The Incidental Economist

Screening for diabetes, and then preventing it, is a no brainer right? I wish. This is Healthcare Triage news.

This episode was adapted from a post I wrote for the AcademyHealth blog. Links to further reading and sources can be found there.

@aaronecarroll

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Kevin Outterson and I have an op-ed in the New York Times today on combating antimicrobial resistance. Here’s a snippet:

Congress needs to think bigger if it wants to fix the broken antibiotic business model. Although the patent system is good at producing new blood-pressure medications and cardiovascular drugs, it’s not the right fit for antibiotics. Because new antibiotics may be held in reserve for years, manufacturers can’t sell enough during the patent term to justify large research investments. Congress should instead reward manufacturers that bring a targeted, highly innovative antibiotic to market with a substantial financial prize; in exchange, manufacturers would surrender their patent.

This kind of “market-entry” reward would enable public health officials and physicians to deploy new drugs precisely where they’re needed. Manufacturers would no longer have an incentive to milk their patent, marketing the drug for inappropriate uses. The antibiotic could also be sold at a reasonable price in developing countries, which might otherwise be unable to afford a patented antibiotic.

Financing market-entry rewards would be expensive, perhaps $4 billion per year in total, or about 10 percent of the annual global bill for antibiotics. But you can’t defeat bacteria on the cheap. They’ve survived for billions of years because they’re so good at adapting to new threats. Staying one step ahead will require ingenuity, money and radical change. Tinkering around the margins isn’t going to cut it.

Read the whole thing here!

@nicholas_bagley

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The following originally appeared on The Upshot (copyright 2017, The New York Times Company).

Medical scientists and academics must publish their research to advance. Medical organizations must release health recommendations to remain relevant. News organizations feel they must report on research and recommendations as they are released. But sometimes it’s hard to separate what’s truly a medical certainty from what is merely solid scientific conjecture.

I thought about this recently when the National Institute of Allergy and Infectious Diseases expert panel changed course and recommended that we start giving babies peanut powder or extract in food before they are six months old rather than make sure they go nowhere near it. The panel said this is good advice, especially if the babies are at higher risk for developing an allergy.

I’ve written about the research supporting these new recommendations before. A recent well-designed study showed that infants exposed to peanut protein developed significantly fewer peanut allergies than those who were not. The measurement, called number needed to treat (N.N.T.), was powerful: For every seven infants exposed to peanut protein, one fewer developed allergies. In the high-risk population, for every four infants exposed, one fewer became allergic. Those numbers are stunning.

But it’s important to remember that the earlier recommendation wasn’t made in the Dark Ages. As recently as 2000, the American Academy of Pediatrics declared that children at risk for allergies be given no peanuts until they were 3 years old. It’s not unrealistic to think that this might have increased the number of children with peanut allergies, not decreased them.

This isn’t an isolated incident. As a pediatrician, I’m more aware of the academy’s recommendations than those of some other medical organizations, and I’ve taken to The Upshot to discuss their statements on car seats on planes, the use of retail clinics and where babies should sleep. In each case, I’ve expressed concerns that the recommendations, which were not supported by strong evidence, may be doing more harm than good.

The American Academy of Pediatrics isn’t acting in bad faith, though, nor is it alone. Recommendations from other medical organizations for mammograms, which weren’t supported by well-designed randomized controlled trials but for years went unchecked, are now being scaled back because of concerns that they may be leading to bad outcomes without compensating benefits.

Recommendations for prostate cancer tests are facing a similar fate. Hormone replacement therapy, recommended widely before the early 2000s, almost went away after the Women’s Health Initiative Study. Today, recommendations argue that we’re not using that therapy widely enough, perhaps leading to deaths.

But nowhere is this recommendation whiplash more disorienting than in nutrition. Recommendations pushing low-fat diets may have led to an increase in carbohydrate consumption, which many experts now believe may have made the obesity epidemic worse. Coffee was considered a potential carcinogen, until overwhelming evidence led to its recognition as part of a healthy diet. You were told you should never miss breakfast, you should drink more water and you should use natural sweeteners like honey. Except none of those things are well supported by science.

