Is An Informed Citizenry Necessary for Democracy?

You have to hand it to the GOP. Give something a derogatory name and watch the Silent Majority come out against it. By the way, the full name is the Patient Protection and Affordable Care Act, which the GOP voted for in 2010 (maybe they didn't understand at the time that it was the same as Obamacare).

Intellectual Dishonesty at NCCAM?

NCCAM is the National Center for Complementary and Alternative Medicine (here) and it is the US Federal Government's lead agency for scientific research on complementary and alternative medicine (CAM). A recent investigation by the Chicago Tribune (here) concluded that "...precious research dollars could be better spent elsewhere." The types of studies funded by NCCAM have included inhalation of lavender and lemon to heal a wound (it didn't), coffee enemas for cancer (no effect), mind-body therapies (yoga, massage and acupuncture, the later found no better than sham acupuncture), energy healing, distant prayer, qigong (manipulation of a universal energy or life force), ginko biloba, saw palmetto (no benefit over placebo), etc.

In this post, I will look at one of the NCCAM studies (Sherman et. al 2011) funded to determine "whether yoga is more effective than conventional stretching exercises or a self-care book for primary care patients with chronic low back pain." In a press release, NCCAM concluded For Low-Back Pain, Yoga More Effective Than Self-Care But Not Stretching (the original study in the Archives of Internal Medicine is here). The study is of interest for a number of technical-statistical reasons which I will explore in my Random Variation blog (here). In this post, I'm just going to make a simple observation: the presented data do not seem to support the conclusions!

If you look carefully at the graphs from the article (presented above and discussed in a note below) you will notice that the error bars (confidence intervals) at the study's end point (week 26) overlap. Just eye-balling the graph, it would seem that self-care (the red line) will eventually be completely equal to either yoga or stretching which are clearly not different. What if they had run the study out to 32 weeks? To be fair to the authors, they based their conclusions on probability values (p-values), a commonly accepted approach to reporting significant results. Without getting into statistical details, p-values do not say anything about whether we are looking at an important difference in treatment and control effects. Differences of 1 point in the RDQ (Roland-Morris Disability Questionnaire) would seem to be of of questionable importance against 2 point confidence interval spreads (read more on expected values for the RDQ here).

From the standpoint of NCCAMs mission which is ambiguous (can they really conclude alternative medicine is a sham and expect continued funding?), the study certainly doesn't support the underlying theory (presented in the causal diagram above, click to enlarge). Yoga is supposed to be superior due to the "mental enhancement" of meditation. Since Yoga was no better than stretching, it seems for sure that the "mind-body" aspect of the trial was a failure.

However, the researchers go on to conclude that Yoga is safe and should be recommended by physicians for patients with low back pain. I don't follow these conclusions especially when there is anecdotal evidence of How Yoga Can Wreck Your Body. The researchers neither mention nor test these issues and I'm not sure why they would continue to recommend Yoga. And, in a related editorial in the same journal, Timothy S. Carey, MD, MPH, concludes that "The study by Sherman et. al. in this issue is an excellent example of a pragmatic comparative effectiveness trial (p. 2027)". The developing concensus about Comparative Effectiveness Research (CER) is important because it is a cornerstone of attempts to reform the US health care system. I will never have time to review all the CER studies, but I'm getting a little queasy feeling in my lower intestinal tract over CER and whether people will actually be treated based on CER studies let alone CAM.

NOTE: The four graphs above present two of the study outcome measures, the RDQ score and the Bothersome score (How bothersome was your back pain?). The left panel displays the raw scores and the right panel displays the adjusted scores to equalize initial conditions. Notice that no confidence intervals were provided for baseline. Statistically, I'm guessing that the initial conditions were not different. Any adjustment without expanding the end-point confidence intervals to reflect the uncertainty of the initial conditions seems questionable to me.

Why Medicare Is In Trouble

Listening to the Washington debate about Medicare (here, here, here, here, and here) one would think the program is in trouble because it's a government entitlement program that is handing out free health care to underserving freeloaders. And, if that is the problem, then the solution is to privatize the program (according to Rep. Paul Ryan, R-WI in the video below).

First, Medicare is not an entitlement program, it is a social insurance program that people pay into during their working years so they can have health insurance in retirement. The only sense it which it is an entitlement is that we are entitled to the care that we payed for with our payroll deductions. It is an insurance program because some people will need more care than others even though there have been relatively equal contributions.

Medicare, however, is in trouble because payed-out benefits exceed collections. This problem could be solved in two ways: increasing payroll deductions or decreasing payouts.

