• Help me learn new things in 2018 – The Fall of Rome/The Dark Ages!

    This post is part of a series in which I’m dedicating a month to learning about periods in history this year. The full schedule can be found here. This is month two. (tl;dr at the bottom of this post)

    Let’s get one thing out of the way, first. It seems like the phrase “The Dark Ages” has fallen out of style. I, having finished high school in the long ago, was unaware of this. I won’t be using it the rest of this post.

    This time period covers an ENORMOUS length of time. It’s almost unfathomable. Still – the Roman Empire managed to hold on in various forms throughout this period. It seems like a long time ago, but the staying power is almost too big to comprehend.

    I’m grateful to readers who suggested I not just focus on Western Europe for this month. While the empire seemed to collapse into chaos and barbarians more quickly in the West, forming totally new countries, things were very different in the East.

    The first book I read was The Fall of the Roman Empire: A New History of Rome and the Barbarians by Peter Heather. A variety of theories exist as to who the Roman Empire collapsed. Some think that corruption took it apart from within. Others think that it became too big to be sustainable. Heather argues it was the barbarians. He shows how the Huns started interfering with the somewhat fragile balance of power in Western Rome, which forced many goths to move into the Empire as refugees. It wasn’t easy to absorb them. The Romans tried to regain control, and it didn’t go well. They lost to the Goths at Hadrianople (something almost unthinkable at the time), and they were sacking Rome thirty years later. The Vandals went after western Europe, and then North Africa. This was critically important (and something I never understood). The Western Roman Empire was hugely dependent on Northern Africa for its food. It’s like the United States’s Midwest. It was the farmland, and in the mid-fifth century, the Romans lost it.

    The Huns used a different battle tactic than any others the Romans faced before. They fought on horseback, with a whole different type of bow, and they were perfectly suited to destroy an otherwise unbeatable Roman army. Why they came out of the Steppes of Eastern Europe isn’t totally understood, but they did, and they crushed everyone. By the time Atilla arrived, they were destroying armies from France all the way back to Eastern Rome. Ironically, when Atilla died, it likely hastened the collapse of the Roman Empire. Everyone took advantage of the situation, and the Vandals wound up defeating the Byzantine Armada in a tragic battle that pretty much ended the Western Empire. The Eastern Empire, on the other hand, went on for a long, long time.

    As a contrast, consider How Rome Fell: Death of a Superpower by Adrian Goldsworthy. He argues that Rome collapsed from within. His book begins with Marcus Aurelius (who is basically the Emperor who dies at the beginning of the movie Gladiator). At that time, the Emperor ruled, but still relied pretty heavily on the Senate to back him up and implement his will (and army). But the system had a big flaw – the Emperor chose his successor, often from his family, and always with the military behind him.

    His son Commodus (the bad guy played by Joaquin Phoenix in Gladiator) wasn’t so good, and things went South. He was assassinated, and the military sort of took over. Over the next century or so, most Emperors only made it a few years before being assassinated, overthrown, or killed. Emperors were popping up all over, wherever an army chose a new one, and they’d fight with each other. Eventually, things quieted down; but it was too late.

    The new Emperors had to rely on a growing bureaucracy to rule the empire. Corruption was inevitable. The smaller Senate might have been able to hold together a national sense of purpose, but local rulers in the far reaches of the Empire didn’t share this feeling. Mistrust became common, as did fear of losing power. Emperors began to travel extensively to control the Empire, and, of course, they could not.

    Barbara Tuchman’s A Distant Mirror: The Calamitous 14th Century was completely different. She followed the life of a reasonable high level French noble to give a flavor of how life and politics changed for France in the 1300’s. That time was pretty much a disaster. We begin with the plague, which killed like a quarter of all people. So… not a good start. Then, we see how chivalry ruined everything further. A desire to achieve valor on the battlefield led to a number of unbelievable military disasters (including Crecy, which I was aware of thanks to Warren Ellis’s Crecy, a brilliant graphic novel that covered the battle from the English side.) The Hundred Years War was as much the fault of the French nobility as anything else.

    Her main character – Enguerrand de Coucy serves as sort of a “Forrest Gump” to be there for all the momentous occurances. It works. The book is well written, and it makes me glad I wasn’t there. Lots of treason and lots of popes. Utter chaos. It seemed like half the rules were mad, likely from inbreeding.

