There Be Luddites and Skeptics...

By John Ballard

If more Congressional interns and staff would tear themselves away from legislative mouseprint long enough to read another language (scientific research, for example) health care reform would be more effective and less costly at the same time. It's a stretch, but I keep hoping.

In a shocking development yesterday a business group clearly NOT bought and paid for by the usual suspects changed it's position on health care reform from pro to con, not because they were not getting a big enough piece of the pie, but because unless something isn't done right and quickly, health care reforms under consideration will do little if anything to curb health care inflation. 

Without fundamental changes to the current health reform plans, the White House and congressional Democrats risk losing the last major corporate group that is standing by their effort: The Business Roundtable.

In an interview with POLITICO on Friday, Roundtable President John Castellani raised concerns about the effectiveness of cost containment provisions in the proposal, and the timing of various fees and taxes that ultimately could be passed on to employers that provide insurance to workers.

�If these areas aren�t improved the reform effort will not work and we need something that works,� said Castellani.

Castellani wouldn�t say how long the group is giving Democrats to fix the bill, but said, �We are going to be much louder and much more insistent on improving� the legislation.

To simplify, what the group is saying is that legislation must do more to contain future costs, not by harvesting yet another layer of taxes but by actually lowering costs at the source, namely the medical bills where those costs originate.

What a concept! Lower costs by having lower bills from the outset. Why didn't someone think of that sooner?

� Access to data collected by the Centers for Medicare and Medicaid Services that can be used to identify cost-effective treatments, efficient hospitals and best performing physicians, which could help businesses develop more efficient and effective private insurance packages for their employees.

�Right now that data sits there and nobody has access to it,� said Castellani. �You know more about the cost and quality of a flat screen TV than you do about heart-bypass surgery.�

� An expansion of the authority of the proposed Independent Medicare Advisory Board so that it can search for cost savings in all health care sectors. The current legislation exempts some groups from scrutiny, including hospitals. In addition, the board should be charged to search for efficiency measures in the private sector that can replicated in the Medicare system.

� An acceleration and expansion of pilot programs aimed at changing the way Medicare reimburses doctors and hospitals by providing bundled payments to cover patient testing and consultations rather than paying for each service delivered, which critics say leads to unnecessary treatment.

As someone who spent an entire working lifetime trying to squeeze a nickel or two from every dollar of revenue, I have seen this whole issue through a business lens from the start. It does my heart good to see actual business leaders combing through the mess and taking a sensible position against pissing away money carelessly.

In our humanitarian hearts we Liberals are so fixed on the idea of making health care universal that we tend not to remember that what "health care" means is neither agreed upon nor in many cases financially realistic. The original authors of the legislation, together with the medical and scientific communities, began the legislative effort with a coherent proposal. But the fear-mongering and toxic politics of opponents have succeeded to the point that actual cost controls have almost disappeared. As the Wonk Room report says, this is a chance to push some of the best features of the original proposals back into the bills being written.

The amendments also broaden the scope of the Independent Medicare Advisory Board (IMAB) by pushing the board to consider total health system spending and make system-wide recommendations to ensure that cuts in Medicare don�t result in cost shifts to other parts of the health system.

Like the latest CMS report, which criticized the Senate bill for not doing enough to control the growth in health care spending, the Roundtable�s �threats� should be treated as opportunities to improve the bill. Again, their concerns are valid. They should be addressed.

Rather than complain about the Senate bill�s insufficient cost containment measures, �moderate� lawmakers should use this opportunity to insert even more stringent cost-control mechanisms into the final bill. Take on the providers by giving IMAB the authority to recommend payment adjustments to doctors and hospitals � after all, the health industry has already admitted to inefficiencies and pledged to reduce the growth rate in annual health spending by 1.5 percentage points a year over the next 10 years. Allow IMAB to hold them to that pledge.

When I came across that article yesterday my first impulse was to jump on it and write a post. But putting up posts with the same message in different forms, time after time, is about as meaningless as tossing coins into a fountain, or bottles with messages into the ocean. Odds are slim now -- in a deafening chorus of  tweets -- that yet another blog post with the same tired message will get legs.

But this morning I am encouraged by two more good reads along the same line, one from Wired (H/T Azra Raza) and one from Business Week in May 2006, three and a half years ago!

Rather than parse these two readings, I will link them for further investigation by anyone curious enough to plow through them. In a nutshell, both are about a man and his machine and the revolutionary impact they are having on medical and scientific research. From the content of these two articles, I wonder if Dr. David Eddy might be a nominee for some big prize for his accomplishments. I never heard of him but many in the scientific community certainly do.

Dr. Eddy's "machine" is in reality an elaborate computer model designed to do for medicine what crash dummies do for car makers. Here is how the Business Week article opens.