On the payout side, Medicare is in trouble partly because of private sector billing practices. The DHHS Inspector General released a report last December documenting Questionable Billing for Medicare Outpatient Therapy Services. The graphic above, from the report, shows the "high-utilization" counties, counties that supply up to eight times the level of services per beneficiary and thus services about eight times the level of payment for services.

Of these counties, Miami-Dade is the worst having "the highest average Medicare payments per beneficiary among the high-utilization counties and the highest total Medicare outpatient therapy payments in 2009." The higher payments are not going to produce better health for Medicare patients but are going to increased physician payments and higher executive salaries in the private health care sector.

Privatization will only make the problem of over-billing worse. And, strangely enough, all but one of the high-utilization counties is in a state with a Republican governor.

Rep. Ryan Gets a Sobering Lesson From the Netherlands

Rep. Paul Ryan, R-WI, is a conservative philosopher of the first rank. He doesn't really have to pay attention to anything that happens in the Netherlands when deducing policy recommendations from the postulates of privatization (the Netherlands, really, they smoke pot legally in coffee shops).

Unfortunately, whether it's from smoking too much weed or drinking too much neoconservative Kool-Aid, the Dutch decided to take Mr. Ryan's advice and privatize their mixed health insurance system in 2006. The rationale was that competition would reduce health care spending, enhance consumer choice and improve quality of care. In 2011, the Dutch now know that privatization was a failure.

A recent study in the New England Journal of Medicine (here) found that (1) competition has not slowed the growth of health care spending (national health expenditure is increasing faster than the rate of inflation and total costs of health insurance have increased 40% due to increases in administrative costs), (2) the number of uninsured have increased as have the number of "defaulters"--people who haven't payed their mandatory health insurance premiums for more than 6 months, (3) competition has not provided more choice (four insurance conglomerates control 90% of the insurance market, only about 4% of people change plans and 65% are dissatisfied with their coverage), and (4) the Netherlands still relies heavily on regulation (the government must still enforce global budgets, price controls and patient cost sharing).

Quoting from the study:

The myth that competition has been key to cost containment in the Netherlands has obscured a crucial reality. Health care systems in Europe, Canada, Japan, and beyond, all of which spend much less than the United States on medical services, rely on regulation of prices, coordinated payment, budgets, and in some cases limits on selected expensive medical technologies, to contain health care spending. Systemwide regulation of spending, rather than competition among insurers, is the key to controlling health care costs.

What the authors of the study don't acknowledge is that scientific data has nothing to do with policy deductions made from philosophical first principles.

BMI and All-Cause Mortality: New Results

A paper on the relationship between Body-Mass Index (BMI) and health hazards appeared in the recent New England Journal of Medicine (NEJM, here). The study re-analyzed 19 prospective studies of 1.46M white adults from 19-84 years of age. All-cause mortality was adjusted to age, study, physical activity, alcohol consumption, education and marital status.

The results (displayed in the graphic on the right as hazard ratios--click the graphic to enlarge) confirm the conventional wisdom that a BMI of between 22.5 and 24.9 had the lowest all-cause mortality hazard ratio and seems to refute some early evidence that healthy people were a little fatter.

The graphic confuses me a little since healthy subjects who never smoked had a faster rising hazard curve as compared to all subjects (I would have thought that healthy people would have a flatter hazard curve) but the result may be due to sample size issues or some misunderstanding I have about the study. If anyone has any ideas, let me know.

What's also interesting is that underweight (BMI less than 22.5) is associated with an elevated hazard ratio. There are lots of problems with the BMI, but it seems to work well at least in population studies. The median BMI for the study was 26.2, suggesting people need to loose a little weight.

TSA and Health Care Reform

Recent enhanced screening measures (body scanners and more invasive pat-downs) are starting to upset airline passengers in the US. At the same time, Republicans in Congress are calling for the repeal of health reform.

Although the Republicans have, so far, been quiet on rolling back TSA security measures, here's an idea that will allow the US to have strongly invasive airport screening while at the same time shifting the cost of some routine health care procedures to the private sector (something Republicans should like).

Combine routine proctological and gynecological exams with air travel. We can screen for enlarged prostates, positive pap smears, and underwear bombs all at the same time. Yes, people will have to get to the airport a little early but when was your primary care provider ever on time? And, for those who travel a lot, on-line medical records will allow TSA to determine that someone is good to go.

I suppose it would be simpler to have people pre-screened for air travel (much like the military and some law enforcement agencies award security clearances after an investigation), but that doesn't solve our health care problem. There just aren't enough primary care physicians.

Stent vs. Bypass: The Gold Standard Study?

