Dialysis and the Problem of Unintended Consequences

A recent New York Times article by Gina Kolata highlighted the debate surrounding dialysis as an end-of-life treatment.  In reading the article and surfing the internet for counter-arguments, I found two points of interest.

Background

According to the Medicare ESRD Network Organizations Manual, Section 299I of the Social Security Amendments of 1972, Pub. Law 92-603, which “created the National End Stage Renal Disease (ESRD) Program … [and] extended Medicare coverage to individuals with ESRD who require either dialysis or transplantation to maintain life.”  In addition, depending on your perspective, Sec. 299I requires/limits the entitlements for/to individuals under the age of 65 who have insurance coverage (remember this age and insurance coverage part — it will be important later in the discussion).

By the time the legislation was adopted in 1972, only 10,000 individuals were being dialyzed in the country and only 20,000 to 25,000 were considered candidates for the procedure.  Section 299I was estimated to cost $250 million over the first four years.  Now, according to the N.Y. Times, about 400,000 people will undergo dialysis at an estimated cost of $40 billion to $50 billion in this year alone.

Has the entitlement had the unintended consequence of benefiting those over 65?

Kolata argues that this law was intended “to keep young and middle-aged people alive and productive” and has had the unintended consequence of financing dialysis treatment for (primarily elderly) individuals who are too sick to benefit from the treatment.  She explains:

When Congress established the entitlement to pay for kidney patients in October 1972… [Congress expected] that most of those patients would be healthy — except for their failed kidneys — and under age 54.

Now… More than a third of the patients are 65 or older, and they account for about 42 percent of the costs. People over 75 make up the fastest-growing group of dialysis patients. And most elderly dialysis patients have other serious diseases like diabetes, heart failure, stroke and even advanced dementia. One-third of them have four or more chronic conditions.

Others, however, would argue that Sec. 299I has not benefited the elderly because they were already entitled to Medicare coverage prior to its enactment.  In the “Dialysis from the sharp end of the needle” blog, Bill Peckham writes in response to Kolata’s argument:

No no no. Dialyzors who are “old and have other medical problems” have access to Medicare due to age or disability, “patients who take advantage of the law” are few: only about 25,000 people [out of about 417,000] have access to Medicare as a consequence of Section 299I of the Social Security Amendments of 1972.

Well…  According to Kaiser, the source of Peckham’s figures, only 5.8% of Medicare enrollees with ESRD directly benefit from Section 299I.  But what about indirect benefits? A comprehensive history of Section 299I can be found in Origins of the Medicare Kidney Disease Entitlement: The Social Security Amendments of 1972, a chapter in Biomedical Politics.  Richard A. Rettig writes:

It was presumed that the benefit existed for the elderly, however, because a Medicare benefit could not be established for those under 65 and not be available for the elderly. In fact, very few elderly persons were being dialized at the time and none were receiving transplants.  Although the Bureau of Health Insurance had answered several inquiries in the previous year, the nature and extent of coverage for the elderly had not been clarified.

The entitlement for those under the age of 65 extends from the third month after “a course of renal dialysis is initiated” until a year after the person has a renal transplant or ends the course of dialysis.  This section could have been read to provide an entitlement to dialysis and renal transplant solely to those under the age of 65, or it could be interpreted to create a near universal entitlement to such treatments.

It seems that President Nixon’s administration read Section 299I according the latter interpretation, because in his statement on the Signing of the Social Security Amendment of 1972 Nixon said, “it extends Medicare coverage for kidney transplants and renal dialysis.”

Aggressive Treatment and End of Life Care

“Clearly, when the program was initiated in the 1970s, the hope and expectation was that this program would return otherwise healthy people back into society so they could work and be productive,” said Dr. Manjula Kurella Tamura, a kidney specialist at Stanford. But, she added, “dialysis at the end of life is a different sort of treatment.”

A second important aspect of the article is its focus on end-of-life care.  Even Peckham concedes that, “caring for the elderly is expensive and aggressive treatment may not always be in the interest of the ill. That is a serious discussion our electorate should have but has not been able to have.”

The article highlights new clinical practice guidelines produced by the Renal Physicians Association designed to promote, through shared decision-making and informed consent, “medical management without dialysis.”  Particularly concerning is that the provision of dialysis gives patients false hope of survival.  According to the NY Times:

Recent studies have found that dialysis does not prolong life for many elderly people with other serious chronic illnesses. One study found that the procedure’s main effect is to increase the chances that such patients will die in the hospital rather than at home.

