Archive for April, 2011

Don’t Regulate DTC Genetic Testing

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

Today, consumers can purchase dozens of medical tests without a prescription–tests that tell them whether they are pregnant, have a urinary infection, their cholesterol is too high, and so on.

Should direct-to-consumer (DTC) genetic tests be as readily available? These are the mail-in saliva tests that tell consumers about their genetic susceptibility to Alzheimer’s disease, type 2 diabetes, heart disease and other conditions.

DTC genetic tests are different from the genetic tests that have been used for decades in prenatal and newborn screening, and more recently in predictive testing (like the BRCA test for breast cancer risk).

The difference is not the substrate being tested. In both cases, it’s DNA. Rather, it’s who owns the testing process.

For the legacy DNA tests, health professionals own the process. As per protocol, they obtain permission (informed consent) from patients before ordering the test. Then, they consult with and support the patient once the results are known.

In contrast, DTC genetic tests transfer ownership of the genetic testing process to consumers. A person can decide for herself whether to get a DTC genetic test. She doesn’t need permission from a provider, and has no obligation to share the information with her provider.

This bothers many physicians, bioethicists and consumer advocates. They point out that DTC genetic test reports can be difficult to interpret (for physicians as well, I might add, despite claims that they are universally qualified to do so). They decry the lack of regulatory oversight of testing facilities which might help assure the accuracy and reliability of the information. Furthermore, reports of “egregious…deceptive marketing” by some DTC genetic testing vendors suggest that consumers maybe harmed, they say.

These people call for regulatory oversight of DTC genetic testing. The FDA has in certain limited instances, already begun to do just that.

Physician organizations tend to support the regulation of DTC genetic testing. In particular, they favor rules that transfer ownership of DTC genetic testing to (guess who?) physicians who can then serve as custodians of the information, just as they do for the traditional genetic tests mentioned above.

Set the Data Free
I disagree. People who want access to their genetic-risk information should be free to pay their own money to obtain it, period. The only place where regulation has a role in DTC genetic testing is to assure the quality of the results being generated. That’s it.



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New Alzheimer’s Guidelines: Better Late than Never

April 25th, 2011 | No Comments | Source: Commentary

For the first time in 30 years, an expert panel has updated guidelines for the diagnosis of Alzheimer’s disease. The long overdue facelift should favorably impact care for millions and accelerate badly needed research on the disease.

The guidelines were produced by representatives from the National Institute on Aging and the Alzheimer’s Association. They portray Alzheimer’s for the first time as a three-stage disease. In addition to ‘Stage 3,’—the full-blown clinical syndrome that had been described in earlier versions of the guidelines—the new guidelines describe an earlier ‘Stage 2,’ of mild cognitive impairment due to Alzheimer’s, and a ‘Stage 1, or preclinical’ phase of the disease. The latter can only be detected with biochemical marker tests and brain scans.

The guidelines legitimize years’ worth of observations by the family members of Alzheimer’s patients, who recognize in retrospect that Grandpa had a slowly progressive cognitive disorder long before he was diagnosed. The guidelines also reflect progress on the research front, where it has now been established that the disease begins years before patients become symptomatic.

Alzheimer’s patients and their families, and the teetering US health system that supports them, would have been better served by the publication of these guidelines 2-3 years ago.

The science was compelling enough back then, and a 2 to 3 year lead-time on research could have had an enormously positive impact on our economy and our health system. In a report last summer for example, the Alzheimer’s Association concluded that unless disease-modifying treatments are found quickly, the number of Americans with Alzheimer’s disease will jump from 5.1 million to 13.5 million by 2050. The total costs of caring for these folks will have exceeded $20 trillion, in today’s dollars, by then. A lions’ share of these expenses will be borne by government entitlement programs, Medicare and Medicaid.

The New Guidelines Will Improve Care
Meanwhile, several commentators have criticized the new guidelines as confusing and stress-provoking. ‘Why should we rush to tell people they have something we can’t treat?’ is the crux of their argument.

