The Obama Administration Gets Into the Pre-Approval Business: "Coming Between You and Your Doctor"

Unless you are a national T.V. reporter, vacuous socialite Paris Hilton or a leading official in the Obama Administration, you probably already know that health insurers do not deny coverage of medical services based on cost. Instead, payment (or non-payment) for healthcare services is based on an assessment of "medical necessity," which, in turn, is ultimately determined by published evidence, expert opinion, clinical guidelines and national standards of care (here's an example). Once what is covered is known, it's a matter of knowing the unit charge and expected utilization and rolling that up into the insurance benefit design and the price of the premium. From time to time, insurers may require knowing if the medical treatment fits the science. That can be complicated and can be a source of insurer mischief. Doctors and patients can get tangled up in differing interpretations of a policy. Ultimately, however, the often derided "insurers coming between you and your doctor" is typically a function of thought, not thievery.

Well, thanks to this summary, courtesy of the New England Journal of Medicine, we are now witnessing an intrusion of the Federal government into the decision-making between doctors and their patients. Aside from a problem with occasionally killing patients, Avandia remains an important option in the treatment of diabetes. It's possible for a doctor and a patient to weigh the benefits, risks and alternatives and correctly mutually decide to use it. Their problem now, however, is that they'll need to seek permission. According to the Journal, the Food and Drug Administration's "Risk Evaluation and Mitigation Strategy" (REMS) will require the following prior to obtaining approval to use the drug:

"Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns"

The Disease Management Care Blog points out that the FDA is doing this because of two reasons 1) it's science-based and 2) using that science to come between a doctor and a patient works. So, the DMCB says "welcome to the managed care club" to the FDA and the Obama Administration.

By the way, the better health insurers typically strive to streamline this kind of pre-approval process by making toll-free lines available 24-7 or using web portals with data entry fields that can be completed in minutes. The DMCB hopes the FDA sets up a similar process for Avandia. Doing this by paper promises to be a bureaucratic nightmare.

Is A Back Door Being Built For A Single Payer System?

That question is considered in the guest post that was provided below by a DMCB physician-colleague.......

From my perspective as a solo family doctor it looks that way to me.

I am seeing some disturbing changes in how physicians bill for their services, the rise of insurance mandates and increasing consolidation of the health insurance industry. Carried to their logical conclusion, the government will need to step in. Maybe that's the intent.

My daughter recently had an appointment with her pediatrician for a “well-child” visit. When I received a copy of the physician’s bill, I noticed that there was a fee for the well visit as well as for an intermediate acute visit (99213). This is important because my family insurance uses a high deductible policy. When I brought the possibility that there may be overbilling to the attention of physician’s office, they claimed it was well within coding guidelines.
I didn’t agree, so I asked for a copy of the physician’s office note. This was enough to have my inquiry referred to the physician’s coding and compliance officer. After reviewing my daughter’s chart, he agreed that it did not meet requirements for a 99213 intermediate visit and informed me that the account would be credited.

This is more important than now being able to enjoy a night out with my spouse. That pediatrician’s practice was recently acquired by a hospital that is positioning itself to become an “Accountable Care Organization” (ACO). Before the hospital owned the pediatrician's practice, it was unheard of it to bundle a well and acute visit. But now, the hospital has apparently launched an aggressive coding initiative that is designed to maximize revenue. I predict that future ACO’s will find this and other ways to maximize revenue in ways that would have never been considered by well-meaning physicians and policy makers. This will increase costs.

In the news, I hear that some are calling the individual insurance mandate unconstitutional. They are trying to strike this provision from “Obamacare”. If this is taken out without modifying the other provisions (i.e. dealing with preexisting conditions ), there is evidence that this will bankrupt insurance companies or cause skyrocketing premiums.

Government mandates for coverage without regard for actuarial consequences will also cause premiums to dramatically increase. In Pennsylvania we now have an autism mandate for enhanced coverage to care for autism patients. Any enhanced or generous coverage for any specific disease process has the ability to bend the cost curve in the wrong direction. This will also increase costs.

Lastly, insurance company mergers and acquisitions have been commonplace in the last decade. If oligopolies occur (and by many accounts they already have) prices will go up and the government may be inclined to enact anti-trust protections, further increasing the involvement of government in health care.

Taken together, these developments and others may ultimately open up a back door for the single payer system. The combination of aggressive clinical billing, expanded disease coverage without universal coverage and insurance oligopolies may set the stage for increased government intervention backed by a frustrated voting public.

The most worrisome aspect is that the government may be as dumb as a fox. It is well known that the Obama Administration is enamored with increased federal involvement of healthcare. Between navigating the health care system for myself and my patients, watching the news and following the political dramas, it sure looks as if the stage has been set for the eventual passage of a single payer system.

Ideology vs. Values in Health Reform: We Deserve Better

Following the collapse of the housing market back in 2008, former Federal Reserve Board Chair Alan Greenspan appeared before the U.S. House Oversight Committee for a rather painful post-mortem examination. Over the course of several hours, he endured biting criticism for relying on what was described as a flawed free market "ideology." Henry Waxman's metaphysical questioning of the humbled former Fed Chief was a masterful combination of partisan opportunism, photo-op politics and angry revenge.

It was also a demonstration of the political process run amok.

David Brooks, writing recently in the New York Times, has it right: the political classes' ideological anger is out of step with Main Street citizens' anger over values. While the two concepts overlap, the former deals with creed and belief systems, while the latter deals with interests and materiality. The former has led to intellectual/political gridlock that now presides over a bloated, metastasizing and unwieldy thicket of statutes, regulations, law suits, lawyers, unions and craven complex of private sector government contractors. Mr. Brooks argues this has ultimately short-circuited a key American value: being able to benefit or suffer from the upsides and downsides (including luck) of personal initiative. He's not sure that things will necessarily change after the midterm elections, but he does predict that to succeed, a future President may need to understand the difference.

And look no further for a poisonous example of recent ideological jousting than HHS Secretary Kathleen Sebelius' editorial in the September 28 Wall Street Journal. In it, Ms. Sebelius retreads an ultimately ideological perspective that the purpose of health insurance, apparently in the absence of a preferred single payer system, is to guarantee access to care by selling "reasonably" low-priced insurance policies that cover all the medical costs for anyone who wants to buy it anytime. And, as typical for ideologues, falsely contrived good vs. evil battle lines are drawn: in this instance she pits down-on-their-luck self-employed, hard-working persons against faceless and avaricious health insurers.

As testimony to the righteousness of Ms. Sebelius' side, her Exhibit A is a recent North Carolina Blue Cross Blue Shield premium rebate. It turns out that the story is a little bit more complicated. For that, see Carl Mecurio's excellent summary of what happened here. Basically, the introduction of exchanges in the near term meant that the insurer's reserves against long term costs were becoming redundant. Sending checks out for a few hundred dollars to the involved BCBS enrollees was based on an actuarial decision that had little to do with the HHS' saintliness.

