Source: FDA.gov
maithri
Guidelines are in the Eye of the Beholder
Hence we have the new guidelines for PSA testing. (Given that many patients with prostate cancer have normal PSAs and lots of patients with high PSAs don’t have prostate cancer, it doesn’t seem semantically correct to call it “prostate cancer screening”.) Surprise! Turns out that not only does PSA testing not save lives, but that urologists don’t really care. Certainly not enough to stop recommending PSAs to just about everyone they can get their hands on.
Nor do breast surgeons have any intention of modifying their recommendations, not only in light of new understandings of the limitations of mammography, but even as their own treatment recommendations contract, becoming ever more targeted and less invasive. I recently heard a local surgeon speak about the progression from radical mastectomies to partial mastectomies to lumpectomies; from axillary node dissections to sentinel node sampling; from whole-breast radiation to intra-cavitary seeds. Listening to him, breast cancer therapy is becoming downright minimalist.
Yet at the end of the talk, when asked about the new recommendations for biennial mammography, his response was, “Every woman should have an annual mammogram starting at age 40. I mean, there are no downsides to mammography.” Never mind the psychological stress of extra views, ultrasounds, and false positives, not to mention the bruising and even skin tearing that I see far more often than I’d like. “No downsides”? Not for him, that’s for sure. When will they realize that mammography catches slower-growing cancers that would be treated just as easily if they were found a year later? Women die of aggressive tumors that pop up between annual mammograms, which by definition would not be detected by standard screening.
The gynecologists are no better. They all still insist on annual visits for paps to find cancers that take 10 years to grow (and then only in the presence of HPV) and pelvic exams that detect, well, nothing. Whether driven by legal concerns or patient insistence, scientifically unnecessary medical care is running rampant in this country, playing a pivotal role in bankrupting us in the Orwellian name of “the best medical care in the world”.
What to do, though?
The Return of Conservative Medicine
Forty years ago, Dr. Jack Wennberg and colleagues at Dartmouth Medical School published the first of a series of groundbreaking studies of medical resource utilization and practice variations that would eventually become the Dartmouth Atlas of Health Care.
They found huge variations in how often elective surgeries such as tonsillectomies were performed in different parts of New Hampshire, even in neighboring cities and counties.
These geographical variations could not be explained by differences in the demographics or health of patient populations, and outcomes in areas with more surgeries per capita were no better, and sometimes worse, than in those with fewer surgeries. Subsequent studies identified similar unwarranted variations in many other procedures and treatments paid for by Medicare, leading to a consensus among policymakers that the U.S. health system spends hundreds of billions of dollars each year on medical care (termed “waste”) that has no health benefits and often harms patients.
To my profession’s credit, physician organizations are finally taking unprecedented steps to confront the problem of waste in medicine. The American Board of Internal Medicine Foundation’s Choosing Wisely campaign, which asks each partnering group to identify 5 commonly performed tests or treatments that should be questioned by physicians and patients, has signed up more than 50 specialty organizations to date, with more to come in the next several months.
This week, screening and diagnostic experts from all over the world gathered at Dartmouth to discuss strategies for Preventing Overdiagnosis, a problem that is largely created by physicians looking too hard for diseases with imperfect tests that lead to many false positive results and more invasive procedures, such as biopsies. (Even if the tests themselves were perfect, they are often performed in patients who could not possibly benefit from the results, such as patients with terminal cancer.)
But if the problems of medical waste and overdiagnosis are familiar to doctors, most patients are still in the dark about the basics. Continue reading…
Biopharma + Digital Health?
Biopharma – especially big pharma – gets all sorts of grief for being large, stodgy, and unable to innovate (or evolve);this Corey Goodman interview represents the perspective well.
Before writing off these companies entirely, however (an ignorant reaction in any case), it’s important to consider how much experience they have in doing two very difficult, very important things: (a) documenting the medical value of their products through a rigorous series of clinical studies conducted in a highly regulated environment; and (b) navigating their way through a complex maze of stakeholders in order to successfully market their products.
Much of the difficulties facing the industry these days stem not from their lack of regulatory experience or marketing skill, but rather from the intrinsic value proposition of the products they offer; simply put, making an impactful new drug is extremely hard and quite expensive, as Matt Herper’s recent piece makes clear.
My sense is that the view from the digital health/start-up side is in many ways the mirror-image of this: the space seems to be brimming with promising nascent ideas; yet, as I’ve discussed before, the measurable health impact of these technologies is usually unclear (at best).