These people have it wrong. Denial is not the way to go with Alzheimer’s. The sooner patients and their families find out they have it or are at risk to develop it, the more time they have to develop care plans that reflect their preferences. Mildly affected individuals get to decide for themselves how to enjoy what may be a limited number of years-worth of relatively unimpaired mental functioning. They also get to decide whether to participate in clinical trials and which ones to participate in. They and their families can access counseling and support groups more quickly, a benefit that can improve the quality of life for everyone involved. Even providers themselves can use the enhanced lead-time to implement a patient support plan that respects the needs of the patient and his family.

Today, full-blown Alzheimer’s affects 5.1 million Americans. In all likelihood, at least that many have mild cognitive impairment due to Alzheimer’s (the new ‘Stage 2′). These are the people that will benefit immediately by the expanded definition.

The New Guidelines Will Improve Research
By formally recognizing that Alzheimer’s is slowly progressive and establishing criteria for each stage of the disease, the guidelines facilitate scientific inquiry into various diagnostic and therapeutic options. They allow patients to be grouped by stage of illness (a breakthrough similar to what tumor staging has done for cancer research). Most importantly, they encourage patients to enter clinical trials at a time in the natural history of their disease when treatment success is more likely. (more…)


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How to Measure Happiness

April 20th, 2011 | 3 Comments | Source: Commentary

Nowadays, a lot of folks pursue happiness as if it were their primary mission in life. But what is happiness?

Philosophers tell us there are at least 2 kinds. There is so-called “hedonic well-being” which is short-term pleasure derived from things like a tasty meal, great sex or a day in the amusement park.  Then there’s “eudaimonic well-being” which comes from living with a sense of purpose, which is usually actualized by participating in meaningful activities like volunteering for a worthy cause, raising children or caring for others.

Scientists have recently joined their philosopher brethren in the analysis of happiness. Remarkably, they have produced evidence which suggests that people who are driven to achieve eudaimonic  happiness actually have better health outcomes than those motivated to achieve hedonic happiness. They are more likely to remain intact cognitively, for example. They even tend to live longer.

For example, in a cohort study of 7,000 people known as MIDUS (the Mid-Life in the US National Study of Americans), Carol Ryff and colleagues at the University of Wisconsin have tried to identify social and behavioral factors that predict one’s ability to maintain good health into old age. The team has focused on sociocultural sub-populations known to be associated with poor health outcomes…things like low education level.

Ryff’s group showed that people with low education levels and high levels of eudaimonic well-being had lower blood levels of interleukin-6, a bio-marker of inflammation that has been linked to cardiovascular disease, Alzheimer’s disease, even after accounting for hedonic well-being into account. Their write-up appears in Health Psychology.

As well, a study of 950 community-dwelling elderly folks linked eudaimonic well-being to a lower risk of developing Alzheimer’s disease. During their 7-year follow-up of this cohort, David Bennett and colleagues at Rush University Medical Center found that participants who reported having less of a sense of purpose in their lives were at least twice as likely to develop the debilitating condition as those who reported a greater sense of purpose. Their write-up appears the journal Archives of General Psychiatry. (more…)



Peter Thiel’s Take on Education

April 18th, 2011 | 2 Comments | Source: Commentary

In a recent piece for TechCrunch, Sarah Lacy highlights the views of Peter Thiel—the PayPal co-founder, hedge fund manager and venture capitalist—on higher education in America. According to Lacy, Thiel believes that America is under the spell of a bubble in higher education. “A true bubble is when something is overvalued and intensely believed,” Thiel explained. “Education may be the only thing people still believe in in the United States. To question education is really dangerous. It is the absolute taboo.”

OK fine, but in Lacy’s article, Thiel never actually questions education. What he questions is its price. Thiel says a college education costs too much. He also says college education is exclusionary. People “pretend that if they could just go to Harvard, they’d be fine,” he says. “Maybe that’s not true.”

Maybe it’s a good thing Thiel didn’t question a college education per se, since for all its inefficiencies and uneven quality, it’s clearly a good thing to have from an economic standpoint. The median income for US adults with a bachelor’s degree is $53,000 per year. That number is $33,000 for those who have only a high school diploma, and lower still for people who didn’t graduate high school. Over the course of a lifetime, an American citizen who has a college degree will earn nearly $1 million more than one who doesn’t. And unemployment rates for people without college degrees are more than twice as high as the rates among those who have such degrees.

