Archive for June, 2011

HHS Serves Up Prevention ‘Lite’

June 29th, 2011 | No Comments | Source: Commentary

In the 1993 film Groundhog Day, Bill Murray plays a TV weatherman who finds himself trapped in a do-loop, covering the numbingly boring display of Punxutawney Phil, over and over again.

Forgive those of us who follow news from the Department of Health and Human Services for feeling like Bill Murray in that movie.

Last month, HHS released an action plan to reduce racial disparities in health care. The plan called for new care models, more service delivery sites, a beefed-up health and human services workforce, and targeted efforts to reduce cardiovascular disease, childhood obesity and other scourges of minority populations.

Remarkably however, the plan came with no funding. Apparently, it was supposed to prompt agencies within HHS to assure that their own internal plans were aligned with the effort to reduce racial disparities. Worse yet, the plan involved only HHS itself. In effect, it assumed that a ‘medical model’ can solve racial disparities in health care. However as I argued here, these disparities aren’t about health, at all. They are about socioeconomic status, and HHS can’t fix that by itself.

Solving the problem of racial disparities in health care clearly requires input from many branches of government, including those involved with education, urban planning, transportation and more, in addition to HHS.

When it was all said and done, the HHS plan came off looking like a political stunt by the Obama administration. While the administration probably does want to fund a bona fide effort to reduce racial disparities, today’s incessant (and appropriate) focus on deficit reduction forced the administration to release a plan with no teeth. It isn’t going to make a dent in the problem.

“Oops!…I Did It Again.” Britney Spears

Now barely a month later, HHS has pulled the same stunt again! With considerable fanfare, it released something called a National Prevention Strategy. It too, is not funded.

To its credit, the National Prevention Strategy does involve multiple agencies. “If we want to achieve our goals and make a real change in the health of our nation, it can’t just be one department doing the work. If we’re going to serve healthier school lunches, we need to work with the departments of Agriculture and Education … If we want to create healthier homes, we need to work with the Department of Housing and Urban Development,” HHS Secretary Sebelius explained. (more…)



Medtronic, Infuse and the Senate Finance Committee

June 27th, 2011 | No Comments | Source: Commentary

Spinal fusions jumped 1,500% among Medicare patients between 2002 and 2007. The explosion had nothing to do with changes in prevalence of the conditions for which the complex surgery is performed. It had everything to do with the release of Infuse, a bone growth stimulator that reduces the complexity of the procedure.

Infuse (pictured) is marketed by Medtronic. It was approved by the FDA in 2002, specifically for spinal fusions of the lumbar (lower) spine using a particular surgical technique: the frontal approach. Soon after the FDA green-light however, surgeons began using it for other kinds of lumbar fusions and cervical (neck) fusions as well. Peer-reviewed studies of these non-approved uses helped drive the explosion in spinal fusions. Now, remarkably, off-label use accounts for 85% of Infuse use. The biological garners nearly $900 million in annual revenues for Medtronic.

There’s More to the Story
Unfortunately, newer studies of spinal fusion have found it to be no more effective for common back pain than physical therapy. Use rates of Infuse have not responded to this growing literature.

Beyond this, the off-label use studies mentioned above were sponsored by Medtronic and led by scientists that received tens of millions of dollars’ worth of royalty payments and consulting fees from Medtronic. It has recently been alleged that these scientists knew about certain complications caused by Infuse, and either failed to disclose them or de-emphasized them in their write-ups.

The complications include some that are potentially fatal– neck swelling severe enough to compromise breathing, and possibly an increased cancer risk, for example. They also include sterility in men, a complication Medtronic and surgeons with financial ties to Medtronic appear to have been aware of—but did not report–since 2002. (more…)


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The Mobile Phone-Brain Cancer Link

June 22nd, 2011 | 2 Comments | Source: Commentary

Some of the greatest discoveries in the history of modern medicine came from scientists who noted spatial and temporal relationships between events that had not been previously recognized, and deduced from their observations that the events were causally linked.

