• Healthcare Triage News: Another Year, Another Flu Shot

    The flu vaccine is tailored from year to year to match the current/expected strains. That means it’s sometimes a home run, and sometimes less of one. You, and your kids, should still get one every year

    @aaronecarroll

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  • Something Happened to U.S. Drug Spending in the 1990s

    The following originally appeared on The Upshot (copyright 2018, The New York Times Company). It also appeared on page B4 of the print edition on November 13, 2018Research for this piece was supported by the Laura and John Arnold Foundation.

    There was a time when America approximated other wealthy countries in drug spending. But in the late 1990s, U.S. spending took off. It tripled between 1997 and 2007, according to a study in Health Affairs.

    Then a slowdown lasted until about 2013, before spending shot up again. What explains these trends?

    By 2015, American annual spending on prescription drugs reached about $1,000 per person and 16.7 percent of overall personal health care spending. The Commonwealth Fund compared that level with that of nine other wealthy nations: Australia, Canada, France, Germany, the Netherlands, Norway, Sweden, Switzerland and Britain.

    Among those, Switzerland, second to the United States, was only at $783. Sweden was lowest, at $351. (It should be noted that relative to total health spending, American spending on drugs is consistent with that of other countries, reflecting the fact that we spend a lot more on other care, too.)

    Several factors could be at play in America’s spending surge. One is the total amount of prescription drugs used. But Americans do not take a lot more drugs than patients in other countries, as studiesdocument.

    In fact, when it comes to drugs primary care doctors typically prescribe — including medications for hypertension, high cholesterol, depression, gastrointestinal conditions and pain — a recent study in the journal Health Policy found that Americans use prescription drugs for 12 percent fewer days per year than their counterparts in other wealthy countries.

    Another potential explanation is that Americans take more expensive brand-name drugs than cheaper generics relative to their overseas counterparts. This doesn’t hold up either. We use a greater proportion of generic drugs here than most other countries — 84 percent of prescriptions are generic.

    Though Americans take a lower proportion of brand-name drugs, the prices of those drugs are a lot higher than in other countries. For many drugs, U.S. prices are twice those found in Canada, for example.

    Prices are a lot higher for brand-name drugs in the United States because we lack the widespread policies to limit drug prices that many other countries have.

    “Other countries decline to pay for a drug when the price is too high,” said Rachel Sachs, who studies drug pricing and regulation as an associate professor of law at Washington University in St. Louis. “The United States has been unwilling to do this.”

    For example, except in rare cases, Britain will pay for new drugs only when their effectiveness is high relative to their prices. German regulators may decline to reimburse a new drug at rates higher than those paid for older therapies, if they find that it offers no additional benefit. Some other nations base their prices on those charged in Britain, Germany or other countries, Ms. Sachs added.

    That, by and large, explains why we spend so much more on drugs in the United States than elsewhere. But what drove the change in the 1990s? One part of the explanation is that a record number of new drugs emerged in that decade.

    In particular, sales of costly new hypertension and cancer drugs took off in the 1990s. The number of drugs with sales that topped $1 billion increased to 52 in 2006 from six in 1997. The combination of few price controls and rapid growth of brand-name drugs increased American per capita pharmaceutical spending.

    “The scientific explosion of the 1970s and 1980s that allowed us to isolate the genetic basis of certain diseases opened a lot of therapeutic areas for new drugs,” said Aaron Kesselheim, an associate professor of medicine at Harvard Medical School.

    He pointed to other factors promoting the growth of drug spending in the 1990s, including increased advertising to physicians and consumers. Regulations on drug ads on TV were relaxed, which led to more advertising. More rapid F.D.A. approvals, fueled by new fees collected from pharmaceutical manufactures that began in 1992, also helped push new drugs to market.

    In addition, in the 1990s and through the mid-2000s, coverage for drugs (as well as for other health care) expanded through public programs. Expansions of Medicaid and the Children’s Health Insurance Program also coincided with increased drug spending. And Medicare adopted a universal prescription drug benefit in 2006. Studies have found that when the potential market for drugs grows, more drugs enter it.*

    In 2007, U.S. drug spending growth was the slowest since 1974. The slowdown in the mid-2000s can be explained by fewer F.D.A. approvals of blockbuster drugs. Annual F.D.A. approvals of new drugs fell from about 35 in the late 1990s and early 2000s to about 20 per year in 2005-07.