Medical Guesswork

From heart surgery to prostate care, the health industry knows little about which common treatments really work

The signs at the meeting were not propitious. Half the board members of Kaiser Permanente's Care Management Institute left before Dr. David Eddy finally got the 10 minutes he had pleaded for. But the message Eddy delivered was riveting. With a groundbreaking computer simulation, Eddy showed that the conventional approach to treating diabetes did little to prevent the heart attacks and strokes that are complications of the disease. In contrast, a simple regimen of aspirin and generic drugs to lower blood pressure and cholesterol sent the rate of such incidents plunging. The payoff: healthier lives and hundreds of millions in savings. "I told them: 'This is as good as it gets to improve care and lower costs, which doesn't happen often in medicine,"' Eddy recalls. "'If you don't implement this,' I said, 'you might as well close up shop."'

The message got through. Three years later, Kaiser is in the midst of a major initiative to change the treatment of the diabetics in its care. "We're trying to put nearly a million people on these drugs," says Dr. Paul Wallace, senior adviser to the Care Management Institute. The early results: The strategy is indeed improving care and cutting costs, just as Eddy's model predicted.

For Eddy, this is one small step toward solving the thorniest riddle in medicine -- a dark secret he has spent his career exposing. "The problem is that we don't know what we are doing," he says. Even today, with a high-tech health-care system that costs the nation $2 trillion a year, there is little or no evidence that many widely used treatments and procedures actually work better than various cheaper alternatives.

The rest of the article tracks the growth and impact of his work. Here are a couple of paragraphs to whet your appetite.

What's required is a revolution called "evidence-based medicine," says Eddy, a heart surgeon turned mathematician and health-care economist. Tall, lean, and fit at 64, Eddy has the athletic stride and catlike reflexes of the ace rock climber he still is. He also exhibits the competitive drive of someone who once obsessively recorded his time on every training run, and who still likes to be first on a brisk walk up a hill near his home in Aspen, Colo. In his career, he has never been afraid to take a difficult path or an unpopular stand. "Evidence-based" is a term he coined in the early 1980s, and it has since become a rallying cry among medical reformers. The goal of this movement is to pierce the fog that envelops the practice of medicine -- a state of ignorance for which doctors cannot really be blamed. "The limitation is the human mind," Eddy says. Without extensive information on the outcomes of treatments, it's fiendishly difficult to know the best approach for care. 

?000?

Even when common treatments are proved to be dubious, physicians don't rush to change their practice. They may still firmly believe in the treatment -- or in the dollars it brings in. And doctors whose oxen get gored sometimes fight back. In 1993, the federal government's Agency for Health Care Policy & Research convened a panel to develop guidelines for back surgery. Fearing that the recommendations would cast doubt on what the doctors were doing, a prominent back surgeon protested to Congress, and lawmakers slashed funding for the agency. "Congress forced out the research," says Floyd J. Fowler Jr., president of the Foundation for Informed Medical Decision Making. "It was a national tragedy," he says -- and not an isolated incident. The agency's budget is often targeted "by special interest groups who had their specialty threatened," says Arkansas' Dr. Thompson.

Sound familiar?
Remember, this was three and a half years ago.
The bitching we hear now is nothing new. It's been going on ever since Louis Pasteur announced the existence of germs. Except for an open-minded minority, a whole generation of old-fashioned doctors had to die before scientific evidence started to save lives. I want to believe that is no longer the case, but the evidence I am reading suggests otherwise.

Jennifer Kahn's article in this month's Wired is where I found the link to the Business
Week story. She describes in outline form Dr. Eddy's "Archimedes," a computer model approach to medical testing which in an era of explosive computer gaming should be received with enthusiasm.

She opens with a description of a diabetes study conducted at great expense over six or seven years. A few weeks before the results of the study were released, The American Diabetes Association asked Dr. Eddy to in effect guess what the outcome might be.

It took Eddy and his team roughly two months to construct the virtual trial, but once they hit Return, the program completed the study in just one hour. When he got the results, Eddy sent them to the ADA. He also mailed a copy to the Cards investigators. Months later, when the official results were made public, it became clear that Eddy had come remarkably close to predicting exactly how everything would turn out. Of the four principal findings of the study, Archimedes had predicted two exactly right, a third within the margin of error, and the fourth just below that. Rather than seven years, Eddy�s experiment had taken just a couple of months. And the whole project had cost just a few hundred thousand dollars, which Eddy estimates to be a 200th of the cost of the real trial. The results seemed to vindicate his vision for the future of medicine: faster, cheaper, broader clinical trials � all happening inside a machine.

This is not science in the traditional meaning of the word. But it's a by-damn close simulation that can save lives, time and money. The reader is urged to read and decide for yourself how this man's work should be viewed and interpreted. There are critics enough, starting with the comments thread, without additional caveats from me.

