An exciting movement known as "culture change" is sweeping through nursing homes. It seeks to transform nursing homes into homey environments that focus on what residents want, not what's best for the institution and its staff. They are supposed to let residents decide what they want to do--when they want to get up, when to have meals, what they'd like to eat, and how they spend their days. To this end, staff are empowered (they are supposed to get to know the residents for whom they provide care so they can figure out how best to help them) and cross-trained (all staff members perform all tasks, like a family rather than an institution). A recent study found that fully 85% of directors of nursing in a large sample of nursing homes say that their facilities have incorporated at least some features of culture change, compared to 56% in a study done by the Commonwealth Fund in 2008. But does culture change succeed in improving quality of life?
My father lives in a nursing home that is supposed to fully embody culture change. The facility is beautiful. Almost every resident has a private room. The building is carved up into "households" of only 14-15 residents. Life in the household is organized around a bright "country kitchen," similar to what many people experienced in their own homes. But as a home that is supposed to enhance well-being, it is unequivocally a failure.
My dad is 89 years old and has moderate dementia and Parkinson's. Like most of the people in his household, he needs help with the most basic activities--going to the bathroom, getting dressed, bathing, and walking. He cannot initiate activities. He expresses no interest in the various events that take place in the building such as concerts or discussion groups, so unless a visitor takes him, he does not attend. He used to spend most of his time in his room, looking at the New York Times or watching television; because he sometimes got up without calling for help and often fell, he is now required to spend all day sitting at the dining room table where the staff can keep an eye on him. He has nothing to do other than watch a large screen TV that is on continuously and study the daily "schedule of events" (none of which he attends) that is distributed to each resident.
As a group, the nursing assistants at this nursing home are kind and gentle and provide adequate personal care--though they often neglect to put in my father's hearing aid, forget to shave him, do not take him to the bathroom with sufficient regularity to avoid accidents, and leave him wearing soiled clothes. They do not try to engage him in conversation or come up with suggestions for how he might spend his time.
My father lives in an extremely high end facility that was designed from its inception to implement resident-centered care. Perhaps the facility succeeds with the small minority of residents who have no cognitive impairment. Perhaps the facility succeeds with residents who are mobile. The idea behind culture change is inspiring. But either it doesn't work or its implementation is tremendously flawed. In either case, it's time for high quality research to monitor the outcomes of culture change and to figure out what needs to be done to make the dream a reality.
June 02, 2013
The Truth About Prognosis
We've known for years that cancer patients think their life expectancy is considerably greater than it really is--and that their oncologists think it is. This kind of wishful thinking has serious consequences: patients who believe they have years to live are likely to want their doctors to do everything possible to prolong their lives, even if the treatment is painful and risky. Patients who believe their time is very limited tend to want their doctors to provide treatment geared to promoting quality of life. This past week, a new study published in JAMA Internal Medicine by Melissa Wachterman and colleagues reports a similar gap between dialysis patients and their nephrologists.
A small group of dialysis patients (half of whom were over age 70) were interviewed along with their kidney doctors. The patients were significantly more likely than the doctors to believe they would be alive in one year or in five years, and were almost twice as likely as their doctors to think they were candidates for a kidney transplant. As with cancer patients, the majority of kidney failure patients who were pretty sure they would be alive in a year wanted medical treatment focused on extending life (though just under half did not) but fewer than ten percent of those patients who were not so sure they would live a year wanted a focus on life prolongation.
This study confirms how important it is for patients to understand the nature of their illness. All too often, physicians try to determine their patients' goals of care and corresponding treatment preferences without first making sure patients know their prognosis. But people rarely have fixed views about what is best for them--whether living longer or being comfortable or remaining independent is paramount depends on their situation. Physicians need to be clear with their patients about what they can expect and patients should push their doctors to tell them.
What is not addressed in the Wachterman study--and what may be even more important for patients to grasp if they are to make informed decisions about treatment--is the overall trajectory of their illness, not just prognosis in the narrow sense of survival time. Patients need to know in general terms what they are likely to experience in the coming weeks, months, or years: will they be able to stay at home or will they need extensive personal assistance, perhaps living in a nursing home? Will they need to spend a lot of time in the hospital? Are they likely to experience frequent relapses followed by improvement or should they anticipate a slow downward slide? Planning for future care is tremendously important for every person with a serious illness. And gaining a good understanding of one's general medical condition is the crucial first step in advance care planning.
A small group of dialysis patients (half of whom were over age 70) were interviewed along with their kidney doctors. The patients were significantly more likely than the doctors to believe they would be alive in one year or in five years, and were almost twice as likely as their doctors to think they were candidates for a kidney transplant. As with cancer patients, the majority of kidney failure patients who were pretty sure they would be alive in a year wanted medical treatment focused on extending life (though just under half did not) but fewer than ten percent of those patients who were not so sure they would live a year wanted a focus on life prolongation.
This study confirms how important it is for patients to understand the nature of their illness. All too often, physicians try to determine their patients' goals of care and corresponding treatment preferences without first making sure patients know their prognosis. But people rarely have fixed views about what is best for them--whether living longer or being comfortable or remaining independent is paramount depends on their situation. Physicians need to be clear with their patients about what they can expect and patients should push their doctors to tell them.
What is not addressed in the Wachterman study--and what may be even more important for patients to grasp if they are to make informed decisions about treatment--is the overall trajectory of their illness, not just prognosis in the narrow sense of survival time. Patients need to know in general terms what they are likely to experience in the coming weeks, months, or years: will they be able to stay at home or will they need extensive personal assistance, perhaps living in a nursing home? Will they need to spend a lot of time in the hospital? Are they likely to experience frequent relapses followed by improvement or should they anticipate a slow downward slide? Planning for future care is tremendously important for every person with a serious illness. And gaining a good understanding of one's general medical condition is the crucial first step in advance care planning.
Back in Business
After a one-year hiatus, I am returning to blogging. "Perspectives on Aging" has been reborn as "Life in the End Zone." It is intended for anyone interested in issues arising in life's final stage: people with advanced illness or old age, their friends and family members, policy-makers, and clinicians. I plan to publish one short post each week, typically a response to an article in the medical literature or a report in the media. In honor of the blog's rebirth, and thanks to Google and the wonders of technology, the blog has a new look. Please send me feedback about both the appearance and the content of "Life in the End Zone."
May 23, 2012
The Truth About Tube-Feeding
For the last 15 years, physicians have raised questions about the efficacy of artificial nutrition—tube-feeding—in individuals with advanced dementia. Study after study of the outcomes of feeding tubes in patients with advanced dementia has failed to show any measurable benefit. But despite the
mounting evidence, feeding tubes continue to be used. For the first time, a study has been published concluding that not only do feeding tubes fail to benefit people with advanced dementia, they actually harm them. In fact, they seem to cause one of the conditions they are intended to prevent, pressure ulcers. But is it true?
Advanced dementia is a progressive neurological condition in which there is gradual loss of all the most basic capacities, including the ability to speak, to use the bathroom independently, to walk, and to eat. Fully 86% of nursing home residents who develop advanced dementia also develop difficulty eating. Once the technology for artificial feeding became simple and widespread—a feeding tube is inserted into the stomach through a minor surgical procedure and allows liquid nutritional supplements to enter the body directly, bypassing the need for the person to chew or swallow food—the temptation to use it in anyone who couldn’t eat was irresistible, regardless of whether the cause of the problem eating was a temporary, post-surgical condition, a congenital abnormal of the gastrointestinal system or, as with dementia, an end-of-life condition. In particular, tube feeding was used in patients with advanced dementia even though it does not prevent aspiration pneumonia, a common cause of death in demented individuals in which food goes into the lungs instead of the stomach; it does not prevent pressure ulcers, another common condition in which skin breaks down due to immobility; and it does not prolong life. Tube feeding nonetheless continues to be used because families find nutrition of symbolic importance as a means of demonstrating caring, because many physicians and families are skeptical of the clinical data, none of which are based on randomized, controlled studies, and in part because it is financially advantageous for nursing homes to tube feed demented residents than to hand feed them.
The trouble is that without a randomized trial, in which roughly half the patients are arbitrarily chosen to receive a feeding tube and the other half do not, it’s very difficult to be sure that whatever outcome is measured—whether it is pressure ulcer development or survival or anything else—is directly
related to the feeding tube. And physicians and families have been extremely reluctant to randomize patients with advanced dementia in this way to definitively answer the question. After all, the patients are profoundly cognitively impaired and unable to make decisions about whether to accept tube feeding. Their caregivers, who must make decisions on their behalf, tend to have strong feelings about tube feeding, as do their physicians. The current study attempts to circumvent the problem of bias due to non-randomization through several ingenious strategies: the patients with feeding tubes are “propensity-matched” to patients who did not get feeding tubes (the two groups are similar in terms of the major characteristics associated with the development of pressure ulcers); and patients must have recently developed advanced dementia to be enrolled in the study (the two groups are therefore similar in the stage of their disease based on standardized, federally mandated assessments performed every few months in all nursing homes).
