Yesterday the California Senate Health Committee killed California’s vigorous foray into health care reform, by a 7 to 1 vote, with 3 abstentions. California’s reform effort, which was modeled on Massachusetts, suggests three important lessons about ethics and politics.
1. For now, public fear of expanding government run insurance is too strong to overcome. I believe this fear is largely driven by 28 years of Republican led attack on government itself. Medicare and Medicaid have flaws, but we should ask the insurance program without flaws to cast the first stone. But whatever the source of the fear, even in a state as liberal as California, it wins.
2. We haven’t figured out how to integrate communitarian values with individual responsibility values. Like Massachusetts, California depended on a jerry-rigged combination of individual mandate and communitarian tax support. This led to political opposition from the left (the reform was not a single payer plan) and the right (the reform taxed individuals & businesses and involved governmental activism). We need a policy level vision of what every experienced clinician knows: successful health care requires both communitarian values (“you are my patient & I will not abandon you”) and tough love (“we won’t get anywhere unless you do XYZ”). Good clinicians integrate TLC and tough love seamlessly. To solve the health care reform puzzle, political leaders must do the same.
3. Health care reform won’t get anywhere until we own up to the need for rationing. In my view, cost control is ultimately an ethical problem. We in the U.S. are paralyzed by the idea of rationing. We rely on the fairy tale that efficiencies will produce painless cost containment or the hard nosed claim that “skin in the game” (financial risk for individuals) will do the job. Efficiency and individual responsibility are required, but we won't put in the necessary muscle into them until we recognize that the alternative is even more rationing. (Dan Brock's recent article - "Health Care Resource Prioritization and Rationing: Why is it so Difficult" - discusses U.S. confusion about rationing in depth.)
Happily, Governor Schwarzenegger says "I am someone who does not give up, especially when there is a problem as big as health care that needs to be fixed...One setback is just that - a setback." When the Terminator promises that he will be back there is hope that health care reform will move forward.
Tuesday, January 29, 2008
Monday, January 28, 2008
Physician Incentives, Generic Medications, and Ethics
A recent Wall Street Journal shows how hard it is to get incentives right.
Blue Care Network, an HMO owned by BCBS of Michigan, paid primary care physicians $100 for every patient switched from two branded statins (Lipitor and Lescol) to generic Simvistatin. The rationale for the effort was to save money for the insurer (in drug costs) and the insurees (in reduced copayments). The rationale for the $100 payment to physicians was that (a) deciding whether the switch was OK for a particular patient, (b) explaining the recommendation, and (c) answering questions, (d) takes time, for which (e) they should be paid.
The rationale for rewarding the physicians is correct. High quality cost effective practice takes time. If physicians aren't paid for the effort their compensation/time drops. They are penalized for doing the right thing.
The rationale for helping BCBS achieve savings is also correct. BCBS of Michigan is a not for profit company with a 70 year history in the state. Physicians encouraging generics don't have to wonder if the savings go to hedge fund investors. They can be reasonably confident that savings benefit enrollees, not day traders.
Despite the good reasons in favor of the incentives, the system, which was time limited, was a mistake.
The AMA correctly notes that the incentives look too much like kickbacks to pass the smell test, especially if the patient is not aware of the payments. Unfortunately the AMA's otherwise educative discussion perpetuates our national muddle-headedness about the ethics of considering costs:
“Physicians should prescribe drugs, devices, and other treatments based solely upon medical considerations and patient need and reasonable expectations of the effectiveness of the drug, device or other treatment for the particular patient.” (emphasis added)
An ethical health care system should ask its physicians to care about costs. Societies need physicians to consider the denominator(insured populations) as well as the numerator (individual patients). Patients aren't harmed by choosing the branded product over a qualified generic, but society is.
The US is a test case for what happens when we ignore communitarian ethics - uneven care, 47 million uninsured, and runaway costs. As I argued ten years ago in the BMJ ("Fairness as a Problem of Love and the Heart: A Clinician's Perspective on Priority Setting"), we can only ask physicians to take a communitarian perspective in organizational settings in which physicians and their patients can be confident that savings advance the health of the involved population.
Michigan BCBS is such a setting. The aim of the incentive program was correct, but the incentive was structured wrongly. Less direct incentives, like increasing reimbursement for office visits to physicians who practice high quality, cost-effective medicine, is the way to go.
Blue Care Network, an HMO owned by BCBS of Michigan, paid primary care physicians $100 for every patient switched from two branded statins (Lipitor and Lescol) to generic Simvistatin. The rationale for the effort was to save money for the insurer (in drug costs) and the insurees (in reduced copayments). The rationale for the $100 payment to physicians was that (a) deciding whether the switch was OK for a particular patient, (b) explaining the recommendation, and (c) answering questions, (d) takes time, for which (e) they should be paid.
The rationale for rewarding the physicians is correct. High quality cost effective practice takes time. If physicians aren't paid for the effort their compensation/time drops. They are penalized for doing the right thing.
The rationale for helping BCBS achieve savings is also correct. BCBS of Michigan is a not for profit company with a 70 year history in the state. Physicians encouraging generics don't have to wonder if the savings go to hedge fund investors. They can be reasonably confident that savings benefit enrollees, not day traders.
Despite the good reasons in favor of the incentives, the system, which was time limited, was a mistake.
The AMA correctly notes that the incentives look too much like kickbacks to pass the smell test, especially if the patient is not aware of the payments. Unfortunately the AMA's otherwise educative discussion perpetuates our national muddle-headedness about the ethics of considering costs:
“Physicians should prescribe drugs, devices, and other treatments based solely upon medical considerations and patient need and reasonable expectations of the effectiveness of the drug, device or other treatment for the particular patient.” (emphasis added)
An ethical health care system should ask its physicians to care about costs. Societies need physicians to consider the denominator(insured populations) as well as the numerator (individual patients). Patients aren't harmed by choosing the branded product over a qualified generic, but society is.
The US is a test case for what happens when we ignore communitarian ethics - uneven care, 47 million uninsured, and runaway costs. As I argued ten years ago in the BMJ ("Fairness as a Problem of Love and the Heart: A Clinician's Perspective on Priority Setting"), we can only ask physicians to take a communitarian perspective in organizational settings in which physicians and their patients can be confident that savings advance the health of the involved population.
Michigan BCBS is such a setting. The aim of the incentive program was correct, but the incentive was structured wrongly. Less direct incentives, like increasing reimbursement for office visits to physicians who practice high quality, cost-effective medicine, is the way to go.
Saturday, January 26, 2008
Murder and Medical School
I've never had an ethics consultation like the one that could have come from Karolinska Institute in Stockholm: "We just found out that one of our medical students has done time for murder -- what should we do?"