I for one am encouraged and impressed. Dr. Eddy is not advocating the substitution of virtual simulation over science, but exactly the opposite, demanding to know how evidence supports policy and practice.

After settling in Wyoming in 1987, Eddy began working as a consultant for Kaiser Permanente � at the time a midsize insurer and health care provider. He also continued a consulting gig he had with Blue Cross Blue Shield, helping the insurer set up a program to determine when the evidence of a treatment�s effectiveness was sufficient to justify coverage. The work often pitted Eddy against doctors who believed he was interfering with their ability to treat patients. In one particularly contentious case, Eddy argued against covering a complicated, potentially dangerous treatment involving high-dose chemotherapy followed by a bone marrow transplant that was believed to help breast cancer patients. It cost up to $150,000, and there was no evidence that the transplant actually made patients live longer, so Blue Cross decided not to cover the treatment. But Eddy�s argument didn�t fly with oncologists and advocacy groups, who pilloried him for denying patients access to a potentially lifesaving treatment and accused Blue Cross of sacrificing women�s health for its bottom line.

The dispute ignited the national media. �The country was in a furor,� Eddy says. �There was hate mail and that kind of thing.� A cover story in Time magazine included a photo of a doctor gagged with a surgical mask.

Several years later, clinical trials confirmed that the high-dose chemotherapy and bone marrow transplant had no effect on patient survival. �We held the line and stopped a dangerous treatment,� he says. �The first rule is �Thou shalt have evidence.��

Again, does this sound familiar?
How about that flap a couple of weeks ago over mammograms?
Hmmm???
That's a perfect example of how science has a hard time intersecting with politics and special interests. 

The mammogram flap exploded because no one (even now) pays attention to the word "recommendation." It's about as nutty as conflating end-of-life counseling with death panels. 

Kahn's article is not all accolades. She tempers the big picture of impressive results with criticisms.

Eddy�s secretive habits are also troubling, according to David Nathan, director of the Diabetes Center at Massachusetts General Hospital. �If you listen to David, he has 10,000 variables and differential equations describing everything from blood sugar to office furniture,� Nathan says. �But it�s never quite clear what they are or how they interact. All the calculations happen inside a black box. And that�s a problem because there�s no way to tell whether the model�s underlying assumptions are right.�

Eddy tends to answer such criticism by citing his record of success � specifically the 74 validations, which he maintains were chosen for their difficulty. �The trial validations show that the model reflects the reality of how diseases progress,� he says. �Whether or not we know exactly what drives them.�

This argument has so far failed to convince many clinicians. Several epidemiologists, who didn�t want to be named, insist that Eddy has remained frustratingly tight-lipped about the details of his creation. �In the end I think he just wants to guard his property,� one said. It�s a particularly ironic critique, given his history as a champion of hard data and clear evidence.

One commenter says of the 74 validations, "I am skeptical of the archimedes model. They claim that 74 clinical trials were validated. They make no mention of how many trials they could NOT validate. What if that number is 210? As pointed out in the article, did they just get lucky? Or just predict what they know they can do well?"

Here, toward the end, is the real big picture.

Theoretically, Eddy argues, Archimedes� mistakes could actually become virtues, by enabling researchers to identify where their understanding of human biology is faulty. Etheredge agrees. �When Archimedes is wrong, that�s when it�s going to get really interesting,� he says. �We�ve put everything we know about physiology into Archimedes � and it gave us the wrong answer! What does that mean? It means we�re missing something. So it can actually help us figure out where we have a gap in our knowledge.�

That assumes, of course, that the model itself is not the source of the mistake. Eddy has argued that Archimedes is simply too complex for most researchers to grasp � relying as it does on a string of equations that are unintelligible to the average clinician. But the stacks and stacks of unexplained equations are precisely what worry critics. Because every piece in Archimedes is linked to every other through a series of simultaneous equations, changing one variable has the potential to cause cascading complications. A new piece of information about the way arteries work could throw off an estimation about the blood flow in another part of the model. At best, this could make Archimedes less nimble. But some modelers worry that it could also turn Archimedes into a mathematical kludge: a piece of software built on the shifting sands of medical knowledge and kept running through complex rewiring � to the point where even the original architects can�t follow all the links and assumptions.

Which raises a question: Is Archimedes like medical knowledge itself, growing richer and closer to reality with every added layer of detail, or is it more like an ambitious Rube Goldberg contraption, functioning in spite of itself but only as long as all the parts can be kept in balance?

Asked exactly that, Jonathan Brown, who models diabetes at Kaiser�s Center for Health Research, pauses for so long that it seems the phone line has gone dead. �Real physiology is incredibly complex,� he says finally. �And our understanding of disease is changing almost week by week.� He sighs, then adds, �The risk with a model like Archimedes is that it may just end up codifying our ignorance.�

So there you have it again.
The operative word remains recommendation.
That's why it's called the practice of medicine.