Using a large database of just over 18,000 nursing home residents with advanced dementia, the authors of the new study were able to identify 1124 patients in whom a feeding tube was inserted and who had no pressure ulcers initially and match them with 2082 other nursing home residents who did not
receive a feeding tube and who also had no pressure ulcers. The two groups were comparable in their other medical conditions and in their risk factors for developing skin breakdown. Their six-month mortality rate was likewise similar, though it was slightly higher in the residents without feeding tubes (24.0%) than in those with feeding tubes (20.6%). The striking finding was that the risk of developing a new pressure ulcer (stage 2 or higher: ulcers are graded from stage 1, which is minimal skin erosion, to stage 4, in which the ulcer extends deep into the muscle or bone) was a shocking 35.6% in residents with gastrostomy tubes and only 19.8% in those without.
The new study also looked at whether feeding tubes could help heal existing pressure ulcers. Using an identical procedure, the authors identified 461 nursing home residents who had a pressure ulcer (stage 2 or higher) at the time the feeding tube was inserted and compared them to another similar group of 461 residents with a pressure ulcer but no feeding tube. Surprisingly, pressure ulcers improved in 34.6% of the residents without a gastrostomy tube, but in only 27.1% of those with the tube.
Prior studies have demonstrated that feeding tubes don’t help. But could it be true that feeding tubes actually make nursing home residents with advanced dementia worse off? The study’s authors try to explain their counterintuitive findings by suggesting that individuals with dementia who get a feeding tube may be physically restrained to prevent them from pulling out the tube and that the restraints impair mobility, predisposing to pressure ulcers. But this group had very limited mobility even before they had a feeding tube. The authors argue that tube feedings (the liquid dripped into the stomach through the gastrostomy tube) can cause diarrhea, which may accelerate pressure ulcer formation, but they provide no evidence that the patients in their study actually had diarrhea.
What I think is more likely, although I cannot prove this hypothesis, is that feeding tubes are just a marker for an aggressive approach to care and that it was that aggressive approach that led to the higher rate of pressure ulcers. After all, the patients in the Archives study were not randomized to receive a
gastrostomy tube. They got a tube because their families and their physicians believed that medical interventions were appropriate care for patients with advanced dementia. These medical interventions no doubt included a variety of strategies, of which feeding tubes were only one example. The current
study says nothing about what other interventions, aside from the feeding tube, the nursing home residents received after enrollment. But in a landmark study of the natural history of advanced dementia carried out by some of the same authors,fully 41% of nursing home residents with advanced dementia underwent at least one burdensome intervention in the last months of life: either a hospitalization, a visit to the emergency room, intravenous therapy, or a feeding tube. Undoubtedly, patients who were treated with one of those modalities were often treated with several of them. It seems plausible that it was the various aggressive medical treatments given to the nursing home residents with advanced dementia that caused them to develop new or non-healing pressure ulcers, not necessarily the tube feeding in isolation. It is even possible that tube feeding alone could have been beneficial, but it was typically administered in concert with a variety of other measures that produced harm.
So what can we conclude about tube feeding in advanced dementia? Without a randomized trial, we still do not know for sure what clinical outcomes, if any, tube feeding alters. Perhaps the time has come to focus on the indisputable fact that advanced dementia is a terminal condition and that only those measures that are inextricably associated with preserving the patient’s dignity and comfort, such as keeping the person warm and clean and clothed, are appropriate.
mounting evidence, feeding tubes continue to be used. For the first time, a study has been published concluding that not only do feeding tubes fail to benefit people with advanced dementia, they actually harm them. In fact, they seem to cause one of the conditions they are intended to prevent, pressure ulcers. But is it true?
Advanced dementia is a progressive neurological condition in which there is gradual loss of all the most basic capacities, including the ability to speak, to use the bathroom independently, to walk, and to eat. Fully 86% of nursing home residents who develop advanced dementia also develop difficulty eating. Once the technology for artificial feeding became simple and widespread—a feeding tube is inserted into the stomach through a minor surgical procedure and allows liquid nutritional supplements to enter the body directly, bypassing the need for the person to chew or swallow food—the temptation to use it in anyone who couldn’t eat was irresistible, regardless of whether the cause of the problem eating was a temporary, post-surgical condition, a congenital abnormal of the gastrointestinal system or, as with dementia, an end-of-life condition. In particular, tube feeding was used in patients with advanced dementia even though it does not prevent aspiration pneumonia, a common cause of death in demented individuals in which food goes into the lungs instead of the stomach; it does not prevent pressure ulcers, another common condition in which skin breaks down due to immobility; and it does not prolong life. Tube feeding nonetheless continues to be used because families find nutrition of symbolic importance as a means of demonstrating caring, because many physicians and families are skeptical of the clinical data, none of which are based on randomized, controlled studies, and in part because it is financially advantageous for nursing homes to tube feed demented residents than to hand feed them.
The trouble is that without a randomized trial, in which roughly half the patients are arbitrarily chosen to receive a feeding tube and the other half do not, it’s very difficult to be sure that whatever outcome is measured—whether it is pressure ulcer development or survival or anything else—is directly
related to the feeding tube. And physicians and families have been extremely reluctant to randomize patients with advanced dementia in this way to definitively answer the question. After all, the patients are profoundly cognitively impaired and unable to make decisions about whether to accept tube feeding. Their caregivers, who must make decisions on their behalf, tend to have strong feelings about tube feeding, as do their physicians. The current study attempts to circumvent the problem of bias due to non-randomization through several ingenious strategies: the patients with feeding tubes are “propensity-matched” to patients who did not get feeding tubes (the two groups are similar in terms of the major characteristics associated with the development of pressure ulcers); and patients must have recently developed advanced dementia to be enrolled in the study (the two groups are therefore similar in the stage of their disease based on standardized, federally mandated assessments performed every few months in all nursing homes).
Using a large database of just over 18,000 nursing home residents with advanced dementia, the authors of the new study were able to identify 1124 patients in whom a feeding tube was inserted and who had no pressure ulcers initially and match them with 2082 other nursing home residents who did not
receive a feeding tube and who also had no pressure ulcers. The two groups were comparable in their other medical conditions and in their risk factors for developing skin breakdown. Their six-month mortality rate was likewise similar, though it was slightly higher in the residents without feeding tubes (24.0%) than in those with feeding tubes (20.6%). The striking finding was that the risk of developing a new pressure ulcer (stage 2 or higher: ulcers are graded from stage 1, which is minimal skin erosion, to stage 4, in which the ulcer extends deep into the muscle or bone) was a shocking 35.6% in residents with gastrostomy tubes and only 19.8% in those without.
The new study also looked at whether feeding tubes could help heal existing pressure ulcers. Using an identical procedure, the authors identified 461 nursing home residents who had a pressure ulcer (stage 2 or higher) at the time the feeding tube was inserted and compared them to another similar group of 461 residents with a pressure ulcer but no feeding tube. Surprisingly, pressure ulcers improved in 34.6% of the residents without a gastrostomy tube, but in only 27.1% of those with the tube.
Prior studies have demonstrated that feeding tubes don’t help. But could it be true that feeding tubes actually make nursing home residents with advanced dementia worse off? The study’s authors try to explain their counterintuitive findings by suggesting that individuals with dementia who get a feeding tube may be physically restrained to prevent them from pulling out the tube and that the restraints impair mobility, predisposing to pressure ulcers. But this group had very limited mobility even before they had a feeding tube. The authors argue that tube feedings (the liquid dripped into the stomach through the gastrostomy tube) can cause diarrhea, which may accelerate pressure ulcer formation, but they provide no evidence that the patients in their study actually had diarrhea.
What I think is more likely, although I cannot prove this hypothesis, is that feeding tubes are just a marker for an aggressive approach to care and that it was that aggressive approach that led to the higher rate of pressure ulcers. After all, the patients in the Archives study were not randomized to receive a
gastrostomy tube. They got a tube because their families and their physicians believed that medical interventions were appropriate care for patients with advanced dementia. These medical interventions no doubt included a variety of strategies, of which feeding tubes were only one example. The current
study says nothing about what other interventions, aside from the feeding tube, the nursing home residents received after enrollment. But in a landmark study of the natural history of advanced dementia carried out by some of the same authors,fully 41% of nursing home residents with advanced dementia underwent at least one burdensome intervention in the last months of life: either a hospitalization, a visit to the emergency room, intravenous therapy, or a feeding tube. Undoubtedly, patients who were treated with one of those modalities were often treated with several of them. It seems plausible that it was the various aggressive medical treatments given to the nursing home residents with advanced dementia that caused them to develop new or non-healing pressure ulcers, not necessarily the tube feeding in isolation. It is even possible that tube feeding alone could have been beneficial, but it was typically administered in concert with a variety of other measures that produced harm.
