sought out relevant materials which FDA used to deny approvability of a COX-2 like drug, parecoxib (sold under the brand name Dynastat in Europe). A safe assumption is that Sidney Wolfe wasn’t seeking to compete with Pfizer and was seeking to initiate a public risk/benefit debate.

Not only did FDA fail to grant access to the data in its possession, redacted or not, but has not yet responded to the request at all. This is the old "stonewall" response–not "yes", not "no"–typical of FDA. May be the data that lead to the turndown of parecoxib would have substantiated the position of Whistleblower Graham on Vioxx, et al.

The vision is of the FDA topside huddled together, planning their next move for their own agenda—the world and naysayers be damned.

Need we have further proof of the bankruptcy the policies and abilities of those presently holding FDA positions of control. Let’s wish Sid Wolfe swift success in the courtroom.

Meanwhile, the studies from Express Scripts which showed that most patients on COX-2s should not have been, were borne out by this study.

INDUSTRY: The Birmingham kid is innocent!

As the trial begins of Healthsouth CEO Richard Scrushy for the largest outright health care fraud ever, it’s good to know that in America you can start a huge company from nothing, be totally responsible for all its success, pay yourself vast amounts of money–enough not only to buy all the cars, houses and planes you need but also to sponsor Christian rock boy bands and hire in actors from The Wonder Years as PR Monkeys–and go through seemingly dozens of CFOs. And all the while you never need to have any idea at all about the financial state of your own company.

QUALITY: Pawelski’s out of line in accusing the NCI by Oren Grad

Oren Grad, a physicians and an independent consultant whose work focuses on policy and strategy in the health sciences, didn’t think much of what Greg Pawelski said yesterday on THCB about cancer research being aimed at the wrong things. Nor did he much appreciate the way that he said it. Again, I’m no expert in these issues and, although I have some sympathy with the position that we do too much at the margin in oncology that promotes the profit of the oncologists rather than of the patients, I understand that this is a very, very delicate area. Greg has good reasons for holding his positions, but here’s Oren’s explanation of why he’s wrong.

I have to say that Greg Pawelski’s post today on cancer research was annoying. I think he’s out of line in both tone and substance, and his "expose" is in fact pretty stale by now.

It’s not as if the leadership of NCI aren’t very well aware of the issues Greg raises, as well as many more that he doesn’t. The CTWG initiative described in these links is but one of several being pushed vigorously by NCI director Andrew von Eschenbach. A lot of very smart, very busy people both within and outside NCI are currently chewing up substantial time figuring out how to adjust NCI’s approach to meet today’s challenges rather than yesterday’s.

From a scientific perspective as well, the implication that Greg’s found magic answers that are being scandalously overlooked is way off base. Both metastasis and ways of individualizing treatment are very much on people’s minds, and will, appropriately, see increased research effort in coming years. Only time will tell whether the insights brought by these efforts will in fact pan out in improved patient outcomes. Cancer is fundamentally a very hard problem.

It’s certainly difficult to redirect a large public agency like NCI quickly. But as a long-time observer of cancer research policy and bureaucratic politics, I do think that as the current initiatives play out we can expect to see changes that will help NCI respond more effectively to new scientific findings and opportunities.

QUALITY: Now cancer is top killer, let’s attack it using common sense, by Greg Pawelski

Greg Pawelski has posted frequently on THCB about cancer care. On the occasion of cancer becoming the nation’s biggest killer for those under 85, he appeals for sensible use of scientific funding to go after the process behind metastasis.

The Associated Press reported that Cancer is the Top Killer for Those Under 85. There has been no real progress in the treatment of most common forms of cancer. Recent NCI data showed that U.S. cancer mortality rates have increased and age-adjusted cancer mortality rates in response to treatment have not improved in several decades, despite the introduction of many new drugs. There is a mind-set of cancer culture that pushes tens of thousands of physicians and scientists toward the goal of finding the tiniest improvements in treatment rather than genuine breakthroughs, that rewards academic achievement and publication over all else.

The January 10, 2002 issue of the New England Journal of Medicine noted that 20 years of clinical trials yielded survival improvement of only 2 months for patients with advanced lung cancer. It also pointed out that oncologists at a single institution may obtain a 40-50% response rate (not cure) in a tightly controlled study, but when these same studies are administered in a real world setting, the response rates (not cure rates) decline to only 17-27%.

In the March 15, 2004 issue of the Journal of Clinical Oncology, an editorial stated that a review of all the large, prospective, randomized trials published comparing the newer taxane-based regimens, none of these regimens have increased either complete response rates or overall survival, with median survivals remaining at two years or less. This is precisely the same results which were being obtained 30 years ago.

The results of nearly 30 years of clinical investigation in the treatment of patients with cancer, neither standard or high-dose regimens had done a great deal to improve the outcome of patients. For over the past 20 years, they relentlessly combined chemical agents in various regimens with ever-increasing dose intensity and the survival for patients is exactly the same, less than two years. Not a hint of significantly improved survival.

In the March 22, 2004 issue of Fortune, an extensive expose of why there has been no progress in drug treatment of cancer in three decades, the author writes that it is not localized tumors that kill people with cancer, it is the process of metastasis, 90% of the time. Aggressive cells spreading to the bones, liver, lungs, brain or other vital areas, that are wreaking havoc. You’d think cancer researchers would be bearing down on the intricate mechanisms of invasion and spread? However, according to a Fortune examination of NCI grants going back to 1972, less than 0.5% of study proposals focused primarily on metastasis, trying to understand its role in cancer or just the process itself. Of nearly 8,900 NCI grant proposals awarded in 2003, 92% didn’t even mention the word metastasis.

So pharmaceutical companies don’t concentrate on solving the problem of metastasis (the thing that really kills people); they focus on devising drugs that shrink tumors (the thing that doesn’t). There is a national problem in the way we treat the problem. It is time to set aside empiric "one-size-fits-all" treatment of cancer for "individualized" treatment based on testing the individual properties of each patient’s cancer.

assetto corsa mods