• What the Science Says About Long-Term Damage From Lead

    The following originally appeared on The Upshot (copyright 2016, The New York Times Company).

    Many eyes are now focused on Flint, Mich., where government failures have resulted in elevated lead levels in the city’s drinking water. But the effects on Flint’s residents, particularly its children, may not show up until long after the cameras have left town.

    Lead intoxication or poisoning is somewhat of a misnomer. The levels of lead in the water in Flint in the last year or so will probably not lead to many seizures, hospitalizations or medical events. But doctors still become alarmed when lead levels in the blood reach 5 micrograms per deciliter, or µg/dL.

    The percentage of children under age 5 in Flint with lead levels that high has been estimated to have doubled, from 2.4 percent to 4.9 percent, according to recently published work in the American Journal of Public Health. In the areas with the highest levels of lead, more than 10 percent of children have now had a blood lead level at least that high.

    Jessica Wolpaw Reyes, a leading expert on the effects of lead exposure in children, found that not only did elevated lead levels correspond to low achievement test scores in third and fourth grade, but also that communities where people managed to lower their lead levels in the 1990s saw increased scores in the 2000s.

    For every 1 percent increase in the proportion of children with a lead level above 10 µg/dL, the proportion of those achieving an unsatisfactory test score rose 0.2 percent.

    And for every 1 percent increase in the proportion of children with a lead level above 20 µg/dL, the proportion achieving an unsatisfactory test score rose 1 percent. In the absence of randomized controlled trials, which would be unethical, these studies are often the best available evidence to show what kind of causal effects lead can have on development.

    Even so, they’re not perfect. For a long time, research into the effects of lead was complicated by other factors. Some theorized that those people who clustered together in places where lead levels were high were different (i.e., more socioeconomically disadvantaged) in ways that accounted for the negative cognitive effects associated with higher blood lead levels.

    In the early 20th century, lead was so common in pipes that people’s exposure to it was related not to the quality of their housing but to the acidity of their water. More acidic water liberates more lead from pipes, solder, faucets and water heaters.

    Economists examined data on a cohort of more than 5,500 World War II soldiers who took the Army General Classification Test, used to assess the intellectual capacity of enlistees. They found that, after controlling for other factors, growing up in a city with water with a pH (a measure of acidity) of 5.5, versus a pH of 6.0, was associated with a five-point drop in the intelligence test. For those who were exposed to more acidic water, and therefore to more lead, there was an even greater negative effect.

    Blood lead levels don’t have to reach spectacularly high levels in children to have a detrimental effect. A study published in Pediatrics in 2013 examined more than 3,400 children in Rhode Island. Researchers found that while 32 percent of children with a low lead level in their blood (0 to 4 µg/dL) fell below the benchmark for reading readiness in kindergarten, 38 percent of those with a blood lead level of 5 to 9 µg/dL fell below it. More than half with a blood lead level of at least 10 µg/dL fell below it. These relationships held even after adjusting for demographic and socioeconomic factors.

    Similar work in Connecticut showed that even lead levels between 3 and 4 µg/dL are associated with reduced reading scores, and levels between 4 and 5 µg/dL are associated with reduced math scores. Levels as low as 4 µg/dL were linked to higher chances of being classified as learning disabled in elementary school.

    The damage associated with lead exposure goes far beyond schooling. In a paper published in Economic Inquiry last year, Ms. Reyes used data from the National Longitudinal Survey of Youth to examine the possible link between lead exposure in early childhood and later behavioral outcomes. She found that, even after controlling for other factors, high blood lead levels were associated with increased oppositional, hyperactive and bullying behaviors in children.

    Teenagers who had high lead levels in childhood were more likely to have had sex by 13, be pregnant by age 17 and smoke or drink while in their early teens. There is even some evidence of a connection to crime.

    We no longer allow leaded gasoline, and we no longer allow lead in our paint. But there’s still a long way to go. It’s thought that between 3 million and 6 million miles of pipe leading from water mains to homes contain lead. If water isn’t treated properly, it can corrode those pipes enough to free up the lead. That’s what happened in Flint; it’s also what happened with the World War II enlistees. This problem is old, and it won’t be solved as long as those pipes remain in use.

    In Flint, the pipes will remain the main concern for some time. Ms. Reyes emailed me: “Once the lead has been mobilized from the pipes, it’s not so easy to put it back: Lead may continue leaching into the water for some time. Further, water filters have finite capacity, and filters dealing with heavily contaminated water may need to be changed more often than every three months.”

    Moreover, too much lead is still around in old paint in deteriorating housing. It’s still in the soil from when lead was commonly airborne from exhaust. Until we solve the lead problem for good, we may be condemning children to a lifetime of problems. Flint is just the latest example.