The Disease Management Care Blog will be the first to admit that it and its fellow bloggers suffer from a sometimes overzealous dose of ideology, but heck, they're blogs. Their role is to use all the tools of rational thought to uncover points of view that deserve higher visibility. Public service and governance, on the other hand, calls for a far more subtle, balanced and difficult job of reining in ideology and reconciling the important notion of personal responsibility with our other cherished values of progressivism, justice and others. It's not easy, but the talent is out there.

The Wall Street Journal editorial only demonstrates how badly this Administration's lack of that talent is failing in that key attribute when it comes to health care reform.

"Treat to Target": Disease Management on Steroids

Writing in the latest issue of the American Journal of Managed Care, medical student David Margolius and academic scholar Thomas Bodenheimer describe an approach to hypertension management called "Treat to Target."

It has three ingredients:

1. Home blood pressure monitoring and recording

2. "... regular phone calls from a nonphysician team member who reinforces blood pressure goals and provides coaching on diet, exercise, and medication adherence. These team members—also referred to as health coaches—may be registered nurses, pharmacists, medical assistants, or other nonclinicians trained in behavior-change counseling."

3. Standing physician orders, which can be jointly used by the coaches and the patients to up doses are start new medications.

The authors quote several peer-reviewed studies that have shown it works. The secret sauce, they say, is making physician instructions understandable to patients, bringing them into the decision making, improving low medication compliance rates and overcoming clinical inertia.

The DMCB likes the idea because it takes the disease management coaching model (already in place in about 20% of all patients with a chronic condition nationwide) and gives it an additional punch. While physicians and policy makers may tut-tut about the potential to undercut the doctors' role, the fact is that "standing orders" are one of the great secrets of countless well-run clinics and, if done right, fall well within scope of practice laws in most States.

As typical of most academicians nowadays, Dr. Bodenheimer suggests all that is needed is insurer coverage of home monitoring and payment for the accompanying physician effort. The DMCB suggests these ingredients are necessary but not sufficient. Another resource is the disease management vendors. They've probably been thinking on how to systematize something like this across a network while simultaneously preserving the individual physician-patient dyad.

Finally, why stop at hypertension? This could also work in diabetes mellitus and hyperlipidemia.

Now that we have an scholarly article that links standing orders and disease management, the DMCB hopes its vendor-colleagues are printing out that article and approaching its buyer/purchaser/insurer customers with the next step up population care management. Hopefully, all of us will get to read about those outcomes in a future issue of AJMC.

a Summary of the Latest Population Health Management Journal

Like you, the Disease Management Care Blog has been busy. Yet, it finally managed to find some time to crack the latest issue of the Population Health Management Journal. What's more, the DMCB kept some notes for your quoting pleasure. Check it out and if any of the articles catch your interest, you can access the abstracts here.

Michael French, Jenny Homer, Shay Klevay, Edward Goldman, Steven Ullmann and Barbara Kahn: Is the United States Ready to Embrace Concierge Medicine?

This is a very detailed review of an emerging kind of primary care where, “in exchange for a retainer or membership fee, patients receive same day or next day appointments for non-urgent care, access 24 hours a day and preventive medical services not usually offered through health insurance.” Here are some facts that caught the DMCB eye: concierge medicine started in 1996, up to an estimated 5000 physicians are CM docs and the retainer fee is typically not covered by insurance. The practice has spawned its own not-for profit trade/advocacy association (http://www.aapp.org//). While you might think the phenomenon is limited to small physician-owned clinics, there are companies that employ physicians in concierge practices. The retainer fees range from $1500-$3600 per patient. Docs typically have just under 500 patients in their panel, allow about 10 visits per day and enjoy incomes as high as $800,000. The authors suggest this could crowd out regular primary care and further strain access. There is precious little research on quality or outcomes Last but not least, Medicare specifically prohibits billing beneficiaries for services that it already covers, which could lead to some physicians becoming ensnared in accusations of double billing. In light of all the attention concierge practices have received, the DMCB is surprised at the low numbers and the emergence of concierge "chains." It asks if and when there will be tipping point and wonders if the SGR will play a role.

Iftekhar Kalsekar, Samantha Record, Karly Nesnidal and Bruce Hancock: National Estimates of Enrollment in Disease Management programs in the United States: An Analysis of the National Ambulatory Medical Care Survey (NAMCS) Data.

The authors used data from the NAMCS to estimate the level of participation in disease management (DM) programs. Their bottom line estimate is that 21.3% of eligible patients are enrolled in DM. While the DMCB would have guessed that chronic heart failure is the chronic condition that the highest penetrance, the answer is that it's chronic renal failure at 40%. The other usual conditions range between 16 and 29%. In reading the methodology for this article, the DMCB couldn’t quite understand how the authors got at the DM enrollment information. Since it trusts PHM’s peer review process and the authors quote other studies that have similar figures, the DMCB finds the numbers credible. Assuming they are correct, they point to the considerable upside growth potential of the disease/care/population health management industry.

Richard Feifer, Laurie Greenberg, Sandra Rosenberg-Brandi Ellen Franzblau-Isaac: Pharmacist Counseling at the Start of Therapy: Patient Receptivity to Offers of In-Person and Subsequent Telephonic Clinical Support

100 consecutive patients who had just started a new medication for a chronic condition were contacted for disease management. Prior to the counseling, the authors used a short survey to ask these patients about their experience when they first picked up their prescription at their community pharmacy. 58% didn’t recall being offered counseling, 11% refused it and 12% couldn’t recall getting useful advice. While it’s difficult to generalize from such a small survey involving a small number of patients, it confirms the DMCB skepticism about the notion that retail pharmacy windows can be retrofitted to deliver disease management. The DMCB also better understands why its own personal chain pharmacy gets its sign-off on a mechanized offer of counseling - which it never gets and doesn't want.

Justin Schaneman, Amy Kagey, Stephen Soltesz, Julie Stone: The Role of Comprehensive Eye Exams in the Early Detection of Diabetes and Other Chronic Diseases in an Employed Population

The research database of Human Capital Management Services contains a vast amount of demographic, employment, compensation, medical claims, pharmacy claims, disability, workman’s comp and work absence information on millions of employees from across the United States – including, maybe, you. Do not, however, be paranoid, because the authors looked at persons with either specific check-box notification of, or, a claim consistent with a screening eye exam that was subsequently followed by the appearance of new claims for diabetes (N=620), hypertension (N=1558) or high cholesterol (2824). When that happened (eye exam, followed by insurance claims), the authors assumed that the eye examination discovered the condition, which then led to a referral for care. These persons were compared to 2,668 persons who also had new claims for diabetes (2668), high blood pressure (17,112) or high cholesterol (12,059) but without the preceding eye exam. . The authors found the eye exam group, compared to those without the exams, appeared to have a less costly course of care. What’s more, the eye exam was associated with less disability and lower workman’s comp claims and a lower likelihood of being terminated. It all added up to more than $4.5 million in possible savings. The authors correctly point out that there may be unidentified sources of bias that could account for the differences and that this may also be a classic example of lead-time bias. The DMCB also points out that association doesn’t mean causality.

