Via Pascal Meier:
The following originally appeared on The Upshot (copyright 2016, The New York Times Company).
Things sometimes go wrong with airbags,food and drugs, prompting recalls. It can also happen with medical devices, though you’d think lifesaving devices like heart defibrillators or artificial hips would be closely monitored.
But the data needed to systematically and rapidly identify dangerous medical devices are not routinely collected in the United States.
It wouldn’t be that hard to do.
Problems with medical devices are not infrequent. Defibrillators implanted in nearly 200,000 patients were recalled in 2011 because of a faulty part. More recently, the Essure birth control device implanted in women’s fallopian tubes has been associated with pain and deaths. Improper handling of duodenoscopes — used by doctors to examine the small intestine — was linked to hundreds of cases of antibiotic-resistant infections in 2013 and 2014.
According to a report from the Brookings Institution, medical device problems that we know about contribute to about 3,000 deaths per year in the United States. There may be many more we do not know about because we do not track medical device use the way we track prescription drugs for quality and safety. Codes that uniquely identify prescribed drugs are routinely included in medical claims data — such as those made public by the Medicare program. These can be mined for signals of problems.
Instead, for medical devices, we rely on a passive system that’s not up to the task. Hospitals, nursing homes and medical device manufacturers and importers are required to notify the Food and Drug Administration of device safety problems. Doctors, nurses and other health care professionals are not. The F.D.A. has characterized the data collected through these channels as potentially “incomplete, inaccurate, untimely, unverified or biased.”
Reflecting this haphazard approach, a Senate report released this year accused Olympus, a Japanese manufacturer of contaminated duodenoscopes, of delayed reporting of known problems and chided the F.D.A. for its lethargic investigation of them. The report also found that none of the hospitals where problems surfaced properly documented them. Experts convened by the F.D.A. excoriated the manufacturer of the Essure birth control device for not collecting data that could have detected its risks.
The solution seems simple: Do for devices what we do for drugs. The F.D.A. has established the Sentinel Initiative to mine medical data to confirm or clear suspected problematic drugs. For example, one inquiry confirmed reports of intestinal problems associated with an antihypertensive drug.Another investigated whether a new anticoagulant drug was associated with a higher risk of bleeding than others.
We can’t have a Sentinel Initiative for medical devices in the United States because unique device identifiers are not required to be included in standardized medical claims data. Though claims reveal what procedure is performed on which patient, they do not indicate what exact devices were used — like which of the dozens of makes and models of artificial hip was implanted in a hip replacement. (There are plans to make it easier for hospitals to use their electronic records to track which devices are used in which patients, but those records are not standardized — as claims data are — and do not fully integrate with those from other systems, severely limiting their use for surveillance and patient safety.)
Other nations have detected issues with such monitoring systems before American doctors and patients were probably aware of them. For instance, systems in Australia and England and Wales led to the discovery of problems with metal-on-metal artificial hip joints, before the F.D.A. called for a review of them and they were recalled in the United States. A Swedish system associated early drug-coated stents with increased risk of death compared with conventional bare-metal stents.
High-risk medical devices already include unique identifiers and bar codes similar to those on drug packaging and suitable for tracking. In the coming years, other devices will include them as well. Some members of Congress favor including device identifiers in medical claims, and F.D.A. Commissioner Robert Califf supports the approach. Peter Orszag, the former director of the Office of Management and Budget, reported in a Bloomberg View column last year that many medical societies, insurers and health care providers support it as well.
Not everyone agrees. The American Hospital Association and Marilyn Tavenner, while she was administrator for the Centers for Medicare and Medicaid Services, expressed concerns, citing higher costs.
The price tag for a medical device surveillance system that relies on such data is about $50 million a year. This does not include the one-time costs hospitals would have to pay to adapt to the system. Even at a multiple of the price, however, if it saved only a few tens of lives — and chances are it would save many more than that — it would be considered cost-effective. The defective defibrillators cost Medicare an estimated $287 million. The Inspector General of the Department of Health and Human Services, Daniel Levinson, says that faulty medical devices have cost taxpayers billions of dollars.