This extraordinary story was in yesterday's New York Times. In 2000, Karl Svensson, now 31, was convicted of killing Bjorn Soderberg. Soderberg had complained to his employers about neo-Nazi materials a co-worker had displayed. The co-worker, a friend of Svensson's, was fired. Svensson himself had been under surveillance for his own neo-Nazi activities.
Svensson was sentenced to 11 years in prison, but was paroled after 6 1/2 years, as is common in Sweden. While in prison he took many web-based courses and did well enough to meet the Karolinska entry requirements. In a remarkable failure of interviewing, neither of the admissions officers he spoke with asked him about the 6 1/2 year gap on his CV!
When the story came to light, Svensson's fellow students were split. Many felt he had done his time and should be allowed to become a doctor. Others reported being afraid of having him as a classmate.
The students who wanted Svensson to stay had a point. Respect for every person is a core medical value. Physicians care for murders as well as their victims. Physicians believe that change, and repentance, are possible.
People convicted of murder can be outstanding physicians. In 2001 a medical specialist to whom I had referred many patients, including a member of my own family, was sent to prison for the 1999 murder of his wife. (He maintains his innocence.) He did more than provide excellent technical care - he gave outstanding human attention as well. I was moved by my patients' description of his skill and compassion and was proud to have him as a colleague.
But the Hippocratic Oath articulates another value - "In purity and holiness I will guard my life and my art."
The classmates who wanted Svensson to stay in Karolinska were half right. People who have done their time should have the opportunity to build a new life. For all we know Svensson may have had wanted to make amends for the crime he had been convicted of. But for me the Hippocratic value is the deciding point here. Medicine has its anthropological roots in religion. Many of the prophets in all religions were healers of the body as well as the soul. The obligations the privilege of being a physician entails go beyond what we do in the office and hospital.
I hope that Svensson is committed to making up in the rest of his life for the murder the court concluded he had done. But Karolinska Institute, which expelled him last week, did the right thing.
This extraordinary story was in yesterday's New York Times. In 2000, Karl Svensson, now 31, was convicted of killing Bjorn Soderberg. Soderberg had complained to his employers about neo-Nazi materials a co-worker had displayed. The co-worker, a friend of Svensson's, was fired. Svensson himself had been under surveillance for his own neo-Nazi activities.
Svensson was sentenced to 11 years in prison, but was paroled after 6 1/2 years, as is common in Sweden. While in prison he took many web-based courses and did well enough to meet the Karolinska entry requirements. In a remarkable failure of interviewing, neither of the admissions officers he spoke with asked him about the 6 1/2 year gap on his CV!
When the story came to light, Svensson's fellow students were split. Many felt he had done his time and should be allowed to become a doctor. Others reported being afraid of having him as a classmate.
The students who wanted Svensson to stay had a point. Respect for every person is a core medical value. Physicians care for murders as well as their victims. Physicians believe that change, and repentance, are possible.
People convicted of murder can be outstanding physicians. In 2001 a medical specialist to whom I had referred many patients, including a member of my own family, was sent to prison for the 1999 murder of his wife. (He maintains his innocence.) He did more than provide excellent technical care - he gave outstanding human attention as well. I was moved by my patients' description of his skill and compassion and was proud to have him as a colleague.
But the Hippocratic Oath articulates another value - "In purity and holiness I will guard my life and my art."
The classmates who wanted Svensson to stay in Karolinska were half right. People who have done their time should have the opportunity to build a new life. For all we know Svensson may have had wanted to make amends for the crime he had been convicted of. But for me the Hippocratic value is the deciding point here. Medicine has its anthropological roots in religion. Many of the prophets in all religions were healers of the body as well as the soul. The obligations the privilege of being a physician entails go beyond what we do in the office and hospital.
I hope that Svensson is committed to making up in the rest of his life for the murder the court concluded he had done. But Karolinska Institute, which expelled him last week, did the right thing.
Friday, January 25, 2008
Transparency, Pharma Ethics, and the Blogosphere
“Transparency” is arguably the key political concept for the early 21st century. But I often feel that the term is used as a PC slogan, without any real content. Like putting “organic” or “green” onto a food label.
The uprising about potential insider trading in the Zetia/Vytorin story provides a vivid case study of how the abstract concept actually plays out on the ground. Here's how it unfolded in the last ten days:
January 14: Brandweek reported that Carrie Smith Cox, president of Schering-Plough, sold 900,000 shares of company stock before the ENHANCE trial scandal began to emerge. (I don’t know how Brandweek found out.)
January 16: CBS News Online picked up the story and put it out into the wider public.
January 16: Brandweek published comments said to come from an internal Schering-Plough message board about the stock sale, saying things like “she has disgraced the company” and “Carrie knew as did the rest of the ‘leaders’ of the company!! I was there when she was told [about the problems that led to a decline in stock price].”
January 22: John Dingell, chair of the House Committee on Energy and Commerce, along with Bart Stupak, Chair of the Subcommittee on Oversight and Investigations, sent a letter demanding information from Schering-Plough and Merck, with the Cox sale as a prominent part.
January 22: Jacob Goldstein of the Wall Street Journal reports on the Dingell/Stupak letter and on a rapid decline in market share for Zetia and Vytorin.
January 24: Chuck Grassley, ranking member of the Senate Finance Committee, asks the SEC to investigate the stock sales.
Within the ten day period the insider trading story went from a squeak in the blogosphere to a roar from major media and the government. For Schering-Plough it must seem like David coming at them from one side and Goliath from the other.
That's transparency in action!
The uprising about potential insider trading in the Zetia/Vytorin story provides a vivid case study of how the abstract concept actually plays out on the ground. Here's how it unfolded in the last ten days:
January 14: Brandweek reported that Carrie Smith Cox, president of Schering-Plough, sold 900,000 shares of company stock before the ENHANCE trial scandal began to emerge. (I don’t know how Brandweek found out.)
January 16: CBS News Online picked up the story and put it out into the wider public.
January 16: Brandweek published comments said to come from an internal Schering-Plough message board about the stock sale, saying things like “she has disgraced the company” and “Carrie knew as did the rest of the ‘leaders’ of the company!! I was there when she was told [about the problems that led to a decline in stock price].”
January 22: John Dingell, chair of the House Committee on Energy and Commerce, along with Bart Stupak, Chair of the Subcommittee on Oversight and Investigations, sent a letter demanding information from Schering-Plough and Merck, with the Cox sale as a prominent part.
January 22: Jacob Goldstein of the Wall Street Journal reports on the Dingell/Stupak letter and on a rapid decline in market share for Zetia and Vytorin.
January 24: Chuck Grassley, ranking member of the Senate Finance Committee, asks the SEC to investigate the stock sales.