    Finally, The Fate of Rome: Climate, Disease, and the End of an Empire by Kyle Harper has a whole other hypothesis: climate change. I kid you not. Using all kinds of bone records and such, he makes a case that the Empire really did well in the first two centuries because it was warm, wet, and there were few pandemics. Things changed after that. Disease, in the form of plagues, had a huge impact. So did the temperature in general. People have wondered for a long time what brought the Huns out of the Steppes, and this is as good an argument as any. It’s also possible that there’s a dual cause things going on. Perhaps Rome at its peak was more able to withstand external climate change, but once it was weakened, these changes pushed it over the edge. He notes four main turns: (1) Pandemics during the age of Marcus Aurelius, (2) Drought, pestilence, and political change in the middle of the third century, (3) The Huns coming out of the Steppes, and (4) Bubonic plague coupled with a small ice age.

    Harper writes well, and I thought his book was constructed a bit more for the lay reader. Take that or leave it.

    All of this was fascinating, but I’m ready for something completely different. Bring on the American Revolution!

    tl;dr: If you want to read three different theories on why Rome fell, there are three books you can try. The Fall of the Roman Empire: A New History of Rome and the Barbarians argues it was external forces,  How Rome Fell: Death of a Superpower argues it died from within, and  The Fate of Rome: Climate, Disease, and the End of an Empire argues it was climate change. All are good.

    @aaronecarroll

     

     
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  • Help me learn new things in 2018 – The Revolutionary War! (What should I read?)

    I’m going to spend April learning about the history of The Revolutionary War. You’ve already given me some great ideas. I want to post them here, so you can help me prioritize what to read. If you think I’m missing something, please tell me. I’m opening comments, or you can tweet me.

    1. Whirlwind: The American Revolution and the War That Won It by John Ferling
    2. John Adams by David McCullough
    3. 1776 by David McCullough
    4. American Revolutions: a Continental History by Alan Taylor
    5. American Colonies: The Settling of North America by Alan Taylor
    6. Angel in the Whirlwind: The Triumph of the American Revolution by Benson Bobrick

    What do you all think? Any thoughts on the order?

    @aaronecarroll

     
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  • What We Know (and Don’t Know) About How to Lose Weight

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

    The endless array of diets that claim to help you shed pounds tend to fall into two camps: low fat or low carbohydrate. Some companies even claim that genetics can tell us which diet is better for which people.

    A rigorous recent study sought to settle the debate, and it had results to disappoint both camps. On the hopeful side, as The New York Times noted, people managed to lose weight no matter which of the two diets they followed.

    The study is worth a closer look to see what it did and did not prove.

    Researchers at Stanford University took more than 600 people (which is huge for a nutrition study) aged 18 to 50 who had a body mass index of 28 to 40 (25-30 is overweight, and 30 and over is obese). The study subjects had to be otherwise healthy. They couldn’t even be on statins, or drugs for Type 2 diabetes or hypertension, which might affect weight or energy expenditure. They were all randomly assigned to a healthful low-fat or a healthful low-carbohydrate diet, and they were clearly not blinded to which group they were in.

    All participants attended 22 instructional sessions over one year in groups of about 17 people. The sessions were held weekly at first and were then spaced out so that they were monthly in the last six months. Everyone was encouraged to reduce intake of the avoided nutrient to 20 grams per day over the first eight weeks, then participants slowly added fats or carbohydrates back to their diets until they reached the lowest level of intake they believed could be sustained for the long haul.

    Everyone was followed for a year (which is an eternity for a nutrition study). Everyone was encouraged to maximize vegetable intake; to minimize added sugar, refined flour and trans fat intake; and to focus on whole foods that were minimally processed. The subjects were also encouraged to cook at home as much as possible.

    All the participants took a glucose tolerance test as a measurement of insulin sensitivity. Some believe that insulin resistance or sensitivity may affect not only how people respond to diets, but also how well they adhere to them. The participants were also genotyped, because some believe that certain genes will make people more sensitive to carbohydrates or fat with respect to weight gain. About 40 percent of participants had a low-fat genotype, and 30 percent had a low-carbohydrate genotype.

    Data were gathered at the beginning of the study, at six months and at one year. At three unannounced times, researchers checked on patients to see how closely they were sticking to the instructions.

    This was a phenomenally well-designed trial.

    People did change their diets according to their group assignment. Those in the low-fat group consumed, on average, 29 percent of their calories from fats, versus 45 percent in the low-carbohydrate group. Those in the low-carbohydrate group consumed 30 percent of their calories from carbohydrates, versus 48 percent in the low-fat group.

    They did not, however, lose meaningfully different amounts of weight. At 12 months, the low-carbohydrate group had lost, on average, just over 13 pounds, compared with more than 11.5 pounds in the low-fat group. The difference was not statistically significant.