Often recommendations are born out of a need to do more for more people. If something works for one group, we tend to believe that it should work for more. People at high risk for breast or prostate cancer may need to be screened for the diseases. Expanding that screening to people at low risk, however, yields more false positives than true revelations. Hormone replacement therapy most likely benefits some women, especially younger women and those who have had a hysterectomy. Others get the same side effects or harms with little benefit.

Other times, recommendations consider only the upside and fail to consider the potential pitfalls. This would apply to recent sleep recommendations, which may (and I stress may) benefit babies but also might hurt them and parents in other ways.

But most often, recommendations fail because they aren’t supported by high-quality research. They have only observational trials behind them, not the full weight of randomized controlled trials. Too many times, organizations have been burned when the associations we see don’t translate to causal changes in the more strict randomized controlled trials.

Unfortunately, when it comes to food, the problems run together. Pick any food fad, be it low-fat, low-carb, gluten-free or peanut avoidance, and you’ll see the markers. Some people benefit from avoiding certain foods, so organizations proclaim that all people will benefit. They have observational studies that support their beliefs, and if other such studies contradict them, well, those can be ignored. Few consider the downsides of these changes, until years later, when we look back and wonder what we were thinking.

There’s growing evidence that simple lifestyle changes may be more influential than many medical interventions. That advice, though, is bland and nonspecific. Get some exercise. Don’t smoke. Don’t drink too much. Don’t be obese. And try to eat a bit better. But none of them advocate drastic change or abstinence in any one nutrient or food. Moderation may not only feel right; it may be right, too.

This was the thinking behind my food recommendations years ago. It’s the philosophy behind many of my recent columns as well. Of course, if everyone started applying common sense to these issues, I’d have a lot fewer columns to write.

I’d be willing to make that sacrifice, though, if you’d all — medical professionals and everyone else — be willing to be more thoughtful and skeptical of what we “know” to be right.

@aaronecarroll

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Obamacare’s marketplaces were supposed to give consumers choices of health plans from insurers that compete to keep premiums down. But fewer insurers are participating, and premiums are increasing sharply.

Fixing this problem will obviously be politically difficult with a Republican-controlled Congress that has vowed to “repeal and replace.” President-elect Donald J. Trump has also said he wants to get rid of the ACA, although he amended that recently by saying he’d like to keep some elements. Replacing the law, without a Senate supermajority, would also be politically difficult.

From a policy standpoint, however, some solutions to problems facing the marketplaces are ones that Republicans have endorsed before: for Medicare. That’s the topic of this week’s Healthcare Triage.

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

@aaronecarroll

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Screening for and then working to prevent Type 2 diabetes seems like a no brainer. I wish that were the case. Come be depressed with me over at the AcademyHealth blog, and read my latest post.

@aaronecarroll

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The following originally appeared on The Upshot (copyright 2017, The New York Times Company). I forgot to post it the week it came out, but better later than never!

My friends know they are going to get an evidence-based read on medical practices when they turn to me for advice. Not all of them enjoy the eye rolls that involuntarily occur when I hear what they are considering, like when a friend asked me about the benefits of whole body cryotherapy.

Cryotherapy is the practice of subjecting tissue or lesions in tissue to very cold temperatures in an effort to kill something that is considered unhealthy. It can also mean the application of ice packs to reduce swelling or pain on a part of the body.

But whole body cryotherapy exposes the body for a couple of minutes to vapor that has been supercooled to somewhere between minus 200 and minus 300 degrees Fahrenheit. It was once confined mostly to elite athletes, but now centers have cropped up across the country asserting that the practice can lead to any number of health benefits.

There is not much evidence, however, to back this up. A 2015 Cochrane systematic review looked at studies assessing the benefits and harms of whole body cryotherapy in preventing and treating exercise-induced muscle soreness in adults. The authors found four laboratory-based randomized controlled trials that included 64 young adults (average age 23), 60 of whom were male. All of the studies were judged to have some problems with design features (explained here), and over all, they found insufficient evidence to support the use of whole body cryotherapy for muscle soreness. Moreover, there was almost no evidence supporting its use for women or for the middle-aged and older people.