As for America’s competitiveness, education policy experts from the left and the right agree that the US needs a more educated workforce if it is to compete successfully with China, the EU nations and rising Asian nations, all of which place enormous importance on education. Many of these countries have already passed the US on several measures of national competitiveness that would be of interest to Thiel, like per capita economic performance, entrepreneurship, human capital and innovation capacity.

Well then, what about Mark Zuckerberg, Bill Gates and many other entrepreneurs who achieved success without a college degree?

It turns out that they have something in common with Thiel. They grew up in a comfortable, middle- to upper-middle-class environment. Thus, in all likelihood, they had caring, educated parents who made sure they never had to worry about where their next meal would come from or fear for their personal safety. They were educated at the dinner table, and attended top-flight elementary and high schools. Thiel himself attended Stanford and Stanford Law School. (more…)



Cartoon Characters Impact Kids’ Cereal Preferences

April 15th, 2011 | 1 Comment | Source: Archives Peds. Adol. Med., NPR

Based on their experience during countless schleps to the market, moms know that kids pick cereals whose boxes have cartoon characters on them. Previous research by Yale scientists explained the phenomenon: kids say that the stuff poured from such boxes tastes better than the same stuff when poured from a cartoon-less box. The same thing happens when kids pick graham crackers, carrots and gummy fruit snacks.

Pictures of Shrek, Dora the Explorer, Scooby Doo and their kin make just about anything taste yummier, it seems.

Can this observation be leveraged to encourage kids to select healthier foods? Yes, it turns out. But the story isn’t as straightforward as you’d think.

To study the impact of licensed media spokescharacters and other nutrition cues on kids’ taste assessment of food products, scientists at the University of Pennsylvania fed cereal from a box that had been labeled either “Sugar Bits” or “Healthy Bits” to 80 kids. Half the boxes in each “brand category” were adorned with cute cartoon penguins, while the other half were not. The kids were between 4 and 6 years old.

The scientists then asked the kids to rate the taste of the cereals on a 1 to 5 smiley face scale. Surprisingly, kids loved the Healthy Bits, which scored 4.5 regardless of whether the penguin was present or not. However, the penguins had a marked impact on kids’ taste preferences for Sugar Bits. For this brand, the taste score sans penguins was below 3, whereas it was over 4 if the cereal was delivered from a box featuring the friendly penguins.

Lead author Matthew Lapierre didn’t know for sure why this happened. “One of the explanations we’ve been working with is that kids grow up with this negative association with sugar,” he reasoned in an interview.

To support his hypothesis, Lapierre noted that many cereal brands have replaced the word “sugar” with other words that imply a somewhat healthier message. Sugar Smacks are now called  Honey Smacks, for example. Sugar Crisps are now sold as Golden Crisps.

If Lapierre is right, then these healthier messages have been internalized by kids to the point that they have negative perceptions of the word ‘sugar’ in the faux brand created by his group. (more…)


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How Obama Would Cut Medicare and Medicaid

April 14th, 2011 | 2 Comments | Source: MedPageToday, Washington Post

Yesterday, President Obama finally entered the debate about the national debt with a proposal to reduce US government borrowing by $4 trillion over the next 12 years. The proposal called for higher taxes on rich folks as well as deep cuts in military and domestic spending, including Medicare and Medicaid.

But unlike an earlier proposal by Representative Paul Ryan (R-Wisconsin), the Big O’s plan did not include making fundamental changes to the 2 US health entitlement programs, nor did it scale back the primary objective of the health reform law passed last year (the Affordable Care Act, or ACA), which is to provide health-care coverage for millions of uninsured Americans.

“We don’t have to choose between a future of spiraling debt and one where we forfeit investments in our people and our country,” he said. “To meet our fiscal challenge, we will need to make reforms. We will all need to make sacrifices. But we do not have to sacrifice the America we believe in. And as long as I’m president, we won’t.”