The New England Journal of Medicine recently published the results of the SYNTAX trial (here), a multi-center, multi-country randomized clinical trial comparing percutaneous coronary intervention (PCI) with drug-eluting stents vs. coronary-artery bypass grafting (CABG). The study seems to suggest that more patients should be undergoing CABG since there was more revascularization in the PCI group (death rates at 12 months were the same, although stroke in the CABG group was higher). Let's take a closer look using the causal model of heart attacks discussed in an earlier post (here).

Consider first the problems of designing a true randomized clinical trial comparing a procedure (PCI) with an invasive surgery (CABG). You simply cannot randomly assign patients to either treatment condition. Many patients would prefer to avoid a seriously invasive procedure such as CABG and a few more patients would prefer to avoid any procedure at all. And, that's exactly what happened. From the hierarchy diagram above (click on the diagram to see an enlarged view) 1262 patients were found ineligible, the majority because they had a treatment preference (probably PCI). Another 1275 were eligible only to be placed in a parallel, nested registry where 1077 enrolled in CABG and 198 enrolled in PCI. In other words 2537 patients were not randomized compared to 1800 that were randomized.

As a practical matter, self-selection cannot be avoided. As a consequence, study results really are only applicable to people that meet criteria (three-vessel or left main coronary artery disease) and had no treatment preference. It would be nice to know the rates of revascularization, mortality and stroke in the groups that were not randomized.

The study has a number of other limitations reported by the authors but no mention is made of the 12-month histories of cardiac rehabilitation in any of the groups. If there was no cardiac rehabilitation (e.g., substantially increased aerobic exercise), the rate of revascularization might be explained by that alone. If, for example, all 1800 patients were sedentary in the first 12 months, CABG may produce better outcomes. What cardiac rehabilitation, weight control or smoking cessation programs the PCI group went on (if any) is unclear. The issue isn't discussed in either the paper or the supplementary material, although my guess is that the standards of cardiac rehabilitation are very different in the countries that participated in the study.

On the basis of this study (and the other existing clinical trials reviewed in the paper), should treatment protocols change?

Doctors, Patients and Causality

Boston.com reported on a study that found a "yawning disconnect between what doctors say and what patients hear." The study, in the Annals of Internal Medicine (here), asked 153 patients who had received angioplasties whether the patients thought that the procedure could prevent death or heart attach. The same question was posed to 27 cardiologists. The patients thought stents would reduce the chances of heart attack while the cardiologists didn't. The study interpreted the finding as the result of misunderstanding in communication (something similar to problems reported for husband-wife communication).

From a theoretical perspective, there are a number of problems with that conclusion. The cardiologists, patients and the researchers are confusing counterfactual, causal, interventional and probability statements. The counterfactual question for patients that had a heart attack: "If you didn't have angioplasty, would you have had a heart attack?" The causal question: "What causes heart attacks?" And, the intervention question: "What diagnoses and treatments might prevent a heart attack?"

The differences in questions can be seen from the causal diagram above. There are lots of "causes" for heart attacks (the "back-door criterion) in addition to coronary blockage (genetics, life style, some kind of event or "shock," etc.). As a result of a heart attack or a diagnosis, either drugs or stents or both are used to treat the blockage. Would a patient with coronary blockage and chest pain and troponin elevation (meaning they had a heart attack) have had the heart attack with an earlier diagnosis and angioplasty? Probably not. But other blockages, not alleviated by stents, can develop over time and other causes, unrelated to blockage, can cause heart attacks.

Maybe too many people are receiving angioplasty when they have stable angina. Maybe drug treatment or prevention treatment or life-style changes would reduce the angina. But, if someone has 95% blockage in an artery, it's probably time for a stent. Essentially, the study poses a trick question for both patients and cardiologists by only asking about the stent -> heart attack link. Although patients and doctors may not communicate clearly, if patients and doctors were oriented to a better causal map (the one above could be improved), they'd probably reach the same conclusions.

PS: There are lots of other problems with the study: (1) small sample size, (2) lack of randomization, (3) single-site bias (all patients were treated at the Baystate Medical center), etc.

Stent vs. Bypass

I recently participated in a study at the University of Wisconsin asking about patient preferences for coronary stents or coronary artery bypass surgery. The question of the study was "given a range of probabilities for death from either procedure and ranges of probabilities for having to repeat the procedure, which one would you choose". Conventional bypass surgery is quite invasive (although newer, minimally invasive procedures exist).

Stents inserted using cardiac catheterization are minimally invasive although there are some risks. Patients are quite often awake, if mildly sedated, during the procedure.

Blocked arteries (indicated with arrows above) are opened and a stent is inserted in each blocked area.