    In addition, the patents of many top-selling drugs (like Lipitor) expired, and as American prescription drug use tipped back toward generics, per capita spending leveled off.

    The spike starting in 2014 mirrors that of the 1990s. The arrival of expensive specialty drugs for hepatitis C, cystic fibrosis and other conditions fueled spending growth. Many of the new drugs are based on relatively recent advances in science, like the completion of the human genome project.

    “Many of the new agents are biologics,” said Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center. “These drugs have no meaningful competition, and therefore command very high prices.”

    A U.S. Department of Health and Human Services issue brief estimated that 30 percent of the rise in drug spending between 2000 and 2014 could be attributed to price increases or greater use of higher-priced drugs. Coverage expansions of the Affordable Care Act also contributed to increased drug spending. In addition, “there has been a lowering of approval standards,” Dr. Bach said. “So more of these new, expensive drugs are making it to market faster.”

    “As in the earlier run-up in drug spending, we’re largely uncritical of the price-value trade-off for drugs in the U.S.,” said Michelle Mello, a health law scholar at Stanford. “Though we pay high prices for some drugs of high value, we also pay high prices for drugs of little value. The U.S. stands virtually alone in this.”

    If the principal driver of higher American drug spending is higher pricing on new, blockbuster drugs, what does that bode for the future? “I suspect things will get worse before they get better,” Ms. Sachs said. The push for precision medicine — drugs made for smaller populations, including matching to specific genetic characteristics — may make drugs more effective, therefore harder to live without. That’s a recipe for higher prices.

    Democratic politicians have tended to be the ones advocating governmental policies to limit drug prices. But recently the Trump administration announced a Medicare drug pricing plan that seems to reflect growing comfort with how drug prices are established overseas, and there’s new optimism the two sides could work togetherafter the results of the midterms. Although the effectiveness of the plan remains unclear, it is clearly a response to public concern about drug prices and spending.

    CVS also recently announced it would devise employer drug plans that don’t include drugs with prices out of line with their effectiveness — something more common in other countries but unheard-of in the United States. Even if these efforts don’t take off rapidly, they are early signs that attitudes might be changing.

    * Not noted in the original piece, this reflects a tradeoff between revenue (or profit) that can be earned by drug manufacturers and pace of pharmaceutical innovation. If profits were to fall with price reductions, we should expect less innovation in the future.

    @afrakt

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  • Healthcare Triage: The Reality of Work Requirements for Medicaid

    We’ve spent the last few weeks talking work requirements for safety net programs, and it’s all been leading up to this: work requirements for Medicaid. By looking at the EITC and TANF, we learned some things. Can these lessons inform decisions about whether and how to implement work requirements for Medicaid? If so, how?

    Thanks as always to the Robert Wood Johnson Foundation for their support in the making of these videos.

    @aaronecarroll

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  • Peer Review: The Worst Way to Judge Research, Except for All the Others

    The following originally appeared on The Upshot (copyright 2018, The New York Times Company). 

    Even before the recent news that a group of researchers managed to get several ridiculous fake studies published in reputable academic journals, people have been aware of problems with peer review.

    Throwing out the system — which deems whether research is robust and worth being published — would do more harm than good. But it makes sense to be aware of peer review’s potential weaknesses.

    Reviewers may be overworked and underprepared. Although they’re experts in the subject they are reading about, they get no specific training to do peer review, and are rarely paid for it. With 2.5 million peer-reviewed papers published annually worldwide — and more that are reviewed but never published — it can be hard to find enough people to review all the work.

    There is evidence that reviewers are not always consistent. A 1982 paperdescribes a study in which two researchers selected 12 articles already accepted by highly regarded journals, swapped the real names and academic affiliations for false ones, and resubmitted the identical material to the same journals that had already accepted them in the previous 18 to 32 months. Only 8 percent of editors or reviewers noticed the duplication, and three papers were detected and pulled. Of the nine papers that continued through the review process, eight were turned down, with 89 percent of reviewers recommending rejection.

    Peer review may be inhibiting innovation. It takes significant reviewer agreement to have a paper accepted. One potential downside is that important research bucking a trend or overturning accepted wisdom may face challenges surviving peer review. In 2015, a study published in P.N.A.S. tracked more than 1,000 manuscripts submitted to three prestigious medical journals. Of the 808 that were published at some point, the 2 percent that were most frequently cited had been rejected by the journals.