So what can we conclude about tube feeding in advanced dementia? Without a randomized trial, we still do not know for sure what clinical outcomes, if any, tube feeding alters. Perhaps the time has come to focus on the indisputable fact that advanced dementia is a terminal condition and that only those measures that are inextricably associated with preserving the patient’s dignity and comfort, such as keeping the person warm and clean and clothed, are appropriate.
March 01, 2012
Birth Control is a Medicare Issue
The battle over whether contraception is a basic benefit that must be included in any American health care plan has been called a lot of things. It’s been called a fight about religious liberty. It’s been called a fight about women’s health. Some have suggested it’s just an excuse for attacking the Affordable Care Act, Obama’s signature first-term achievement. No doubt it is all these things. But it is also, most dangerously, an attack on the concept of delineating “basic medical care.” And coming up with a single definition of basic care—and implicitly determining the essential insurance benefits that cover such care—is critical for the Medicare population, along with the rest of the country.
For universal coverage to work, either medical care must be provided directly by a centralized authority or medical care can be provided by the private sector, but government requires insurance coverage. The easiest way to achieve the latter is through single-payer insurance (Medicare-for-all); the US has rejected this option and chosen instead a decentralized approach: it is retaining its system of private health plans. It is not, contrary to widespread propaganda, offering government-run, top-down health care, or even a government-run health insurance program. If the system of multiple health insurance plans is to persist, AND coverage is to be truly universal, those plans must conform to national standards for what constitutes basic medical care. This is true however universality is achieved—whether it’s by a mandate or by a “health tax” that in turn gives a person a voucher to purchase insurance coverage.
The alternative to defining basic medical care is a system in which insurance companies can deny coverage for just about anything. They can institute the notorious pre-existing conditions exclusion. They can opt not to cover a variety of diagnoses, from prenatal care to alcoholism, to cancer, so as to avoid paying for conditions that are expensive under the guise of moral repugnance. This would make a mockery of “universal” coverage.
If we wish to retain the private health insurance system, and apparently this is what the US has decided on, insurance plans have to meet certain conditions. They have to be regulated. They can’t exclude coverage for pre-existing conditions. They have to provide a drug benefit. In short, they have to cover “standard medical care,” which means we must achieve a consensus about what standard medical care is.
Defining a standard is not such a terribly radical idea. The concept of basic benefits is well-established internationally. Developing countries have even endorsed the concept of “essential medicines,” or those drugs that make up basic medical care for a particular population.
Allowing a contraceptive exclusion and a host of other coverage limitations, ostensibly on moral grounds, undermines the very concept of basic benefits, the concept that is at the core of any universal coverage system. Medicare today is mandated by law to provide coverage for treatments that are “reasonable and necessary.” It is increasingly clear that this, too, involves defining what constitutes “essential treatment” or “basic benefits.” Medicare will become sustainable when it guarantees coverage for the basics and allows patients to decide about everything else. That’s the way it should be. Attacking the idea of basic benefits, which is what the contraceptive battle amounts to, is dangerous to the health of all of us.
For universal coverage to work, either medical care must be provided directly by a centralized authority or medical care can be provided by the private sector, but government requires insurance coverage. The easiest way to achieve the latter is through single-payer insurance (Medicare-for-all); the US has rejected this option and chosen instead a decentralized approach: it is retaining its system of private health plans. It is not, contrary to widespread propaganda, offering government-run, top-down health care, or even a government-run health insurance program. If the system of multiple health insurance plans is to persist, AND coverage is to be truly universal, those plans must conform to national standards for what constitutes basic medical care. This is true however universality is achieved—whether it’s by a mandate or by a “health tax” that in turn gives a person a voucher to purchase insurance coverage.
The alternative to defining basic medical care is a system in which insurance companies can deny coverage for just about anything. They can institute the notorious pre-existing conditions exclusion. They can opt not to cover a variety of diagnoses, from prenatal care to alcoholism, to cancer, so as to avoid paying for conditions that are expensive under the guise of moral repugnance. This would make a mockery of “universal” coverage.
If we wish to retain the private health insurance system, and apparently this is what the US has decided on, insurance plans have to meet certain conditions. They have to be regulated. They can’t exclude coverage for pre-existing conditions. They have to provide a drug benefit. In short, they have to cover “standard medical care,” which means we must achieve a consensus about what standard medical care is.
Defining a standard is not such a terribly radical idea. The concept of basic benefits is well-established internationally. Developing countries have even endorsed the concept of “essential medicines,” or those drugs that make up basic medical care for a particular population.
Allowing a contraceptive exclusion and a host of other coverage limitations, ostensibly on moral grounds, undermines the very concept of basic benefits, the concept that is at the core of any universal coverage system. Medicare today is mandated by law to provide coverage for treatments that are “reasonable and necessary.” It is increasingly clear that this, too, involves defining what constitutes “essential treatment” or “basic benefits.” Medicare will become sustainable when it guarantees coverage for the basics and allows patients to decide about everything else. That’s the way it should be. Attacking the idea of basic benefits, which is what the contraceptive battle amounts to, is dangerous to the health of all of us.
January 06, 2012
Is Heavy Metal Hip?
Type “metal-on-metal hip replacement” into your favorite search engine, and you will bring up dozens of hits from personal injury lawyers. These devices, initially touted as being more durable than conventional metal and plastic or metal and ceramic versions, have proved to be considerably less reliable. A substantial proportion produce problems within a few years after insertion: either the device fails, causing pain and disability, and needs to be replaced (necessitating another operation) or it sheds tiny metal flakes into the circulation, triggering both local inflammation and systemic illness. The British Orthopedic Association reported in 2011 that metal-on-metal (MoM) devices had a shocking 21% failure rate within 4 years and a 49% failure rate at 6 years. Several products have been taken off the market. The cost of replacing the joints is expected to reach billions of dollars in the coming years, and that doesn’t include the human suffering or lost productivity. What happened?
In discussing the perils of metal-on-metal hips, it’s critical to recognize that hip replacement surgery has been an enormous boon to aging Americans. Osteoarthritis, or wear and tear arthritis, is found in 50% of people over age 65, making it one of the most common chronic diseases of older people. It can cause pain and difficulty walking, debilitating symptoms that are often completely alleviated by replacing the worn out joint. And while hip replacement surgery has been around for decades, it has been plagued by the risk of hip dislocation or the artificial joint itself wearing out. Hence the holy grail of hip replacement surgery has been a hip made of better materials and with a better design. Metal-on-metal hip prostheses were once thought to be the answer to the orthopedist’s prayers.
Something else stimulated development of metal-on-metal hip joints as well as the desire for an improved device. With the benefits of surgery well established, the number of hip replacement operations remained fairly stable in the 1990s (adjusting for the aging of the population). Device manufacturers realized that if they could make a joint that lasted longer than the 15 years expected with conventional devices, they could increase sales by marketing to a younger population. Metal-on-metal hip prostheses, in which both the ball (femoral head) and the socket (acetabulum) are removed and replaced with metal parts, seemed to fit the bill; mechanical stimulation studies in the laboratory suggested they would last longer than existing devices.
The new MoM hips were rapidly introduced into practice and the total number of operations performed each year soared. Estimates from Kaiser Permanente, a large multi-specialty group practice that decided to keep track of all joint replacements in their patients, are that 35-40% of all joint replacements are now done in people under 65. Then anecdotal reports of early device failure began appearing. Device manufacturers initially denied any problems associated with MoM hips but in 2007, the Australian National Joint Replacement Registry reported a higher rate of hip revision surgery with MoM devices. Finally, in August, 2010, DePuy Orthopedics, a subsidiary of the giant Johnson & Johnson, recalled its MoM total hip implant system. A total of 90,000 people had had the device inserted, just about half of them in the US.
What is striking in this saga is that no randomized controlled trials comparing MoM hip joints to existing models were required for Food and Drug Administration (FDA) approval. Since the FDA considered these devices only “moderate risk” and since they regarded them as “substantially equivalent” to existing devices, only the most cursory approval process was necessary to bring them to market. High risk or radically new devices, by contrast, undergo rigorous pre-market testing, often involving sophisticated—and expensive—randomized clinical trials. To demonstrate “substantial equivalence,” all that’s required is to show that the new device has the same intended use as an existing device and the same technological characteristics. The FDA uses this expedited “510(k)” review process for an estimated 90% of the devices it approves. (A related surgical approach, but which did require a full premarket review, involves hip “resurfacing” rather than total hip replacement. This technique has also met with difficulties when the head of the femur is capped with metal rather than plastic, but it is not the subject of this article.)