The arteries are then held open by the stent. There are two types of stents, bare metal and coated. Bare metal stents must be used with larger arteries (as pictured above). The coated stents fight accumulation of plaque on the stent (although drugs such as clopidogrel are used to act as an antiplatelet agent).

Since I'm basically very conservative, the chances of death from stent insertion had to be 100% before I would be willing to undergo bypass surgery. What the study questionnaire should have asked is whether one would choose either procedure if neither decreased mortality (as the current studies seem to indicate).

Had they asked the question, I still would have chosen the stent, but...

Health Care Reform: The Day After Tomorrow

The New York Times is calling passage of health care reform legislation "A Big Win for Obama, but at What Cost?" Lost was the promise of a "postpartisan" Washington. Actually, I see this as a win. Obama's bipartisanship verged on being naive. The Republican party as it is now configured will never embrace bipartisanship and health care reform was substantially weakened trying to attract Republican votes.

Bipartisanship is a nice idea but it is also import to get things done and there's lots remaining to get done: financial reform, climate legislation, immigration reform, repairing international relationships, ending two wars, etc. The Democrats now realize that they can get something done. It's difficult. Maybe they don't have the energy for the struggle. My advice would be to ram through as much legislation as possible before the mid-term elections and run on accomplishments.

Back to health care, a lot remains to be done to strengthen reform. The current bill is a "Boon for Hospitals and Drug Makers." Here's another lesson for the Democratic party. You've picked off one of the interest groups, the Health Insurance Lobby. Now take on each of the other interest groups one at a time: hospitals, drug companies and physicians. The physicians could be easy. Congress must reauthorize increases in Medicare physician payments, the "Doc Fix," or physicians will face a 21 percent pay cut. Twenty-one percent is close to the right number for required reductions in physician payments (the actual number is 32 percent). Forget the "Doc Fix," pass legislation that requires physicians to accept Medicare payments and move on to the other interest groups.

Should We Control Direct-to-Consumer Advertising of Pharmaceuticals?

The brief answer, following up on an earlier post, is NO! We need to be more concerned about the promotional impact of free-samples. Free-samples, handed out by physicians, hook both the patient and the physician on future, insurance-supported payments for expensive patented vs. less expensive generic drugs.

If you're interested in how the promotional process works and how important free samples are to kicking off a promotional campaign, you can read my recently published paper here (WARNING: it's technical and statistical).

How Canada Avoided the Financial Bubble

This page is currently UNDER CONSTRUCTION, but you can start thinking about the Questions below while viewing the video above and the State-Space Model outputs below.

Canada avoided the Financial Crisis of 2007-2010 using simple, no-nonsense financial regulation involving (1) capital requirements (targets for tier-one capital holdings), (2) quality of capital regulations (75% of tier-one capital in common rather than preferred stock) and (3) a leverage ratio of 20 to 1.

Similar lesson about no-nonsense control and regulation of the health care system are also available from Canada: (1) control of physicians salaries, (2) control of capital investment and technology and (3) control of drug prices.

Even though Canada has flirted with Neoliberalism, it seems to have avoided the nonsensical parts.

Notes

Readings

Pasdirtz (2007) Controlling the US Healthcare System with Policy Wedges Springer Health.

The Three-legged Health Care Stool

In a NY Times OP-ED piece, Paul Krugman argues that health care reform is a three-legged stool that cannot be passed incrementally. The legs of the stool are (1) banning insurance discrimination (underwriting), (2) mandating universal coverage and (3) providing financial aid to low-income families. In the long-run, that's probably correct. In the long-run, however, the three legs of the stool, even if all in place, don't address the fundamental health care cost drivers (capital investment/technology, pharmaceutical prices and prices for physician services). In any event, the current legislation won't be phased in for a few years which in politics becomes the long-run.

The way government in the US seems to work is to address one crisis at a time. If passing a law banning underwriting leads to a "death spiral" where "healthier Americans would choose not to buy insurance, leading to high premiums for those who remain, driving out more people, and so on..." then Congress would have to deal with that problem when it happened. Since Congress can only seem to deal with one problem at a time, maybe this is the best that can be expected from our political institutions.

Returning to the analogy, maybe the seat of the health care reform is sustainability and only one leg is social equity (the image above from Sustainability Now!) Maybe Mr. Krugman doesn't have all the legs or even the seat, for that matter.

Mr. Brown Goes to Washington

Scott Brown (R-MA) won the special election to fill Ted Kennedy's seat. As the 41st Republican Senator, he finds himself in a powerful position. In his press conference this morning, he said that (1) he favors state-level health programs like the Massachusetts Health Care Program, (2) he favors health care reform at the national level, (3) he is independent, even though he will caucus with Republicans, (4) he wants to solve problems rather than take ideological positions and (5) he seems to get along with President Obama.