When we get into specific treatments, the evidence is even more scant. A recent two-week study (which doesn’t appear to have been randomized or blinded) found whole body cryotherapy to be similar to traditional rehabilitation in improving outcomes for 44 patients with rheumatoid arthritis. A case control study of 24 patients with multiple sclerosis found that those who received whole body cryotherapy had improved functional status and reduced feelings of fatigue. In a small randomized controlled trial lasting eight weeks, 12 patients with restless leg syndrome seemed to see improvements in symptoms and quality of life.

These were all small studies, involving few patients, over short periods of time, with minimal overall changes. Given the likelihood of publication bias here (positive results are more likely to be published than negative ones), it’s hard to make sweeping recommendations based on these findings.

Because so little data is available, the Food and Drug Administration has not certified cryotherapy chambers to treat anything at all, including muscle pain or inflammation. For this reason, they cannot be marketed to treat diseases.

That doesn’t stop all kinds of other assertions from centers that offer whole body cryotherapy. Some say that it can help people lose weight. Others argue that it can help to slow down aging and make you look younger. There are even those who maintain that it can make a difference in your mental health. None of these claims have been the subject of well-designed studies.

Most of the research on whole body cryotherapy doesn’t focus on disability or disease but on athletic performance. In 2013, a meta-analysis published on 21 randomized controlled trials showed no significant benefit to endurance, strength or the ability to jump. There was some benefit to sprint performance, but even this seems to be the result of one outlying study.

This hasn’t stopped these athletes from continuing to use cryotherapy. But as I’ve discussed before, many athletes are willing to spend money and try therapies with little proof of potential gain.

The bad news is that even the use of ice to take care of localized injuries isn’t nearly as well supported as you might imagine. A systematic review published in The Journal of Athletic Training in 2012 gathered evidence from studies testing “rest, ice, compression and elevation” therapies. They found limited evidence to support the use of ice in the treatment of ankle sprains.

A 2004 systematic review looking at the use of ice for a variety of soft-tissue injuries found that “many more high-quality trials are needed to provide evidence-based guidelines in the treatment of acute soft-tissue injuries.”

Of course, applying an ice pack has few potential harms and almost no cost. If people find benefit from that, I’m not going to argue that they should stop. The potential downsides of whole body cryotherapy are much more significant.

Whole body cryotherapy is also inherently dangerous, which is why it should never be done alone. In 2015, an employee using a cryotherapy chamber after hours unaccompanied was found dead inside. Freezing your body can also result in hypothermia or frostbite, adding to the necessity that the procedure be monitored closely.

Whole body cryotherapy isn’t cheap, either. Sessions can run between $50 and $100, and no insurance plans I know of will help you cover those bills. Given all of this, and the utter lack of proven benefits, when my friend asked about it, an eye roll was probably the appropriate response.

@aaronecarroll

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When SAMHSA issued its proposed rule, I had two concerns about its scope. Writing on AcademyHealth’s behalf, I asked SAMHSA for clarification. Both of my concerns have been addressed in the final rule—one satisfactorily, the other not so much.

First, a provision on data linkages—efforts to link Medicare and Medicaid data with other datasets—could have been read to say that researchers couldn’t do such linkages on their own, but would have to ask CMS to perform such linkages for them. That would have been bad. As AcademyHealth explained, “CMS is overtaxed, and we are not optimistic that it will be able to expeditiously, inexpensively, and accurately do the complex work associated with linking data across disparate data sets.”

SAMHSA apparently agreed. In the final rule, it clarified “that the data linkages provision is not intended to prohibit a researcher from linking a data set in the researcher’s possession that contains part 2 data with a data set from a third party source.” In other words: victory!

Second, the proposed rule didn’t seem to allow records relating to substance use disorders to be shared with data intermediaries, including the all-payer claims databases (APCDs) that now exist in about 18 states. Because APCDs and other intermediaries aren’t providers or payers, they aren’t “lawful holders” of such records within the meaning of the regulations. As such, they can’t collect those records and they can’t share them with researchers.