In light of several well-publicized recalls of devices that entered clinical use via the 510(k) route, the FDA requested a review of the expedited review process. The review was conducted by the Institute of Medicine (IOM), a widely respected, not-for-profit, independent organization dedicated to providing advice to government policymakers. The IOM report was released last summer. Its conclusions were clear: “The committee finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life.” Would this kind of approach, transparent and based on sound science, have avoided the MoM fiasco? \
If MoM artificial hips had been compared to existing products in a randomized controlled trial, flaws would likely have emerged early. While most of the device failures take five years to develop, much longer than the duration of a typical clinical trial, data from the British National Joint Registry suggest there are signs of trouble much earlier. For women aged 60-69, the Registry the revision rate for cemented hips one year after initial insertion is .65%; the revision rate for metal on metal hips in this population is 1.42%, or more than double. By year three, the gap is even more impressive: 1.32% of cemented hips require revision compared to 4.11% of MoM joints, a near tripling of the rate.
Adequate pre-market testing would have raised red flags; systematic post-market surveillance, which is non-existent in the US, would have revealed any problems that had escaped early detection. The Australians, who maintain a Registry of all the artificial joints inserted in their population, observed a spike in surgical revisions after hip replacement in 2007, with the highest revision rates in MoM joints, and the British reported a similar finding based on their Registry soon afterwards. A US database, which would have been far larger, might have detected problems even more quickly.
Any rational observer would conclude that our story will have a happy ending: the recommendations of the IOM committee will be implemented by Congress, we will have a new improved regulatory process for medical devices. Tales such as the metal-on- metal hip fiasco will provide fodder for future historians who will write of the bad old days when corporate greed and medical wishful thinking led to needless suffering in hundreds of thousands of patients, at a cost of billions. But the reality is strikingly different. The IOM report was dead on arrival. In a shocking development, the report was viciously attacked even before it was released. As the NY Times put it in a July 27, 2011 article: “Allies of the medical device industry are waging an extraordinary campaign in Washington to discredit a coming report by one of the country’s pre-eminent scientific groups.” The article continued that business groups took “the highly unusual step of making a pre-emptive strike,” claiming that better regulation would “slow innovation, harm patients and cost jobs.” Industry does not want to modify the 510(k) process, substituting more thorough, time-consuming, and costly studies of potentially risky devices. Their lobbyists responded to the IOM report by barraging the media, Congress, and other thought-leaders with a blistering counter-attack. The result? Deafening silence in the halls of Congress, which would need to pass legislation to further amend the Food and Drug Administration Act.
The metal on metal hip story is not unique. A recent article in the Archives of Internal Medicine reviewing all FDA device recalls between 2005 and 2009 found that 71% of the devices recalled because they were felt to cause serious health problems or death had been approved by the 510(k) expedited review process. Patients who have been harmed by dangerous devices are busily trying to salvage their own health and are relying on the courts for monetary compensation for their injuries. But it is consumers who put pressure on government back in 1976 to demand regulatory protection from dangerous devices. It was consumers, reacting to dramatic examples such as deaths related to the Dalkon Shield, an intrauterine contraceptive device, who demanded and finally prevailed upon Congress to pass the Medical Device Amendments of 1976, for the first time giving the FDA jurisdiction over devices. How many more disasters will we need before we act again?
In discussing the perils of metal-on-metal hips, it’s critical to recognize that hip replacement surgery has been an enormous boon to aging Americans. Osteoarthritis, or wear and tear arthritis, is found in 50% of people over age 65, making it one of the most common chronic diseases of older people. It can cause pain and difficulty walking, debilitating symptoms that are often completely alleviated by replacing the worn out joint. And while hip replacement surgery has been around for decades, it has been plagued by the risk of hip dislocation or the artificial joint itself wearing out. Hence the holy grail of hip replacement surgery has been a hip made of better materials and with a better design. Metal-on-metal hip prostheses were once thought to be the answer to the orthopedist’s prayers.
Something else stimulated development of metal-on-metal hip joints as well as the desire for an improved device. With the benefits of surgery well established, the number of hip replacement operations remained fairly stable in the 1990s (adjusting for the aging of the population). Device manufacturers realized that if they could make a joint that lasted longer than the 15 years expected with conventional devices, they could increase sales by marketing to a younger population. Metal-on-metal hip prostheses, in which both the ball (femoral head) and the socket (acetabulum) are removed and replaced with metal parts, seemed to fit the bill; mechanical stimulation studies in the laboratory suggested they would last longer than existing devices.
The new MoM hips were rapidly introduced into practice and the total number of operations performed each year soared. Estimates from Kaiser Permanente, a large multi-specialty group practice that decided to keep track of all joint replacements in their patients, are that 35-40% of all joint replacements are now done in people under 65. Then anecdotal reports of early device failure began appearing. Device manufacturers initially denied any problems associated with MoM hips but in 2007, the Australian National Joint Replacement Registry reported a higher rate of hip revision surgery with MoM devices. Finally, in August, 2010, DePuy Orthopedics, a subsidiary of the giant Johnson & Johnson, recalled its MoM total hip implant system. A total of 90,000 people had had the device inserted, just about half of them in the US.
What is striking in this saga is that no randomized controlled trials comparing MoM hip joints to existing models were required for Food and Drug Administration (FDA) approval. Since the FDA considered these devices only “moderate risk” and since they regarded them as “substantially equivalent” to existing devices, only the most cursory approval process was necessary to bring them to market. High risk or radically new devices, by contrast, undergo rigorous pre-market testing, often involving sophisticated—and expensive—randomized clinical trials. To demonstrate “substantial equivalence,” all that’s required is to show that the new device has the same intended use as an existing device and the same technological characteristics. The FDA uses this expedited “510(k)” review process for an estimated 90% of the devices it approves. (A related surgical approach, but which did require a full premarket review, involves hip “resurfacing” rather than total hip replacement. This technique has also met with difficulties when the head of the femur is capped with metal rather than plastic, but it is not the subject of this article.)
In light of several well-publicized recalls of devices that entered clinical use via the 510(k) route, the FDA requested a review of the expedited review process. The review was conducted by the Institute of Medicine (IOM), a widely respected, not-for-profit, independent organization dedicated to providing advice to government policymakers. The IOM report was released last summer. Its conclusions were clear: “The committee finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life.” Would this kind of approach, transparent and based on sound science, have avoided the MoM fiasco? \
If MoM artificial hips had been compared to existing products in a randomized controlled trial, flaws would likely have emerged early. While most of the device failures take five years to develop, much longer than the duration of a typical clinical trial, data from the British National Joint Registry suggest there are signs of trouble much earlier. For women aged 60-69, the Registry the revision rate for cemented hips one year after initial insertion is .65%; the revision rate for metal on metal hips in this population is 1.42%, or more than double. By year three, the gap is even more impressive: 1.32% of cemented hips require revision compared to 4.11% of MoM joints, a near tripling of the rate.
Adequate pre-market testing would have raised red flags; systematic post-market surveillance, which is non-existent in the US, would have revealed any problems that had escaped early detection. The Australians, who maintain a Registry of all the artificial joints inserted in their population, observed a spike in surgical revisions after hip replacement in 2007, with the highest revision rates in MoM joints, and the British reported a similar finding based on their Registry soon afterwards. A US database, which would have been far larger, might have detected problems even more quickly.
Any rational observer would conclude that our story will have a happy ending: the recommendations of the IOM committee will be implemented by Congress, we will have a new improved regulatory process for medical devices. Tales such as the metal-on- metal hip fiasco will provide fodder for future historians who will write of the bad old days when corporate greed and medical wishful thinking led to needless suffering in hundreds of thousands of patients, at a cost of billions. But the reality is strikingly different. The IOM report was dead on arrival. In a shocking development, the report was viciously attacked even before it was released. As the NY Times put it in a July 27, 2011 article: “Allies of the medical device industry are waging an extraordinary campaign in Washington to discredit a coming report by one of the country’s pre-eminent scientific groups.” The article continued that business groups took “the highly unusual step of making a pre-emptive strike,” claiming that better regulation would “slow innovation, harm patients and cost jobs.” Industry does not want to modify the 510(k) process, substituting more thorough, time-consuming, and costly studies of potentially risky devices. Their lobbyists responded to the IOM report by barraging the media, Congress, and other thought-leaders with a blistering counter-attack. The result? Deafening silence in the halls of Congress, which would need to pass legislation to further amend the Food and Drug Administration Act.
The metal on metal hip story is not unique. A recent article in the Archives of Internal Medicine reviewing all FDA device recalls between 2005 and 2009 found that 71% of the devices recalled because they were felt to cause serious health problems or death had been approved by the 510(k) expedited review process. Patients who have been harmed by dangerous devices are busily trying to salvage their own health and are relying on the courts for monetary compensation for their injuries. But it is consumers who put pressure on government back in 1976 to demand regulatory protection from dangerous devices. It was consumers, reacting to dramatic examples such as deaths related to the Dalkon Shield, an intrauterine contraceptive device, who demanded and finally prevailed upon Congress to pass the Medical Device Amendments of 1976, for the first time giving the FDA jurisdiction over devices. How many more disasters will we need before we act again?