Jeanne Clark, Hsien–Yen Chang, Shari Bolen, Andrew Shore, Suzanne Goodwin, and Jonathan Weiner: Development of a Claims-Based Risk Score to Identify Obese Individuals

These Johns Hopkins researchers had concurrent access to the self-reported height and weight data from health risk assessments (HRAs) as well as insurance demographic and claims data from seven Blues plans of over 71,000 individuals. Logistic regression was used to determine which kinds of insurance claims data could be used to predict the presence of obesity in the absence of an HRA. Armed with such an “obesity risk score” tool, commercial plans could presumably use this to recruit patients that appear to have obesity into disease management programs. While the sensitivity and specificity of the modeling was far from perfect (the area under the ROC curve ranged from .67 to .73), this study shows, once again, how health plans can infer important conclusions about their enrollees based on claims data. It should be no surprise that the regression equation it self with the weights were not reported, presumably because that will only be available if you pay for it.

Manjiri Pawaskar, Steven Burch, Eric Seiber, Milap Nahata, Ala Iaconi and Rajesh Balkrishnan: Medicaid Payment Mechanisms: Impact on Medication Adherence and Health Care Service Utilization in Type 2 Diabetes Enrollees

According to the Kaiser Foundation, about 45% of Medicaid recipients nationwide are enrolled in “capitated” Medicaid plans. Are taxpayers getting their money’s worth and are these patients being care for properly? To find out, the authors looked at the claims data from between 1999 and 2005 of 8581 adults age 18 to 64 years with diabetes who were newly started on an oral anti-diabetic medication from 8 unnamed Medicaid managed care plans. 3763 patients were enrolled in “capitated” plans (where most medical services were paid for on a capitated basis) and 4818 were in fee-for-service plans. Logistic regression demonstrated that being in a capitated plan was statistically significantly associated with a greater likelihood of hospitalization and a lower frequency of outpatient visits and a lower likelihood of getting prescriptions filled. Hm, says the DMCB: maybe Medicaid plans should use disease management to make up for these shortfalls.

Nasiya N. Ahmed and Shannon Pearce: Acute Care for the Elderly: A Literature Review

Ever hear of Acute Care for the Elderly (ACE) Units? These are small 10-20 bed inpatient settings that are specially configured for the special needs of elderly persons with acute illness. It involves specialized geriatric care and interdisciplinary teaming all configured to maximize the likelihood of returning the patient to independent living. The authors summarized all the published literature on the topic and conclude that the clinical trials that do exist seem to show that ACEs, compared to usual care, generally lead to a shorter length of stay, have a lower likelihood of readmissions, end up with fewer transfers to a nursing home for longer term care, result in less functional decline, have a lower risk of delirium, reduce the chance of polypharmacy and experience lower cost. The authors caution the literature, while promising, is relatively limited and more research is necessary.

Potatoes and Human Health, Part II

Glycoalkaloids in Commonly Eaten Potatoes

Like many edible plants, potatoes contain substances designed to protect them from marauding creatures. The main two substances we're concerned with are alpha-solanine and alpha-chaconine, because they are the most toxic and abundant. Here is a graph of the combined concentration of these two glycoalkaloids in common potato varieties (1):

We can immediately determine three things from this graph:

• Different varieties contain different amounts of glycoalkaloids.
• Common commercial varieties such as russet and white potatoes are low in glycoalkaloids. This is no accident. The glycoalkaloid content of potatoes is monitored in the US.
  
• Most of the glycoalkaloid content is in the skin (within 1 mm of the surface). That way, predators have to eat through poison to get to the flesh. Fortunately, humans have peelers.

I'll jump the gun and tell you that the generally accepted safe level of potato glycoalkaloids is 200 mcg/g fresh weight (1). You can see that all but one variety are well below this level when peeled. Personally, I've never seen the Snowden variety in the store or at the farmer's market. It appears to be used mostly for potato chips.

Glycoalkaloid Toxicity in Animals

Potato glycoalkaloids are undoubtedly toxic at high doses. They have caused many harmful effects in animals and humans, including (1, 2):

• Death (humans and animals)
  
• Weight loss, diarrhea (humans and animals)
  
• Anemia (rabbits)
• Liver damage (rats)
  
• Lower birth weight (mice)
  
• Birth defects (in animals injected with glycoalkaloids)
  
• Increased intestinal permeability (mice)

However, it's important to remember the old saying "the dose makes the poison". The human body is designed to handle a certain amount of plant toxins with no ill effects. Virtually every plant food, and a few animal foods, contains some kind of toxic substance. We're constantly bombarded by gamma rays, ultra violet rays, bacterial toxins, free radicals, and many other potentially harmful substances. In excess, they can be deadly, but we are adapted to dealing with small amounts of them, and the right dose can even be beneficial in some cases.

All of the studies I mentioned above, except one, involved doses of glycoalkaloids that exceed what one could get from eating typical potatoes. They used green or blemished potatoes, isolated potato skins, potato sprouts or isolated glycoalkaloids (more on this later). The single exception is the last study, showing that normal doses of glycoalkaloids can aggravate inflammatory bowel disease in transgenic mice that are genetically predisposed to it (3)*.

What happens when you feed normal animals normal potatoes? Not much. Many studies have shown that they suffer no ill effects whatsoever, even at high intakes (1, 2). This has been shown in primates as well (4, 5, 6). In fact, potato-based diets appear to be generally superior to grain-based diets in animal feed. As early as 1938, Dr. Edward Mellanby showed that grains, but not potatoes, aggravate vitamin A deficiency in rats and dogs (7). This followed his research showing that whole grains, but not potatoes, aggravate vitamin D deficiency due to their high phytic acid content (Mellanby. Nutrition and Disease. 1934). Potatoes were also a prominent part of Mellanby's highly effective tooth decay reversal studies in humans, published in the British Medical Journal in 1932 (8, 9).

Potatoes partially protect rats against the harmful effects of excessive cholesterol feeding, when compared to wheat starch-based feed (10). Potato feeding leads to a better lipid profile and intestinal short-chain fatty acid production than wheat starch or sugar in rats (11). I wasn't able to find a single study showing any adverse effect of normal potato feeding in any normal animal. That's despite reading two long review articles on potato glycoalkaloids and specifically searching PubMed for studies showing a harmful effect. If you know of one, please post it in the comments section.