Within the ten day period the insider trading story went from a squeak in the blogosphere to a roar from major media and the government. For Schering-Plough it must seem like David coming at them from one side and Goliath from the other.
That's transparency in action!
Tuesday, January 22, 2008
Harvard Medical School Embraces the 21st Century
In the movie Casablanca, just before accepting a bribe from the croupier at Rick’s casino, Captain Renault (Claude Rains) says, “I'm shocked, shocked to find that gambling is going on in here!”
This great scene captures a widespread view of organizational ethics – pious platitudes at best, but more often hypocrisy and outright lying. Academic institutions are not immune to this taint.
Corporations often say things like “our people are our greatest asset.” But words are cheap. Bureaucratic structures, like Harvard Medical School’s new Criteria for Appointment and Promotion, show what an organization truly values.
As a member of the faculty who had absolutely nothing to do with developing them, I read the new criteria with pleasure and pride. The introduction describes them as “a flexible structure which provides a ‘menu’ of activities, allowing assembly of a profile that reflects the unique combination of activities and accomplishments of each faculty member…recogniz[ing] the broad range of faculty activities that contribute to the academic mission including administrative leadership and service to the community.”
The criteria define three areas of excellence – “teaching and educational leadership,” “clinical expertise and innovation,” and “investigation.” All require scholarship. “Scholarship,” however, is defined much more broadly than in the past “to include not only peer-reviewed publications but also educational materials, policy statements, assessment tools, and guidelines for patients care…in print or alternative media.” "Teaching" is defined broadly as well, to include teaching peers, academic administration, simulation programs, and web-based training.
If the new criteria are applied in the open minded spirit in which they are written, Harvard Medical School will have taken a big step into the 21st century.
This great scene captures a widespread view of organizational ethics – pious platitudes at best, but more often hypocrisy and outright lying. Academic institutions are not immune to this taint.
Corporations often say things like “our people are our greatest asset.” But words are cheap. Bureaucratic structures, like Harvard Medical School’s new Criteria for Appointment and Promotion, show what an organization truly values.
As a member of the faculty who had absolutely nothing to do with developing them, I read the new criteria with pleasure and pride. The introduction describes them as “a flexible structure which provides a ‘menu’ of activities, allowing assembly of a profile that reflects the unique combination of activities and accomplishments of each faculty member…recogniz[ing] the broad range of faculty activities that contribute to the academic mission including administrative leadership and service to the community.”
The criteria define three areas of excellence – “teaching and educational leadership,” “clinical expertise and innovation,” and “investigation.” All require scholarship. “Scholarship,” however, is defined much more broadly than in the past “to include not only peer-reviewed publications but also educational materials, policy statements, assessment tools, and guidelines for patients care…in print or alternative media.” "Teaching" is defined broadly as well, to include teaching peers, academic administration, simulation programs, and web-based training.
If the new criteria are applied in the open minded spirit in which they are written, Harvard Medical School will have taken a big step into the 21st century.
Friday, January 18, 2008
Civil Disobedience in the British National Health Service
This week the UK government considered ruling that GPs in the National Health Service will no longer be allowed to provide treatment to asylum seekers or undocumented migrants.
During the same week, in a highly publicized case, the UK deported 39 year old Ama Sumani to Ghana. Ms. Sumani had come to the UK on a student visa, but had overstayed and was working when, in 2006, she developed multiple myeloma. She developed kidney failure and was on dialysis in Wales when she was deported. Immigration officers escorted her back to Ghana, but the supposed plan for continued dialysis collapsed when Ms. Sumani was not able to make the required $5,000 deposit. The payment was made by a concerned individual in the UK, so three months of dialysis is now assured.
A Lancet editorial described the deportation as “an atrocious barbarism,” and chided medical leaders for not coming forward against it. In response, a petition signed by 276 GPs declared:
“This would impose serious health risks on [undocumented migrants] and on the general public. It would also interfere with our ability to carry out our duties as doctors. It is not in keeping with the ethics of our profession to refuse to see any person who may be ill, particularly pregnant women with complications, sick children or men crippled by torture. No one would want such a doctor for their GP.
We call on the government to retreat from this foolish proposal, which would prevent doctors from investigating, prescribing for, or referring such patients on the NHS.
We pledge that, in the event this regulation comes into effect, we will: (a) continue to see and examine asylum seekers and to advise them about their health needs, whatever their immigration status; (b) document their diagnoses and required clinical care; (c) with suitable anonymisation and consent, copy this documentation to the responsible ministers, [members of parliament] and the press; (d) inform the public of the human costs, to harness popular disgust at what is being ordered by the government in their name; (e) campaign to speedily reverse these ill-advised policies.”
The European Union is facing a real problem. Citizens of poorer countries, not surprisingly, are coming to EU countries in hope of receiving needed treatment that is not available at home. Others, like Ama Sumani, become ill after their [illegal] migration. As we are seeing in the U.S., there is a public backlash against undocumented migrants.
But we should cheer for the petition signers. Refusing to care for sick people – whatever their status – violates fundamental medical, and human, values. A policy that orders health professionals to abandon their historical commitment to provide care is not acceptable.
During the same week, in a highly publicized case, the UK deported 39 year old Ama Sumani to Ghana. Ms. Sumani had come to the UK on a student visa, but had overstayed and was working when, in 2006, she developed multiple myeloma. She developed kidney failure and was on dialysis in Wales when she was deported. Immigration officers escorted her back to Ghana, but the supposed plan for continued dialysis collapsed when Ms. Sumani was not able to make the required $5,000 deposit. The payment was made by a concerned individual in the UK, so three months of dialysis is now assured.
A Lancet editorial described the deportation as “an atrocious barbarism,” and chided medical leaders for not coming forward against it. In response, a petition signed by 276 GPs declared:
“This would impose serious health risks on [undocumented migrants] and on the general public. It would also interfere with our ability to carry out our duties as doctors. It is not in keeping with the ethics of our profession to refuse to see any person who may be ill, particularly pregnant women with complications, sick children or men crippled by torture. No one would want such a doctor for their GP.
We call on the government to retreat from this foolish proposal, which would prevent doctors from investigating, prescribing for, or referring such patients on the NHS.
We pledge that, in the event this regulation comes into effect, we will: (a) continue to see and examine asylum seekers and to advise them about their health needs, whatever their immigration status; (b) document their diagnoses and required clinical care; (c) with suitable anonymisation and consent, copy this documentation to the responsible ministers, [members of parliament] and the press; (d) inform the public of the human costs, to harness popular disgust at what is being ordered by the government in their name; (e) campaign to speedily reverse these ill-advised policies.”