November 15, 2011
What's $3 Billion Anyway?
GlaxoSmithKline (GSK), the fifth largest drug company in the world, just settled with the Department of Justice for a cool $3 billion. It implicitly acknowledged guilt for a multitude of sins, principally but by no means exclusively for doing everything within its not inconsiderable power to sell its diabetes drug, Avandia (rosiglitazone, still on the market but available only through a “restricted access program”), despite clear evidence that the drug posed significant cardiovascular risks. GSK tried to suppress doctors who raised concerns about Avandia. It funded biased “medical education” programs to “teach” physicians about the merits of Avandia. It manipulated research findings to portray the drug in a positive light.
The GSK deal tops the previous record, the $2.3 billion settlement made by the number one drug manufacturer, Pfizer, in 2009 for illegally promoting its pain-killer, Bextra (valdecoxib, now withdrawn from the market), for non-FDA-approved indications. But the day the settlement was announced, GSK’s stock price remained unchanged. Clearly, the company had already budgeted for its anticipated “fine.” If anything, investors breathed a sigh of relief—the legal case was history and, all things considered, the outcome wasn’t as bad as it might have been.
The charges against GSK are virtually identical to those in the earlier Justice Department case against Pfizer. And they’re very similar to the case against Merck for its handling of the anti-inflammatory drug Vioxx (rofecoxib, now withdrawn from the market), as well as to the $1.4 billion case against Eli Lilly for illegal marketing of the antipsychotic drug Zyprexa (olanzapine) and the $1.3 billion case against Abbott Labs for unacceptable promotion of the anti-seizure drug Depakote (valproic acid). GSK was found to have promoted the drugs Paxil (paroxetine) and Wellbutrin (bupropion) for off-label indications: while physicians are allowed to prescribe a drug for any plausible indication once it has been approved, pharmaceutical companies are prohibited from marketing drugs for non-FDA-approved conditions.
The pattern of abuse found at GSK is evidently endemic and persistent—it has endured in many of the major drug companies over a period of years. What does this say about the regulations that are supposed to protect consumers? At the same time that some politicians are advocating rolling back regulations, claiming they stymy progress, critics of the drug industry argue that the federal government needs to devote more resources, not fewer, to enforcing existing regulations. Other critics, such as Kevin Dufferson of the BU Health Law Program, suggest that the current regulations are inadequate deterrents. He describes the $3 billion payment as merely “a speed bump,” saying the company will merely regard it as “the cost of doing business.” Compared to GSK’s 2010 revenues of $36.2 billion, the settlement with the Department of Justice is arguably small potatoes. Drug companies know exactly how much the DOJ and the FDA devote to investigating and prosecuting drug fraud cases; their cost-benefit analysis persuades them to continue to violate the regulations with impunity. Only when their CEO’s are prosecuted and sent to jail, some critics claim, will the situation change.
On balance, regulation seems essential to protect the health and safety of the consumer. Without regulations, drug companies would likely distort and mislead in promoting all their drugs, not merely the blockbuster drugs where they have the most to gain. Better enforcement and greater executive accountability may well improve drug company behavior. But given that the policing alone is unlikely to guarantee integrity, it is also essential that drug companies fundamentally alter their organizational culture. Only with deep-seated cultural change will deliberate falsification of data become unthinkable. Only when a new ethos prevails will it become impossible to mistake propaganda for science. The CEO of GSK claims that just such a process is underway: a press release asserts that the company has hired more “compliance staff” and it has strengthened its training programs on ethical conduct. Most importantly, it has changed its incentive compensation program for sales reps so as to reward them based on customer evaluation and selling “competency” rather than on meeting sales targets. Whether a profit-driven company can truly reform its culture without changing its fundamental mission remains to be seen.
The GSK deal tops the previous record, the $2.3 billion settlement made by the number one drug manufacturer, Pfizer, in 2009 for illegally promoting its pain-killer, Bextra (valdecoxib, now withdrawn from the market), for non-FDA-approved indications. But the day the settlement was announced, GSK’s stock price remained unchanged. Clearly, the company had already budgeted for its anticipated “fine.” If anything, investors breathed a sigh of relief—the legal case was history and, all things considered, the outcome wasn’t as bad as it might have been.
The charges against GSK are virtually identical to those in the earlier Justice Department case against Pfizer. And they’re very similar to the case against Merck for its handling of the anti-inflammatory drug Vioxx (rofecoxib, now withdrawn from the market), as well as to the $1.4 billion case against Eli Lilly for illegal marketing of the antipsychotic drug Zyprexa (olanzapine) and the $1.3 billion case against Abbott Labs for unacceptable promotion of the anti-seizure drug Depakote (valproic acid). GSK was found to have promoted the drugs Paxil (paroxetine) and Wellbutrin (bupropion) for off-label indications: while physicians are allowed to prescribe a drug for any plausible indication once it has been approved, pharmaceutical companies are prohibited from marketing drugs for non-FDA-approved conditions.
The pattern of abuse found at GSK is evidently endemic and persistent—it has endured in many of the major drug companies over a period of years. What does this say about the regulations that are supposed to protect consumers? At the same time that some politicians are advocating rolling back regulations, claiming they stymy progress, critics of the drug industry argue that the federal government needs to devote more resources, not fewer, to enforcing existing regulations. Other critics, such as Kevin Dufferson of the BU Health Law Program, suggest that the current regulations are inadequate deterrents. He describes the $3 billion payment as merely “a speed bump,” saying the company will merely regard it as “the cost of doing business.” Compared to GSK’s 2010 revenues of $36.2 billion, the settlement with the Department of Justice is arguably small potatoes. Drug companies know exactly how much the DOJ and the FDA devote to investigating and prosecuting drug fraud cases; their cost-benefit analysis persuades them to continue to violate the regulations with impunity. Only when their CEO’s are prosecuted and sent to jail, some critics claim, will the situation change.
On balance, regulation seems essential to protect the health and safety of the consumer. Without regulations, drug companies would likely distort and mislead in promoting all their drugs, not merely the blockbuster drugs where they have the most to gain. Better enforcement and greater executive accountability may well improve drug company behavior. But given that the policing alone is unlikely to guarantee integrity, it is also essential that drug companies fundamentally alter their organizational culture. Only with deep-seated cultural change will deliberate falsification of data become unthinkable. Only when a new ethos prevails will it become impossible to mistake propaganda for science. The CEO of GSK claims that just such a process is underway: a press release asserts that the company has hired more “compliance staff” and it has strengthened its training programs on ethical conduct. Most importantly, it has changed its incentive compensation program for sales reps so as to reward them based on customer evaluation and selling “competency” rather than on meeting sales targets. Whether a profit-driven company can truly reform its culture without changing its fundamental mission remains to be seen.
October 07, 2011
Is the Hospital Bad for Your Health?
Decreasing the risk of readmission to a hospital is a hot area of research. It has been a target for quality improvement ever since a study in the New England Journal of Medicine found that just under 20% of all fee-for-service Medicare patients who had been hospitalized during 2003-2004 were readmitted within 30 days of discharge (. The estimated cost of all the unplanned readmissions (90% were assumed to be unanticipated) was a cool $17.4 billion.
The NEJM study was widely interpreted to imply that these patients received sub-optimal care, quite possibly downright poor care. Either they were discharged before their condition was adequately diagnosed or treated, or the plan for follow-up care was inadequate. Sometimes patients were admitted for one problem, say heart failure, but were found to have a second problem, say anemia, and the primary problem was addressed but the second one was not. Sometimes patients were sent home on the wrong medicines—an important medication had been accidentally omitted during the hospital stay and wasn’t restarted when the patient returned home, or a medication was “held” during the hospitalization for good reasons but should have been resumed on discharge at a lower dose. Or patients were simply overwhelmed when they went home and confused about exactly what pills they were supposed to take and what appointments they were expected to make. In response to the high readmission rates, countless programs and projects have been developed to decrease “avoidable” readmissions, which are both burdensome to patients and costly to society. Some of these programs have reported dramatic successes; most have moved the dial only a little bit.
Now two new reports in the medical literature shift the focus from “readmissions” to all hospitalizations near the end of life. For many patients, hospitalization entails risk (for instance, hospital acquired infection, acute confusion associated with a changed environment). As people approach the end of life, these risks may outweigh any benefit. The benefit/burden balance shifts even more decisively for nursing home residents with advanced dementia, to whom invasive medical interventions are incomprehensible, frightening and, given that they are close to death, at best minimally useful. One of the new studies looks at exactly this group of patients, individuals they for some mysterious reason refer to as having “cognitive issues” when in fact they have severe, endstage dementia. What the investigators found was that 19% of such individuals experienced at least one “burdensome transition” in the last 90 days of life.