    An even bigger issue is that peer review may be biased. Reviewers can usually see the names of the authors and their institutions, and multiple studies have shown that reviews preferentially accept or reject articles based on a number of demographic factors. In a study published in eLife last year, researchers created a database consisting of more than 9,000 editors, 43,000 reviewers and 126,000 authors whose work led to about 41,000 articles in 142 journals in a number of domains. They found that women made up only 26 percent of editors, 28 percent of reviewers and 37 percent of authors. Analyses showed that this was not because fewer women were available for each role.

    A similar study focusing on earth and space science journals found that women made up only about a quarter of first authors and about 20 percent of reviewers. They had higher acceptance rates than men, though.

    In 2012, the journal Nature undertook an internal review of its peer review process, finding balance in its editors and reporters but disparities elsewhere. In 2011, women made up only 14 percent of the more than 5,500 peer reviewers for papers. Only 18 percent of the 34 researchers profiled in 2011-12 were women, and only 19 percent of the articles written for the “Comment and World View” section were by women.

    It’s possible women declined opportunities to review, but studies have documented that male editors tend to favor male reviewers. This year, Nature reported that it had increased participation of women in the “Comment and World View” section to 34 percent, while the percent of reviewers had climbed only to 16 percent.

    Unesco estimates that women make up 29 percent of the worldwide science work force.

    But there are also data to support the value of peer review. A 1994 study, published in Annals of Internal Medicine, reviewed the quality of papers submitted to the journal before and after the peer review and editorial system. Researchers used a tool that assessed the manuscript’s quality on 34 items, and their work showed that all but one got better. The biggest improvements were in the discussion of a study’s limitations, its generalizations, its use of confidence intervals and the tone of the conclusions. Probably none of these would have occurred without the nudge of peer review.

    How then to improve the existing system?

    For starters, more formal training might improve quality and speed. Given how hard it is to recruit good reviewers, journal editors could consider better incentives, such as paying reviewers for their time. The unpaid costs of peer review were estimated at 1.9 billion pounds (almost $3.5 billion) in 2008. Or journals could offer, without promise of acceptance, quicker turnaround for a reviewer’s future papers. Academia might offer more formal recognition for review work as well.

    A number of journals have moved toward fully blinded reviews, in which reviewers don’t know the authors or institutions of papers they’re judging. This could eliminate some biases. It’s hard to do this, though, because papers often refer to prior work or to where the research occurred. It also doesn’t solve the relative lack of women in the editorial and review process in general.

    One way to detect problems with research earlier would be to let researchers post manuscripts online before submission, for public judgment before formal peer review. This is already common in some sciences, such as physics. Medical journals would probably resist this, however, because it could reduce their ability to get press and attention once the research was fully published.

    A significant improvement would require a change in attitude. Too often, we think that once a paper gets through peer review, it’s “truth.” We’d do better to accept that everything, even published research, needs to be reconsidered as new evidence comes to light, and subjected to more thorough post-publication review.

    As an author of papers, and as a writer who comments on papers in the news media, I’ve seen how the peer review process can fail. But I’m also an editor at the journal JAMA Pediatrics. There, as at many journals, a paper’s first gatekeeper is an editor. Those getting past that hurdle are sent out to a few experts in the field who are asked to read and offer their views to the editor. This informs what might happen next: acceptance, rejection or a chance to respond to reviewer comments before a decision is made.

    Each week we meet by teleconference to discuss papers we are considering for publication. We talk about the reviews, and ultimately decide what few studies make the cut. I’m always impressed by the quality of the discussion and the seriousness with which people take their charge. We also follow papers we turn down to see if we made mistakes in deciding to reject. We use that data to review and improve our process. I’m sure other journals do the same. And I’m sure we make our share of bad calls, as other journals do.

    Peer review is still better than the alternatives. It might make more sense, though, to see it (and publication) as steps on the road to assurance, not a final stamp of approval.

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  • The Trump administration targets the contraception mandate

    With the midterms out of the way, HHS has released two final rules affording employers wide leeway to opt out of the so-called contraception mandate. The first exempts employers with religious beliefs from the obligation to include contraception in the health insurance package they offer to their employees. The second does the same for employers with “moral convictions opposing services covered by the contraceptive mandate.”