In 1854 for example, John Snow observed that high cholera death rates in 2 districts of Soho were linked by a common water supplier. Snow created maps (pictured) to display the link and eventually traced the outbreak to one of the supplier’s water pumps. He convinced the supplier to remove the pump handle and treat the water with chlorine, and that promptly ended the epidemic. Snow’s work was canonized as a founding event in the science of epidemiology.

Then in 1928, Alexander Fleming–already renowned as a brilliant scientist with an untidy laboratory–accidentally spilled a beaker filled with a fungus (genus, Penicillium) onto a petri dish containing the staphylococcus bacteria, just before he left on vacation.

Upon returning, Fleming noticed that staph colonies close to the spill had died. Fleming subsequently showed that the fungus produced a substance which killed staph and many other bacteria. He named the substance Penicillin. The discovery revolutionized the treatment of bacterial infections and spawned the entire pharmaceutical industry in the process.
Last month, Finnish scientists used similar spatiotemporal analyses to explore the purported link between mobile phone use and brain cancer. Unfortunately, their results were not nearly as clear-cut as those of Snow and Fleming.

Here’s the Story
Mobile phones produce radio-frequency electromagnetic fields. To date, no study has proven that the radiation is tumorigenic, but doubt persists because it has proven difficult to quantify the amount radiation exposure in various areas of the brain, and the long latency period before cancer first develops and becomes clinically manifest. (more…)


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The Affordable Care Act and the PCP Manpower Shortage

June 20th, 2011 | No Comments | Source: Commentary

The Affordable Care Act is the most important piece of federal health care legislation since the Social Security Act created Medicare in 1965. It assures that 32 million Americans will gain access to health insurance for the first time. But who will care for these people?

The flood of newly insured people will create a surge in demand for physician services. By 2015—one year after the major provisions of the ACA take effect—the US will have 63,000 fewer physicians than it needs to meet this demand, according to the Association of American Medical Colleges.

The shortfall will hurt everyone, but its impact will be devastating for medically underserved populations where finding a doctor is already difficult. This includes nearly 20% of the US population.

Unfortunately, the ACA doesn’t include a manpower plan that sufficiently accommodates the surge. The most optimistic projections suggest it will add 500 or so physicians per year to the workforce during the next decade, and even that modest growth has recently come under attack by House Republicans.

Two weeks ago, the GOP-controlled House voted 234 to 185 to eliminate $230 million in mandatory ACA funding for the creation of a new teaching model for residents in primary care. The model is based around “teaching health centers,” which would be placed in medically underserved areas and mirror the practice environment residents will enter upon completion of their training.

The GOP isn’t against the new training model, but objects to the automatic, mandatory payouts associated with it. They propose that funding for the manpower initiative should be subjected to votes each year during Congress’ annual appropriations process. “It’s time to move these programs back to the discretion of this Congress,” Marsha Blackburn (R-Tenn.) explained, referring to it as one of many  “slush funds” provided by a debt-ridden federal government. (more…)


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Does Being Diagnosed with a Chronic Disease Improve Healthy Behavior?

June 16th, 2011 | 1 Comment | Source: Commentary

We have all seen people exhibit flagrantly unhealthy behavior. Some of us–though we’d never admit it–derive a certain, smug satisfaction by observing them. At least I don’t do that!

Somewhere in the course of our daily lives though, most of us do exhibit behavior that suggests at least some disregard for our health. We don’t change our diet, though we know we should. We don’t floss, take medications as prescribed, or get the screening tests we’re supposed to. 

Multiple intertwining causes underlie all unhealthy behavior, of course. I had always figured that one pervasive cause was the lack of a simple, observable connection between health-related behaviors and health outcomes. There is a long delay for example, between establishing unhealthy dietary preferences  and the sequellae of that behavior ( a heart attack, diabetes or whatever). The longer the delay between cause and effect, the more likely someone will be to exhibit unhealthy behavior.

On the other hand, if there’s a short interval between cause and effect—it only takes minutes for susceptible people to develop a severe allergic reaction after eating peanuts, for example—well, that’s where I’d expect high adherence to the required healthy behavior.