    @aaronecarroll

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  • AJMC: Medical management of pricey drugs

    This past fall, I participated in a series of discussions hosted by the American Journal of Managed Care about health reform and the changing health insurance and delivery landscape. The video below is one exchange from the series, focused on medical management of pricey drugs. One thing I say:

    You can’t just grant market exclusivity and say, “The price is whatever you guys want to charge.” That’s just not going to fly anymore.

    I was joined by

    • Leah Binder, President and CEO of The Leapfrog Group
    • Margaret O’Kane, President of the National Committee for Quality Assurance
    • Matt Salo, Executive Director of the National Association of Medicaid Directors
    • Dennis Scanlon (moderator), Professor of Health Policy and Administration and Director of the Center for Healthcare and Policy Research, College of Health and Human Development, The Pennsylvania State University

    I’ll post other videos from the discussion series, but if you can’t wait, you’ll find more here.

    @afrakt

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  • Healthcare Triage: Booze Isn’t All Bad

    While we have discussed the dangerous effects of alcohol abuse and misuse, that doesn’t mean it’s always bad. Besides being part of many complex and delicious beverages, there are any number of studies which show that alcohol is linked to health benefits.

    That doesn’t mean it’s all good news, either, or that the evidence is a slam dunk. There’s certainly enough, though, to warrant a thorough review. That’s the topic of this week’s Healthcare Triage.

    This was adapted from a column I wrote for the Upshot. Links to further reading and references can be found there.

    @aaronecarroll

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  • Sidelining all-payer claims databases

    As I wrote yesterday, SAMHSA has proposed a rule that’ll go far to relieve Austin’s and my concerns about counterproductive restrictions on research into substance use disorders. But the rule has at least one glaring problem. As written, it would make the all-payer claims databases (APCDs) that now exist in about sixteen states all but useless when it comes to figuring out how to help those who struggle with addiction.

    Under the proposed rule, researchers can get patient identifying data about substance use disorders from anyone who’s a “lawful holder” of such data, subject to a whole bunch of rules to protect patient privacy. In SAMHSA’s view, a “lawful holder” is someone who receives identifiable data “as the result of a … patient consent … or as a result of one of the limited exceptions to the consent requirements specified in the regulations.”

    The problem is that APCDs don’t appear to be lawful holders. To my knowledge, patients don’t consent to sharing data on substance use disorders with APCDs. Nor is there an exception in the federal privacy rules that would enable such data sharing. State laws that try to require payers to disclose that information to APCDs would, I think, be preempted.

    Under the rule, then, APCDs will be ineligible to receive identifiable data on substance use disorders. That’ll blow an enormous hole in the databases. (Although it may not matter much: the Supreme Court is considering a case that could blow an even bigger hole in them.) APCDs in Massachusetts, Vermont, and New Hampshire, for example, will be scrubbed of data pertaining to the heroin epidemic. That’s completely loony.

    I’m not sure SAMHSA appreciates the problem. The proposed rule says nothing about APCDs. It’s as if they didn’t exist.

    That’s weird. As third party payers, state Medicaid agencies already hold substance use claims. Indeed, because they’re lawful holders, they can share their claims data with researchers. SAMHSA has even said that it’s open to letting state databases link identifiable data for researchers.

    If we trust state Medicaid agencies to compile and share addiction-related claims, why not trust APCDs to do the same? APCDs are unique among data sets because they offer a comprehensive view of a state’s health-care system—and they were designed in large part to facilitate research. If their security procedures are up to snuff, I don’t see the case for preventing them from doing their jobs.

    From my perspective, the best result would be for SAMHSA to clarify in the final rule (1) that APCDs are eligible to receive data on substance use disorders if they have adequate privacy protections in place and (2) that APCDs are “lawful holders” and can thus share such data with qualified researchers where appropriate.

    But the agency won’t do any of that unless APCDs and the research community make the case. SAMHSA is taking comments until April 1. Let’s not squander the opportunity.

    @nicholas_bagley

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  • Women, children, and drinking: The double standard

    The Centers for Disease Control has a new public health campaign with the message that sexually active women who are not using birth control should stop drinking. The goal is to prevent Fetal Alcohol Spectrum Disorder. I agree with Aaron that the CDC is pursuing an important goal, but their messaging has many problems. What puzzles me most is that the message is only for women, because children can be harmed in many ways by their father’s drinking.

    There is good evidence a father’s exposure to alcohol before conception can harm children. In a 2015 review, Fingeresh and his colleagues report that

    In humans, several groups have now shown that children of fathers with AUD [Alcohol Use Disorder] have higher risk for psychosocial abnormalities, including increased risk for psychiatric disorders…, decreased performance on measures of intelligence…, personality changes…, and increased incidence of attention-deficit hyperactivity disorder (ADHD)… Some of these effects are specific to fathers who had active AUD compared to those who were in remission.