    This isn’t the first time we’ve seen these rules. In October 2017, the Trump administration tried to put them into effect without offering any notice and comment. At the time, I argued that the rules were procedurally defective, and obviously so, because the administration had no good reason for skipping notice and comment. In the inevitable litigation that ensued, two district courts (here and here) agreed and put the rules on hold. The Trump appealed, and the cases are pending in front of the Fourth and Ninth Circuits.

    In the meantime, HHS took public comments. The final rules released yesterday include responses to those comments and vary slightly—but only slightly—from the original versions. In this long post, I’ll cover what they do, whether they’re legal, and what the Trump administration should’ve done instead.

    * * *

    Under the new rules, employers have three options. First, they can continue to adhere to the contraception mandate, as most will surely do. Second, they can use an Obama-era “accommodation” to omit contraception from their plan, but their insurer (or third-party administrator) will independently arrange to cover contraception. Think of this as a workaround that guarantees contraception coverage to employees while allowing employers to distance themselves from its provision. In 2015, it appears that just 63 employers invoked the accommodation.

    Third, employers can claim an outright exemption from the mandate for all or some forms of contraception. That’s a big change. Previously, only houses of worship could get an exemption. Now, any employer can. Even publicly traded companies can invoke a religious exemption (though they cannot get an exemption for moral, non-religious objections).

    It’s not clear how many employers will take advantage of either the accommodation or the newly expanded exemption. HHS estimates that perhaps 100 employers, covering roughly 2.4 million people, will invoke religious accommodation. Another 109 employers, representing 727,000 people, are expected to invoke the full-blown religious exemption. HHS estimates that only a trivial number will take advantage of the exemption for moral objections.

    I have no idea of those estimates are right, and HHS has an incentive to downplay the exemptions’ effects. Still, they sound plausible to me. The moral exemption appears to be crafted specifically to cover just two non-religious anti-abortion groups. Even for religious organizations, invoking the exemption will be controversial. The University of Notre Dame, for one high-profile example, has come under intense fire for circumscribing access to contraception coverage. Few employers, even those with sincere religious convictions, will want to pick that fight.

    But I can’t be sure about the numbers, and HHS can’t be sure either. No matter how you cut it, many thousands of women who work at some religious institutions—think in particular here of evangelical and Catholic universities, Catholic hospitals, Catholic schools—will no longer receive contraception coverage from their employers. They’ll have to buy it on their own.

    * * *

    Are the rules legal? Procedurally, HHS is on safer ground now that it’s walked through notice and comment. To be sure, the courts are sometimes nervous when agencies issue interim final rules and purport to conduct notice and comment after the fact. If a rule has already gone into effect, the courts ask, isn’t the notice-and-comment process a farce? Does the agency, at that stage, really have an open mind about the comments it receives?

    Those concerns will certainly be in play here. Oddly enough, though, the fact that the courts put the initial rules on hold will play into the Trump administration’s hands. Because the interim final rules weren’t allowed to take effect, they acted in practice like proposed rules. And there’s nothing anomalous about taking notice and comment on proposed rules. I’d expect the Trump administration to seek dismissal of the pending appeals on the ground that the existing injunctions, which ran against the interim final rules, no longer apply.

    * * *

    On the merits, HHS hasn’t put its best foot forward. For both rules, HHS argues that it’s allowed, under section 2713(a)(4) of the Public Health Service Act, to offer whatever exemptions it wishes to from the contraception mandate.

    Go read that provision, though. It doesn’t say anything of the kind. It says, instead, that employers and insurers “shall, at a minimum provide coverage for and shall not impose any cost sharing requirements for [certain forms of preventive care] and … with respect to women, such additional preventive care and screenings as provided for in comprehensive guidelines supported by the Health Resources and Services Administration,” which is an HHS subagency.

    Simple, right? In the Obama administration, HRSA said that contraception was a qualifying preventive service. So contraception has to be covered without cost-sharing, unless and until HRSA decides that contraception isn’t a preventive service.

    HHS sees matters differently. Its entire argument hinges on a single word: “as.”