Some emerging digital health companies don’t worry about this – they are deliberately seeking to circumvent the regulatory process by aiming directly at consumers, and avoiding explicit health claims. Others seem to be leaning pretty heavily on the concept of being so disruptive that, in effect, the world will change for them.
I’d suggest that there still is a huge opportunity for digital companies that are keen to robustly demonstrate health benefits, at the high level of rigor that is standard in the medical products industry.Continue reading…
The Economics of Reimplantation
From The Annals of Internal Medicine doctors from the US have shown that ICDs can be safely resterilized and re-used for indigent patients in another country. In their study, Pavri et al collected 106 ICDs with three or more years of estimated battery life from either deceased patients or patients having devices explanted because of “upgrades” or infection and implanted then in 81 patients in a single hospital in Mumbai, India. From the Methods section of their paper:
We deleted all identifying patient information and lead information; programmed them to nonpacing mode, when possible, or lowered the outputs to the minimum possible values; turned off all sensing and therapies for ventricular tachycardia (VT) and ventricular fibrillation (VF); and deactivated all ICD alerts (auditory and vibratory). When a sufficient number of devices were collected, they were transported to India in batches. Transport was most often done by physicians (or friends and family members of physicians) who were traveling from the United States. The devices were placed in checked-in baggage in a clear plastic bag, and 2 letters were placed in prominent view. The first letter was signed by the donating physician, stating that the devices were of no commercial value and that they were being donated for reuse in patients who could not afford such devices. The second letter was signed by the Chief Executive Officer of Holy Family Hospital, stating that the hospital was expecting the devices for donation to such patients. Contact information for all physicians was provided in the letters.
Attempts at sending explanted devices by courier or mail proved difficult; without precedent, it was simply not possible to describe the purpose and nature of the shipment to shipping authorities or to insure the contents. We finally resorted to carrying the devices during travel to India in our personal baggage, as described. Some difficulties (requiring lengthy explanations) were encountered during baggage screening and, especially, at Customs in Mumbai.
Money, Medicine and Ethics
The American College of Physicians has published their updated manual on ethics for physicians and the following passage is causing quite a stir:
Physicians have a responsibility to practice effective and efficient health care and to use health care resources responsibly. Parsimonious care that utilizes the most efficient means to effectively diagnose a condition and treat a patient respects the need to use resources wisely and to help ensure that resources are equitably available.
On the right, American Enterprise Institute scholar Scott Gottlieb writes “Parsimonious, to me, implies an element of stinginess, and stinginess implies an element of subterfuge.” (Quote of the Day in American Health Line.)
On the left, Aaron Carroll writes:
I would fight tooth and nail to get anything — and I mean anything — to save [his own child]. I’d do it even if it cost a fortune and might not work. That’s why I don’t think you should leave these kinds of decisions up to the individual. Every single person feels the way I do about every single person they love, and no one will ever be able to say no. That’s human.
Similarly, I don’t think that it’s necessarily fair to make it a physician’s responsibility. I also want my child’s doctor to fight tooth and nail to get anything that might save my child. Many times, physicians have long-standing relationships with patients. Asking them to divorce themselves from the very human feelings that compel them to do anything that might help their patients is not something that I think will necessarily improve the practice of medicine. They also should be human.
So whose job is it? Well, mine for instance. That’s what I do as a health services researcher. That’s what policy makers should also do….
That’s a roundabout way of saying that only the government can ration care the right way. Here is Don Taylor’s (Incidental Economist) take on the subject.
My view: people in health care have become so completely immersed in the idea of third-party payment that they have completely lost sight of the whole idea of agency.
[youtube]http://www.youtube.com/watch?v=BQMI7TksYo0&feature=player_embedded[/youtube]
This game of life I play
Living and dying with the choices I made
Can you imagine a lawyer discussing the prospects of launching a lawsuit without bringing up the matter of cost? What about an architect submitting plans for a building but completely ignoring what it would cost to build it? Outside of medicine, can you imagine any professional anywhere discussing any project with a client and pretending that money doesn’t matter? Of course not.
Then what is so special about medicine? Answer: the field has been completely corrupted by the idea that (a) patients should never be in a position to choose between health benefits and monetary cost, (b) doctors shouldn’t have to think about such tradeoffs either, (c) in order to insulate the patient from having to choose between health care and other uses of money, third-party payers should pay all the medical bills and (d) since no one else is going to think about what anything costs, the third-party payer is the only entity left to decide which services are worthwhile and which ones aren’t.