    Of course, there are many confounding factors in these studies that make it hard to say whether it’s the actual consumption of alcohol by the dads that causes these problems. But there is also an experimental literature in which randomly selected rats are dosed with alcohol and then mated.

    Rodent studies provide clearer evidence for transmission of acquired effects of ethanol, since sires do not contribute to offspring rearing and isogenic strains minimize potential genetic effects… Several groups have found that paternal ethanol induces physiologic abnormalities in offspring in the absence of maternal ethanol exposure, including low birth weight…, increased number of runts…, altered organ weights…, thickening of layers of the cerebral cortex…, and low testosterone levels. Several behavioral abnormalities have also been noted, including decreased spatiotemporal learning…, decreased novelty seeking behavior.., increased immobility…, increased anxiety- and impulsivity-like behaviors.

    Do we know how much alcohol a father has to drink to put his child at risk? I doubt it, but of course the same is true for the child’s mother.

    Moreover, paternal drinking post-conception and post-partum poses many risks to children. Unintentional injuries are the leading cause of death for children from their first birthday on. Many of these are car accidents. Men have substantially higher rates of fatal accidents then women, both in terms of deaths per 100,000 population and deaths per 100 million miles driven. In 2013, 38% of male drivers who died in accidents had blood alcohol levels higher than 0.8%, compared to only 21% of female drivers. I don’t have data on children who died in accidents in which a drunk father was driving, but it’s not a great stretch to infer that their father’s drinking puts them at risk.

    One of the primary psychological effects of alcohol is disinhibition, which is wonderful for romance, but it also means that alcohol consumption increases the risk of violence. Men (and women) who drink are more likely to abuse children and to be involved in intimate partner violence, exposure to which harms children.

    Both drinking per se and high volume drinking are more prevalent among men, across cultures. It’s strange, then, that discussion of parental alcohol consumption and risks to children is focused so often on women. Does the CDC have a campaign with the message, “You’re a dad now. Time to think about your drinking, for the sake of your kids.”? Or, “If you’ve had a drink, here’s another reason to wear a condom.” (Or even, “She’s had a drink. You really, really, ought to put on a condom.”) If the CDC doesn’t have these campaigns, they should.

    Women and men ought to think about children when they make lifestyle choices. Unfortunately, the world seems to believe that worrying about risks to children is women’s work.

    @Bill_Gardner

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  • Healthcare Triage News: Texts for Meds, and Untreated Parental Depression Hurts Kids

    Text messaging improves medication adherence, and parental depression is bad for kids in so many ways. This is Healthcare Triage News.

    For those of you who want to read more:

    @aaronecarroll

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  • 4th Annual International Children’s Health Services Research Symposium

    pic-downtown-indyAre you interested in Children’s Health Services Research? Please join us for the 4th Annual International Children’s Health Services Research Symposium in Indianapolis, Indiana on April 18-20, 2016! This symposium brings together pediatric health services researchers and fellows from across the country and the world for a series of talks by luminaries in the field, as well as new talent, in a forum that emphasizes lots of time for conversation and networking. This year’s topic is Pediatric-focused health information technology

    The CHSR symposium will take place over and two and a half day period and will include poster presentations, breakout sessions to assist with career development, and more. It will be held at the Health Information and Translational Sciences Building at Indiana University School of Medicine, located on the downtown Indianapolis canal.

    In addition to the regular sessions we will have Special Interest Group dinners on the first night hosted by faculty members at Indiana University School of Medicine and a gala event at the Indiana State Museum on the second night.

    The event is limited to 100 people. You can be one of them!!!

    You can check out the final schedule here.

    @aaronecarroll

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  • A victory for research—and a question

    On Friday, SAMHSA released a long-awaited proposed rule that would, among other things, restore research access to Medicare and Medicaid claims involving substance use disorders. I’m still digging into the rule, and I’ve got a big question I can’t nail down to my satisfaction. But I think the rule looks pretty darn good. If it’s adopted, it should bring a victorious end to Austin’s and my long-running campaign to get SAMHSA to rethink its policy.

    What SAMHSA’s proposing is an overhaul of the federal regulation governing research disclosures of substance use-related medical claims for identifiable patients. Before, only providers could legally share that kind of data with researchers. Now, anyone who is a “lawful holder” of data on substance use disorders can do so. Those lawful holders include third-party payers—not only Medicare and Medicaid, but also private employers and private insurers.

    Such disclosures won’t go unregulated. Patient privacy is still a paramount concern. But in an especially elegant move, SAMHSA has decided that the existing rules governing human-subjects research do enough to protect patient privacy. Although researchers will have to get a HIPAA waiver and adhere to the Common Rule, they can do both by securing IRB approval for their research. Researchers already get such approval as a matter of course.