     
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  • Healthcare Triage News: Yellow Fever, Theranos, and Low Nicotine Cigarettes

    On this Healthcare Triage News, we’re talking about an outbreak of Yellow Fever in South America, and why there aren’t enough doses of the highly effective vaccine on the market. We’ll also look at developments in the huge and fascinating Theranos case, with all the fraudulent blood tests, and we’ll look at new, lower nicotine requirements for cigarettes.

    @aaronecarroll

     
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  • Healthcare Triage: Teeth Aren’t Just for Chewing. So Why Doesn’t Medicaid Cover Dental?

    Medicaid doesn’t cover dentistry. But dental health affects many different aspects of a person’s life. Bad teeth can cause social difficulty, and make it hard to find employment, aside from the fact that an unhealthy mouth can lead to or exacerbate many conditions.

    This video was adapted from a column Austin wrote for the Upshot. Links to further reading can be found there.

    @aaronecarroll

     
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  • JAMA Pediatrics Podcast: Learn about a new paper each week!

    As I mentioned in a previous post, I’m now the Web and Social Media Editor at JAMA Pediatrics. One of the new projects we’re starting THIS WEEK is a podcast where I discuss a paper form the journal. I’ll do my best to pick good ones. Usually, they will also be free to read – we’ll put them outside the firewall. That way, if you enjoy the podcast, you can also go read the paper.

    Please consider giving this a listen, and subscribe! Doing so makes it more likely that I’ll be able to keep doing this.

    This week, I’m covering “Vaccination Patterns in Children after Autism Spectrum Disorder Diagnosis and in their Younger Siblings”:

     
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  • A ‘right-to-try’ explainer

    Gilbert Benavidez is a Policy Analyst with Boston University’s School of Public Health. He tweets at @GBinsolidarityResearch for this piece was supported by the Laura and John Arnold Foundation.

    ‘Right-to-try’ legislation recently passed in the House after having previously passed in the Senate. The bills will now move on to a conference committee. If you haven’t been following the bills, this explainer will bring you up to speed.

    What is the ‘right-to-try’?

    Roughly speaking, the concept of ‘right-to-try’ is to increase access of terminally ill patients to experimental drugs or medical products. The legislative manifestation of this goal on the Federal stage has been toward the establishment of a means by which terminally ill patients could access experimental drugs (those that have passed Phase I of the Food and Drug Administration (FDA) clinical drug trial process) without getting FDA approval.

    The patient’s rights movement behind right-to-try is made up of multiple organizations, led largely by the Goldwater Institute, an Arizona-based conservative think tank. The Goldwater institute has spearheaded successful efforts to get state level legislation passed in 38 states. The right-to-try is also supported by the President.

    But, over 75 patient groups oppose the legislation, saying that it creates “false hope” and “…would cause serious harm to the most vulnerable patients.” Former FDA commissioners are also pushing back against the bill. For ease of exposition, I will use the term ‘triers’ for participants in this movement.

    What’s the landscape now?

    Currently, to access experimental treatments, patients can either enroll in clinical trials or seek ‘compassionate use’ exceptions from the FDA. Triers see the FDA requirements for compassionate use as red tape and that they seek to circumvent. Those requirements are:

    • The patient and a licensed physician are both willing to participate.
    • The patient’s physician determines that there is no comparable or satisfactory therapy available to diagnose, monitor, or treat the patient’s disease or condition.
    • The probable risk to the person from the experimental treatment is not greater than the probable risk from the disease or condition.
    • The FDA determines that there is sufficient evidence of the safety and effectiveness of the experimental treatment to support its use in the particular circumstance.
    • The FDA determines that providing the treatment will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval.
    • The sponsor (generally the company developing the investigational product for commercial use) or the clinical investigator (or the patient’s physician in the case of a single patient expanded access request) submits a treatment plan that is consistent with the FDA’s statute and applicable regulations.
    • The patient is otherwise unable to obtain the treatment or to participate in a clinical trial.

    Research by Jarow et al. shows that from 2005-2014, over 1000 compassionate use applications were received per year by the FDA’s Center for Drug Evaluation and Research. All but 0.3% of them were approved. In October 2017 the FDA made the process even easier. Now, use of the drug can go forward with approval from merely one Institutional Review Board (IRB) member at the prescribing physician’s facility, as opposed to approval from the entire IRB.

    What are the bills about?