A significant limitation of medical surveillance systems is that their findings rely on correlations that may not be indicative of causation. However, as I and Steven Pizer, a Northeastern University health economist, noted in the American Journal of Managed Care, the point of such surveillance is to use a large amount of data to detect problems missed by more rigorous, but necessarily smaller, randomized trials. Statistical techniques can increase confidence that correlations from surveillance systems imply a causal relationship (when they really do) or cast doubt (when they don’t).
Medical devices are intended to cure, but some may cause harm. We’re not collecting the data that would help us know the difference.
Out-of-pocket costs for a physician visit can be high, but there’s another personal cost that’s even higher. It’s rarely discussed. Do you know what it is? Read my new AcademyHealth post to find out.
My latest JAMA Forum post is out. Here’s an excerpt:
A $1 million pill that extended life by 10 years would be considered cost-effective, but to provide it to every American would require an expenditure that is equivalent to more than 1000 years of US drug spending. It would be both painful and difficult to deny such a pill to patients who could not afford it. But alternative methods of rationing are perhaps even less palatable. Such are the financial, political, and cultural limits of our ability to manage spending for expensive, effective medicine.
In fact, we may have already have reached the point of confronting the fact that we cannot all have it all. New, expensive drugs for hepatitis C—Viekera Pak, Sovaldi, and Harvoni—severely stress budget-constrained programs like Medicaid and the Veterans Health Administration. Even at the steep discounts those programs receive, these treatments—though cost-effective—are indicated for such large populations that their aggregate cost would overwhelm budgeted resources. The day that life-extending $1 million “miracle” pill arrives (or the precision-medicine equivalent of a collection of drugs), we may look back on the current hepatitis C treatment funding problems nostalgically. As innovation continues, drug pricing and budgeting problems will only get worse.
Go read the rest.
The following originally appeared on The Upshot (copyright 2016, The New York Times Company).
New evidence suggests Medicare Advantage may not serve some sicker Medicare beneficiaries as well as it does healthier ones.
Medicare Advantage’s private health insurance plans offer at least the same benefits as the public, traditional Medicare program for older Americans, as well as some who are disabled or have certain diseases. The private plans may also offer additional benefits not available from traditional Medicare — like coverage for hearing aids and eyeglasses — and lower patient cost sharing. These features make Medicare Advantage attractive and help explain why the program is surging in popularity.
But several new studies raise doubt about whether Medicare Advantage plans are as good as traditional Medicare for all beneficiaries. Though some evidence suggests Medicare Advantage plans offer higher quality andgreater efficiency than traditional Medicare, that may not benefit some sicker people — like those needing hospitalization, home health care or nursing home care — or those with certain mental illnesses, like depression.
One way the plans may disadvantage some sicker beneficiaries is by making care harder to get. Many Medicare Advantage plans try to manage care, sometimes requiring pre-approval or a doctor’s referral for certain services. Some of these care management practices may promote more efficient use of health care resources. A study by Katherine Baicker of Harvard and Jacob Robbins of Brown showed that managed care practice patterns spill over into traditional Medicare, increasing efficiency in that program as well.
Another study by the economists Mark Duggan of Stanford, Jonathan Gruber of M.I.T. and Boris Vabson of Nuna Health and Wharton found that Medicare Advantage enrollees travel farther to visit hospitals than patients in traditional Medicare do. Perhaps in part for this reason, they found that Medicare Advantage enrollees used fewer hospital services, though they were no worse off for it.
But to achieve efficiencies, the private Medicare plans can exclude some doctors and hospitals from their networks. A Government Accountability Office report released last year documented weak standards for Medicare Advantage plan networks and lax oversight, raising the possibility that all types of patients do not get equal access to care. Because sicker beneficiaries need more care, restrictions on access hit them hardest.