The European Union is facing a real problem. Citizens of poorer countries, not surprisingly, are coming to EU countries in hope of receiving needed treatment that is not available at home. Others, like Ama Sumani, become ill after their [illegal] migration. As we are seeing in the U.S., there is a public backlash against undocumented migrants.
But we should cheer for the petition signers. Refusing to care for sick people – whatever their status – violates fundamental medical, and human, values. A policy that orders health professionals to abandon their historical commitment to provide care is not acceptable.
Tuesday, January 15, 2008
Access to Experimental Drugs - the Supreme Court Gets it Right
Today’s Los Angeles Times reports that the Supreme Court has turned down an appeal that claimed a right for dying patients to have access to experimental drugs not yet approved by the FDA. The appeal was brought by the Abigail Alliance, founded in memory of Abigail Burroughs, a beautiful young woman whose picture is on the website. Abigail got a rare head and neck cancer in 1999. Her Johns Hopkins physician wanted to give her an experimental medication, but was not able to. Abigail died in 2001. The drug subsequently received FDA approval. A short, powerful statement of the Abigail Alliance’s argument is in the January 11 Wall Street Journal.
The constitutional right the appeal argued for is based on the fifth amendment guarantee that no person shall “be deprived of life, liberty, or property, without due process of law.” Patients in “last chance” situations, when standard treatment offers no hope – are facing death. The Abagail Alliance argues that by not facilitating access to drugs that have passed through Phase 1 trial, the FDA is depriving them of the right to opt for to a potentially life-saving intervention.
As heartbreaking as it is to contemplate the death of 21 year old Abigail Burroughs and others like her, I think the Supreme Court got it right, for four main reasons. The court recognized the first two:
* The appeal argued for a terminally ill patient’s right to weigh the benefits and risks of taking the experimental medication and to pay for it with their own means. But Phase 1 testing does not provide the kind of information required for truly informed physician recommendation or patient consent, especially in desperate circumstances. The public, through the FDA, has a legitimate interest in the public safety implications of the FDA restrictions.
* Substantially unfettered access to experimental medications would severely undermine the ability to conduct rigorous controlled trials. Patients would be much less willing to enter a double blinded study if they could get access to the experimental agent by another route. Here too, the public has a legitimate interest in fostering rigorous testing of proposed new treatments.
* Although the appeal was limited to drugs in last chance situations and required self payment for access, there is every reason to expect that public and private insurance programs would soon be asked to cover the cost, and that patients with serious but not terminal conditions would press for the same kind of access. The cost of health care is already causing serious harms through uninsurance and job loss from diminished economic competitiveness. The public has a legitimate interest in mitigating the harms caused by runaway cost increases.
* Finally, the appellant’s argument would add to public confusion about the difference between evidence-based treatment and wishful thinking about experimental agents. Our health system is already permeated by magical thinking and denial of death. As well-intentioned as the appeal is, it would add to this unfortunate aspect of U.S. culture.
(For those with time and inclination to read a 22 page document, the decision of the District of Columbia Circuit Court, which the Supreme Court upheld by declining to hear an appeal, makes fascinating reading.)
The constitutional right the appeal argued for is based on the fifth amendment guarantee that no person shall “be deprived of life, liberty, or property, without due process of law.” Patients in “last chance” situations, when standard treatment offers no hope – are facing death. The Abagail Alliance argues that by not facilitating access to drugs that have passed through Phase 1 trial, the FDA is depriving them of the right to opt for to a potentially life-saving intervention.
As heartbreaking as it is to contemplate the death of 21 year old Abigail Burroughs and others like her, I think the Supreme Court got it right, for four main reasons. The court recognized the first two:
* The appeal argued for a terminally ill patient’s right to weigh the benefits and risks of taking the experimental medication and to pay for it with their own means. But Phase 1 testing does not provide the kind of information required for truly informed physician recommendation or patient consent, especially in desperate circumstances. The public, through the FDA, has a legitimate interest in the public safety implications of the FDA restrictions.
* Substantially unfettered access to experimental medications would severely undermine the ability to conduct rigorous controlled trials. Patients would be much less willing to enter a double blinded study if they could get access to the experimental agent by another route. Here too, the public has a legitimate interest in fostering rigorous testing of proposed new treatments.
* Although the appeal was limited to drugs in last chance situations and required self payment for access, there is every reason to expect that public and private insurance programs would soon be asked to cover the cost, and that patients with serious but not terminal conditions would press for the same kind of access. The cost of health care is already causing serious harms through uninsurance and job loss from diminished economic competitiveness. The public has a legitimate interest in mitigating the harms caused by runaway cost increases.
* Finally, the appellant’s argument would add to public confusion about the difference between evidence-based treatment and wishful thinking about experimental agents. Our health system is already permeated by magical thinking and denial of death. As well-intentioned as the appeal is, it would add to this unfortunate aspect of U.S. culture.
(For those with time and inclination to read a 22 page document, the decision of the District of Columbia Circuit Court, which the Supreme Court upheld by declining to hear an appeal, makes fascinating reading.)
Monday, January 14, 2008
Genes, Organizational Ethics, and Calling
Many people – myself included - see health care as a calling. But as I asked a few months ago - where does the calling come from?
For those who ground their sense of calling in religion, the answer is easy – the call comes from God. Secular individuals and organizations, however, can’t take that route.
Steven Pinker’s article on “The Moral Instinct” in yesterday’s New York Times, which draws heavily on Jonathan Haidt’s book “The Happiness Hypothesis,” speaks to the issue of secular “calling.”
Haidt speculates that five moral “themes” have been wired into us through evolution:
it is bad to harm others, and good to help them
people should get what they deserve (fairness)
we should be loyal to our group(s)
we should respect legitimate authority
we should seek purity and sanctity, and avoid defilement
Haidt and Pinker’s perspective is that these sentiments are “natural” – they are attitudes characteristic for our species, though not universal to every person. Individuals, groups, and societies give different weights to these values, and attach them to different phenomena. But the values themselves, Haidt and Pinker argue, create a basic moral vocabulary.
I think Haidt and Pinker’s hypothesis about the hard wiring of moral sentiments sheds light on why folks at the front lines of health care cringe at the application of market terminology to the field, such as: “health care industry;” “providers;” “consumers;” “marketing;” and, “brand identity.”
Concepts like these, and others from business and economics, explain a lot about how health organizations function, and are crucial for running them. Mother Theresa was a superb marketer!
Those who work in faith-based organizations can say – “We have to recognize that we are economic entities functioning in a market economy, but we always have to remember that we are doing God’s work.” Those in secular organizations can’t say this. But they feel it – even though they may not be able to explain why.