Yet, a 78-year-old woman is quoted as saying, “I go to dialysis because I want to live.  I want dialysis.”  Although he doctors explained that dialysis would not necessarily prolong her life, she chose aggressive treatment because, “Some life is better than no life.”  This anecdotal story raises a HUGE informed consent problem because it appears that the patient may not have understood the risks and benefits of undergoing dialysis.

Key to the decision to forego, commence, or withdraw dialysis is a properly informed consent. The above guidelines state that certain patients, including those age 75 years and older, those with high comorbidity scores, those with marked functional impairment, or those with severe chronic malnutrition, “should be informed that dialysis may not confer a survival advantage or improve functional status over medical management without dialysis and that dialysis entails significant burdens that may detract from their quality of life.”

***

The ESRD program has provided life-saving dialysis to many people.  However, as with many other tests and treatments performed in the last year of life, it is important to ensure that patients (or their legal decision-makers) are properly informed about the risks and benefits of all options, including palliative care, at the end of life.

Our Own Devices

"More Love Hours Than Can Ever Be Repaid" & "The Wages of Sin"

Health care finance is always going to be a contentious topic. Two recent stories about devices in health care show the unexpected ways in which technological innovation can generate new burdens, worries, and ethical dilemmas for patients and their families.

Katy Butler authored a heart-rending account of her father’s decline (and her mother’s near-exhaustion as a caregiver) in the NYT last week. Her father’s stroke changed both his and Butler’s mother’s lives:

The day before [the stroke], my mother was an upper-middle-class housewife who practiced calligraphy in her spare time. Afterward, she was one of tens of millions of people in America, most of them women, who help care for an older family member.

The story of what happens next is long and complex, but for health policy makers the nub comes down to a decision the family must make about whether to implant a permanent pacemaker when her father needs surgery to repair a hernia:

[T]he cardiologist, John Rogan, refused to clear my dad for surgery unless he received a pacemaker. . ..  The decision fell to my mother — anxious to relieve my father’s pain, exhausted with caregiving, deferential to doctors and no expert on high-tech medicine. She said yes. One of the most important medical decisions of my father’s life was over in minutes. . . .

[If my father's primary care physician had] had the chance to sit down with my parents, he could have explained that the pacemaker’s battery would last 10 years and asked whether my father wanted to live to be 89 in his nearly mute and dependent state. He could have discussed the option of using a temporary external pacemaker that, I later learned, could have seen my dad safely through surgery. But my mother never consulted Fales. And the system would have effectively penalized him if she had. Medicare would have paid him a standard office-visit rate of $54 for what would undoubtedly have been a long meeting — and nothing for phone calls to work out a plan with Rogan and the surgeon.

Medicare has made minor improvements since then, and in the House version of the health care reform bill debated last year, much better payments for such conversations were included. But after the provision was distorted as reimbursement for “death panels,” it was dropped. In my father’s case, there was only a brief informed-consent process, covering the boilerplate risks of minor surgery, handled by the general surgeon.

Butler’s family’s situation was clearly a troubling one. I do not agree with her harsher critics, who charge the New York Times has used her story to promote its political agenda:

The New York Times is continuing its promotion of the Obama administration’s cost-cutting health care legislation three months after it was signed into law. Central to the newspaper’s support for the bill is its drive to cut back on “unnecessary” treatments and procedures and to target for elimination “overly generous” insurance benefits. . . . The article is a cynical attempt to utilize the author’s family’s personal story—unarguably tragic and heartrending—to make the case that artificial pacemakers are being widely over-utilized.

But I was also troubled by Butler’s quoting the following studies:

In a 1997 study in The Journal of the American Geriatrics Society, 30 percent of seriously ill people surveyed in a hospital said they would “rather die” than live permanently in a nursing home. In a 2008 study in The Journal of the American College of Cardiology, 28 percent of patients with advanced heart failure said they would trade one day of excellent health for another two years in their current state.

I have not experienced “advanced heart failure,” but I know people who do, and it’s inconceivable to me that they would trade a day of “perfect health” for two months, much less two years, of stasis. Moreover, as Alasdair MacIntyre argues in his book Dependent Rational Animals, caring for others and being dependent are essential, important human experiences.

As I read Butler’s piece, I kept wishing that society had done more (perhaps along the lines of Britain’s Social Care programs) to help her family.

But even some forms of aid for the cared for (and their caregivers) are filled with philosophical complexities. Consider the Paro, a robotic seal I blogged about in last month and back in 2006. The Paro has been approved as “a Class 2 medical device (a category that includes powered wheelchairs)” to help soothe elderly patients. Here is one example of its powers:

One recent morning, staff at Marian Manor in Pittsburgh, one of Vincentian Collaborative’s homes, circulated three Paros among residents gathered for a sing-a-long. As 77-year-old Anita Biro sat down at a table, she berated two fellow residents and told them to leave, recalls Beth Kuenzi, activities manager for the home’s dementia unit. But when Ms. Kuenzi put Paro in front of Ms. Biro, her mood changed. As Ms. Biro stroked the robot’s synthetic fur, the machine batted its eyelashes and tracked movement with its head and eyes.

