Via Kyle Hill:
After writing for years about how research shows we may be too aggressive in screening for breast cancer, it’s only fair that I acknowledge the newer – and more conservative – recommendations from the USPSTF. This it Healthcare Triage News:
For those of you who want to read more
- Breast Cancer Screening Draft Recommendations
- ACA Doesn’t Restrict Mammograms
- Draft Recommendation Statement
when it comes to breakthroughs that could cure — not just treat — the most expensive diseases, government is unique. It alone can bring the necessary resources to bear… And it is ultimately on the hook for the costs of illness. It’s irresponsible and shortsighted, not prudent, to let financing for basic research dwindle.
But as Yuval Levin pointed out in 2007, the NIH budget was doubled from 1998 to 2003 and the results were in many ways disappointing. The rapid funding growth was followed by an abrupt stall.
The glut of graduate students enticed by the growing support a few years ago have since found it difficult to get their own work funded once they finished their training, and the sudden deceleration in funding has left many researchers feeling slighted even though their funding grew by leaps and bounds in the past decade. Slower growth over a longer period would have offered a far more stable and sustainable means of expanding the American biomedical research enterprise.
Moreover, Levin correctly noted that Congress missed the opportunity to overhaul
the agency’s exceedingly inefficient and bulky institutional structure [27 separate Institutes], which both wastes resources on needless duplication of administrative overhead and is so specialized that it creates overly rigid and nearly permanent channels of funding.
So if you were redesigning the NIH, what would you do? Here are four proposals:
- Wind down most of the NIH intramural research and direct the funding to the competitive peer review process. Perhaps the intramural laboratories should be spun off with endowments. The point would be to make them compete on an even footing with other scientists.
- Continue to develop the NIH information infrastructure in support of science. PubMed isn’t broken, so don’t fix it. Let’s figure out how to make national repositories for clinical data work better.
- Bring the many other federal and quasi-federal health research institutions into the NIH. I refer to the Agency for Health Research and Quality, the Centers for Disease Control, the Center for Medicare and Medicaid Services, the Patient-Centered Outcomes Research Institute, and the research wing of the Substance Abuse and Mental Health Services Administration. The goals pursued by these agencies should always have been part of the NIH’s mission.
- Break up the silos of the NIH Institutes and rebuild its programs around a few big scientific themes. How about these?: I. Origins and determinants of health and disease. II. Treatment research. III. Health systems and services delivery. IV. Informatics, Research Methods, and Ethics. Whatever scheme is chosen, it should have a definite sunset and be reviewed at least every 20 years.
There are many other issues. Did the recent reform of peer review succeed? Are you satisfied with the system of paying indirect costs on extramural grants? Should we have more support for scientific careers and less for specific projects, or the reverse?
h/t to Ramesh Ponnuru for the link to Yuval Levin.
In addition to the well-publicized aspects of the SGR fix, the legislation also addressed a long standing problem in the fraud and abuse laws that limited hospital “gainsharing” programs.
Gainsharing is similar to the ACO “shared savings” bonuses paid by Medicare if the health system achieves cost and quality targets, but classic gainsharing agreements are entirely private (i.e., between health systems and physicians who practice there). For example, a hospital and a group of surgeons might sign a gainsharing agreement that shared savings in the OR from more economical ordering and use of medical supplies and devices.
The catch was Section 1128A(b)(1) of the Social Security Act, which prohibited any payments by a hospital to a physician as an inducement to reduce or limit services provided to Medicare or Medicaid beneficiaries who are under the direct care of the physician. Hospital counsel worried — with good reason — that a gainsharing program would be considered a payment to induce a reduction in services, resulting in very substantial civil monetary penalties.
Even if the services were wasteful, unnecessary or dangerous, federal law prohibited these gainsharing payments. I co-authored a paper for the American Health Lawyers Association describing the problem in detail – in 1999.
Fast forward 16 years and Congress has finally acted, by adding the words “medically necessary” to the statute. Gainsharing is now permitted, so long as medically necessary services are not reduced or limited. Alternative payment models now need not fear the CMP as much (see my 2014 TIE post on alternative payment model language in the SGR fix bill).
For more on this gainsharing development, see a briefing by my former firm, MWE.