Haidt and Pinker would say – those feelings arise from our hard wired moral sentiments. Health care is all about helping sick people have fair chances in life. Good hospitals, clinics, health plans, and other health organizations, are committed to these goals just as religious organizations are. And the Hippocratic Oath is replete with references to authority, holiness, and purity.
Health organizations and their leaders have to walk a complex line. They are economic entities in an economic world. Without an economic margin they can’t pursue their mission. But whether or not they are founded on a conventional theology, they are, at heart, religious entities as well. When that is forgotten those who are part of the organization ultimately become cynical and alienated, and those who deal with it ultimately cease trusting it.
Pinker and Haidt would say - listen to your genes. They are calling you!
For those who ground their sense of calling in religion, the answer is easy – the call comes from God. Secular individuals and organizations, however, can’t take that route.
Steven Pinker’s article on “The Moral Instinct” in yesterday’s New York Times, which draws heavily on Jonathan Haidt’s book “The Happiness Hypothesis,” speaks to the issue of secular “calling.”
Haidt speculates that five moral “themes” have been wired into us through evolution:
it is bad to harm others, and good to help them
people should get what they deserve (fairness)
we should be loyal to our group(s)
we should respect legitimate authority
we should seek purity and sanctity, and avoid defilement
Haidt and Pinker’s perspective is that these sentiments are “natural” – they are attitudes characteristic for our species, though not universal to every person. Individuals, groups, and societies give different weights to these values, and attach them to different phenomena. But the values themselves, Haidt and Pinker argue, create a basic moral vocabulary.
I think Haidt and Pinker’s hypothesis about the hard wiring of moral sentiments sheds light on why folks at the front lines of health care cringe at the application of market terminology to the field, such as: “health care industry;” “providers;” “consumers;” “marketing;” and, “brand identity.”
Concepts like these, and others from business and economics, explain a lot about how health organizations function, and are crucial for running them. Mother Theresa was a superb marketer!
Those who work in faith-based organizations can say – “We have to recognize that we are economic entities functioning in a market economy, but we always have to remember that we are doing God’s work.” Those in secular organizations can’t say this. But they feel it – even though they may not be able to explain why.
Haidt and Pinker would say – those feelings arise from our hard wired moral sentiments. Health care is all about helping sick people have fair chances in life. Good hospitals, clinics, health plans, and other health organizations, are committed to these goals just as religious organizations are. And the Hippocratic Oath is replete with references to authority, holiness, and purity.
Health organizations and their leaders have to walk a complex line. They are economic entities in an economic world. Without an economic margin they can’t pursue their mission. But whether or not they are founded on a conventional theology, they are, at heart, religious entities as well. When that is forgotten those who are part of the organization ultimately become cynical and alienated, and those who deal with it ultimately cease trusting it.
Pinker and Haidt would say - listen to your genes. They are calling you!
Sunday, January 13, 2008
Transplant Ethics in China
An article in today's China Daily describes China's effort to clean up its act with regard to transplantaion ethics.
China has been notorious for sale of organs - often "harvested" from executed prisonors - since a transplant doctor at NYU told the Village Voice in 2001 about patients who had come to him after purchasing kidneys in China for $10,000.
In May, 2007, China set new regulations for organ donation, limiting donation to spouses, close relatives, or "people who have a proven close relationship with the donors." In the case described today, two patients needing transplants had no good match within their own family, but family members from each were good matches for the other patient.
The new regulations prohibited He Yiwen's father from donating a kidney to He Zhigang, whose cousin was prepared to donate a kidney to He Yiwen. The hospital, however, ultimately carried out the kidney exchange, with the clear rationale that organ sale was not involved, and the two families were carrying out an arrangement that provided benefit to all.
In a previous posting I discussed the ethics of "medical tourism" - travel, typically from the developed world to developing areas, for treatment, including transplantation. Executing prisoners as a source of organs, like selling children for sexual exploitation, ranks high as a moral crime. If China is truly cleaning up its act in the domain of transplantation it will be a significant contribution to improved global medical ethics.
China has been notorious for sale of organs - often "harvested" from executed prisonors - since a transplant doctor at NYU told the Village Voice in 2001 about patients who had come to him after purchasing kidneys in China for $10,000.
In May, 2007, China set new regulations for organ donation, limiting donation to spouses, close relatives, or "people who have a proven close relationship with the donors." In the case described today, two patients needing transplants had no good match within their own family, but family members from each were good matches for the other patient.
The new regulations prohibited He Yiwen's father from donating a kidney to He Zhigang, whose cousin was prepared to donate a kidney to He Yiwen. The hospital, however, ultimately carried out the kidney exchange, with the clear rationale that organ sale was not involved, and the two families were carrying out an arrangement that provided benefit to all.
In a previous posting I discussed the ethics of "medical tourism" - travel, typically from the developed world to developing areas, for treatment, including transplantation. Executing prisoners as a source of organs, like selling children for sexual exploitation, ranks high as a moral crime. If China is truly cleaning up its act in the domain of transplantation it will be a significant contribution to improved global medical ethics.
Thursday, January 10, 2008
Suicide, Malpractice, and Clinical Ethics
Ruth Farrell, a 41 year old librarian in Westport, Connecticut, was admitted to Silver Hill Hospital in mid January, 2002. On January 28, 2002, in between 15 minute checks on her status, she hanged herself, using her own spandex pants.
The executor of her estate, David Kervick, a 60 year old lawyer from New Jersey, who she had met in 2001 when they were both inpatients, sued the hospital and Ms. Farrell’s psychiatrist, Dr. Ellyn Shander, for not preventing her death. On January 3, 2008, a Superior Court jury in Stamford, Connecticut, ruled in favor of the hospital and Dr. Shander.
The New York Times articles from November 23, 2007 and January 4, 2008, tell a painful story. Ms. Farrell was named for a grandmother who had died by suicide. She began cutting herself in high school. During college she was hospitalized for a year for depression. Her pastor said “I have no idea how she lasted as long as she did.” Ms. Farrell’s final admission to Silver Hill was her seventeenth.
Given that suicidal risk was so obvious, how could the jury find for the hospital and psychiatrist?
From my reading of the two New York Times articles, the answer is (1) clinical ethics and (2) a realistic view of the limits of what medicine can accomplish.
After the trial, a juror commented that she was “impressed that when Ms. Farrell could not afford the fees, the doctor often accepted homemade treats in lieu of payment…Ellyn [the psychiatrist] would take cookies, and a lot of doctors won’t do that.” The jury concluded that Dr. Shander cared deeply about Ms. Farrell, stretched herself to be available, and was not mercenary.