If I’m right, then we have a problem. For many chronic diseases (diabetes, heart disease, some cancers) the interval between cause and effect can be decades.

How might this reasoning apply to a person that has already been diagnosed with a chronic disease? Assuming providers have explained things to him or he has learned these things on his own, that’s a person that knows his behavior caused his predicament. And if he knows that, he should also know he has a fresh chance to rectify matters, at least to a degree. If he modifies his unhealthy behavior, then he can control the progression of, and indeed sometimes reverse the progression of his disease. (more…)



The Effectiveness of Online Health Intervention Programs

June 13th, 2011 | No Comments | Source: Commentary

In recent posts on Web-based and mobile behavioral intervention programs, we reviewed evidence suggesting that social support, in one form or another, can improve participants’ adherence and engagement with the program. That didn’t always mean however, that participants achieved better outcomes as a result. In one study for example, an online community increased engagement with and utilization of a Web-based activity program, but it did not increase participants’ actual activity levels.

Another study, slightly older than the ones reviewed above, did show that a Web-based program improved outcomes. In this case, the intervention was an online videogame known as Re-Mission. Since I haven’t touched previously on outcome studies for automated lifestyle intervention tools or videogames as an example of such programs, I’ll do that here.

Re-Mission is intended improve medication compliance in teens and young adults with a history of cancer. In the game, players control a nanobot within a 3-dimensional body of a young person that has cancer. Play involves destroying cancer cells and managing chemotherapy-related adverse effects like vomiting and bacterial infections by using antiemetics and antibiotics. The game purports to help users understand their disease and its treatment and improve their sense of self-efficacy: they can take control of their disease.

In their randomized trial of Re-Mission, Pamela Kato and colleagues chose compliance with prescribed medications as the behavioral outcome. The Stanford scientists randomized 375 teens to play either Re-Mission or Indiana Jones and the Emperor’s Tomb, an entertainment game with a structure and controller interface similar to that in Re-Mission. They asked participants in both groups to play the assigned game for 1 hour each week during the 3-month study.

Kato’s group measured pre- and post-intervention adherence to the antibiotic trimethoprim-sulfamethoxazole using an electronic pill-monitoring device. They measured adherence to 6-mercaptopurine, chemotherapy drug used to treat many childhood cancers, using serum assays. (more…)


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Online Communities & Attrition from Health Intervention Programs

June 8th, 2011 | No Comments | Source: Commentary

Provider-centric, face-to-face health intervention programs that help people quit smoking, lose weight and increase activity levels have been shown to work, but they are expensive, don’t scale, and inconvenient. By contrast, Internet-based programs with similar goals can be disseminated widely and inexpensively, and can be accessed by consumers at a convenient time and place.

Although many of the latter programs have been shown in clinical trial settings to be efficacious, attempts to commercialize them have been plagued by attrition. People stop using the programs because they lose motivation, can’t find the time, or become frustrated by clunky interfaces and data entry requirements.

In one study for example, only 26% of participants in a randomized trial of a free physical activity website dropped out of the study before it was completed, whereas 67% of registered open access users dropped out during the same course of time. The open access users also spent less time on the site.

The lower attrition rate in the trial was likely driven by the emotional, cognitive and logistic support provided by trial personnel. It follows that the commercial success of online health intervention programs hinges on their ability to support users in the same way as trained personnel do in clinical trial settings.

Online communities have been proposed for this purpose. These tools permit users to communicate via the posting and reading of messages on a group message board. Social learning theory suggests they can reduce attrition by favorably impacting motivation to change, helping users learn vicariously and gain inspiration, and providing content that encourages users to return to the site.

Recently, a study by Caroline Richardson and colleagues at the University of Michigan showed in fact that an online community associated with an Internet-mediated walking program did reduce attrition.