    Through use of the word “as” in the phrase “as provided for,” [the provision] requires that HRSA support how those services apply—that is, the manner in which the support will happen, such as in the phrase “as you like it.” When Congress means to require certain activities to occur in a certain manner, instead of simply authorizing the agency to decide the manner in which they will occur, Congress knows how to do so. Thus, the inclusion of “as” … , and its absence in similar neighboring provisions, shows that HRSA has been granted discretion in supporting how the preventive coverage mandate applies—it does not refer to the timing of the promulgation of the Guidelines.

    This is specious. The word “as” does not license HHS to adopt any and all limitations on the coverage of preventive services that it wishes. If it did, HHS would have the legal authority to say that preventive services are covered on Tuesdays, but not on Wednesdays, or to cover only those women whose last names start with Z.

    That’s not a tenable reading. By its terms, the statute requires coverage of the “additional preventive care and screenings” that HRSA selects from the broader universe of “care and screenings.” That limited charge makes sense: HRSA is a health agency, one that “work[s] to improve the health of needy people.” So it’s sensible that the statute allows HRSA to say what gets covered, not who has to cover it.

    To sharpen the point, consider the following statute: “All cars must have seatbelts that meet certain specifications, including any additional specifications as provided for in guidelines drafted by the Seatbelt Safety Administration.” If the Seatbelt Safety Administration exempted red cars from its guidelines, that wouldn’t plausibly be an exercise of its delegated authority to write safety guidelines. It would constitute a revision Congress’s judgment that “[a]ll cars”—red and blue and gray alike—must have safe seatbelts.

    Yet that’s exactly the argument that HHS is pushing. The agency saying that everyone who objects on religious or moral grounds—all those red cars—should be exempted. That’s a terrible argument, and I think it should fail.

    * * *

    HHS does have a better argument up its sleeve, at least for the rule about religious exemptions. (Nothing can save the misbegotten moral exemption rule.) There’s a deep question—one that I don’t pretend to know the answer to—about whether and to what extent agencies can invoke the Religious Freedom Restoration Act (RFRA) to tailor exemptions to statutes.

    RFRA says generally that the government can’t impose a substantial burden on a person religious exercise unless it’s got a good reason to do so. But RFRA contemplates that courts will grant relief for any violation, not agencies. It doesn’t purport to give agencies the open-ended power to craft exemptions based on the agencies’ sense of the depth of the religious objection and the substantiality of Congress’s interest in adopting the rule. Maybe that means that Congress hasn’t delegated that power to agencies at all.

    On the other hand, RFRA says that any statutes that Congress adopts are “subject” to RFRA “unless such law explicitly excludes such application.” So maybe the Affordable Care Act should be understood to contain within it a silent proviso: agencies must faithfully implement the law as written, except to the extent that doing so would conflict with RFRA. That kind of argument explains why the Obama administration could offer an exemption to houses of worship in the first place. Maybe it’s also why the Trump administration, with a different view about how to strike the right balance between governmental objectives and religious exercise, has the power to put that exemption on steroids.

    But that view, which HHS is pushing hard, also raises some tough questions. What if the courts, for example, take a narrower view of what RFRA requires than the agency does? Should the agency’s views or the court’s prevail? If there’s a clean doctrinal answer to whether RFRA affords agencies the power to exempt private parties from generally applicable statutes, I’m unaware of it. My suspicion is that we’re in for some very interesting litigation.

    * * *

    One last point. Nothing in the ACA itself requires employers to cover contraception. The statute says only that employers have to cover those preventive services for women that are listed in HRSA guidelines.

    There are all sorts of good reasons that the Obama-era HRSA listed contraception. Among other things, contraception allows women to “avoid unwanted pregnancies and space their pregnancies to promote optimal birth outcomes.” There’s nonetheless a reasonable case to be made that contraception isn’t primarily aimed at avoiding future disability or disease, so it’s not really a preventive service. If that’s right, the Trump administration has the discretion to omit contraception from the guidelines altogether.

    So why monkey around with all these legally dubious exemptions? Given the Trump administration’s apparent commitment to bulldozing the contraception mandate, I remain baffled why it hasn’t adopted an approach that presents fewer legal pitfalls.

    @nicholas_bagley

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  • Healthcare Triage News: Election Results Impact the ACA, Medicaid Expansion, and Marijuana

    Yesterday’s election results have a lot of impact on health care in the United States. The new Democratic House of Representatives and the ACA, expansion of Medicaid in red states, and medical and recreational marijuana are all affected by last nights returns.