The definition of “burdensome transition” is a bit complicated: it includes any kind of transition to a new form of care in the last 3 days of life, or multiple hospitalizations in the last 90 days of life, or lack of continuity in nursing home care in the final 90 days. I could quibble with some of these measures. For example, hospice enrollment in the last 3 days of life (occurring in 4.4% of the nearly 475,000 nursing home residents who died between 2000 and 2007) is less than ideal, but for dying patients surely it’s better than not enrolling in hospice at all. The degree of burden is very different for these patients, say, than for the 4.2% of patients who were hospitalized 3 or more times in the last 90 days of life. But the main point of the article remains valid: some nursing home residents who are close to the end of life are subjected to interventions that are painful (to them) and costly (to society) for little if any benefit to anyone.
The second study asks how many Medicare fee-for-service patients had an inpatient surgical procedure in the year before their death. What they found is that among the 1.8 million Medicare beneficiaries who died in 2008, 32% had an operation in the hospital during their last year of life. In fact, 18% had a procedure in the last month and 8% in the last week of life. Now, it’s important to remember that, as with the previous study, neither the physicians nor the patients could have known with certainty that death would come very soon. Most likely, surgeons offered the procedure in the hope, however slim, that it would improve quality of life (for example by repairing a fractured hip) or prolong life (by opening a narrowed coronary artery). And in fact, surgery may well have been life-prolonging in all those patients who underwent an operation but by definition didn’t make it into the study because they didn’t die. Nonetheless, the study points to the indisputable reality that a large number of older people had surgery, especially individuals in their seventies, only to die within a year.
The message most readers will take away from these studies is that American medicine continues to over-treat patients, fueled by the technological imperative and by our refusal to come to terms with our own mortality, and paid for by Medicare’s generosity. That’s an important message, though one we’ve heard before. But I think there’s a second message as well. If we want patients or their surrogates to consider forgoing hospitalization, patients who are very old and ill and in some cases severely demented, we need to offer them a reasonable alternative. Nursing home patients ought to already have such an alternative available to them: most were hospitalized for infections or dehydration, both of which should in principle be treatable in the nursing home. But evidently 19% of the time (and considerably more often, in some states), we don’t provide patients, even in the nursing home, timely assessment of an acute medical condition. We don’t send a physician or nurse practitioner to evaluate their fever or their lethargy (possible signs of infection and dehydration, respectively). We don’t offer simple blood tests and basic X-rays in the facility. We don’t routinely administer intravenous antibiotics or fluids. We don’t provide vigorous symptomatic treatment of shortness of breath and agitation, which commonly result from infection. Instead, we give patients the alternatives of hospital treatment or no treatment. “No treatment” is not an acceptable option.
Likewise for the case of surgery. If we want patients to contemplate forgoing surgery, we need to offer a viable alternative. We need to explain that medical therapy for a gallbladder infection has a good chance of treating the problem, that surgery to prevent recurrence makes sense for someone with a 10- or 20-year life expectancy, but not for someone with a 1- or 2-year life expectancy. We need to explain that medical treatment for coronary artery disease may well be successful and that placement of a stent or, even more invasive, coronary artery bypass surgery, may be excessively burdensome.
As physicians struggle to develop a better way to care for their elderly patients, they will need to develop creative strategies to keep patients out of the hospital and to prevent those who are admitted from recidivism. To achieve this end, physicians will need to design models of care that offer a robust alternative to the hospital. The troubling truth behind the reports in the NEJM and the Lancet is that much of American primary care offers no acceptable treatment for acute medical problems other than hospitalization. Only hospice provides care that is in time, comprehensive, and compassionate. For those patients who meet the criteria for hospice enrollment and who accept an approach focused exclusively on comfort, hospice is a wonderful program. For the many frail, sick, older individuals who are in the final phase of life but who are either not hospice eligible or who are not ready to forgo all potentially life-prolonging treatment, we need another approach. We have to provide better care in the home and the nursing home—with both qualified clinicians and the many low tech diagnostic and treatment interventions that can make a difference to patients—if we want to give high quality care outside the hospital.
The NEJM study was widely interpreted to imply that these patients received sub-optimal care, quite possibly downright poor care. Either they were discharged before their condition was adequately diagnosed or treated, or the plan for follow-up care was inadequate. Sometimes patients were admitted for one problem, say heart failure, but were found to have a second problem, say anemia, and the primary problem was addressed but the second one was not. Sometimes patients were sent home on the wrong medicines—an important medication had been accidentally omitted during the hospital stay and wasn’t restarted when the patient returned home, or a medication was “held” during the hospitalization for good reasons but should have been resumed on discharge at a lower dose. Or patients were simply overwhelmed when they went home and confused about exactly what pills they were supposed to take and what appointments they were expected to make. In response to the high readmission rates, countless programs and projects have been developed to decrease “avoidable” readmissions, which are both burdensome to patients and costly to society. Some of these programs have reported dramatic successes; most have moved the dial only a little bit.
Now two new reports in the medical literature shift the focus from “readmissions” to all hospitalizations near the end of life. For many patients, hospitalization entails risk (for instance, hospital acquired infection, acute confusion associated with a changed environment). As people approach the end of life, these risks may outweigh any benefit. The benefit/burden balance shifts even more decisively for nursing home residents with advanced dementia, to whom invasive medical interventions are incomprehensible, frightening and, given that they are close to death, at best minimally useful. One of the new studies looks at exactly this group of patients, individuals they for some mysterious reason refer to as having “cognitive issues” when in fact they have severe, endstage dementia. What the investigators found was that 19% of such individuals experienced at least one “burdensome transition” in the last 90 days of life.
The definition of “burdensome transition” is a bit complicated: it includes any kind of transition to a new form of care in the last 3 days of life, or multiple hospitalizations in the last 90 days of life, or lack of continuity in nursing home care in the final 90 days. I could quibble with some of these measures. For example, hospice enrollment in the last 3 days of life (occurring in 4.4% of the nearly 475,000 nursing home residents who died between 2000 and 2007) is less than ideal, but for dying patients surely it’s better than not enrolling in hospice at all. The degree of burden is very different for these patients, say, than for the 4.2% of patients who were hospitalized 3 or more times in the last 90 days of life. But the main point of the article remains valid: some nursing home residents who are close to the end of life are subjected to interventions that are painful (to them) and costly (to society) for little if any benefit to anyone.
The second study asks how many Medicare fee-for-service patients had an inpatient surgical procedure in the year before their death. What they found is that among the 1.8 million Medicare beneficiaries who died in 2008, 32% had an operation in the hospital during their last year of life. In fact, 18% had a procedure in the last month and 8% in the last week of life. Now, it’s important to remember that, as with the previous study, neither the physicians nor the patients could have known with certainty that death would come very soon. Most likely, surgeons offered the procedure in the hope, however slim, that it would improve quality of life (for example by repairing a fractured hip) or prolong life (by opening a narrowed coronary artery). And in fact, surgery may well have been life-prolonging in all those patients who underwent an operation but by definition didn’t make it into the study because they didn’t die. Nonetheless, the study points to the indisputable reality that a large number of older people had surgery, especially individuals in their seventies, only to die within a year.
The message most readers will take away from these studies is that American medicine continues to over-treat patients, fueled by the technological imperative and by our refusal to come to terms with our own mortality, and paid for by Medicare’s generosity. That’s an important message, though one we’ve heard before. But I think there’s a second message as well. If we want patients or their surrogates to consider forgoing hospitalization, patients who are very old and ill and in some cases severely demented, we need to offer them a reasonable alternative. Nursing home patients ought to already have such an alternative available to them: most were hospitalized for infections or dehydration, both of which should in principle be treatable in the nursing home. But evidently 19% of the time (and considerably more often, in some states), we don’t provide patients, even in the nursing home, timely assessment of an acute medical condition. We don’t send a physician or nurse practitioner to evaluate their fever or their lethargy (possible signs of infection and dehydration, respectively). We don’t offer simple blood tests and basic X-rays in the facility. We don’t routinely administer intravenous antibiotics or fluids. We don’t provide vigorous symptomatic treatment of shortness of breath and agitation, which commonly result from infection. Instead, we give patients the alternatives of hospital treatment or no treatment. “No treatment” is not an acceptable option.
Likewise for the case of surgery. If we want patients to contemplate forgoing surgery, we need to offer a viable alternative. We need to explain that medical therapy for a gallbladder infection has a good chance of treating the problem, that surgery to prevent recurrence makes sense for someone with a 10- or 20-year life expectancy, but not for someone with a 1- or 2-year life expectancy. We need to explain that medical treatment for coronary artery disease may well be successful and that placement of a stent or, even more invasive, coronary artery bypass surgery, may be excessively burdensome.