To appreciate how doctors could do the same thing other professionals do in advising patients on how to spend their own money, take a look at the graphic below. These numbers are several years old and there may be more recent studies, but the graphic will serve our heuristic purpose. Armed with this information, what would a responsible doctor tell her patient about Pap smears and how often the patient should get them?
Source: Tammy O. Tengs et al., “Five Hundred Lifesaving Interventions and Their Cost-Effectiveness,” Risk Analysis, June 1995.
Note that getting a Pap smear every four years (versus never getting one) costs $12,000 per year of life saved, when averaged over the whole population. What the responsible doctor should say is, “In the risk avoidance business, this is a really good buy. Based on choices people like you make in other walks of life, this is a good decision. This type of risk reduction is well worth what it costs.”
What about getting the test every three years (versus every four) or every two years (versus every three)? Here the doctor should say, “Now we are moving toward the upper boundary of what most other people are willing to spend to avoid various kinds of risks. So at this point, serious thought needs to be given to whether the test is really worth what it cost.”
How about getting the test done every year (versus every two years)? Here the responsible doctor will say, “This is definitely a bad buy (unless there is some specific indication). The cost of an annual Pap smear in relation to the amount of risk reduction achieved is way outside the range of choices most people make with respect to other risks.”
Notice what is going on here. The responsible doctor, functioning as an agent of a patient who is not familiar with the medical literature and who is not skilled at evaluating risks or trading off risk reduction for other uses of money, advises her patient in these matters. She helps her patient manage both her health and her money — because both are important.
When Dr. Carroll says “I’d do it even if it cost a fortune and might not work,” I am sure he is being sincere. But I am equally sure that is not how he normally makes decisions. It is in fact easy to spend a fortune to avoid small-probability events. The EPA makes the private sector do it every day. But if an ordinary family tried that, they would end up spending their entire income avoiding trivial risks. And that is not what normal people do.
Here is another example of a money-is-no-object-no-matter-how-improbable-the-prospects-if-life-and-death-are-at-sake choice. This is Zeke Emanuel, writing in The New York Times the other day:
Proton beam therapy is a kind of radiation used to treat cancers. The particles are made of atomic nuclei rather than the usual X-rays, and theoretically can be focused more precisely on cancerous tissue, minimizing the danger to healthy tissue surrounding it. But the machines are tremendously expensive, requiring a particle accelerator encased in a football-field-size building with concrete walls. As a result, Medicare will pay around $50,000 for proton beam therapy for a patient with prostate cancer, roughly twice as much as it would if the patient received another type of radiation.
Emanuel claims there is no evidence the treatment works for prostate cancer — so the therapy is a waste of $25,000. Is he right? I don’t know. If you’re paying the extra $25,000 out of your own pocket, listen to what the doctors at Mayo have to say (in favor of its use) and then listen to what Emanuel has to say and make up your own mind.
Bottom line: helping patients manage their health dollars as well as their health care should be what doctoring is all about.
John C. Goodman, PhD, is president and CEO of the National Center for Policy Analysis. He is also the Kellye Wright Fellow in health care. His Health Policy Blog is considered among the top conservative health care blogs where health care problems are discussed by top health policy experts from all sides of the political spectrum.
Penn State’s Wellness Disaster: How to Avoid Employee Rejection of Wellness Programs–and Even Get Buy-In
One of the lessons I frequently relearn in life is that people do not want unsolicited advice. An example that most parents can relate to is that my 6-year-old daughter does not want my help tying her shoes, even when we’re running late. Similarly, most employees — and certainly their dependents — do not believe they need to change how they manage their health.
This is why Penn State’s moderately structured, but poorly executed, wellness program failed so disastrously. The recent New York Times article about the program reports that “[a]fter weeks of vociferous objections by faculty members” University President Rodney A. Erickson—not the human resources leadership—announced it was abandoning the $1,200 annual surcharge levied against employees who refused to meet certain requirements. Those requirements included filling out a health risk assessment (HRA), participating in a biometric screening, and getting a medical check-up.
Human resources professionals’ fear of this type of outcome prevents many potentially meaningful and engaging wellness programs from even being introduced. To overcome this inherent resistance to wellness, broad employee understanding and support of the program is a prerequisite. The administrators at Penn State failed to attain this goal. Wellness — like any major change — cannot solely be a top-down effort, launched with a letter from the president, especially at consensus-driven academic institutions.