In the next post, I'll write about the effects of potatoes in the human diet, including data on the health of traditional potato-eating cultures... and a curious experiment by the Washington State Potato Commission that will begin on October 1.


*Interleukin-10 knockout mice. IL-10 is a cytokine involved in the resolution of inflammation and these mice develop inflammatory bowel disease (regardless of diet) due to a reduced capacity to resolve inflammation.

Snippets From A Conference on Health Care

The note-taking Disease Management Care Blog attended the World Congress Leadership Summit on Health Care Reform today. Thanks to a day of keynote presentations, panel discussions and audience questioning, the DMCB culled some of the more interesting pointers from the presenters:

State regulation of health insurance rates – to make sure they are reasonable – also means State responsibility for solvency. If a health insurer has to declare insolvency/bankruptcy, it’s up to the regulator to clean up the mess, which means helping to settle any outstanding claims. Up until now, that’s been a State budget issue. Members of the National Association of Insurance Commissioners (NAIC) fear Federal meddling in setting insurance premiums too low could eventually lead to some health insurers going out of business, leaving it up to the State taxpayers to have to step in.

Elements of health reform from 2012 to 2017 are vulnerable to two election cycles, one of them involving the Presidency. A lot can change between now and then.

Many employers are looking at the coming administrative hassles of providing health insurance and they don't like what they see. Dropping out and pushing employees into the State exchanges could lead to higher-than-expected number persons into the individual market, which may mean a need for higher-than-expected subsidies.

Health insurers in the individual market in Idaho and Maine are or will ask CMS for waiver of the 85% MLR rule.

Prior to passage of the Affordable Care Act (ACA), health insurers were required to convert to ICD-10-based claims systems. This considerable additional administrative expense is unfolding at the same time that the ACA is forcing insurers to maintain their medical loss ratios (MLRs) at 80% to 85%.

Thousands of self-insured employers, who pay claims every day, don’t buy the hard-ball demonization of the health insurance industry by the Obama Administration.

At the same time that the United States’ gross domestic product tanked, hospital prices increased.

Facing a death spiral in the face of looming guaranteed issue regulations, there are rumors that commercial health insurers are exiting the “child only” insurance market.

If the DMCB doesn't have it right, misheard or if anyone can clarify, please share.

A Prospective Randomized Trial of Disease Management in the Latest New England Journal Shows It Saves Money

In this prior post, the Disease Management Care Blog defended and defined disease management as the use of a package of mutually supportive interventions to improve quality and/or mitigate the insurance risk of a population defined by the presence of a chronic condition. It predicted that, thanks to greater sophistication in both the targeting (for patients that are likely to benefit) and the provision (behaviorally-based engagement, dealing with barriers, motivational coaching) of the interventions, that the "disease management" brand would regain its luster. All that was needed was for disease management industry to act a little less like a business and adopt medicine's tradition of rigorous scientific inquiry with sharing of its evolving knowledge to advance the health care for everyone.

Well, the industry is getting there and in the prestigious, staid and sometimes hostile New England Journal of Medicine, no less. Check out this important study by David Wennberg, Amy Marr, Lance Lang, Stephen O'Malley and George Bennett that was just published in the Sept 23 issue, titled "A Randomized Trial of a Telephone Care-Management Strategy."

Good thing you read the DMCB. You can, once again, quickly familiarize yourself with the study's, bottom line and sagely discuss the results with colleagues, enemies, audience members, bosses, bosses' bosses and, if you have the President's ear, with our nation's Chief Executive. Heaven knows he needs all the help he can get.

Two regional insurers that contracted with Health Dialog agreed to compare two telephonically based care management approaches: one was "usual" and the other was "enhanced." The latter enhanced used a variety of predictive modeling techniques (that also importantly included the risk of surgery for a preference sensitive condition) with lower cut-off points for risk. This, in turn, resulted in greater numbers of persons being targeted. The modeling also allowed Health Dialog to focus on patients who were neither too sick or too well to benefit from care management. Once patients in the usual or enhanced groups were contacted, the telephony care management content was the same.

Within each of the two health plans, there was an HMO, POS and PPO. To neutralize the effect of the varying insurance benefit, enrollees were randomized within each benefit plan. The household member at highest predicted financial risk determined assignment for all the household members. Persons had to opt out. They also weren't aware of the assignment.

There were a total of 215,006 eligible persons, of which 34,629 were excluded because of missing enrollment information (which the DMCB knows is not uncommon). An additional 667 were excluded because of high cost conditions like HIV or end stage renal disease. An additional 5590 persons lost or changed their plan coverage while the study was being set up, resulting in 174,120 final subjects. This included 7000 enrollees over age 65 with concurrent Medicare coverage.

All the targeted persons received recruitment outbound mail, interactive voice response calls and live calls by Health Dialog personnel, but the enhanced group got five attempts vs. three in the usual support group. Once patients were enrolled, the care management involved the state-of-the-art coaching by a spectrum of non-physicians. This involved motivational couseling aimed at behavioral changes and increasing shared decision making in interactions with physicians, all supplemented with a variety of media aids. Coaching was also tailored for the burden of the chronic conditions as well as the likelihood of surgery for the preference sensitive condition. The authors estimated that the total program cost for the insurers for the enhanced program amounted to $2 per member per month (PMPM).

Because the study was prospectively randomized, the usual and enhanced groups were demographically similar (for example, the average age was around 37 years with a typical baseline commercial per member per month cost of around $170), the burden of chronic conditions was the same (about 10% in both groups had at least one). The difference was that 26% of the enhanced group was targeted for outreach vs. 7.8% in the usual care group. Ultimately 10.4% of the subjects in the enhanced group ended up getting coached vs. 3.7% in the usual group.

Over the year of study, compared to the usual care group, there was a statistically significant medical claims savings of $8.48 PMPM in the enhanced group. This represented a 4.4% reduction in claims expense. Pharmacy costs went UP in the enhanced group by $0.52. When everything was added up, the overall expenditures decreased by a net of $6 PMPM or 3.6%, including the $2 PMPM cost of the program. Much of the savings appeared to result from fewer hospitalizations as well as an 11.5% reduction in admissions for preference sensitive conditions.

Well done, says the DMCB. There aren't many options for addressing our nation's rising health care costs that doesn't involve more government, more barriers or more bureaucracy. One of those options, according to this study, is disease management, otherwise often known as telephone care-management.

Note that this study didn't compare care management vs. no management. Instead, the DMCB thinks that argument that the intervention worked is based on a correlation with exposure. In other words, if more persons get the intervention and more costs are saved, it's safe to assume the intervention worked. That's what happened here.