In welcome news for the research community, the Substance Abuse and Mental Health Services Administration (SAMHSA) is planning on proposing a rule to restore research access to substance use data in Medicare and Medicaid files.
The rule is nearing internal clearance, Pam Hyde, administrator for the [SAMHSA], said Friday. “We are having to work with the law and the regs and the lawyers about what it takes to get that and still be in line with the way the law is currently written,” Hyde said. A 1987 law requires express patient consent for health professionals to share substance abuse information. The law is unlikely to change soon—“most of us have determined that probably now is not the time to get Congress to change that,” Hyde said—so SAMSHA is chipping away at parts of it through regulation. Research is one use of the information that could be enabled through regulation.
This is terrific news. Austin and I have been encouraging SAMSHA to issue a proposed rule along these lines. The agency should be commended for pressing forward.
But it’s much too soon to declare victory. Shepherding a rule through the rulemaking process is almost comically difficult. Below is a stylized map of the typical rulemaking process (in reality, it’s even more complicated than this). Of the nine major steps, SAMHSA is on step three.
The rule could get derailed at any one of the next six steps. In particular, the rule could easily get stuck at step four: review at the Office of Information and Regulatory Affairs (OIRA), part of the White House’s Office of Management and Budget. In my prior academic work, I’ve written about how OIRA oversight of agency rulemaking puts a drag on rulemaking since any given rule can get entangled in bureaucratic or political snarls. That’s especially so when the rule raises sensitive questions about personal privacy.
So the research community needs to keep beating the drum—and keep beating it hard. To that end, Austin and I are on the hunt for more concrete examples of transformative research that would have been difficult or impossible without the data that CMS is now suppressing. To move the proposed rule from the drawing board to the Code of Federal Regulations, SAMHSA will need all the help it can get.
The following originally appeared on The Upshot (copyright 2015, The New York Times Company).
Over the past few months, I’ve written a number of times on how nutrition recommendations are seldom supported by science. I’ve argued that what many people are telling you may be inaccurate. In response, many of you have asked me what nutrition recommendations should say.
It’s much easier, unfortunately, to tell you what not to do. But here at The Upshot, we don’t avoid the hard questions. So I’m going to put myself on the line. Below are the general rules I live by. They’re the ones I share with patients, with friends and with family. They’re the ones I support as a pediatrician and a health services researcher. But I acknowledge up front that they may apply only to healthy people without metabolic disorders (me, for instance, as far as I know).
These suggestions are also not supported by the scientific weight of rigorous randomized controlled trials, because little in nutrition is. I’ve inserted links to back them up with the available evidence. They are not “laws” and should not be treated as such. No specific nutrients will be demonized, and none will be held up as miracles. But these recommendations make sense to me, and they’ve helped me immensely.
Full disclosure: I did not invent most of these. I’ve developed them from reading the work of others, including what may be the most impressive “official” nutritional guidelines, those of Brazil, as well as from earlier suggestions from readers, as in this great NYT interactive graphic. It captures readers’ responses to food rules by Michael Pollan. He is, of course, the promulgator of the well-known advice: “Eat food. Not too much. Mostly plants.”
1. Get as much of your nutrition as possible from a variety of completely unprocessed foods. These include fruits and vegetables. But they also include meat, fish, poultry and eggs that haven’t been processed. In other words, when buying food at the market, focus on things that have not been been cooked, prepared or altered in any way. Brown rice over white rice. Whole grains over refined grains. You’re far better off eating two apples than drinking the same 27 grams of sugar in an eight-ounce glass of apple juice.
1b. Eat lightly processed foods less often. You’re not going to make everything yourself. Pasta, for instance, is going to be bought already prepared. You’re not going to grind your own flour or extract your own oil. These are meant to be eaten along with unprocessed foods, but try to eat less of them.
1c. Eat heavily processed foods even less often. There’s little high-quality evidence that even the most processed foods are dangerous. But keep your consumption of them to a minimum, because they can make it too easy to stuff in calories. Such foods include bread, chips, cookies and cereals. In epidemiologic studies, heavily processed meats are often associated with worse health outcomes, but that evidence should be taken with a grain of salt (not literally), as I’ve written about before.
