In the past I’ve spoken highly of VistA, the Veteran’s Administration computerized health records system—and with good reason. VistA has a lot going for it. In 2006, it won an “Innovations in American Government Award” from Harvard. Studies show that use of VistA has improved VA productivity by 6 percent a year since national implementation was achieved in 1999. In a time of sky rocketing health care costs, VA care has become 32 percent less expensive than it was in 1996 in part thanks to VistA. The computerized system also has helped the VA reach an amazing prescription accuracy rate of over 99.997 percent. And last—but certainly not least—VistA is a flexible program that allows for much independent tinkering in the name of improvement, both by techies outside of the VA and those within the administration.

Given all these pluses, you’d think that the government would be happily throwing its weight behind VistA and ensuring that the system is firmly institutionalized for the long-term. But in fact, just the opposite is happening. VistA is under attack; and it’s the federal government that’s leading the assault.

According to Dana Blankenhorn, a writer at ZDNet (a much-trafficked techie website),  VistA is dying “of starvation and neglect.” It’s demise comes in part from an unlikely source: the Department of Defense (DoD). In 2005, the DoD introduced it’s own computerized health records system, called AHLTA. The system was developed by Integic, a private firm that was acquired by defense giant Northrop Grumman a mere nine months before AHLTA’s formal roll-out.

So why would the DoD contract out the development of a health records system instead of co-opting VistA, which can be reworked for different contexts? It’s not because of it’s too difficult, that’s for sure. Blankenhorn quotes Phillip Longman, a senior fellow at the New America Foundation and an outspoken champion of the VA  noting that the government “could wire Walter Reed or Bethesda (the two biggest military hospitals) for VistA in an afternoon. Technically there’s no big problem….”

Yet still, the DoD created an entirely new system—one which has only limited interoperability with VistA. Longman, the author of The Best Care Anywhere: Why VA Health Care is Better Than Yours, explains just how bad things are: “I just gave 11 [speeches] to front line VA employees in the last few weeks, and I heard over and over again their frustration over not being able to get to the people at the [DoD] making the hand-offs [of patients between departments]. Not only can’t the computers talk to each other, they can’t get the Army doctor in Germany on the phone to answer a simple question.”

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Kenneth Raske, president of the Greater New York Hospital Association…attributed the aggressiveness of private hospitals in New York simply to the sophistication of the patients and their families…"that’s a reflection of the New York culture that we have.” –The New York Times

All together now: when it comes to medical care, more is not necessarily better. This is a point we’ve driven home here on Health Beat, but a JAMA study published this week adds a new dimension to the discussion by showing that even patients feel that more is not better.

The research, authored by experts from UMass Boston, the Foundation for Informed Medical Decision Making, and Dartmouth, surveyed 2,515 Medicare patients across the nation to find out how they felt about the medical care that they received over the past year. The survey specifically asked whether patients felt that their needs were met, how they perceived the quality of ambulatory care, and how they perceived the  quality of overall care.

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In last week’s JAMA, distinguished legal and public health scholar Lawrence Gostin, affiliated with both Georgetown Law and Johns Hopkins, takes on the Supreme Court decision on the case of Riegel v Medtronic Inc. The case, decided in February, established that federal law preempts state law when it comes to medical devices. What this means is that, once the FDA approves of a medical device, consumers cannot use state liability laws to sue device-makers should they fall victim to device malfunctions or problems.

When the Riegel decision was first announced, I slammed it for expecting way too much of the FDA—which is under-funded, under-staffed, and often reliant on industry for financial support. In saying that federal law trumps all, the Supreme Court is giving final say in consumer safety to an agency that can barely do its job. As Gostin puts it so succinctly, “the court’s confidence that the agency has the expertise, resources, and information necessary to ensure the safety of food, drugs, and medical devices is misplaced.”