SAMHSA recognized the issue and, in its rule, offered what it apparently considered a solution. The agency clarified that APCDs and other data intermediaries “are permitted to obtain [data on substance use disorders] under the research exception, provided that the conditions of the research exception are met.” At that point, APCDs and intermediaries would become “lawful holders” of the data and “would therefore be permitted to redisclose [those] data for research purposes.”

That sounds good. But if you look at the new rule, it appears that APCDs and other intermediaries can’t take advantage of the research exception. Under the rule, you’re eligible for the exception only if you’re (1) a HIPAA-covered entity or (2) subject to HHS rules governing human subjects research.

APCDs and other data intermediaries don’t appear to qualify. Because they’re not providers, plans, or payment clearinghouses, they’re not “covered entities” within the meaning of HIPAA. And I don’t see why APCDs or other intermediaries would be subject to the rules governing human subjects research. They’re not federal entities and, to my knowledge, their research isn’t supported by federal funds.

If that’s right—and it’s possible I’m missing something—then SAMHSA has effectively prohibited APCDs and other data intermediaries from receiving identifiable records pertaining to substance use disorders. The states that were hoping to use their APCDs to help them tackle the opioid epidemic can forget about it.

@nicholas_bagley

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Three years ago, and without notice, data about patients with substance use disorders began to disappear from Medicare and Medicaid files widely used in health services research. Because researchers had been afforded access to those data for decades, the change was mystifying. Austin raised an alarm, and he and I began to look into it.

The culprit was a 1976 regulation governing the privacy of information pertaining to substance use disorders. On its face, the regulation—which was drafted well before electronic records came into common use—seemed to prohibit the Centers for Medicare and Medicaid Services (CMS) from sharing such information with researchers. No one apparently noticed until 2013, at which point CMS started scrubbing its data.

This was a calamity for health services research. The data scrubbing made it impossible to use Medicare and Medicaid records to study efforts to combat addiction and the consequences of substance use. Beyond that, the non-random withholding of data would predictably skew research into any condition that was more common among people with substance use disorders—a point elegantly confirmed by a research team from Brigham & Women’s Hospital in Boston.

Here at the blog and in the pages of the New England Journal of Medicine and the New York Times, Austin and I exhorted the Substance Abuse and Mental Health Services Agency (SAMHSA) to revisit the 1976 rule. Last February, SAMHSA agreed to do so, issuing a proposed rule to end the data-scrubbing. We crossed our fingers and waited.

The wait was rewarded on Friday with the release of a final rule that closely tracks the original proposal. Under the rule, CMS is free to share addiction-related records with researchers who secure Institutional Review Board approval and agree to appropriate safeguards—standard procedure for receipt and use of all identifiable CMS research data. In considering the comments that it received, the agency took real pains to enable research into addiction and correlated conditions, pointedly rejecting input that would have imposed needless burdens.

In short, the rule is excellent. SAMHSA should be commended.

There’s still a shadow here, however. Because the rule doesn’t take immediate effect, the incoming administration can still withdraw it. And President Trump will almost certainly impose a moratorium on any Obama-era regulations to allow his administration to review them. That doesn’t mean the rule is dead: given the President’s expressed interest in curtailing the opioid epidemic, Austin and I are cautiously optimistic that the rule will eventually go through.

But nothing is certain. The fight isn’t quite over yet.

@nicholas_bagley

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The recent election has caused many to question whether significant changes are about to happen to Medicaid. Repeal of the Affordable Care Act would, of course, lead to the elimination of the Medicaid expansion, which could result in significant numbers of adults losing their coverage overnight.

But even without repeal, many Republican replacement proposals also result in significant changes to Medicaid, whether it be through funding, eligibility, or benefits. So, again, let’s talk about what Medicaid does, and whether it’s long term benefits are worth it. This is Healthcare Triage News.

This episode was adapted from a post I wrote for the AcademyHealth blog. Links to further reading and sources can be found there.

@aaronecarroll

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The prices private health insurers pay hospitals have long been above those paid by Medicare and Medicaid. But in recent years, the difference between public and private prices has grown tremendously. Why? Read my latest AcademyHealth post for more.

@afrakt

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