Consider, for instance, patients reporting symptoms of depression. Such patients may have difficulty understanding health plan features and more trouble navigating the additional steps in obtaining care that some private plans impose. Steven Martino, a behavioral scientist with RAND, and his colleagues recently studied the experience of such people with Medicare Advantage and compared it with those with traditional Medicare.
Their analysis, published in the journal Health Services Research, found that though the care they received did not differ, Medicare Advantage enrollees with depressive symptoms reported more difficulty getting needed care and drugs, and rated their experience with the private plans as worse than those in traditional Medicare. In other words, the findings point to worse experiences with private plans, not health care providers.
Another recent study, by the Brown assistant professor Momotazur Rahman and colleagues, found that patients who have been hospitalized or have used home health or nursing home services — all indicating worse health or greater frailty — were more likely to switch from Medicare Advantage to traditional Medicare than vice versa.
Such skewed switching rates suggest Medicare Advantage doesn’t serve certain patients well. Rates for switching out of Medicare Advantage are particularly high for lower-income seniors also enrolled in Medicaid. Such a person who also used home health or nursing home services was three to six times more likely to switch to traditional Medicare than a similar traditional Medicare enrollee was to switch to Medicare Advantage.
Older studies also found that sicker people tended to prefer traditional Medicare and were more likely to leave Medicare H.M.O.s. And other, more recent studies found that lower-income, less educated and sicker people reported worse experiences in Medicare Advantage than in traditional Medicare.
Though Medicare Advantage may be a less attractive option for some patients, in some cases that could be because it more effectively limits wasteful or fraudulent care than traditional Medicare. For example, the traditional program has, at times, experienced rampant home health care fraud. It’s also worth noting that even if Medicare Advantage doesn’t serve some sicker patients as well as traditional Medicare on average, experience can vary within groups.
About seven in 10 beneficiaries opt for traditional Medicare, and that alone suggests that many consumers believe they are better served by it.
In January, I devoted every walk from my home to the train to the contemplation of work details, hoping to improve my recall of them. That was my New Year’s resolution, and so far I’ve stuck to it.
In every one of those walks I was also retracing a memorization technique known to the ancients and shown by modern science to be highly effective.
The “Rhetorica ad Herennium,” written in the 80s B.C. by an unknown author, is the first known text on the art of memorization. (It’s also the oldest surviving Latin book on rhetoric.) It teaches the “method of loci,” also known as the “memory palace.” As its names suggest, the approach involves associating the ideas or objects to be memorized with memorable scenes imagined to be at well-known locations (“loci”), like one’s house (“palace”) or along a familiar walking route.
You can test the method for yourself. If you’re like most people, you would not easily commit to long-term memory a 10-item shopping list. But I bet you could remember it — and for more than a few minutes — if you first visualized it along a walk through your house: The entryway of your house is festooned with toilet paper; your kitchen sink is full of lobsters, dancing; a bathtub-size stick of butter melts on your dining room table; your family is singing karaoke in a swimming pool of hummus in your living room; your hallway is so full of grapes you cannot avoid crushing them with each step; your stairway has a runner of lasagna noodles slippery with tomato sauce; a mooing cow is being milked in your bedroom; stalks of corn grow down from the ceiling in the spare bedroom; a crop of multicolored mushroomsblooms in your shower.
Take a few moments to burn these images and locations into your mind (adding motion, sounds, smells and tactile sense to your imagined scenes helps). We’ll test your memory with an imaginary trip to the grocery store at the end of this article.
Joshua Foer wrote a book about how he trained to win the United States Memory Championship. He points out that we’re so good at forming mental maps and recalling images that we hardly notice it. Recall the last party you attended at a home you had not previously visited. Though you probably only walked through the house a few times, you can probably remember most or all of its layout and location of major furniture. Anything else distinctive you saw — like unusual or appealing pieces of art, vivid wall colors — and the faces of people you met are probably also easy to recall. Effortlessly, you retained hundreds or thousands of visual memories and spatial details.