To Health Dialog's advantage, the study also showed that its version of disease management (with a focus on coaching patients with preference sensitive conditions, which you can read about here) works better than its "usual" competition. That's called a two-fer. The advantage is that Health Dialog can have its cake and eat it too. The disadvantage is that the DMCB can't tell how much of the study's success was due to recruiting more patients, targeting the right patients or using Health Dialog's special emphasis on preference sensitive conditions. It might be all of the above.

Note that this study also addressed the canard that "disease management" is limited by focusing solely on one disease at a time, leading to the "balkanization" of health care. In this study, the telephony was tailored to the patients' total disease burden.

It's also interesting to note that recruiting only 10% of patients of a population at risk translates into real savings. In other words, not every patient at risk needs to be called to make a difference.

The DMCB also suggests that the study's credibility was increased by the observation that pharmacy costs increased. The DMCB has personally witnessed that in other programs and it would be an expected outcome of aggressive patient coaching.

As Journal readers would expect, the authors did a good job of pointing out the caveats about generalizing this study to all patients everywhere. This study was limited to commercial patients and there is no guarantee that this would work in fee-for-service Medicare. However, that didn't stop the authors from estimating that about half of the observed savings went to the U.S. Treasury thanks to lower costs among the 7000 Medicare participants.

The only downside to this study is that there is little information on the accompanying quality of care or about the possibility that the interventions somehow led to denials of needed care. The DMCB doubts this happened. This is a huge study with a very large database, so it's possible that there were be follow-on studies providing a clearer picture of what happened. Let's hope so.

This study is adding to a growing body of research that points to the quality and cost-saving merits of disease management. Right now, the DMCB doesn't have the time to do it, but it suspects there's another meta-analysis that's needed. The results are likely to be different.

Hopefully, as we continue to improve health reform, the important potential of disease management interventions like this will get the attention it deserves.

Heart Failure Self Management Education Doesn't Work. That's Because It's Not Disease Management

The Disease Management Care Blog finally caught up with the negative "Self-management Counseling in Patients with Heart Failure" study by Lynda Powel and colleagues that was published in Sept.22/29 JAMA.

The article is open access but, knowing readers are a busy lot, the DMCB is happy to provide this quick summary.

The authors were interested in testing whether patient "self management" education would be successful in reducing death and hospitalization among patients with chronic heart failure. Their rationale was that self management was different compared to disease management which "keep[s] patients in a passive role and, as such, raise questions about optimum duration and cost effectiveness."

Despite being very misinformed about disease management, the authors devised a rigorous self management intervention that consisted of eighteen 2-hour, 10 patients-per-group sessions that were spread over one year. Health education professionals conducted the sessions using content from American Heart Association-based "tip sheets." In addition to the education, the educators relied on problem-solving formats and barrier management for topics that included medication adherence, addressing weight gain, diet, exercise and stress management.

3152 patients were screened and 902 were eventually enrolled in the trial. Enrollment was limited to patients with NYHA Class 2 or 3 heart failure (1 means generally no symptoms while 4 patients are so ill that different self-management skills are necessary). Half of the enrollees were assigned to the intervention described above, while the patients assigned to the control group were simply mailed the tip sheets. Patients were followed for up to two years after the one year intervention (making it a 3 year study).

The baseline status of the study cohorts was instructive to the DMCB and may serve as a useful benchmark in making assumptions about similar populations with heart failure. 23% had "preserved systolic function" (yes, it is possible), 37% failed to take their life-saving ACE or beta blocker medications at least 80% of the time, most exceeded recommendations for salt intake, 29% had evidence of major depression and 7 was the mean number of medications that were being used.

When the authors finally compared the end-point of hospitalization or death for the two groups, there was no statistically difference (you can see the disappointing graph here). Over three years, the death rate was 21% (control) to 24% (intervention), while the hospitalization rate was 30% (both groups). Other measures in change in the NYHA class, exercise endurance, tobacco use, blood pressure, body mass index, quality of life did not differ over time between the two groups. Except for individuals with low income (defined as less than $30,000 per year) there was also lack of any impact for any of the subgroups within the study..

The DMCB can't say it's surprised at the negative outcome because, as the authors readily admit, this wasn't disease management. In other words, it wasn't personalized patient engagement by a trusted nurse that not only sought behavior change but also interacted with the patient's physician and coordinated other care and community resources. These were group education sessions. It's enough to give the DMCB a Gomer Pyle moment.

While the intervention has been described in greater detail here, the DMCB was also stymied by the apparent lack of any mention about two other study features that could have made a difference:

1. The participation of the intervention group's principal or primary care physicians. It may be that the group sessions occurred without the active support of the doctor. As the disease management industry learned, the lack of that key ingredient can lead to zero improvement in outcomes.

2. How the depression was managed. In fact, the DMCB didn't see this specifically measured in the course of follow-up. If this was ignored, then it's little wonder that some of patients were unable to adopt behavior change, which could have led to the negative study.

Tomorrow the DMCB will compare and contrast the just-released results of a randomized trial involving real disease management program. The study landed at 7:18 PM in the DMCB's email box, but readers may want to take a look at this ahead of time. A randomized trial of a telephone care management strategy reportedly led to some real savings at a cost of only $2 PMPM.

Shared Decision Making in the Patient Centered Medical Home

The Disease Management Care Blog couldn't resist.......





('’)

Healthways Disinters Medicare Health Support

Until now, the DMCB assumed that the hapless Medicare Health Support (MHS) pilot had not only died, but been embalmed, sealed in its casket and buried under six feet of lets-not-speak-of-it-again. But lo, Healthways has pulled out its shovel and has propped up the remains at our national health reform banquet. Come... see, say a host of elder wise-men Tom Daschle, Newt Gingrich and Ken Thorpe, it lives, it... LIVES!

As readers may recall, MHS was the unsuccessful, prospective, randomized and controlled trial of disease management vs. usual care for FFS Medicare beneficiaries. There were several vendors involved, including Healthways. The financial terms for the intervention group involved a monthly fee for disease management in exchange for the expectation of reduced claims expense with budget neutrality or savings in excess of fees. Unfortunately, the study was hobbled by a number of execution problems that included the unequal assignment of beneficiaries to the control and intervention groups, delays in notifying the vendors about hospitalizations and low patient contact rates. Combined with the disease management industry's irrational exuberance, the final negative did-not-save-money results were bitterly disappointing. You can read the disillusioned DMCB's past thoughts on the final results here and here.

What do you know, Healthways decided to take another look at its MHS data. Recall that the MHS report ultimately concluded that, compared to the control group, health care costs increased less (i.e., didn't go up as much) as a result of disease management, but that the savings, versus its average monthly fee of $94, were not budget neutral (go to page 67).