I don’t want to replay the nitty gritty about how the FDA has declined in this post—you can check out previous posts for more details. But suffice to say, it’s incredibly wrong-headed to claim that the FDA is “rigorous” (as did the court) in its approval process, and that this approval is enough to preempt legal recourse on the part of patients who suffer harm thanks to a poorly designed device.

Gostin, however, doesn’t stop here. He also asks some tough questions about how the Riegel decision changes the rulesof the game when it comes to approval and accountability. Gostin asks: what if a medical device is approved by the FDA because “a corporation…deceived the agency into granting that approval”? Is it fair to allow device manufacturers to “use FDA approval as a shield against litigation” if they can scam their way into approval? Of course not—but this is exactly what can happen today. 

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Yesterday, while scouring KevinMD, I stumbled across a post from “Respectful Insolence,” a blog authored by an academic surgeon/scientist who dubs himself “Orac.” In the post, Orac  reports that this Wednesday at the American Society of Clinical Oncology (ASCO) 2008 Annual Meeting,researchers from the Mayo Clinic will be reporting on a disturbing correlation between the use of breast magnetic resonance imaging (MRI) and a rise in the number of women having mastectomies. In this context, Orac offers a cogent, compelling perspective on why too much cancer screening can harm patients.

Orac’s worries specifically relate to using MRI scans to detect breast cancer. Advocates of the procedure rightly claim that MRI scans can detect more growths than other techniques, including mammography [i.e. an x-ray] and a clinical examination. The MRI technology detects so much that, as the New York Times put it last year, the scans reveal “all sorts of suspicious growths in the breast, leading to many repeat scans and biopsies for things that turn out to be benign.”

In other words, breast MRI scans are so sensitive that if you have breast cancer, there’s an almost 100 percent chance that they’ll detect it; but the technology produces many  false positives because it’s not as good at distinguishing between malignant and benign growths. As Orac puts it: “…MRI [scans] now routinely "section" people into "slices" much thinner than 1 cm, making our imaging sensitivity considerably higher than it was 14 years ago.

The problem is that while many people undergo malignant changes in various organs as they grow older than most will never actually develop “clinically apparent cancer.” In fact, some studies have shown that MRI scans accurately detect breast cancer just 30 percent of the time. Though most studies place this rate at a higher level, they also show that mammographies (using x-rays to examine the breast) lead to fewer false positives than MRI scans.

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After being re-elected in 2004, President Bush began touting an ambitious social policy platform, the so-called “ownership society.” Part of this agenda was a strong push for high-deductible health plans (HDHPs) coupled with health savings accounts (HSAs)—tax-free savings accounts to pay for health care expenses.

Like so much else that the Bush Administration attempted, the ownership society flopped, in large part because it called for the privatization of Social Security. With this failure, HDHPs and HSAs fell out of the public spotlight. To the casual observer, the question of whether or not health care reform should move in this direction seemed to have been put to rest.

But even though they are no longer in the political spotlight, HDHPs and HSAs are actually thriving—and in fact penetrating our health care system at a relatively brisk rate. This is problematic. Not only are HDHP/HSA plans poor policy, but their proliferation also weakens the political viability of the health care reform we really need.

Here are the numbers: at the end of last month, the Associated Press reported that the number of Americans enrolled in HDHP/HSA plans has nearly doubled from 2006 estimates, to around 6 million. Admittedly, these plans still have a long way to go before they become a force to be reckoned with.  America’s Health Insurance Plans estimate that enrollment in HDHP/HSA plans comprises just 3.4 percent of the private insurance market in the U.S., and in March, Employee Benefit Research Institute (EBRI) estimates that 42 percent of people who have HDHPs and are eligible for HSAs don’t even use the accounts.

Nevertheless, a doubling of enrollees over two years is nothing to scoff at. And while national rates of enrollment are still meager, the picture’s somewhat different at the state level. The AP reports that in Minnesota, the state with the highest percentage of HDHP enrollees, “about 9.2 percent of the state’s total enrollment in private health insurance comes through high-deductible plans. Following closely behind [are] Louisiana, [at] 9 percent and the District of Columbia, [with] 8.7 percent.”