The juror conveyed a realistic view of psychiatry as helpful, but finite in its capacity, not omnipotent. “With Ms. Farrell’s history of suicidal thoughts and deeds…she could have done it at home, and the hospital and the doctor helped her all these years.” The jury saw the suicide as the end of a tragic life story, not as the fault of Silver Hill or Dr. Shander. Remarkably, the jury has planned a reunion for January 28, the anniversary of Ms. Farrell’s death, and invited the defense team to participate.
Some decades ago I was briefly involved in the treatment of a young person who committed suicide, elsewhere in the country, a few months after our last contact. I met at length with the family after the death – one of the most painful meetings in my career. The family expressed great grief and anger. They challenged me as to whether, in retrospect, I would have done anything differently. I told them that if I could turn back the clock I would indeed have taken a different course of action, and explained why I had not done so at the time.
Several years later a lawyer called about my late patient. I returned the call with great trepidation. The lawyer told me that the family was bringing suit against the facility where my patient had died, but had “said to get information from you, but to make sure that you were not part of the malpractice suit.”
Apparently the family had concluded that although I had not done what, in retrospect, we all agreed would have been the best thing to do, I cared about their family member and provided well thought out, though ultimately ineffective, treatment.
Health professional students are taught about the importance of genuine caring. The importance of loving one’s patients can’t be overemphasized. It is harder to conceptualize what it means for organizations to be loving, but I believe it can be done. This will be a topic in future postings.
The executor of her estate, David Kervick, a 60 year old lawyer from New Jersey, who she had met in 2001 when they were both inpatients, sued the hospital and Ms. Farrell’s psychiatrist, Dr. Ellyn Shander, for not preventing her death. On January 3, 2008, a Superior Court jury in Stamford, Connecticut, ruled in favor of the hospital and Dr. Shander.
The New York Times articles from November 23, 2007 and January 4, 2008, tell a painful story. Ms. Farrell was named for a grandmother who had died by suicide. She began cutting herself in high school. During college she was hospitalized for a year for depression. Her pastor said “I have no idea how she lasted as long as she did.” Ms. Farrell’s final admission to Silver Hill was her seventeenth.
Given that suicidal risk was so obvious, how could the jury find for the hospital and psychiatrist?
From my reading of the two New York Times articles, the answer is (1) clinical ethics and (2) a realistic view of the limits of what medicine can accomplish.
After the trial, a juror commented that she was “impressed that when Ms. Farrell could not afford the fees, the doctor often accepted homemade treats in lieu of payment…Ellyn [the psychiatrist] would take cookies, and a lot of doctors won’t do that.” The jury concluded that Dr. Shander cared deeply about Ms. Farrell, stretched herself to be available, and was not mercenary.
The juror conveyed a realistic view of psychiatry as helpful, but finite in its capacity, not omnipotent. “With Ms. Farrell’s history of suicidal thoughts and deeds…she could have done it at home, and the hospital and the doctor helped her all these years.” The jury saw the suicide as the end of a tragic life story, not as the fault of Silver Hill or Dr. Shander. Remarkably, the jury has planned a reunion for January 28, the anniversary of Ms. Farrell’s death, and invited the defense team to participate.
Some decades ago I was briefly involved in the treatment of a young person who committed suicide, elsewhere in the country, a few months after our last contact. I met at length with the family after the death – one of the most painful meetings in my career. The family expressed great grief and anger. They challenged me as to whether, in retrospect, I would have done anything differently. I told them that if I could turn back the clock I would indeed have taken a different course of action, and explained why I had not done so at the time.
Several years later a lawyer called about my late patient. I returned the call with great trepidation. The lawyer told me that the family was bringing suit against the facility where my patient had died, but had “said to get information from you, but to make sure that you were not part of the malpractice suit.”
Apparently the family had concluded that although I had not done what, in retrospect, we all agreed would have been the best thing to do, I cared about their family member and provided well thought out, though ultimately ineffective, treatment.
Health professional students are taught about the importance of genuine caring. The importance of loving one’s patients can’t be overemphasized. It is harder to conceptualize what it means for organizations to be loving, but I believe it can be done. This will be a topic in future postings.
Wednesday, January 9, 2008
Taking Action for Good Prescribing Ethics
Ethical analysis is only worthwhile if it ultimately leads to action. This is a fan letter about two terrific projects that translate ethical scrutiny of pharmaceutical industry practices into change-promoting efforts.
The peRx (“Prescribing Evidence-Based Therapies”) project , led by Elissa Ladd, PhD, a family nurse practitioner at the Massachusetts General Hospital Institute of Health Professions, developed four video modules (available free on the website) targeted to nurse practitioners, but potentially useful for any and all health professionals and students. The modules, each about 20 minutes long, discuss the drug approval process, Pharma marketing techniques, and prudent prescribing practices. They are informative, engaging, and entertaining.
The project is funded by a grant from the fund created by the settlement between Warner-Lambert and the Attorneys General of all 50 states, to settle allegations about unlawful marketing of Neurontin. This is how money from settlements of this kind should be used – to fund counter-detailing efforts. The peRx project is conducting an evaluation study, but no results are available yet.
No Free Lunch is an information-packed website whose aim is to “[inform] health care providers as well as the general public about pharmaceutical industry efforts to promote their products and influence prescribing; provide, evidence that promotion does in fact influence health care provider behavior, often in ways that run counter to good patient care; and provide products that can replace pharmaceutical company paraphernalia and spread our message.”
Like peRx, the No Free Lunch project is acting, not preaching. I especially like this pledge that health professionals are encouraged to make:
"I, __________________, am committed to practicing medicine in the best interest of my patients and on the basis of the best available evidence, rather than on the basis of advertising or promotion.
I therefore pledge to accept no money, gifts, or hospitality from the pharmaceutical industry; to seek unbiased sources of information and not rely on information disseminated by drug companies; and to avoid conflicts of interest in my practice, teaching, and/or research."
To my eye, peRx and No Free Lunch are exemplary grassroots efforts to promote clinically and ethically informed prescribing practices. They represent a crucial form of ethical activism – advocacy and education directed to clinicians. We need political activists and political leaders to promote “top down” ethical activism, in the form of regulation, legislation, and, where needed, litigation. But we also need “ground up” ethical activism like peRx and No Free Lunch to strengthen the constituency that will demand that our leaders do the right thing.
The peRx (“Prescribing Evidence-Based Therapies”) project , led by Elissa Ladd, PhD, a family nurse practitioner at the Massachusetts General Hospital Institute of Health Professions, developed four video modules (available free on the website) targeted to nurse practitioners, but potentially useful for any and all health professionals and students. The modules, each about 20 minutes long, discuss the drug approval process, Pharma marketing techniques, and prudent prescribing practices. They are informative, engaging, and entertaining.