“I love this baby,” Ms. Biro cooed. Aides also take Paro to residents’ rooms to get them to socialize. At another Vincentian home, Lois Simmeth, 73, doesn’t always participate in group activities, but she ventures into the hall when she hears Paro’s sounds.

“I love animals,” explains Ms. Simmeth. She whispered to the robot in her lap: “I know you’re not real, but somehow, I don’t know, I love you.”

MIT Professor Sherry Turkle concedes that the Paro has some very good effects, but wonders “Why are we so willing to provide our parents, then ourselves, with faux relationships?” Another article explores advances in “building a machine that fills the basic human need for companionship.” Turkle, again, questions the larger social context:

[S]ome social critics see the use of robots with such patients as a sign of the low status of the elderly, especially those with dementia. As the technology improves . . . it will only grow more tempting to substitute Paro and its ilk for a family member, friend — or actual pet — in an ever-widening number of situations.

“Paro is the beginning,” she said. “It’s allowing us to say, ‘A robot makes sense in this situation.’ But does it really? And then what? What about a robot that reads to your kid? A robot you tell your troubles to? Who among us will eventually be deserving enough to deserve people?”

These are all fantastic questions, all-too-ready to be answered by techno-libertarian fantasists. I look forward to tracing the degree to which the decision to approve Paro as a covered device could reflect the larger ethical concerns explored by Dov Fox in his piece on the “gap between ethics and law” in other health decisionmaking.

Drug Study Fails to Mention Risk of Death to Test Subjects

Danse Macabre, XLVII, The Blind Man. Hans Holbein the Younger (1497 or 1498 to 1543)

[Ed. Note: Today's Post is by Maansi K. Raswant, a Seton Hall Law student pursuing the Health Law concentration. She is a research assistant to the Center for Health & Pharmaceutical Law & Policy and an intern at the NYC Health and Hospitals Corporation.]

As reported recently in the Boston Globe, a federal probe found that heart attack survivors enrolled in a clinical trial conducted in over 120 sites nationally had not been adequately informed of the safety risks of the study, including the risk of death.

The process under study, chelation, involves “periodic infusions of a drug– in this case, disodium EDTA.” The infusions are being tested in conjunction with the ingestion of high doses of  vitamins and minerals. However, according to the federal probe, “in 2008 FDA removed disodium EDTA from the FDA’s approved list and withdrew of approval of new drug applications for disodium EDTA.” Test subjects were not informed that disdodium EDTA “is no longer FDA approved for any use and has been removed from the market because of safety concerns.”

Funded by the National Heart, Lung and Blood Institute and the National Center for Complementary and Alternative Medicine, the study has over 1,500 subjects. Though researchers suspended enrollment last August due to the investigation, federal officials allowed the study to continue pending further findings of the probe, a decision that has been highly criticized.

In addition to the deficiencies regarding the  informed consent of study participants, the Boston Globe reported that the investigation found that several co-investigators involved in the study had been disciplined for “substandard practices” or had been involved in insurance fraud. Three were convicted felons. Federal officials explained that they found the substandard practices and convictions of the principal investigators “concerning” but not a reason to “automatically preclude an investigator from participating in research.”

The U.S. Office of Human Research Protections detailed the findings of the investigation and required corrective actions in a letter to the three medical institutions heading the study. In response to the investigation’s findings, the study modified the consent form to recognize death as a “rare complication of the EDTA [chelation] infusions.” The Office of Human Research Protections has also requested further modification of the form to disclose that disodium EDTA had been removed from the market.

Despite the change in consent form, questions remain about the acceptability of the risks posed by the study. As the Globe reports, critics of the study, including the head of bioethics at the University of Pennsylvania, Arthur Caplan, have charged that the risks posed by the study are unethical. The complaint against the study filed with the Office of Human Research Protections noted that since “the mid-1970’s court documents and newspapers have reported at least 30 deaths associated with intravenous EDTA.”

The probe is the lastest in a string of major investigations of clinical trials, including the continuing investigation into payments by device maker Medtronic to Dr. Timothy Kulko (who is accused of falsifying author names and  study results), and the Synthes indictment for allegations that its subsidiary, Norian, conspired to conduct unauthorized clinical trials that placed subjects at risk of death without properly informing them of the risks. In the Synthes/Norian matter, three patients are believed to have died as a result of the use of the companies’ bone cement products.