As physicians struggle to develop a better way to care for their elderly patients, they will need to develop creative strategies to keep patients out of the hospital and to prevent those who are admitted from recidivism. To achieve this end, physicians will need to design models of care that offer a robust alternative to the hospital. The troubling truth behind the reports in the NEJM and the Lancet is that much of American primary care offers no acceptable treatment for acute medical problems other than hospitalization. Only hospice provides care that is in time, comprehensive, and compassionate. For those patients who meet the criteria for hospice enrollment and who accept an approach focused exclusively on comfort, hospice is a wonderful program. For the many frail, sick, older individuals who are in the final phase of life but who are either not hospice eligible or who are not ready to forgo all potentially life-prolonging treatment, we need another approach. We have to provide better care in the home and the nursing home—with both qualified clinicians and the many low tech diagnostic and treatment interventions that can make a difference to patients—if we want to give high quality care outside the hospital.
September 26, 2011
Is the Fountain of Youth Spouting Contaminated Water?
A few days ago, the prestigious biomedical journal Nature reported that the water in the Fountain of Youth was contaminated. While the article’s title didn’t exactly have the ring of a call to battle, “Absence of effects of Sir2 overexpression on lifespan in C elegans and drosophila,” (AKA roundworms and fruit flies) it raised the hackles of pro-longevity scientists. What’s the fuss about and what are the prospects for improving the health of older people through gene manipulation?
Back in the early 1990s, Leonard Guarente of MIT began doing innovative research on genes coding for a protein called Sir2 in species such as roundworms and yeast. The analog of these proteins in mammals is a family of 7 proteins, SIRT1 through SIRT7, collectively known as “sirtuins.” One of Guarante’s early findings was that stimulating production of SIRT1 induced changes in mammals comparable to the life-prolonging effects of calorie restriction. But while decreasing food intake to starvation levels may lengthen life in rats and mice, it hasn’t yet been shown to have the same effects in primates and, more importantly, its prospects as a panacea against aging seem dim in an era when obesity is epidemic. The sirtuins turned out to have a variety of anti-inflammatory and anti-metabolic effects, reportedly protecting against cancer, diabetes, heart disease, and dementia. While it’s wise to be suspicious of any substance that claims to produce such a wide array of benefits, conjuring up the patent medicines of the nineteenth century, Guarante has soberly spelled out many of the discoveries about the sirtuins, writing in a recent review in the New England Journal of Medicine (June, 2011).
Seeking to translate his research findings into drugs that might prevent many of the diseases of old age, Guarente founded Elixir Pharmaceuticals in 1999, partnering with other researchers in the aging field, including centenarian specialist, Tom Perls of Boston Medical Center. Elixir has raised roughly $43 million in venture capital and has 9 drugs in various stages of testing, but as yet no FDA-approved product.
One of Guarante’s postdocs, David Sinclair, made a splash in 2003 when he discovered that resveratrol, a chemical in red wine, could mimic the life-prolonging effects of calorie restriction. Building on this work, he founded a second pro-longevity company in 2004 together with entrepreneur Christoph Westphal, a company that he called Sirtris. According to its website, Sirtris has 7 drugs in the pipeline, all in the earliest stages of testing. The company was purchased by GlaxoSmithKline in 2008 for $720 million. Since that time, Sinclair has become a full professor at Harvard; Westphal resigned as CEO after he was noted to have developed a nonprofit venture called the Health Lifespan Institute, which was selling a year’s worth of resveratrol to customers for $540. In late 2010, GSK halted a trial of resveratrol, a naturally available (read: unpatentable) substance and is focusing exclusively on the synthesis of small molecules that activate sirtuin proteins.
The new article in Nature challenges some of the early studies purporting to demonstrate that Sirtuins mediated the effects of calorie restriction in mammals. It does not undercut the now extensive body of work demonstrating the multiple roles of sirtuins. It does not diminish the appeal of the sirtuin approach, which targets the biochemical process underlying the development of degenerative diseases such as cancer, diabetes, heart disease, and dementia in the first place.
What remains to be seen is whether any of the elaborate studies in molecular biology will in fact produce drugs that prevent disease in people—without adversely affecting other important cellular processes. It’s worth a try. It’s also a good test case for whether collaboration between university-based, NIH and philanthropically funded science (Guarente at the Glenn Laboratory for the Science of Aging at MIT and Sinclair at the Paul Glenn Laboratory for the Molecular Biology of Aging at Harvard) Medical School, and profit-driven drug companies (Elixir Pharmaceuticals and Sirtris of GlaxoSmithKline, both in Cambridge, Massachusetts) will help aging Americans.
Back in the early 1990s, Leonard Guarente of MIT began doing innovative research on genes coding for a protein called Sir2 in species such as roundworms and yeast. The analog of these proteins in mammals is a family of 7 proteins, SIRT1 through SIRT7, collectively known as “sirtuins.” One of Guarante’s early findings was that stimulating production of SIRT1 induced changes in mammals comparable to the life-prolonging effects of calorie restriction. But while decreasing food intake to starvation levels may lengthen life in rats and mice, it hasn’t yet been shown to have the same effects in primates and, more importantly, its prospects as a panacea against aging seem dim in an era when obesity is epidemic. The sirtuins turned out to have a variety of anti-inflammatory and anti-metabolic effects, reportedly protecting against cancer, diabetes, heart disease, and dementia. While it’s wise to be suspicious of any substance that claims to produce such a wide array of benefits, conjuring up the patent medicines of the nineteenth century, Guarante has soberly spelled out many of the discoveries about the sirtuins, writing in a recent review in the New England Journal of Medicine (June, 2011).
Seeking to translate his research findings into drugs that might prevent many of the diseases of old age, Guarente founded Elixir Pharmaceuticals in 1999, partnering with other researchers in the aging field, including centenarian specialist, Tom Perls of Boston Medical Center. Elixir has raised roughly $43 million in venture capital and has 9 drugs in various stages of testing, but as yet no FDA-approved product.
One of Guarante’s postdocs, David Sinclair, made a splash in 2003 when he discovered that resveratrol, a chemical in red wine, could mimic the life-prolonging effects of calorie restriction. Building on this work, he founded a second pro-longevity company in 2004 together with entrepreneur Christoph Westphal, a company that he called Sirtris. According to its website, Sirtris has 7 drugs in the pipeline, all in the earliest stages of testing. The company was purchased by GlaxoSmithKline in 2008 for $720 million. Since that time, Sinclair has become a full professor at Harvard; Westphal resigned as CEO after he was noted to have developed a nonprofit venture called the Health Lifespan Institute, which was selling a year’s worth of resveratrol to customers for $540. In late 2010, GSK halted a trial of resveratrol, a naturally available (read: unpatentable) substance and is focusing exclusively on the synthesis of small molecules that activate sirtuin proteins.
The new article in Nature challenges some of the early studies purporting to demonstrate that Sirtuins mediated the effects of calorie restriction in mammals. It does not undercut the now extensive body of work demonstrating the multiple roles of sirtuins. It does not diminish the appeal of the sirtuin approach, which targets the biochemical process underlying the development of degenerative diseases such as cancer, diabetes, heart disease, and dementia in the first place.
What remains to be seen is whether any of the elaborate studies in molecular biology will in fact produce drugs that prevent disease in people—without adversely affecting other important cellular processes. It’s worth a try. It’s also a good test case for whether collaboration between university-based, NIH and philanthropically funded science (Guarente at the Glenn Laboratory for the Science of Aging at MIT and Sinclair at the Paul Glenn Laboratory for the Molecular Biology of Aging at Harvard) Medical School, and profit-driven drug companies (Elixir Pharmaceuticals and Sirtris of GlaxoSmithKline, both in Cambridge, Massachusetts) will help aging Americans.
June 30, 2011
The Way Forward
The rising cost of the Medicare program has suddenly gone from the concern of a handful of Cassandras like the distinguished biomedical ethicist Daniel Callahan and the former Congressional Budget Director Peter Orszag to a central preoccupation of the US Congress. Gutting Medicare, as the Republican Congressional leadership has proposed, has proved decidedly unpopular: Americans like their government-run health insurance. So how will we put the brakes on Medicare spending? Surprisingly, we may have something to learn from Massachusetts?surprising because health care reform and health care cost containment efforts in Massachusetts focus exclusively on the private sector.
Massachusetts rolled out universal health care coverage in 2006 and began trying to address costs two years later. This month, the Attorney General's Office issued a report analyzing trends in cost control so far. The bottom line is that costs are still spiraling upwards but perhaps more importantly, we have a sense of what strategies might work and which will not.
Before embarking on cost control, Massachusetts commissioned a study to lay out the leading potential cost containment options. Using sophisticated analytical models, the researchers estimated which strategies had the greatest chance of working and just how much of an effect each was likely to have. State government then advocated utilizing selected options from each category, but extended varying (some would say very limited) direct financial support for each of those identified as promising. The Governor publically endorsed bundling payments, an approach that research indicated would have by far the largest effect on reining in costs.
Fundamentally, cost savings arise from either lower prices or a lower volume of services (or both). Possible strategies can be lumped into 4 principal categories: reforms of the payment system, redesign of the health care delivery system, reduction of waste, and promotion of consumer engagement. What has worked, what didn't and what are the obstacles to success?