The project is funded by a grant from the fund created by the settlement between Warner-Lambert and the Attorneys General of all 50 states, to settle allegations about unlawful marketing of Neurontin. This is how money from settlements of this kind should be used – to fund counter-detailing efforts. The peRx project is conducting an evaluation study, but no results are available yet.
No Free Lunch is an information-packed website whose aim is to “[inform] health care providers as well as the general public about pharmaceutical industry efforts to promote their products and influence prescribing; provide, evidence that promotion does in fact influence health care provider behavior, often in ways that run counter to good patient care; and provide products that can replace pharmaceutical company paraphernalia and spread our message.”
Like peRx, the No Free Lunch project is acting, not preaching. I especially like this pledge that health professionals are encouraged to make:
"I, __________________, am committed to practicing medicine in the best interest of my patients and on the basis of the best available evidence, rather than on the basis of advertising or promotion.
I therefore pledge to accept no money, gifts, or hospitality from the pharmaceutical industry; to seek unbiased sources of information and not rely on information disseminated by drug companies; and to avoid conflicts of interest in my practice, teaching, and/or research."
To my eye, peRx and No Free Lunch are exemplary grassroots efforts to promote clinically and ethically informed prescribing practices. They represent a crucial form of ethical activism – advocacy and education directed to clinicians. We need political activists and political leaders to promote “top down” ethical activism, in the form of regulation, legislation, and, where needed, litigation. But we also need “ground up” ethical activism like peRx and No Free Lunch to strengthen the constituency that will demand that our leaders do the right thing.
Tuesday, January 8, 2008
The Ethics of the Hospital Safety Net (2)
The U.S. hospital safety net is under siege. Today’s New York Times reports on yet another safety net hospital - Grady Memorial Hospital in Atlanta - that is teetering on the edge of disaster. This posting takes up where my December 3 discussion of similar issues at the University of Texas Medical Branch in Galveston left off.
Grady has been serving the poor in Atlanta since 1892. A quarter of Georgia’s physicians have had at least part of their training at Grady. The hospital has 953 beds. The Grady Health System, which includes nine neighborhood health centers, does 921,000 outpatient visits per year.
Grady is in dire straits. It has major managerial problems, including allegations of corruption. A consultant’s strategic plan, presented in June, 2007, is painful to read. Grady is deeply in debt and hemorrhaging money each month. The consultant recommended radical managerial surgery, but the governing board, subject to strong political pressures, put off action. In November the board voted to turn Grady over to an independent 501(c)(3) corporation, but that effort is currently embroiled in complex local politics.
From the perspective of ethics, Grady, like the University of Texas in Galveston, faces a classic dilemma, which will not go away even if Grady solves all of its managerial problems. Like the Galveston program, it could improve its financial status by dropping the biggest money-losers. But doing this would violate the charitable mission for which it was founded. The impact of internal resource allocation choices go beyond what a society as wealthy as ours can or should accept. But the wider community is reluctant to reallocate its own resources, whether through increased taxes or other means.
Our fragmented health system makes it all-too-easy for us citizens and our leaders to avoid responsibility for what happens. Grady can blame the outside community. Politicians can blame Grady’s management. Atlanta can blame the suburbs. One has to suspect that one of the purposes of our stupifyingly complex system is just this – to give all parties deniability about the bad things that happen.
Grady has been serving the poor in Atlanta since 1892. A quarter of Georgia’s physicians have had at least part of their training at Grady. The hospital has 953 beds. The Grady Health System, which includes nine neighborhood health centers, does 921,000 outpatient visits per year.
Grady is in dire straits. It has major managerial problems, including allegations of corruption. A consultant’s strategic plan, presented in June, 2007, is painful to read. Grady is deeply in debt and hemorrhaging money each month. The consultant recommended radical managerial surgery, but the governing board, subject to strong political pressures, put off action. In November the board voted to turn Grady over to an independent 501(c)(3) corporation, but that effort is currently embroiled in complex local politics.
From the perspective of ethics, Grady, like the University of Texas in Galveston, faces a classic dilemma, which will not go away even if Grady solves all of its managerial problems. Like the Galveston program, it could improve its financial status by dropping the biggest money-losers. But doing this would violate the charitable mission for which it was founded. The impact of internal resource allocation choices go beyond what a society as wealthy as ours can or should accept. But the wider community is reluctant to reallocate its own resources, whether through increased taxes or other means.
Our fragmented health system makes it all-too-easy for us citizens and our leaders to avoid responsibility for what happens. Grady can blame the outside community. Politicians can blame Grady’s management. Atlanta can blame the suburbs. One has to suspect that one of the purposes of our stupifyingly complex system is just this – to give all parties deniability about the bad things that happen.
Monday, January 7, 2008
Good Politics but Bad Ethics in New Hampshire
On December 20, 2007, in California, 17 year old Nataline Sarkisyan died of leukemia and liver failure. On January 6, in New Hampshire, Nataline’s parents spoke at a John Edwards rally.
Just before Thanksgiving, Nataline received a bone marrow transplant from her brother. Soon after, she went into liver failure. Her doctors at UCLA recommended a liver transplant, reporting their belief that she would have a 65% chance of living for six months. Natline’s insurer, Cigna, refused coverage, reporting that their own medical experts and an outside transplant surgeon concluded that the procedure was “experimental,” and therefore not covered.
Interestingly, in response to the public outcry, Cigna reversed itself on grounds of “empathy for the family.” But Nataline died before the procedure could be tried. It is reported that the local attorney general may press manslaughter charges against Cigna!
I have no expertise about liver transplantation for patients with leukemia who have had a bone marrow transplant. But neither does Senator Edwards. This looks like a situation in which the “left” is making politics out of a tragedy, just as the “right” did with Terri Schiavo.
Every health system has to set limits. This would be true even if Mother Theresa were the health czar. It is entirely reasonable to question the evidence basis for UCLA’s proposal or Cigna’s denial. Similarly, it is entirely reasonable to argue that the bar for evidence should be lower in last chance situations than in other domains of care. But Edwards, who I admire and largely agree with politically, does the public a disservice by presenting the denial as a moral crime.
Edwards favors extending Medicare to a wider range of citizens. If he ends up as president, it will be interesting to see how he addresses the issue of limits. As Oregon Governor John Kitzhaber recognized 20 years ago, universal coverage is impossible without limits. No limits, no universality. It is that simple.
True leaders must be educators. Understanding the ethical necessity for limits is counter-intuitive for those who are not familiar with the health sector. Edwards may have done an effective piece of campaigning yesterday, but he was not providing the kind of ethical leadership that improvement of our health system requires.
This is especially unfortunate. Edwards is a superb communicator -- just the kind of voice we need to help us come to grips with the sad fact that health care limits, well set, are an ethical necessity, not a moral abomination.
