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.
LIFE IN THE END ZONE: A discussion of topical issues for anyone concerned with the final phase of life by Muriel R. Gillick, MD
May 23, 2012
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?