At Penn State, the outcome could have been successful if leaders had built a consensus prior to launching that wellness programs can save lives, reduce costs and improve performance. This is not the type of organization where decisions can be defended by saying: “This program is the one recommended by our health insurer.”
Building consensus for better outcomes
Through consensus-building, Miami University in Ohio successfully launched its voluntary health risk assessment, biometric screening and doctor visit program in 2010 and transitioned to a premium discount program in 2011. Premium discounts started at $15 per month and increased to $45 per month in 2013. More than 85 percent of the covered faculty and dependents participate in the program, and age-specific preventive screenings have increased substantially. The top three factors contributing to Miami University’s success are communication, consistency, and C-suite and departmental manager support.
The ACA’s Crucial Prevention Component
Concern around the Affordable Care Act has reached a fever pitch, as Republican members of the House have succeeded at shutting down the government because the law has not been defunded or delayed. Meanwhile, a handful of states continue their efforts to undermine its implementation, which begins this week. While I by no means want to downplay the urgency of this situation, I would like to offer some reassurance as to the patient’s ultimate prognosis — as long as we remain committed to funding public health prevention efforts.
From 2000 to 2006, I served as minister of health in Mexico, where I spearheaded Seguro Popular, a comprehensive national health insurance program that enrolled more than 52 million previously uninsured persons, achieving universal coverage in less than a decade. In Mexico, as in the United States, introducing such a fundamental reform meant confronting special interests, making pragmatic trade-offs, and facing seemingly insurmountable challenges.
Every health system reform in an advanced nation has gone through such valley-of-death moments. That is the nature of the political process. For a variety of reasons, the United States is coming late to the global movement for expanded health care, the only one of the world’s 25 wealthiest nations lacking some form of universal care as of last year. National reforms inevitably go through great transitions, from vision to legislation, and then from legislation to implementation.
There is always a gap between the ideal vision and the ultimate design — and there are always times of fear that the whole endeavor will collapse under the weight of competing interests. Importantly, there is also no end to the reform process as every nation’s health system continuously evolves.
I believe that the Affordable Care Act will survive this current crisis.
The Power of Small
Everywhere we turn these days it seems “Big Data” is being touted as a solution for physicians and physician groups who want to participate in Accountable Care Organizations, (ACOs) and/or accountable care-like contracts with payers.
We disagree, and think the accumulated experience about what works and what doesn’t work for care management suggests that a “Small Data” approach might be good enough for many medical groups, while being more immediately implementable and a lot less costly. We’re not convinced, in other words, that the problem for ACOs is a scarcity of data or second rate analytics. Rather, the problem is that we are not taking advantage of, and using more intelligently, the data and analytics already in place, or nearly in place.
For those of you who are interested in the concept of Big Data, Steve Lohr recently wrote a good overview in his column in the New York Times, in which he said:
“Big Data is a shorthand label that typically means applying the tools of artificial intelligence, like machine learning, to vast new troves of data beyond that captured in standard databases. The new data sources include Web-browsing data trails, social network communications, sensor data and surveillance data.”
Applied to health care and ACOs, the proponents of Big Data suggest that some version of IBM’s now-famous Watson, teamed up with arrays of sensors and a very large clinical data repository containing virtually every known fact about all of the patients seen by the medical group, is a needed investment. Of course, many of these data are not currently available in structured, that is computable, format. So one of the costly requirements that Big Data may impose on us results from the need to convert large amounts of unstructured or poorly structured data to structured data. But when that is accomplished, so advocates tell us, Big Data is not only good for quality care, but is “absolutely essential” for attaining the cost efficiency needed by doctors and nurses to have a positive and money-making experience with accountable care shared-savings, gain-share, or risk contracts.
Facebook Is Bad For You. And Giving Up Using It Will Make You Happier
In the past few years, the fortunate among us have recognised the hazards of living with an overabundance of food (obesity, diabetes) and have started to change our diets. But most of us do not yet understand that Facebook is to the mind what sugar is to the body. Facebook feed is easy to digest. It has made it easy to consume small bites of trivial matter, tidbits that don’t really concern our lives and don’t require thinking. That’s why we experience almost no saturation. Unlike reading books and long magazine articles (which require thinking), we can swallow limitless quantities of photos and status updates, which are bright-coloured candies for the mind. Sadly, we are still far away from beginning to recognise how toxic Facebook can be.