Research backs this up. After people viewed thousands of images for a few seconds each, studies found that, on average, they could correctly distinguish over 80 percent of them from images they had not seen. This remained true even when the comparison images were of the same object in a slightly different position (like the same cabinet open versus closed or the same telephone at a different angle). Another study found people could usually recall objects they’d seen even after seeing hundreds of intervening ones, demonstrating that visual memories of objects are stored long-term.
It makes sense, then, that numerous studies, extending back decades, showthat the method of loci improves memory. Using the approach, people who could remember only a handful of numbers — seven is the norm, give or take a few — were trained to recall 80 to 90.
Another study found that the method doubled the proportion of people who could remember at least 11 of 12 grocery list items. Students who applied it in an undergraduate economics course outperformed those who did not on an exam. Medical students who used the method of loci to study the endocrine system learned more than those who did not.
Patients who have had treatments known to impair recall and cognitive function — like coronary bypass surgeryand surgery and chemotherapy for breast cancer — improved their memories with the method of loci. As a memory aid, it’s superior to rote memorization and converting items to images alone. Placing those images in a memory palace helps recall.
Before books were common, the method of loci helped lawyers and others retain and recall information necessary for their jobs. The locution “in the first place” is a holdover from this ancient method of memorizing speeches. It works because it harnesses humans’ evolved skill at remembering details of locations, which helped hunter-gatherers recall what was edible and where to find it, and what was poisonous and how to avoid it.
It does not take an extraordinary mind to develop an extraordinary memory. Competitors in memory championships or those seen on Fox’s “Superhuman” — memory athletes — weren’t born with photographic memories. They have practiced for years using the method of loci, supercharged with other mnemonic methods. With them, some can memorize hundreds of random numbers in a few minutes or the order of cards in a deck in tens of seconds. But, as Mr. Foer learned, memory athletes’ memories excel only in areas they’ve trained — they still misplace their keys like the rest of us.
Indeed, science shows that these are normal minds after extraordinary training — the same hardware running different software. Brain anatomy of memory athletes and those without exceptional memories are the same. Because they have trained specifically to recall numbers and faces, memory athletes outperform others in doing so. But recall of magnified images of snow crystals — for which memory athletes have not trained — is identical. After observing a game for five or 10 seconds, master chess players can recall the positions of nearly all the pieces. A novice can recall only a few.The difference is training, not exceptional memory. Shown a random configuration of pieces that could not arise in a game, chess masters are no better than novices at piece position recall.
My commute has become my memory palace, not for groceries, but for aspects of my work. Features of certain landmarks — specific houses and parks I pass — have become loci for them, converted to images and scenes of my own invention. I figuratively walk through my work as I literally walk to it. For example, I associated an analysis of the time patients wait for care with cars waiting at an intersection I cross.
We think memorizing is laborious, boring work because we’ve been taught to do it by rote. You may recall, as I do, countless hours in third grade poring over multiplication tables or, in ninth grade, endlessly conjugating French (or Spanish) verbs, or in 11th grade, incessantly reciting Macbeth’s “Tomorrow, and tomorrow, and tomorrow” soliloquy in the attempt to firmly place them in long-term memory. These brute-force approaches are dull because they’re devoid of any creativity.
In contrast, the best memorizers place the most flamboyant, bizarre, crude and lewd images and scenes (and their actions) in their memory palaces. The more distinctive, the more easily they’re recalled. This is why thePuritans recoiled from the method of loci — they knew students were relying on “impure” and idolatrous imagery — and it fell out of favor as an educational tool. Today our memories are eroded by external memory devices like cellphone cameras and apps.
Now, about that grocery list. In your mind, enter and walk back through your house. What do you see? Can you get all 10 items?