Richardson’s group randomized 324 sedentary adults into 2 groups. Both groups were granted access to a Web-based walking program that required them to wear pedometers for 16 weeks and upload step-count data to a server. All participants could also view graphs of their progress and receive individually-tailored motivational messages. Participants who were randomized to the “online community” group had, in addition, access to online community features embedded in their intervention webpage, enabling them to post and view messages left by other participants. Those in the “no online community” group were not granted access to these features. (more…)


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Increasing the Numbers of Women CEOs in Health IT

June 6th, 2011 | No Comments | Source: Commentary

The appalling lack of women chief executives in today’s Health IT companies has been linked to a paucity of women in IT generally and the scarcity of female mentors and venture capitalists that could support them. Social norms regarding gender identity and child rearing also drive the disparity. In this post, I’ll briefly review these norms and some promising efforts to reduce the disparity.

Social Norms, Women and Tech
Many people believe social norms and expectations regarding women are the most important reason why there are so few female IT leaders out there today. As the father of 3 girls who are succeeding in tech, I don’t necessarily agree with this (I think the phenomenon is driven by these factors).

Still, there are some indisputable facts that have to be mentioned.

It is fact for example, that many parents don’t encourage their girls to pursue science and math—especially when they reach high school. These disciplines build analytic and quantitative skills that can be critically important to success for an entrepreneur. Similarly, many parents don’t encourage certain behaviors in girls—like risk taking, independent thinking and competitiveness—to the extent they do in boys. In so doing, parents unwittingly impede the development of self-confidence in their daughters, a trait that can be decisively important when it comes to managing a board or a big customer.

And of course child-bearing and child care remain largely female-specific responsibilities to this day. These responsibilities peak at the same stage in life when many of today’s successful tech entrepreneurs started their companies.

All tech CEOs face difficult challenges, but only female CEOs deal with questions about their commitment to the company when they miss work because of morning sickness or a child’s appointment with the doctor.

What is being Done?
Thankfully, many organizations have formed in recent years to address the gender disparity in tech leadership. They address most or all the barriers mentioned above (and in my previous post on the subject). These efforts seem likely to shake IT leadership to its core for decades to come. Here are some of the most important efforts in this regard: (more…)



Attrition from Online Health Intervention Programs

June 2nd, 2011 | No Comments | Source: Commentary

In recent years, developers have released thousands of Web-based and mobile intervention programs that purport to help people quit smoking, improve their nutrition and activity levels, and institute other salutary changes in health-related behavior.

These programs have drawn attention because of their potential to improve health for millions, at low cost. In addition, the platforms on which some are built permit developers to add new tools like games, online communities and analytical capacity that can, many believe, enhance their impact.

Clinical trials have shown that many of these programs do work.

For example, a randomized trial by Australian scientists showed that public registrants to a cognitive behavior therapy website had reductions in symptoms of anxiety and depression. Another randomized trial by Swiss scientists revealed that an Internet-based smoking cessation program helped people quit their habit.

Nevertheless, with a few notable exceptions, venture capital firms have been reluctant to invest in startups proposing to commercialize programs like these. It’s likely they’ll stay on the sidelines until startups prove their programs attract large, active user bases and users maintain targeted health benefits outside the controlled environment of a clinical trial. It wouldn’t hurt if startups also had a plan to monetize their applications, as well.

The challenge can be boiled down to the problem of attrition. People stop accessing these programs because they lose motivation, can’t find the time, or become frustrated by clunky interfaces and data entry requirements. Sometimes, they simply move on to another application.

Recently, a study by Miriam Wanner and colleagues from the Institute of Social and Preventive Medicine validated investor concerns about the attrition problem. But to some, it offered hope that newer platform features like games and onlne communities may be able to address it satisfactorily.

The scientists set-out to understand the determinants of utilization of Active-online, a free physical activity website in Switzerland. They found that the key predictor of sustained use was the circumstance in which people began using the site in the first place. Specifically, the attrition rate was 67% among registered open access users and only 26% among those who participated in a randomized trial of the site. Similarly, open access users spent less time on tailored modules (7.5 vs. 9.2 minutes) than trial participants. (more…)


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