    The House and Senate each passed their own, relatively similar, versions of the bill. Both bills would provide a pathway for patients to use experimental drugs outside of clinical trials and without going through the FDA compassionate use process. However, drug manufacturers, sponsors of clinical trials, prescribers, or hospitals could still deny use of experimental drugs. For simplicity, I’ll be focusing on the Senate bill for the remainder of this post, which passed in August of last year.

    Originally introduced in January 2017 by Wisconsin Senator Ron Johnson, the bill is intended to “authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law…”

    Two provisions of the bill are intended to get buy-in from drug manufactures and clinical trial sponsors. One is “Use of Clinical Outcomes,” which states that adverse outcomes (harmful side effects, death, etc.) cannot be used to delay or adversely affect the review or approval of drugs. Moreover, sponsors of clinical drug trials (almost always drug companies themselves) can request that the FDA use the clinical outcomes of triers in the review or approval of the drug. It is not clear in the bill text if such a request must be approved.

    The second is the “No liability” provision, which states that patients and their families must waive their right to sue sponsors of clinical drug trials, manufacturers, and/or prescribers. Patients and families are unable to sue if, for example, the drug kills the patient more quickly or more cruelly than the underlying disease would have.

    What’s controversial about the bill?

    There are many controversies, including undermining of the FDA and providing false hope to patients. I will discuss the three that most concern me.

    1. Patient safety. Clinical drug trials are overseen by the FDA and consist of four phases (three phases before the drug is released to market, and, in some cases, a fourth post-market phase, which is not always honored). If something terrible happens, trials in the first three phases can be shut down by the FDA. Under the legislation, triers use of an experimental medication would fall outside of FDA purview. As noted above, the Senate bill text states that adverse clinical outcomes cannot “delay or adversely affect the review or approval” of the drug in question. If something goes awry during compassionate use, the trial would not necessarily be stopped.

    2. Patient rights. As noted above, in the current Senate bill text, liability of sponsors, manufacturers, and prescribers is waived. Patients and their families effectively waive their right to sue for damages, unless there is evidence of fraud, misrepresentation, or willful misconduct. As Resnik and Parasidis noted in 2013 in the Journal of Medical Ethics,

    The US federal research regulations prohibit informed consent, whether written or oral, from including provisions in which human subjects (or their representatives) waive or appear to waive legal rights.

    The bill text here is antithetical to these regulations. The assumed retort is that compassionate use provides drugs to ‘patients’ not research subjects. That is, we are talking about treatment, not research. That leads directly to my last concern.

    3. Patient/research subject confusion. As noted above, the bill states that sponsors of clinical trials can request that the FDA use the triers’ clinical outcomes in the drug review and approval process. This further blurs the line between patient and research subject, akin to the ‘therapeutic illusion.’ As Annas writes, the therapeutic illusion occurs when

    research, designed to test a hypothesis for society, is confused with treatment, administered in the best interests of individual patients.

    The goal of research is generalizable knowledge through experimentation. Research subjects are not patients, though some of them mistakenly believe they are — that the research is being done for their own therapeutic benefit.

    The right-to-try bill seems to conflate patients and subjects in the following way. Presumably people administered drugs on a compassionate basis are patients. After all, they are not enrolled in a clinical trial and the point is to let them try a new agent in the hopes it will improve their health. But if their outcomes are used by clinical drug trial sponsors in research, as allowed by the bill, the patients become (or are a lot like) research subjects. But, they are not protected by an IRB or U.S. federal research regulations.

    What are the prospects for the bill reaching the President’s desk?

    The bill must now go to a conference committee, where members of the House and Senate will hash out what the final version will look like. Given the similarities of the two bills, I imagine the final bill will be on the President’s desk soon where it will be promptly signed into law. My guess is the concerns expressed above, and others, will remain.

     
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  • It’s time to reform the 340B program

    Boston University policy analyst Elsa Pearson and I have a new piece up at STAT about the unintended and undesirable consequences of the 340B drug discount program. That program requires drug manufacturers to sell drugs to some hospitals and clinics at a discount. However, those organizations can get reimbursed from payers at higher prices, pocketing the difference.

    That could be sensible, depending on what use that net revenue is put. Research suggests that in many cases it isn’t used to benefit the high cost/high risk populations the program is intended to help. We cover that research.

    There are bills in Congress to reform the program. Our piece explains what they are and what they’d do. Go read it!

    Research for this piece was supported by the Laura and John Arnold Foundation.

    @afrakt

     
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  • Traditional Medicare Doesn’t Cover Dental Care. That Can Be a Big Problem.