As the Disease Management Care Blog understands it, third party research through Emory University, Harvard University, The University of Milan and The University of Trieste applied a "Coarsened Exact Matching" to achieve a better statistical balance between the intervention and control groups. Based on this analysis, a recalculated mean savings per beneficiary totalled $2,848 per year, resulting in a net cost savings of $73 per beneficiary.

As noted in this news report, the Feds are unlikely to be impressed and are still likely to get a clawback of some of their fees. Given the lack of any movement in Healthway's stock price (HWAY), the market isn't impressed either.

Yet, should the DMCB and its growing readership be impressed? The DMCB isn't sure:

1) It's challenging to evaluate Healthways' claims based on a press release that provides only summary results. Given the stakes, the claim that savings were ultimately achieved warrants greater detail, more transparency and the input of peer review. Sure, it takes time and effort, but, in the long run, it's worth it.

2) The key feature of this statistical breakthrough is the use of "coarsened extract matching." The DMCB never heard of that before. That same problem is probably getting in the way of other interested stakeholders.

3) And then there's a credibility issue: the uphill part of any post-hoc analysis - even if third party and even if it is Harvard - is overcoming the perception that the methodology used was chosen precisely because of the likelihood of yielding a desired result.

No wonder why few seem impressed. Yet, the DMCB isn't sure reburial of the remains is necessary at this time. It'll look forward to seeing more data and analysis. Sort of like poking it with a fork.... to see if it... moves.

In Further Defense of the Term "Disease Management"

We have much to be thankful for in that curious mix of popular mainstream media, 24/7 news cycles and the Internet. In addition to making us so much brainier, our unending connectedness is also helping us to establish new cultural standards. Examples include Lady Gaga's recent meat and greet fashion trend (fans could really see her in the flesh, adding a whole new dimension to the notion of girding one's sirloins... with beef briefs), the totally unexpected SHOCK of the New York Jets' sexist buffoonery when a woman appeared in the team locker room, the laudable courage of State politicians' ability to command improvements in healthcare with the mere stroke of a pen and the use of, er... lawn sausage as a popularity baseline. Case in point is the smart Vince Kuraitis' recent e-CareManagement blog post that reviews the non-merits of the term "disease management" (DM).

Vince brings up the usual criticisms of DM: in this politically correct age, persons really have health challenges, not "disease," while "management" is contrary to our notion of consumer-patient centeredness that is really the province of providers, not physicians. Let's also face it: the DM industry was too uppity. When it stumbled, physicians and the CMS staffers took their just revenge, sealing the comeuppance an eternally negative brand and droopy vendor stock prices. It only makes sense, then, to look beyond the DMCBs use of mere Google page counts and compare the term disease management to established mainstream cultural standards, as Vince has so ably done.

Lesson learned. In fact, the DMCB will stop feeling good about its thousands of weekly hits and compare its web footprint to something that really matters, like the traffic to this YouTube video of a hand-fart rendition of the Star Wars Imperial March.

Why, then, would the wonky and web savvy DMCB remain so blindly loyal to the term disease management?

1. The physician DMCB thinks diabetes, asthma, heart failure, atherosclerosis, hypertension, obesity and other chronic conditions are ultimately diseases. Caring for them involves a combination of treatment approaches that can be packaged into a state-of-the-art management. Nothing about that precludes the patients' participation with their doctors' help. Disease and management may not have cachet but it's still a good description of the reality. What's more, the term is still used in C-suites, national meetings and strategy sessions.

2. While, at its peak, disease management was an all-things-to-all-people panacea, greater market discipline has led to a more precise definition: the use of a package of mutually supportive interventions to improve quality and/or mitigate the insurance risk of a population defined by the presence of a chronic condition.

3. There is plenty of recent peer-reviewed science that is still using that term to describe impressive outcomes. Examples include this and this.

4. While eCareManagement has correctly noted that 1,300,000 Google pages using the term "disease management" is er..... comparatively modest, the term "patient centered medical home" has appeared in 121,000 pages, and the term "accountable care organization" has appeared in 37,700 pages.

5. Health care advances generally also have their own life cycle of high enthusiasm, followed by an over-reacting crash of bitter disappointment and disdain followed, in turn, by intelligent adoption. The Disease Management Care Blog thinks DM has climbed out of the trough into being a standard part of most insurance plan networks. The Medicare FFS benefit exclusion is the exception and certainly not evidence of Medicare's leadership in this area; rather, they're behind the times. By the way, the PCMH and ACOs are almost certain to follow the same glide path.

6. Plus the DMCB doesn't want to go through the hassle of changing its name,

and, last but not least....

7. When the term "disease management" makes a come-back, the DMCB will be well positioned and be able to continue to share the health policy limelight with e-CareManagement

Potatoes and Human Health, Part I

Potatoes: an Introduction

Over 10,000 years ago, on the shores of lake Titicaca in what is now Peru, a culture began to cultivate a species of wild potato, Solanum tuberosum. They gradually transformed it into a plant that efficiently produces roundish starchy tubers, in a variety of strains that suited the climactic and gastronomic needs of various populations. These early farmers could not have understood at the time that the plant they were selecting would become the most productive crop in the world*, and eventually feed billions of people around the globe.

Wild potatoes, which were likely consumed by hunter-gatherers before domestication, are higher in toxic glycoalkaloids. These are defensive compounds that protect against insects, infections and... hungry animals. Early farmers selected varieties that are low in bitter glycoalkaloids, which are the ancestors of most modern potatoes, however they didn't abandon the high-glycoalkaloid varieties. These were hardier and more tolerant of high altitudes, cold temperatures and pests. Cultures living high in the Andes developed a method to take advantage of these hardy but toxic potatoes, as well as their own harsh climate: they invented chuños. These are made by leaving potatoes out in the open, where they are frozen at night, stomped underfoot and dried in the sun for many days**. What results is a dried potato with a low glycoalkaloid content that can be stored for a year or more.

Nutritional Qualities

From a nutritional standpoint, potatoes are a mixed bag. On one hand, if I had to pick a single food to eat exclusively for a while, potatoes would be high on the list. One reason is that they contain an adequate amount of complete protein, meaning they don't have to be mixed with another protein source as with grains and legumes. Another reason is that a number of cultures throughout history have successfully relied on the potato as their principal source of calories, and several continue to do so. A third reason is that they're eaten in an unrefined, fresh state.

Potatoes contain an adequate amount of many essential minerals, and due to their low phytic acid content (1), the minerals they contain are well absorbed. They're rich in magnesium and copper, two minerals that are important for insulin sensitivity and cardiovascular health (2, 3). They're also high in potassium and vitamin C. Overall, they have a micronutrient content that compares favorably with other starchy root vegetables such as taro and cassava (4, 5, 6). Due to their very low fat content, potatoes contain virtually no omega-6, and thus do not contribute to an excess of these essential fatty acids.