I'm not sure where Mr. Brown stands on all health care issues (and he might not be entirely sure either), but there are plenty of problems to solve. As a problem solver, he should support a divide-and-conquer strategy. Let's take what can be agreed on in the current legislation (e.g., health insurance reform), pass it and move on to other problems on the list.

Let's also call him (and Orin Hatch, R-Utah) on state-level programs taking a page from the successful Race To The Top education grant reform program: put money on the table and States will go far out of their way to compete for it, to the amazing extent of quickly changing laws to qualify for the funding. How about a Race To The Top for health reform?

Good luck in Washington, Mr. Brown. Use your power for good while you've got it.

What is the Individual Mandate?

Here's an excellent policy brief from Health Affairs giving what's in the current legislation and the pros and cons of an individual mandate for health insurance coverage. What caught my attention was the discussion of whether an individual mandate makes sense without a public option.

If your interested in legal issues, read The Constitutionality of the Individual Mandate for Health Insurance by Jack Balkin of the Yale Law School. Bottom line: the mandate is just a tax that can be avoided by purchasing health insurance. Congress has the constitutional power to tax.

Funding Health Care Reform by Taxing "Cadillac" Health Plans

Tonight on the PBS News Hour, Josh Bivens of the Economic Policy Institute commented that (1) in the sort-run, an excise tax on generous health benefit plans will generate revenue but (2) in the long-run, employers will stop offering these plans to employees to avoid the tax. If this happens, where does the federal government go next to fund health care reform?

Controlling Drug Promotion

The US and New Zealand are the only countries that allow direct-to-consumer (DTC) advertising of pharmaceuticals. The policy debate in the US involves whether or not DTC advertising should be controlled. On Wednesday, I presented a paper on the topic in the Health Care Track at the Winter Simulation Conference. My response to the policy debate: controlling DTC advertising is unlikely to have much impact and misses a better approach to controlling overall drug promotion.

The time plot above (from the Donohue et. al. 2007 data set), provides the simplest summary of my findings. DTC advertising has increased modestly since 1997 when the FDA modified its side-effect disclosure rules to allow television advertising. The real action, as can be seen from the time plots, involves free samples and promotional detailing (pharmaceutical sales agents direct contact with physicians). In fact, starting in 2004, there has been a substitution between free samples and promotional detailing. Detailing is expensive and physicians tend to discount claims of sales agents. The marginal cost of handing out free samples is very small and has a powerful effect on future prescribing. Controlling free samples and detailing, rather than the much more visible DTC advertising, provides the most direct path to controlling the effects of drug promotion on the sales of patent medicines.

Improving Health Care Through Computer Simulation

In the morning session at the WSC Conference, Sally Brailsford from the University of Southampton, UK presented an interesting statistic: under 10% of all healthcare simulation studies reported in the massive academic literature were actually implemented! The politics and conflicting stakeholder demands in healthcare present the major hurdles to implementation. This should be contrasted with manufacturing where discrete event simulation has had a major impact on increasing the efficiency of industrial processes. In Tillal Eldabi's presentation, he noted that we are dealing with the "wicked nature of healthcare problems." A wicked problem indeed!

Squeeze the Public Option Trigger

Ben Smith reports that, in response to the Senate shift away from a public option, an insurance industry insider says "We WIN. Administered by private insurance companies. No government competitor."

There are lots of reason to think a public option trigger won't work and will face opposition in the Senate. A well-crafter trigger that went into effect when measurable conditions weren't met (decreasing percent without health insurance, reasonable rates, elmination of regional monopolies, etc.) and was supported by a strong planning effort over the next few years, could be effective. Does anyone think our political process can produce such a result?

In the end, it's time for our political leaders to prove their stuff. They were elected to govern and now they need to deliver. If the only way forward is a public option or if it's expansion of Medicare or if it's expansion of the Federal Employees Health Benefits Plan (FEHB), now is the time to see whether our publicly elected officials can make policy that benefits the American people.

Mammography and the PSA Test

One criticism of both mammography and the PSA test (for prostate cancer) has been that both tests produce false positives. What should be remembered is that positive results from either mammography or the PSA test does not lead immediately to radiation, chemotherapy or surgery.

For mammography, the American College of Radiography has a uniform way for radiologists to describe mammogram findings and suggest a follow-up plan.

Notice that levels 4-6 require a biopsy after a positive test. The same is true for the PSA test. Each is part of a process and the presence of cancer is still established with a biopsy even if the initial screening test is positive.