Ryan’s plan calls for Medicare beneficiaries to select from a pool of private insurance programs, and for the feds to pay a fixed amount of premium funds to the insurer chosen by each beneficiary. Additional costs would have to be borne by the beneficiary.

The president’s plan calls for $480 billion in cuts to Medicare and Medicaid by 2023, and a beefed-up role for the Independent Payment Advisory Board (IPAB), the new independent panel formed by the ACA as a watchdog against health cost escalations.

Responding to the Ryan proposal, Obama said, “Let me be absolutely clear: I will preserve these healthcare programs as a promise we make to each other in this society. I will not allow Medicare to become a voucher program that leaves seniors at the mercy of the insurance industry, with a shrinking benefit to pay for rising costs.”

The cornerstone of Obama’s proposal was a provision that empowers the IPAB to make cost reduction recommendations to Congress in the event that Medicare costs grow faster than the per-capita Gross Domestic Product plus 1%. The provision requires that these recommendations must not impede beneficiaries’ access to appropriate services. Now, Congress wouldn’t have to follow the advice from the IPAB. It could institute its own solution so long as it achieved the target reductions. In the event that Congress failed to act however, the Secretary of HHS would be required to develop and implement a plan that hit the target. (more…)



Designing a Health app that Works

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

As the mobile health apps market explodes, health consumers have been inundated with thousands of tools purporting to help them count calories, track work-outs, control diabetes, quit smoking and so forth.

There are nearly 8,000 health-related apps in the iTunes library alone. Of these, about 60% focus on diet, 20% on exercise, 9% on resistance training and 7% on improving sleep. Although the iTunes app store doesn’t publish download counts, the top free health-related app on the Android Market—an exercise monitoring device known as CardioTracker—has been downloaded between 1 million and 5 million times.

With this panoply of new resources a few clicks away, people have begun to wonder, “Do they actually improve health?”

Perhaps not, sadly. At least not yet. For example, a recent study by mobile health app analyst Pamela Culver revealed that a whopping 26% of people who downloaded a health-related app used it just once (in fairness, many of them probably moved-on to another app). Meanwhile, another study revealed that one-third of those who use health apps do not use them as their developers intended. 

Aside from the fact that many health-related apps are as visually appealing as a 1987 version of Super Mario Brothers, there are 2 major reasons why these tools have yet to live-up to their promise. Let’s take a look at them:

Failure to Leverage Clinical Guidelines
A galling problem with many health-related apps is that they do not incorporate tried-and-true methods to positively impact the behavior they supposedly target.

A study by George Washington University professor Lorien Abroms and colleagues recently made this point in spades. Abroms’ team reviewed 47 quit smoking apps that were available through the iTunes library. The apps ranged in price from free to $9.99. Nearly a third of them amounted to calendars which counted days since, or days until a quit date. An equal number of apps functioned to calculate dollars saved or health benefits accrued by kicking the habit. The remainder were an unsavory mash-up of cigarette rationing tools, hypnosis tools and, vey is mir, “virtual cigarettes” that people are supposed to use to pretend they are smoking. (more…)


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Those Pesky Tension Headaches

April 12th, 2011 | 6 Comments | Source: Wall Street Journal

Tension headaches are a nearly universal affliction. They are characterized by dull, non-pulsatile discomfort on both sides of the temples and forehead. They typically last for 30-60 minutes, but they can go on for days. Tension headaches affect at least 40% of adults in any given year. Nearly 80% of adults have experienced at least one during the course of their lifetimes.

It’s amazing therefore, that scientists don’t yet understand what causes them.


To be sure, scientists and those who’ve experienced tension headaches know when they tend to occur and what things trigger them.

Tension headaches occur most commonly in the early morning and late afternoon. The morning variety is often triggered by lack of sleep, awkward sleeping positions, hangovers and caffeine withdrawal.

Afternoon tension headaches are triggered by poor posture or airborne irritants in the office, eyestrain from looking at a computer screen all day, teeth grinding, and plain-old everyday stress (see YouTube video, above). The hypoglycemia associated with missed lunches is another culprit, as is excessive caffeine intake.