2. Eat as much home-cooked food as possible, which should be prepared according to Rule 1. Eating at home allows you to avoid processed ingredients more easily. It allows you full control over what you eat, and allows you to choose the flavors you prefer. You’re much less likely to stuff yourself silly if you eat home-cooked food. I’m not saying this is easy. Behavioral change takes repetition and practice. It also, unfortunately, takes time.
3. Use salt and fats, including butter and oil, as needed in food preparation. Things like salt and fat aren’t the enemy. They are often necessary in the preparation of tasty, satisfying food. The key here is moderation. Use what you need. Seasoning is often what makes vegetables taste good. Don’t be afraid of them, but don’t go crazy with them either.
4. When you do eat out, try to eat at restaurants that follow the same rules. Ideally, you should eat at restaurants that are creating all of their items from completely unprocessed foods. Lots and lots of restaurants do. Follow Rule 1 even while out to dinner. Some processing is going to be fine, but try to keep it to a minimum.
5. Drink mostly water, but some alcohol, coffee and other beverages are fine. As I’ve pointed out before, you can find a study to show that everything either prevents or causes cancer — alcohol and coffee included. But my take is that the preponderance of evidence supports the inclusion of a moderate consumption of most beverages.
6. Treat all beverages with calories in them as you would alcohol. This includes every drink with calories, including milk. They’re fine in moderation, but keep them to a minimum. You can have them because you like them, but you shouldn’t consume them as if you need them.
7. Eat with other people, especially people you care about, as often as possible. This has benefits even outside those of nutrition. It will make you more likely to cook. It will most likely make you eat more slowly. It will also make you happy.
I’ve avoided treating any food like the devil. Many nutrition experts do, and it may turn out they’re right, but at this point I think the jury is still out. I’ve therefore tried not to tell you to avoid anything completely. My experience tells me that total abstinence rarely works, although anecdotes exist to support that practice. I think you’ll find that many other diets and recommendations work under these rules. These are much more flexible and, I hope, reasonable than what some might prescribe.
All of these rules are subtly trying to get you to be more conscious of what you’re eating. It’s far too easy these days to consume more than you think you are, or more than you really need, especially when eating out. I’ve found that it’s impossible to tell any one person how much they should be eating. People have varying requirements, and it’s important for all of them to listen to their bodies to know when they should eat, and when they should stop.
One other thing: Don’t judge what others eat. One of my closest friends has been avoiding carbohydrates for months, and has seen remarkable results. Another was a pescatarian — a person whose only meat dishes are fish — for a year and was very happy with that. I, on the other hand, avoid no food groups in particular.
People are very different. Some may have real problems consuming even the smallest amount of carbohydrates. Others may be intolerant of certain foods because of allergies or sensitivities. It will most likely take a bit of experimentation, on an individual level, to find the actual diet within these recommendations that works for you. But the above rules should allow for a wide variety of foods and for remaining healthy. At least, I hope so.
I’m curious what readers think of these. I welcome your comments to this column, as well as tweets to me in response.
The Upshot turns one year old today. In celebration, they’re featuring their 250 most popular posts from the last year. Go check it out. I’m thrilled to say you’ll see some from me and Austin.
Let me also take the opportunity to offer both congratulations and gratitude to all the amazing people who work there. It’s an absolute honor to be a part of it.
What is homeopathy?
Homeopathy is a medical philosophy that essentially believes your body is the best weapon to fight disease. Homeopathic medicine is based on the idea that “like cures like,” meaning if something causes a symptom in your body, if you take a diluted form, it will boost your body’s ability to fight it. Typically these remedies include a plant or a mineral in a tiny amount.
An analysis of hundreds of published studies from the National Health and Medical Research Council in Australia found that homeopathic medicine was no more effective than a placebo. There is no evidence that they actually work, the council claimed, and yet it is a multibillion dollar business.
This led to:
The Food and Drug Administration (FDA) [just finished] a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.
This is probably because of stuff like this:
Here’s the thing. I don’t get why there’s such a distinction between “alternative” and “traditional” medicine. I make no such differentiations. To me, there’s only the medicine which we subject to scrutiny and the medicine we don’t. This blog is FULL of posts attacking “traditional” medicine when it fails to work as promised. There are also posts on “alternative” therapies that have been studied, and do work. Those should be used.