On the other hand, I don't have to eat potatoes exclusively, so what do they have to offer a mixed diet? They have a high glycemic index, which means they raise blood sugar more than an equivalent serving of most carbohydrate foods, although I'm not convinced that's a problem in people with good blood sugar control (7, 8). They're low-ish in fiber, which could hypothetically lead to a reduction in the number and diversity of gut bacteria in the absence of other fiber sources. Sweet potatoes, an unrelated species, contain more micronutrients and fiber, and have been a central food source for healthy cultures (9). However, the main reasons temperate-climate cultures throughout the world eat potatoes is they yield well, they're easily digested, they fill you up and they taste good.

In the next post, I'll delve into the biology and toxicology of potato glycoalkaloids, and review some animal data. In further posts, I'll address the most important question of all: what happens when a person eats mostly potatoes... for months, years, and generations?


* In terms of calories produced per acre.

** A simplified description. The process can actually be rather involved, with several different drying, stomping and leaching steps.

Disease Management: A Rose By Any Other Name

In its moments of fancy, the Disease Management Care Blog likes to imagine that it's one of the uncommonly reasonable voices in the healthcare wilderness. Because it links a lot of the peer-reviewed scientific literature, it fancies itself as an island of insight in a sea of evidence-poor rhetoric. Maybe it's better thought of as a narcissistic wannabe that needs to rethink its dreams of vast blogging revenue. Whether the thousands of regular DMCB readers plus one spouse agree with any of those assessments remains an open question, but one thing is clear: the DMCB is one of the remaining intellectual redoubts that's still loyal to the term "disease management."

It wasn't too long ago that acclaim was awarded to to anyone with those two words on their lips. The term's appearance on marketing materials guaranteed fat contracts. Including "disease management" in the title of a manuscript or as a proposed MeSH term was scientific journal editor catnip. That and its inflated jargon (engagement! outcomes!) was enough to prompt a HHS Secretary to turbocharge an industry. Health insurer execs coveted disease management more than their ability to deny life-saving transplantations in children. Budgets doubled, titles inflated and careers were launched.

We all know what happened next. The downward spiral of incredulity reached critical mass when the debacle called Medicare Health Support transpired. When the depths of physician hostility became apparent, it was almost a near death experience. Recriminations led to corporate retreats, which then revamped business models and refreshed branding. Among the many outcomes was that the moniker "disease management," like Britney Spears, partially hydrogenated fats and Teletubbies, lost its luster. Even the "Disease Management Association of America" dropped its name in favor of "DMAA, The Care Continuum Alliance."

But seriously, change happens and, to paraphrase a famous bard, a rose by any other name still smells as sweet. While newer versions of remote coaching services for chronic illness are still going strong, end-to-end and interlocking care programmatic interventions in wellness, prevention, workplace health promotion, behavioral health, technology-enabled care, pharmacy and complex care management are providing a potent mix of patient services to the vast majority of self and fully insurance programs plus the Medicaid insurers. If its big and it's tackling quality and cost in cohorts, networks, populations or books of business, it makes little difference what you actually call it.

It should be no surprise, then, that the DMAA has just changed its name again, erasing all traces of those two words. The newly stamped Care Continuum Alliance represents a huge multi-dimensional industry with a critically important role to play as health care continues to evolve. You can read all about it here.

Call it a foolish loyalist, but the steadfast DMCB is sticking to its guns. Do a Google search on the phrase "disease management" and you'll find that the number of web pages appearing with that term in the last year number over 1.2 million. Perform a search for peer-reviewed published literature using the term "disease management" in the last five years, and you'll find there are more than 7000 articles. Finally, there are over 500,000 blogs that have used the phrase.

In fact, the DMCB predicts the term "disease management" will make a comeback. And its not because of Healthway's hot-off-the-presses release about its achievements in that watershed Medicare Health Support pilot mentioned above.

In a future post, the DMCB will explore why it thinks the phrase "disease management" may still have legs.

In the meantime the DMCB is proud to announce that it's come up with it's own logo. Good bye flamingo eyes.

The Latest Health Wonk Review Is Up

The Colorado Health Insurance Insider Blog has a series of well-written summaries and links to recent blog posts that address the "Politics, Money and Health" of our continuing debate over healthcare reform, costs and quality.  Read this, and you'll be able to amaze your colleagues with your insights, stymie your opponents with your brilliance and impress your boss with your aplomb.  As for getting your significant other to think more highly of you... well that's a different matter.  Enjoy!

The Value of Registries, As Demonstrated by the Scotland Childhood Asthma Study

Electronic health records?  Bleh, not ready, says the Disease Management Care Blog.  Clinical decision support?  Pfft, overrated, scoffs the DMCB.  But mention registries and now you've got the DMCB's lusty attention.  These medical-claims-demographic databases promise to offer up easy access to huge swaths of clinical and economic correlations that are just not possible in a single clinical trial.  

Case in point?  The Smoke-free Legislation and Hospitalizations for Childhood Asthma study authored by Daniel MacKay and colleagues appearing in the Sept. 16 New England Journal.  These researchers had access to the "Scottish Morbidity Record," a national data warehouse that links information on all individual admissions among the 5.1 million inhabitants of Scotland.  They used this data base to examine the impact of the "Smoking, Health and Social Care Act of Scotland," which banned public and workplace tobacco smoking.  Before the legislation went into effect on March 26, 2006, hospital admissions among children age 15 years or less for asthma was increasing at a rate of 5.2% per year.  After it was passed, the asthma admission rate decreased by 13% per year.  The authors went on to mathematically neutralize (statistically control for) the impact of gender, age, urban vs. rural residence, socioeconomic status and number of prior admissions for asthma and the pre-post relationship still held up: there was a 4.4% increase per year before vs. a 20% decrease per year after.  If the child population was split into pre-school and school age groups, it was found that the preschoolers were experiencing an annual increase while the school age children were not. When the smoking ban went into effect: afterwards, both groups dropped by 18% and 21%, respectively. 

This study is important because it demonstrates how public health measures to control tobacco use in public places has an actionable link to the scourge of childhood asthma. This is probably because the smoking ban was accompanied by decreased tobacco use in the home, perhaps from greater adult quit-rates or voluntary restrictions.

Yet, this study is also important because it's another demonstration of the use of large clinical databases to study population health.  This contrasts with the usual gold-standard clinical research approach, involving a two-armed randomized control trial comparing an intervention group (not allowed to use tobacco in public) vs. a control group.  If MacKay et al had decided to answer the question that way, we'd still be waiting for an answer.  Good thing they and others are demonstrating the value of this alternate approach.