State governments are also beginning to turn to HDHPs and HSAs as models for reform. Last week, Georgia passed a law—with the support of Newt Gingrich—that will give insurers $146 million in tax breaks for selling HSA plans. In Indiana, Health Affairs reports that HSAs are being coupled with Medicaid to provide high-deductible health insurance to low-income citizens.

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On Monday the New York Times ran a nice story detailing how Massachusetts is the newest in a long line of states hoping to fund health care initiatives by raising tobacco taxes. The report notes that “bills to raise tobacco taxes have been active in 22 state legislatures in 2008, according to the Tobacco Merchants Association, a trade group. That follows a year in which 11 states enacted increases, according to the National Conference of State Legislatures.” In other words, taxing cigarettes to fund health care reform is an increasingly popular strategy amongst policymakers across the nation.

Big Tobacco is not happy about this. The industry is putting a lot of time, effort, and money into snuffing out health care reform proposals—at both the state and national level—that rely on tobacco tax hikes for funding. In doing so, tobacco companies are torpedoing one of the few politically feasible strategies for raising funds needed to pay for reform.

Consider California. The Times notes that the state’s recent bipartisan plan for instituting universal health care, endorsed by Republican Gov. Arnold Schwarzenegger and Democratic Assembly Speaker Fabian Núñez, “died in the State Senate in January partly because of opposition to the $1.50-a-pack increase it included.”

This wasn’t the first time cigarette taxes have been an issue in California. In 2006, California voters turned back a ballot initiative, Proposition 86, that proposed to increase the cost of a cigarette pack by $2.60. Supporters of the proposition estimated proceeds from the tax at $2 billion—which would have been used to help fund health care reforms—and forecasted a $16.5 billion long-term decline in health care costs thanks to reductions in smoking. Good stuff.

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Earlier this month I attended a conference sponsored by the MacArthur Foundation spotlighting the intersection of mental health and public policy. In introductory comments for the event, Howard Goldman, Professor of Psychiatry at the University of Maryland School of Medicine and director the MacArthur Foundation’s Network on Mental Health Policy Research, called mental illness “an overlooked crisis.” He’s right. But contrary to what you might expect, it’s not just the public which overlooks mental health. Medical practitioners are often slow to adopt well-researched, proven mental health interventions—because they’re rarely profitable.

This is bad news for America, because mental illness is a big problem. Goldman noted that 38 percent of Americans who receive Social Security Disability Insurance have a mental disorder, as do more than 200,000 adults in prison and 30 percent of the nation’s homeless.

But mental illness isn’t just an issue for the have-nots. Jon Fanton, Ph.D., President of the MacArthur Foundation, addressed the conference after Goldman and offered some compelling numbers on the fiscal impact of poor mental health. Every year, said Fanton, mental illness amounts to $80 billion in indirect costs (lost productivity due to illness, premature death, and losses for incarcerated individuals and for individuals providing family care) and another $99 billion in the direct cost of providing care. Fully half of children with mental illnesses drop out of school.

For these reasons, said Fanton, the “interests of those in trouble are not in contrast to the interests of society and or the rest of us”—though “we tend to think…[that] the opposite is actually true.” In the end, mental health is a very public concern.

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Every year 325,000 Americans die from cardiac arrest, and around three-quarters of these deaths occur at home. Unlike a heart attack, where blood flow to the heart is restricted, cardiac arrest is a stopping of the heart beat. While heart attacks aren’t usually fatal, cardiac arrest almost always is: research has shown the survival rate to be as low as 2 percent.

Given these numbers, you’d think that automated external defibrillators (AEDs)—handheld devices that shock the heart back to its normal rhythm after cardiac arrest—would be indispensable for any household worried about its health. Philips, manufacturer of the nation’s only FDA-approved, no-prescription-needed AED, says as much on its website; the company insists that “anyone who wants a safer home” should buy its product.