It sometimes feels like people who use “alternative” medicine oppose its study, or don’t care about results. If that’s the case, then – yes – I can’t say I’m all for that. When something fails to show benefits over harms in research, then I tend to frown upon its use. But anything that succeeds on this metric should no longer be considered “alternative” medicine. It’s just medicine.
After writing for years about how research shows we may be too aggressive in screening for breast cancer, it’s only fair that I acknowledge the newer – and more conservative – recommendations from the USPSTF.
First: The USPSTF recommends screening mammography every two years for women ages 50 to 74 years. This will certainly upset many advocacy groups, which have long advocated for yearly screening to start long before age 50. The ACA also mandates that such yearly mammograms be paid for without co-payments or co-insurance, so following these guidelines means refusing “free” care.
However, this is an acknowledgement of the fact that the harms of yearly screening might outweigh the benefits. The accompanying review and meta-analysis found that if 10,000 women age 50-59 are screened, there will be 8 fewer deaths from breast cancer. In 10,000 women age 60-69, there would be 21 fewer deaths from breast cancer. BUT, about 20% of women who are diagnosed with and treated for breast cancer are getting therapy for something that otherwise would never have caused a health problem or been found. One in five women is overtreated, and the treatment for cancer is not benign.
False positives are common, too. These have costs – financial, emotional, and physical. They happen even more often than overtreatment and overdiagnosis.
The models they used found that using yearly screens instead of every-other year screens had a pretty incremental benefit. But they had a significant increase in harms. So they recommend five, not ten, screens over a decade.
Second: The current evidence is insufficient to assess the balance of benefits and harms of screening mammography in women 75 years and older. There are no RCTs to show a benefit in this age group. The harms are still there, though, so no recommendation is made.
Third: The decision to start screening mammography in women before age 50 years should be an individual one. Women who place a higher value on the potential benefit than the potential harms may choose to begin screening between the ages of 40 and 49 years.
This is a real change for many, too. It’s saying it’s totally fine not to start screening until age 50. Why? There’s a reasonable case to be made here that the harms overwhelm the benefits.
If we screen 1000 women age 50-74 for 10 years, we may prevent 7 breast cancer deaths. If we drop the screening age to 40, then we might prevent 8 breast cancer deaths. One more death. But it’s totally possible that person might die of other causes, meaning there’s no real gain overall.
Plus, there are real problems. Each time we screen 1000 women age 40-49, there are 121 false positives. There are 10 biopsies that didn’t need to happen. There’s also one false negative, or real breast cancer missed.
That’s each time, not the whole 10 years. So multiply those harms by the number of times you screen over a decade. It adds up, and it might overwhelm that benefit.
So the USPSTF hedges. They say each woman should make a personal decision with the help of their physician, and I think that’s the right call. Recommendations should say what we know to be true, and in this case we know the benefits and we know the harms. When they’re overwhelmed in one direction or the other, we should let personal preferences come into play.
Obviously, women at higher than usual risk for breast cancer should be treated differently. That’s how it should be, too. Recommendations should be applied carefully to the populations they are meant for.
Guns are one of those topics that really divide Americans. It’s hard to have a calm, evidence-based discussion. But one area where we really need to be able to do that is in the pediatrician’s office. Why? That’s the topic of this week’s Healthcare Triage.
For those of you who want to read more:
- Promoting Safety and Injury Prevention
- Florida Bill Could Muzzle Doctors On Gun Safety
- IN THE UNITED STATES COURT OF APPEALS FOR THE ELEVENTH CIRCUIT: No. 12-14009
- Youth Suicide and Access to Guns
- The accessibility of firearms and risk for suicide and homicide victimization among household members: a systematic review and meta-analysis
- Injuries due to firearms in three cities
- Hospitalizations Due to Firearm Injuries in Children and Adolescents
- The Association Between Presence of Children in the Home and Firearm-Ownership and -Storage Practices
- Injuries and deaths due to firearms in the home
- Firearm-Related Injuries Affecting the Pediatric Population
Much of this was adapted from a piece I wrote last year at The Upshot at the NYT.