But What Causes Them?
This is what scientists don’t yet understand. For years, the prevailing theory was that muscle tension, especially in the neck and shoulders, caused tension headaches. That theory has been disproven by studies in which tools that measure muscle contractions revealed no correlation between muscle tension and headaches.

Today, the prevailing belief is that the tension-type headache is caused by abnormalities in parts of the brain that perceive pain. These poorly understood abnormalities render the brain hypersensitive to the inputs it receives (similar mechanisms are also thought to be involved in fibromyalgia, a disorder characterized by diffuse bodily sensations of pain).

Typically, tension headaches sufferers just “bear with them” until they subside, or use OTC pain killers like aspirin, acetaminophen and ibuprofen for quick relief. These drugs usually work, but taking them more than 10 days per month can precipitate so-called “rebound” or “medication-overuse” headaches, which feel like the tension headaches they’re supposed to treat. (more…)


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The Sleepy American

April 11th, 2011 | No Comments | Source: ABC News, CBS News, CDC

Sleep deprivation has been linked to motor vehicle accidents, industrial accidents and medical errors. It has also been linked to obesity, diabetes, hypertension, depression, anxiety, reduced problem-solving capacity, memory lapses, an increased risk for the common cold and even premature death.

Recent data published in the CDC’s Morbidity and Mortality Weekly Report, while not cutting new ground in this area, has helped to quantify the extent of the problem among Americans, as well as its impact on car crashes. The news is not good.

According to the CDC report, between 50 and 70 million US adults suffer from chronic sleep deprivation and related disorders. Those estimates came from a study which found that 35% the nearly 75,000 adult participants in a 12-state sleep study reported getting less than 7 hours of sleep per night. Nearly 40% of these people claimed to doze off inadvertently at least once a day.

Furthermore, people who averaged less than 7 hours were more likely to nod-off while driving a car. Overall, nearly 5% of respondents said they had fallen asleep while driving during the last year. According to the CDC, this phenomenon causes 1,550 highway deaths and 40,000 injuries per year.

The numbers are probably higher than this, according to Allan Pack, who directs the Center for Sleep at University of Pennsylvania. “Most of us believe that there are a lot more fall asleep crashes than reported,” he said in an interview. “It’s probably not reported accurately because a number of states don’t even having a ‘falling asleep while driving’ tick in the box when reporting a car crash.” (more…)



NSAIDs Linked to Erectile Dysfunction

April 8th, 2011 | 2 Comments | Source: BurrillReport, J. Urology, MedPageToday

The use of Motrin, Aleve and other non-steroidal anti-inflammatory drugs (NSAIDS) is associated with erectile dysfunction, according to a study by scientists affiliated with Kaiser Permanente.

The apparent link surprised the scientists. They had hypothesized that the commonly used pain-killers would actually reduce the risk of erectile dysfunction since NSAIDS protect against heart disease, which has in turn been linked to the troubling condition.

To reach their surprising conclusion, Steven Jacobsen and colleagues used data from Kaiser’s HealthConnect EHR, an associated pharmacy database, and self-reports about NSAID use and erectile dysfunction from an ethnically diverse population of 80,966 men between the ages of 45 and 69.

After controlling for age, ethnicity, race, body mass index, diabetes, smoking status, hypertension, high cholesterol and coronary artery disease, the scientists found that men who used NSAIDS at least 3 times per day for at least 3 months were 2.4 times more likely to experience erectile dysfunction than those who did not consume them on a regular basis. The link persisted across all age categories.

Remarkable in its own right was the finding that overall, 29% of the men in the study reported some level of erectile dysfunction.

The authors emphasized that their findings do not prove that NSAID use causes erectile dysfunction. For example, the study findings could have been confounded by factors not considered by the scientists (such as subclinical disease or the severity of the comorbid conditions that were studied), and the chance that NSAID use was actually an indicator for other conditions that caused erectile dysfunction.

In addition, the scientists recognized that their study had some limitations. These included an inability to temporally link NSAID use and the development of ED, and possible selection bias. (more…)



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