    The following originally appeared on The Upshot (copyright 2018, The New York Times Company). It also appeared on page 4 of the Sunday Business section on April 8, 2018.

    Many people view Medicare as the gold standard of United States health coverage, and any attempt to cut it incurs the wrath of older Americans, a politically powerful group.

    But there are substantial coverage gaps in traditional Medicare. One of them is care for your teeth.

    Almost one in five adults of Medicare eligibility age (65 years old and older) have untreated cavities. The same proportion have lost all their teeth. Half of Medicare beneficiaries have some periodontal disease, or infection of structures around teeth, including the gums.

    Bacteria from such infections can circulate elsewhere in the body, contributing to other health problems such as heart disease and strokes.

    And yet traditional Medicare does not cover routine dental care, like checkups, cleanings, fillings, dentures and tooth extraction.

    After I wrote a recent article about the lack of coverage for dental care in many state Medicaid programs, I received a lot of feedback from readers saying Medicare was no better.

    I have not had dental coverage since I retired 25 years ago. Any problems and I have to go to a foreign country to get treatment that I can afford. It is incredible that there is no coverage available in America for one of the most important aspects of health and wellness care for seniors. — Tom, La Jolla

    Several of my elderly relatives have just let teeth fall out without being cared for or replaced because of expense. This is no way to care for our senior citizens. — Bronxbee, Bronx

    Paying for dental care out of pocket is hard for many Medicare beneficiaries. Half have annual incomes below $23,000 per year. Those who have the means, but are looking for a deal, might travel abroad for cheaper dental care. Tens of thousands of Americans go to Mexico every year for dental work at lower prices. Many others travel the globe for care.

    Although low-income Medicare beneficiaries can also qualify for Medicaid, that’s of little help for those living in states with gaps in Medicaid dental coverage.

    According to a study published in Health Affairs, in a given year, three-quarters of low-income Medicare beneficiaries do not receive any dental care at all. Among higher-income beneficiaries, the figure is about one-quarter.

    “The separation of coverage for dental care from the rest of our health care has had dramatic effects on both,” said Amber Willink, the lead author of the study and a researcher at Johns Hopkins Bloomberg School of Public Health. “As a consequence of avoidable dental problems, the Medicare program bears the cost of expensive emergency department visits and avoidable hospitalizations. It’s lose-lose.”

    Traditional Medicare will cover dental procedures that are integral to other covered services. So if your Medicare-covered hospital procedure involved dental structures in some way, important related dental care would be covered. But paying for any other care is up to the patient.

    Lack of dental coverage by Medicare is among the top concerns of beneficiaries. The program also lacks coverage for hearing, vision or long-term care services. However, many Medicare Advantage plans — private alternatives to the traditional program — cover these services.

    For example, 58 percent of Medicare Advantage enrollees have coverage for dental exams. In receiving these benefits through private plans, enrollees are also subject to plans’ efforts to limit use by, for example, requiring prior authorization or offering narrow networks of providers. These restrictions can be problematic for some beneficiaries, and about two-thirds of Medicare beneficiaries opt for the traditional program, not a private plan.

    Adding a dental benefit to Medicare is popular. A Families USA survey of likely voters found that the vast majority (86 percent) of likely voters support doing so. The survey also found that when people do not see a dentist, the top reason is cost.

    Ms. Willink’s study estimated that a Medicare dental benefit that covered three-quarters of the cost of care would increase Medicare premiums by $7 per month, or about 5 percent. The rest would need to be financed by taxes.

    The cost of such a benefit might be offset — or partly offset — by reductions in other health care spending, reflecting the fact that poor oral health contributes to other health problems.

    Making a case for this in the political arena would not be easy, though. The initial cost would be an inviting target for politicians who express concern about fiscal prudence, regardless of any potential long-term gain. But expanding Medicare has been done before.

    In 2006, a prescription drug benefit was added to the program. The law for that program was enacted in 2003, and in that same year, the surgeon general released a report calling for dental care to be treated and covered like other health care. Whether by Medicaid or Medicare, that wish is still unfulfilled.

    @afrakt

     
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  • Healthcare Triage: Heart Stents, Angina, and the Placebo Effect

    Stents are a popular treatment for angina pectoris, or chest pain usually resulting from narrowed arteries. Getting a stent is a serious procedure, with no small risk associated with it. And recent studies indicate that stents don’t do much to reduce recipients’ chance of future heart problems. They do offer some pain relief, but research indicates that may just be our old friend, the placebo effect.

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

    @aaronecarroll

     
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