    @aaronecarroll

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  • Healthcare Triage: TANF, Cash Assistance, and How Work Requirements Effect Poverty Relief

    In the next year and a half, we here at Healthcare Triage are going to take some deep dives into issues of health policy, especially those that touch on social determinants of health and health equity. The episodes that do so will be a bit longer than usual. They’ll look a little different. They also come to you thanks to the support of the RWJF, which has generously supported their creation. We’re excited about this opportunity to really dig in, and we hope you will be, too.

    Last week we talked about different ways to promote work in safety net programs: incentives or carrots, like the Earned Income Tax Credit and disincentives or sticks like work requirements. Policy makers have tried out work requirements in a number of programs, thinking that they might lead to reduced poverty and reduced government spending. How did that go? Answering that question might inform our current policy arguments, like work requirements for Medicaid. Let’s delve into the research.

    @aaronecarroll

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  • Come hear the Mystic Brass Ensemble

    I’m one of seven trumpets (as well as other brass instruments and percussion) playing in the Mystic Brass Ensemble on Sunday, November 11 at 3PM at the First Baptist Church of Arlington (819 Mass. Ave., Arlington, MA). Come hear us! The concert is free, though donations are welcome.

    Below is the line up of music, with links to others playing the pieces. The first half of Renaissance music will be antiphonal. That means half our group will be in a choir loft at the front of the church, the other half about 100 feet away in an even higher choir loft at the back of the church. How do we coordinate across this massive distance and still sound amazing? Come and find out!

    Once we tire of dazzling you with antiphonal play, we’ll gather up front for the second half for modern pieces. It’ll be heroic and inspiring, because we’re brass (plus percussion).

    If you come, please stop by to say hello.

    Program

    I. The Renaissance

    Monteverdi: Toccata from L’Orfeo (as played by Concentus Musicus Wien)

    Gabrieli: Canzon Duodecimi Toni (as played by the Empire Brass)

    Gabrieli: Canzon Primi Toni (as played by the Philadelphia and Cleveland Brass Ensembles)

    Gabrieli: Canzon Octavi Toni (as played by the Philadelphia and Cleveland Brass Ensembles)

    Gabrieli: Canzon Septimi Toni No. 2 (as played by the Philadelphia and Cleveland Brass Ensembles)

    II. The Modern

    Copland: Fanfare for the Common Man (as played by the New York Philharmonic)

    Hindemith: Morgenmusik (as played by the Chicago Symphony Brass Ensemble)

    Ewazen: I. Andante, Allegro from Symphony in Brass (as played by Summit Brass)

    Higgins: Colorado Fanfare (no recording available)

    @afrakt

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  • Healthcare Triage News: Women on Web Move to Increase Access to Abortion Pills in the US

    Women on Web is an organization that increases access to pharmaceutical abortion services in countries where those options are limited. The organization has now started a separate service that will fill prescriptions in the United States to replace access in states that have made access to abortion difficult. Healthcare Triage talks through the details.

    I mention it in the video, and we link to it in the description, but you should also read Olga Khazan’s coverage of this at The Atlantic.

    @aaronecarroll

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  • Healthcare Triage Podcast: Of Zebrafish and Diabetes

    The next episode of the Healthcare Triage Podcast is up!

    November is National Diabetes Month, and this month Dr. Aaron Carroll, is talking to Dr. Raghu Mirmira. Dr. Mirmira is the Eli Lilly Professor in Pediatric Diabetes and Director of the Diabetes Research Center at Indiana University Health in Indianapolis, IN. You’ll learn about Type I and Type II diabetes, and the ways people develop the disease.

    The Healthcare Triage podcast is sponsored by Indiana University School of Medicine whose mission is to advance health in the state of Indiana and beyond by promoting innovation and excellence in education, research and patient care.

    IU School of Medicine is leading Indiana University’s first grand challenge, the Precision Health Initiative, with bold goals to cure multiple myeloma, triple negative breast cancer and childhood sarcoma and prevent type 2 diabetes and Alzheimer’s disease.

    As always, you can find the podcast in all the usual places, like iTunes and Soundcloud.

    @aaronecarroll

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