    On top of that, researchers must commit to resisting any efforts to subpoena the sensitive information that’s shared with them. They can’t disclose it to anyone else. They have to report their research in a manner that doesn’t compromise patient privacy. And they’ve got to take good care of the data. Those are essentially the same (completely reasonable) restrictions that researchers worked under before.

    That’s all good news. Here’s my question. The rule contains this funny provision on “data linkages.” The issue arises because researchers typically need to link several datasets together in order to get a full picture of the care that members of a given population receive. If you only look at Medicaid data, for example, you’d miss the care that some of those patients receive through the VA system. To make the necessary linkages, researchers need patient-identifying information.

    So far as I can tell, the rule would allow researchers to perform their own data linkages with raw Medicare and Medicaid data—the same thing they were doing before the unannounced data-scrubbing began. If that’s right, you’ll get no argument from me. SAMHSA should get a big round of applause.

    But the rule also sets out guidelines for any researcher “[t]hat requests linkages to data sets from a federal data repository(-ies) holding patient identifying information.” As SAMHSA explains, this would

    allow a researcher to disclose patient identifying information to a federal data repository and permit the federal data repository to link the patient identifying information to data held by that repository and return the linked data file back to the researcher.

    That’s all fine and good if this is just an option for researchers. Most researchers, though, don’t want to outsource data linkages to the federal government. They want to link the data themselves. They’d be horrified if the only way to link data were to go hat in hand to an overtaxed CMS and beg it to do the linking. Delays would be interminable. The costs would be excessive. And mistakes would be inevitable. Honestly, I’d be surprised if CMS even wanted the job.

    Even so, I’m mildly nervous that SAMHSA believes that all data linkages have to go through the federal government. To be clear, that’s not the best reading of the rule. For one thing, the provision on data linkages applies only to those researchers that “request” a data link. For another, why authorize CMS to share personally identifiable data if researchers can’t use them to link datasets together? Linking is the entire point of identifiers. No need to link? No need to have them.

    But there’s a bit of ambiguity. If it can be cleared away, researchers should breathe a big sigh of relief. The rule doesn’t go as far as it might with respect to all-payer claims databases—I’ll have more to say on that soon. But the Medicare and Medicaid data upon which researchers depend will no longer be scrubbed of critical claims. When it comes to substance use disorders and associated afflictions, we won’t be flying blind anymore.

    @nicholas_bagley

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  • Interface issues

    Via Sampson:

    interface

    @afrakt

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  • Fixing the legislative fix

      0 comments

    In welcome news for researchers, Congress is considering a bill that would stop CMS from deleting claims pertaining to substance use disorders from Medicare and Medicaid data. But the bill isn’t perfect. Federal privacy rules don’t just apply to CMS. They also prevent private payers—think here of employers and insurers—from sharing their data. And the bill as written doesn’t fix that.

    That’s a big problem for the all-payer claims databases that have now been established in about sixteen states. To improve transparency and foster research, these databases are tasked with collecting claims data from public and private payers alike. The idea is to give state officials and researchers a comprehensive picture of what’s going on in the state’s health-care system.

    Taking their lead from CMS, private payers have begun withholding substance use data from these databases. The gaps in the data will impede the effectiveness of these new databases, a particular concern in those New England states that hope to use them to address the growing heroin epidemic.

    Austin and I have also learned that high-profile researchers lucky enough to work with private claims data have encountered obstacles to getting their hands on substance use data. Want to find out whether privately insured people shop around when they get treated for substance use disorders? Whether they’re more price-sensitive than when they’re seeking other kinds of treatments? Or whether HIV-positive employees stop taking their medication when prices go up? Forget about it.

    At the risk of pushing our luck, Austin and I wanted to offer some slightly amended statutory language that would more comprehensively fix the problem:

    In applying this section and part 2 of title 42 of the Code of Federal Regulations, the Secretary shall, by July 1, 2016, establish rules and regulations that will allow “third party payers,” as such term is defined under such part, to disclose patient identifying information to qualified researchers, subject to the privacy restrictions governing the disclosure of such information established in §2.52 of such part. In carrying out the previous sentence, the Secretary shall also, by not later than July 1, 2016:

    (1) establish rules and regulations enabling “third party payers” to share patient identifying information with federal and state officials for the purpose of creating and maintaining a database of health-care claims, and authorizing those state officials to share such data with qualified researchers, subject to the privacy restrictions under §2.52 of such part; and

    (2) restore access to qualified researchers of patient identifying information held by the Centers for Medicare & Medicaid Services for the programs under titles XVIII and XIX of the Social Security Act.

    If you’ve got suggestions for how to improve this language, let me know via twitter, email, or in the comments (which we’ll leave open for a week).

    @nicholas_bagley

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