Hopefully, as health reform continues to evolve, Medicare and Medicaid will work through the privacy restrictions and allow greater access to its claims data sets by qualified researchers. Commercial insurers are certainly showing that it's possible with their large multi-state claims data sets and so, by the way are some enterprising patients.  Based on the the kind of insights from generated by the Scotland Trial, the upside benefit of registries and the kind of research they can support is just too great to squander.   

Image from Wikipedia

Speaking at Wise Traditions 2010

I'm happy to announce that I'll be presenting at the Weston A. Price foundation's 2010 Wise Traditions conference. The conference will be held in King of Prussia, Pennsylvania, Nov 12-14. The theme is the politics of food.

Sally Fallon Morell has invited me to give a talk on the diet and health of Pacific islanders. The talk will be titled "Kakana Dina: Diet and Health in the Pacific Islands", and it will take place on Sunday, November 14th from 4:00 to 5:20 pm. In preparation for the talk, I've read eight books and countless journal articles. Although some of the material will be familiar to people who follow the blog, I will not be rehashing what I've already published. I have nearly an hour and a half to talk, so I'll be going into some depth on the natural history and traditional food habits of Pacific island populations. Not just macronutrient breakdowns... specific foods and traditional preparation methods.

Learn about the health of traditional Pacific island populations, and what has changed since Western contact. Learn about traditional cooking and fermentation techniques. See unpublished photos from the Kitava study, courtesy of Dr. Staffan Lindeberg. Learn about the nutritional and ceremonial role of mammals including pork... and the most gruesome food of all.

I hope to see you there!


Kitava photo courtesy of Dr. Staffan Lindeberg

Dogen Zenji on Nutritionism

Dogen Zenji was the man who brought the Soto lineage of Zen Buddhism to Japan. He was a prolific writer, and many of his texts are respected both inside and outside the Soto Zen community. Last week, my Zen group was discussing the Genjo Koan, one of his works that is frequently used as a chant. Here's an excerpt. It may seem cryptic but bear with me:

...when you sail out in a boat to the middle of an ocean where no land is in sight, and view the four directions, the ocean looks circular, and does not look any other way. But the ocean is neither round or square; its features are infinite in variety... It only look circular as far as you can see at that time. All things are like this.

Though there are many features in the dusty world and the world beyond conditions, you see and understand only what your eye of practice can reach. In order to learn the nature of the myriad things, you must know that although they may look round or square, the other features of oceans and mountains are infinite in variety; whole worlds are there. It is so not only around you, but also directly beneath your feet, or in a drop of water.

What Dogen meant, among other things, is that the world is much more complex than what our conscious minds can perceive or understand. It was true in the 13th century, and it's still true today, despite our greatly expanded understanding of the natural world.

We can apply this principle to nutrition. For example, what is red palm oil? Two hundred years ago, perhaps we only knew a few basic facts about it. It's a fat, it's red, it comes from an African palm fruit and it has a particular melting point and flavor. Then we learned about vitamins, so we knew it contained vitamin E, carotenes (provitamin A), and vitamin K. Then fatty acid composition, so we found out it's mostly palmitic and oleic acids. Now we know red palm oil contains an array of polyphenols, sterols, coenzyme Q10 and many other non-essential constituents. We don't know much about the biological effects of most of these substances, particularly in combination with one another.

Add to that the fact that every batch of red palm oil is different, due to strain, terroir, processing, storage, et cetera. We know what the concept "red palm oil" means, roughly, but the details are infinitely complex. Now feed it to a human, who is not only incredibly complex himself, but genetically and epigenetically unique. How can we possibly guess the outcome of this encounter based on the chemical composition of red palm oil? That's essentially what nutritionism attempts to do.

To be fair, nutritionism does work sometimes. For example, we can pretty well guess that a handful of wild almonds containing a lot of cyanide won't be healthy to eat, due at least in part to the cyanide. But outside extreme examples like this, we're in a gray zone that needs to be informed by empirical observation. In other words, what happens when the person in question actually eats the red palm oil? What happened when a large group of people in West Africa ate red palm oil for thousands of years? Those questions are the reason why I'm so interested in understanding the lives of healthy non-industrial cultures.

I'm not criticizing reductionist science or controlled experiments (which I perform myself); I just think they need to be kept in context. I believe they should be interpreted within the framework of more basic empirical observations*.

One of the most important aspects of scientific maturity is learning to accept and manage uncertainty and your own ignorance. Some things are more certain than others, but most aren't set in stone. I think Dogen would tell us to be wary of nutritionism, and other forms of overconfidence.

* Wikipedia's definition of empirical: "information gained by means of observation, experience, or experiment." As opposed to inferences made from experiments not directly related to the question at hand.

The China Study on Wheat

Denise Minger has just put up another great China Study post that's worth reading if you haven't already. Denise has been busy applying her statistics skills to the mountain of data the study collected. She noted in a previous post that wheat intake was strongly associated with coronary heart disease (CHD), the quintessential modern cardiovascular disease. I, and several other people, requested that she work her mathmagic to see if the association could be due to some other factor. For example, wheat is eaten mostly in the Northern regions of China, and CHD rates are generally higher at higher latitudes (vitamin D insufficiency?). This is true in Europe as well, and may be partly responsible for the purported benefits of the Mediterranean diet. You can mathematically determine if the association between wheat and CHD is simply due to the fact that wheat eaters live further North.

To make a long story short, nothing could explain the association except wheat itself, even latitude. Furthermore, she found a strong association between wheat intake and body mass index, typically a predictor of fat mass although we can't say that for sure. That finding echos a previous study in China where wheat eaters were more likely to be overweight than rice eaters (1, 2). Head over to Denise's post for the full story.

The China Study has major limitations built into its basic design, due to the fact that it was observational and pooled the blood samples of many individuals. Therefore, its findings can never prove anything, they can only suggest or be consistent with hypotheses. However, the study also has some unique advantages, such as a diversity of diets and regions, and the fact that people had presumably been eating a similar diet for a long time. I feel that Denise's efforts are really teasing out some useful information from the study that have been de-emphasized by other investigators.

There has been so little serious investigation into the health effects of wheat in the general population that I have to rely mostly on indirect evidence, such as the observation that the diseases of civilization tend to closely follow the introduction of white flour around the globe. Researchers studying celiac disease and other forms of gluten allergy, and the efforts of the paleolithic diet community in spreading that information (for example, Loren Cordain and Pedro Bastos), have been major contributors to understanding the health effects of wheat. Denise's analysis is one of the strongest pieces of evidence I've come by so far. One of these days, I'll post all of my references incriminating wheat. There are quite a few, although none of them is the smoking gun. I think there's enough indirect evidence that investigators should begin taking the idea seriously that wheat, particularly in the form of industrial flour products, may contribute to chronic disease in more than just a small subset of the population.