But according to a just-released study from the New England Journal of Medicine (NEJM), having an AED at home actually doesn’t make you any safer. Researchers compared survival rates for a group of 7,001 patients who were organized—along with their spouses or companions—into two groups. 3,506 of them were trained to administer CPR and dial 911 in the case of cardiac arrest at home; the remaining 3,495 underwent the same training, but were also given an AED and trained to use it (i.e. placing the device against the patient’s chest and pressing a button to shock the heart back to its normal pace). The study found that overall survival rates were almost identical across the two groups. 

The patients, who hailed from seven countries, were followed from January 2003 to October 2005. Over this period, 169 of them died from cardiac arrest: 84 in the group that received only CPR, and 85 in the group that also used AEDs. Both groups also saw the same number of successful resuscitations (19 in each). In other words, having an AED at home—and knowing how to use it—didn’t help to save lives. 

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It’s a well-known fact that China is the most populous nation in the world. But here’s a question for you: how the heck does a country—especially one in the midst of breakneck economic development—provide health care to 1.3 billion people? The answer is “not all that well,” thanks to a decades long bout of capitalism-gone-wild that’s reduced Chinese health care to a shadow of its former self.

For most of the 20th century, China was a communist society. But in 1978 the government introduced market-based economic reforms aimed at liberalizing the economy. These changes included the creation of open markets for farmers to sell their crops, the creation of pricing systems, bank reforms, and an embrace of foreign direct investment. 

These reforms, along with many others, have produced some spectacular economic results; but by the 1980s they also demolished China’s traditional health care system, which had been in place for some thirty years.

The now-defunct cooperative medical system (CMS) was a three-tiered framework centered on rural communities, the population of which has long constituted the majority of Chinese. According to Gregory Chow, a noted Princeton economist and China expert, the first-tier of the CMS consisted of “part-time [and salaried] barefoot doctors in health clinics [who] provided preventive and primary care.” Despite being farmers who received only minimal medical training, these barefoot doctors were the Chinese equivalent of primary care physicians—the point of first contact for patients with medical concerns.

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After 10 hours on the job, a truck driver must pull off the road. After 16 hours, an airline pilot can no longer legally fly a plane. But after 24 hours or more on the job, with perhaps an hour nap somewhere along the line, a first-year medical resident can perform a surgical procedure, write a prescription, or insert a chest tube.

This introduction to a 2004 article in Focus Online, the newsletter from Harvard Medical, Dental, and Public Health Schools, says it all: we expect doctors to be superhuman.

When you stop and think about it, the expectation that medical residents, especially first-year interns, can, or should, perform incredibly complex procedures with minimal sleep is crazy. Medical researches agree—which is why hospital shifts of doctors-in-training have come under much scrutiny in recent years.

In 2003, the Accreditation Council for Graduate Medical Education (ACGME) created standards to restructure residents’ hours in order to combat fatigue, and the dangerous mistakes that accompany exhaustion. The council’s reforms limited residents’ hours to:

• No more than 80 hours a week
• No more than 6 work days a week, averaged over 4 weeks
• No more than 24 continuous hours of duty, except for another 6 hours of education or transfer of care In-house call no more often than every third night
• No less than 10 hours of rest between duty periods

These changes were meant to benefit not only residents, but also patients: an exhausted doctor is a careless doctor. But for all of the Council’s good intentions, studies show that the ACGME reforms don’t go far enough—residents need more of a break if they are to maximize their effectiveness and ensure the safety of their patients.

How do we know?  Last year, two studies from Kevin G. Volpp, MD, PhD, from the Center for Health Equity Research and Promotion, VA Hospital in Philadelphia, Pennsylvania looked at whether the first four years of the ACGME guidelines had resulted in a meaningful decline in patient mortality—in other words, if the guidelines had saved lines by keeping doctors alert and rested.

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