In the category of reforming the payment system, the technique strongly encouraged by Massachusetts was bundling payments. The most widely touted version is the Accountable Care Organization (ACO), in which provider groups, hospitals, skilled nursing facilities, and other health care groups band together to provide all the types of care a patient might need. The insurance company pays the ACO a single capitated payment for each patient who receives care through the organization. The members of the ACO are forced to "manage" the care and to share the risk. One example of this approach is the "Alternative Quality Contract," in which Blue Cross/Blue Shield offered participating physician practices a global payment for each enrolled patient. The innovative features of this model included providing extra payments for achieving quality and insurance against the high costs from outliers. BC/BS claimed that the project was a resounding success. The Massachusetts Attorney General's Office is not convinced, arguing that while the goal was to decrease the rate of rise of costs, and there was indeed evidence this occurred, total costs went up and not only that, but they did so to a greater extent among physician groups participating in the program than among those that did not. The moral, the Massachusetts report concluded, is that bundled payment strategies might work, but the overall payment has to be small enough to give physicians an incentive to decrease utilization or refer patients to low cost hospitals.
In the realm of redesign strategies, Massachusetts endorsed the "medical home." This is a new name for an old idea: ensuring that all patients have a primary care physician and expecting that physician (perhaps together with a larger team of clinicians) to coordinate care. The problems, as the report reveals, are that certain organizational structures such as a Physician Provider Organization (PPO) do not require that patients have a primary care physician. Coordination of care in such a non-system (there is no structure linking those clinicians who are ostensibly part of a PPO) is impossible. Another difficulty is the shortage of PCP's in the state; even if patients had a financial incentive to designate a PCP, say a premium reduction, there are simply not enough primary care doctors to go around.
In the area of value-based decision-making, the state is attracted to tiered or restricted network health insurance plans. The idea is to make patients "have skin in the game" by structuring their co-payments, say for physician services, according to whether they select an "efficient" clinician or an "inefficient" clinician. The expectation is that market forces would drive patients towards use of physicians who have shown they can achieve good outcomes at a low cost. Similarly, restricted network plans limit the patient's choice of hospitals or physicians to those that are "efficient." The health plan determines who is efficient and who is not using very blunt indicators: no outcome measures are used for evaluating physicians and a handful of standardized "quality indicators" are used to measure hospital performance. Only a few companies have developed such insurance products, but they may be catching on.
The final arena is reduction of waste. The most interesting idea in this category, using cost effectiveness analysis to decide what tests and treatments insurance companies will cover, was dismissed out of hand in the preliminary report commissioned by the state because of a paucity of empirical studies or other data to inform the analysis. Given that none of the other strategies is proving dramatically effective, perhaps it's time to examine this idea more closely.
The assumption underlying a focus on cost effectiveness analysis is that the high cost of medical care is driven to a large extent by technology, a claim supported by numerous studies. Technology, whether a screening test such as cardiac computed angiography, a monitoring test such as a positron emission tomography (PET) scan, or a treatment such as targeted cancer chemotherapy, sometimes improves patient outcomes and sometimes does not. Once a technology has been approved for use (whether based on the FDA's "safe and effective" criteria or Medicare's "reasonable and necessary" criteria), physicians often use it with impunity, typically in a variety of situations for which it was never approved. It's time to recognize that placing the responsibility for cost control on physicians is problematic as long as the culture of medicine (often buoyed by the incentive structure) promotes widespread use of the latest and ostensibly greatest tests and procedures. Placing the onus of cost control on patients is problematic because patients rely on the professional expertise of their physicians to recommend tests and procedures. Moreover, the very nature of health insurance defines the true consumer as the physician, not the patient. Health plans will need to start making more rational decisions about what they will cover. They can choose to pay for the least expensive, proven treatment and patients can opt to pay the difference between the cost of the covered treatment and the unproven therapy their physician recommends. Only when we start rationalizing physician prescribing can we expect to make progress in constraining medical costs. And rationalizing physician behavior will require payment reform, delivery system design, and health plan coverage decisions.
Massachusetts rolled out universal health care coverage in 2006 and began trying to address costs two years later. This month, the Attorney General's Office issued a report analyzing trends in cost control so far. The bottom line is that costs are still spiraling upwards but perhaps more importantly, we have a sense of what strategies might work and which will not.
Before embarking on cost control, Massachusetts commissioned a study to lay out the leading potential cost containment options. Using sophisticated analytical models, the researchers estimated which strategies had the greatest chance of working and just how much of an effect each was likely to have. State government then advocated utilizing selected options from each category, but extended varying (some would say very limited) direct financial support for each of those identified as promising. The Governor publically endorsed bundling payments, an approach that research indicated would have by far the largest effect on reining in costs.
Fundamentally, cost savings arise from either lower prices or a lower volume of services (or both). Possible strategies can be lumped into 4 principal categories: reforms of the payment system, redesign of the health care delivery system, reduction of waste, and promotion of consumer engagement. What has worked, what didn't and what are the obstacles to success?
In the category of reforming the payment system, the technique strongly encouraged by Massachusetts was bundling payments. The most widely touted version is the Accountable Care Organization (ACO), in which provider groups, hospitals, skilled nursing facilities, and other health care groups band together to provide all the types of care a patient might need. The insurance company pays the ACO a single capitated payment for each patient who receives care through the organization. The members of the ACO are forced to "manage" the care and to share the risk. One example of this approach is the "Alternative Quality Contract," in which Blue Cross/Blue Shield offered participating physician practices a global payment for each enrolled patient. The innovative features of this model included providing extra payments for achieving quality and insurance against the high costs from outliers. BC/BS claimed that the project was a resounding success. The Massachusetts Attorney General's Office is not convinced, arguing that while the goal was to decrease the rate of rise of costs, and there was indeed evidence this occurred, total costs went up and not only that, but they did so to a greater extent among physician groups participating in the program than among those that did not. The moral, the Massachusetts report concluded, is that bundled payment strategies might work, but the overall payment has to be small enough to give physicians an incentive to decrease utilization or refer patients to low cost hospitals.
In the realm of redesign strategies, Massachusetts endorsed the "medical home." This is a new name for an old idea: ensuring that all patients have a primary care physician and expecting that physician (perhaps together with a larger team of clinicians) to coordinate care. The problems, as the report reveals, are that certain organizational structures such as a Physician Provider Organization (PPO) do not require that patients have a primary care physician. Coordination of care in such a non-system (there is no structure linking those clinicians who are ostensibly part of a PPO) is impossible. Another difficulty is the shortage of PCP's in the state; even if patients had a financial incentive to designate a PCP, say a premium reduction, there are simply not enough primary care doctors to go around.
In the area of value-based decision-making, the state is attracted to tiered or restricted network health insurance plans. The idea is to make patients "have skin in the game" by structuring their co-payments, say for physician services, according to whether they select an "efficient" clinician or an "inefficient" clinician. The expectation is that market forces would drive patients towards use of physicians who have shown they can achieve good outcomes at a low cost. Similarly, restricted network plans limit the patient's choice of hospitals or physicians to those that are "efficient." The health plan determines who is efficient and who is not using very blunt indicators: no outcome measures are used for evaluating physicians and a handful of standardized "quality indicators" are used to measure hospital performance. Only a few companies have developed such insurance products, but they may be catching on.
The final arena is reduction of waste. The most interesting idea in this category, using cost effectiveness analysis to decide what tests and treatments insurance companies will cover, was dismissed out of hand in the preliminary report commissioned by the state because of a paucity of empirical studies or other data to inform the analysis. Given that none of the other strategies is proving dramatically effective, perhaps it's time to examine this idea more closely.
The assumption underlying a focus on cost effectiveness analysis is that the high cost of medical care is driven to a large extent by technology, a claim supported by numerous studies. Technology, whether a screening test such as cardiac computed angiography, a monitoring test such as a positron emission tomography (PET) scan, or a treatment such as targeted cancer chemotherapy, sometimes improves patient outcomes and sometimes does not. Once a technology has been approved for use (whether based on the FDA's "safe and effective" criteria or Medicare's "reasonable and necessary" criteria), physicians often use it with impunity, typically in a variety of situations for which it was never approved. It's time to recognize that placing the responsibility for cost control on physicians is problematic as long as the culture of medicine (often buoyed by the incentive structure) promotes widespread use of the latest and ostensibly greatest tests and procedures. Placing the onus of cost control on patients is problematic because patients rely on the professional expertise of their physicians to recommend tests and procedures. Moreover, the very nature of health insurance defines the true consumer as the physician, not the patient. Health plans will need to start making more rational decisions about what they will cover. They can choose to pay for the least expensive, proven treatment and patients can opt to pay the difference between the cost of the covered treatment and the unproven therapy their physician recommends. Only when we start rationalizing physician prescribing can we expect to make progress in constraining medical costs. And rationalizing physician behavior will require payment reform, delivery system design, and health plan coverage decisions.
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