Just before Thanksgiving, Nataline received a bone marrow transplant from her brother. Soon after, she went into liver failure. Her doctors at UCLA recommended a liver transplant, reporting their belief that she would have a 65% chance of living for six months. Natline’s insurer, Cigna, refused coverage, reporting that their own medical experts and an outside transplant surgeon concluded that the procedure was “experimental,” and therefore not covered.
Interestingly, in response to the public outcry, Cigna reversed itself on grounds of “empathy for the family.” But Nataline died before the procedure could be tried. It is reported that the local attorney general may press manslaughter charges against Cigna!
I have no expertise about liver transplantation for patients with leukemia who have had a bone marrow transplant. But neither does Senator Edwards. This looks like a situation in which the “left” is making politics out of a tragedy, just as the “right” did with Terri Schiavo.
Every health system has to set limits. This would be true even if Mother Theresa were the health czar. It is entirely reasonable to question the evidence basis for UCLA’s proposal or Cigna’s denial. Similarly, it is entirely reasonable to argue that the bar for evidence should be lower in last chance situations than in other domains of care. But Edwards, who I admire and largely agree with politically, does the public a disservice by presenting the denial as a moral crime.
Edwards favors extending Medicare to a wider range of citizens. If he ends up as president, it will be interesting to see how he addresses the issue of limits. As Oregon Governor John Kitzhaber recognized 20 years ago, universal coverage is impossible without limits. No limits, no universality. It is that simple.
True leaders must be educators. Understanding the ethical necessity for limits is counter-intuitive for those who are not familiar with the health sector. Edwards may have done an effective piece of campaigning yesterday, but he was not providing the kind of ethical leadership that improvement of our health system requires.
This is especially unfortunate. Edwards is a superb communicator -- just the kind of voice we need to help us come to grips with the sad fact that health care limits, well set, are an ethical necessity, not a moral abomination.
Sunday, January 6, 2008
Amazon.com and Organizational Trust
In yesterday’s New York Times, Joe Nocera reports how Amazon rescued his Christmas. The story has lessons for health care organizational ethics.
Nocera had ordered a PlayStation3 for his son, but on December 21 he found that it had gone astray. Amazon was not responsible for the problem – a neighbor, who had signed for the package, left it in a public space from which it was stolen – but Amazon nevertheless got another PlayStation3 to him by Christmas Eve.
Nocera rhapsodizes about Amazon’s determination “to be the most customer-centric company in the world.” He describes how the company has chosen a strategy of “long term value creation” rather than chasing the short term return on investment that Wall Street demands. That strategy has created extraordinary customer loyalty and trust in the Amazon brand.
Amazon is doing what individual clinicians and health care organizations need to do. Without trust, treatment goes nowhere. Without customer (patient) loyalty, organizations go down the tubes.
Nocera attributes Amazon’s ability to resist the short term focus that grips publicly owned organizations to founder Jeff Bezos’ vision and commitment, but also to the fact that Bezos is Amazon’s largest single shareholder. This has made it easier to accept lower current profits for trust-building activities like solving Nocera’s PlayStation3 problem.
Amazon went beyond what its narrow contract with Nocera required – what ethicists call “supererogatory” action. We need to do the same in health care. Excellent clinicians and excellent organizations know that.
The problem with for-profit ownership is not the quest for profit per se, but the short term focus that dominates market behavior. Nocera's story is remarkable for the fact that most of the trust-building interactions were on-line. The only human exchange was on the telephone with a customer service agent. Amazon's blend of high tech/high touch interaction with its customers provides us with a model of how health care organizations can comport themselves to build and hold trust.
Nocera had ordered a PlayStation3 for his son, but on December 21 he found that it had gone astray. Amazon was not responsible for the problem – a neighbor, who had signed for the package, left it in a public space from which it was stolen – but Amazon nevertheless got another PlayStation3 to him by Christmas Eve.
Nocera rhapsodizes about Amazon’s determination “to be the most customer-centric company in the world.” He describes how the company has chosen a strategy of “long term value creation” rather than chasing the short term return on investment that Wall Street demands. That strategy has created extraordinary customer loyalty and trust in the Amazon brand.
Amazon is doing what individual clinicians and health care organizations need to do. Without trust, treatment goes nowhere. Without customer (patient) loyalty, organizations go down the tubes.
Nocera attributes Amazon’s ability to resist the short term focus that grips publicly owned organizations to founder Jeff Bezos’ vision and commitment, but also to the fact that Bezos is Amazon’s largest single shareholder. This has made it easier to accept lower current profits for trust-building activities like solving Nocera’s PlayStation3 problem.
Amazon went beyond what its narrow contract with Nocera required – what ethicists call “supererogatory” action. We need to do the same in health care. Excellent clinicians and excellent organizations know that.
The problem with for-profit ownership is not the quest for profit per se, but the short term focus that dominates market behavior. Nocera's story is remarkable for the fact that most of the trust-building interactions were on-line. The only human exchange was on the telephone with a customer service agent. Amazon's blend of high tech/high touch interaction with its customers provides us with a model of how health care organizations can comport themselves to build and hold trust.
Friday, January 4, 2008
Trust (and lack thereof) in Health Organizations
Without trust, the patient-clinician relationship goes nowhere. Trust encourages us to adhere to the recommendations we receive. And, as the placebo effect shows, trust has powerful healing effects in itself.
But what about trust in the organizations that are increasingly central to healthcare?
An article in yesterday’s Wall Street Journal Health Blog about Morgan Stanley’s “Pharmaceutical CEOs Unplugged” conference reported on CEO claims that the industry is highly trusted. But a recent Harris poll suggests that Pharma is on its way to the dustbin of trust, just as happened to managed care.
When asked "which of these industries do you think are generally honest and trustworthy – so that you normally believe a statement by a company in that industry?" about a series of 17 industries, the winner by far was “none of the above.” 11% find pharmaceutical companies trustworthy. This is better than HMOs (5%), tied with airlines and car manufacturers, and worse than hospitals (28%) and banks (30%). Pharma is trending downward: 2003 (13%); 2004 (14%); 2005 (9%); 2006 (7%); 2007 (11%). When asked "which of these industries do you think should be more regulated by government – for example for health, safety or environmental reasons – than they are now?" Pharma (53%) tied with oil for first place.
With regard to regulation, in 2003 60% of those polled felt that HMOs should be more regulated. This percentage has dropped steadily, to 45% -- the largest change for any industry. But the decreased demand for regulation has come at a high cost to the public – in the form of premium increases as HMOs have backed off from managing care.
To promote quality and efficiency, societies have to manage care. But thus far we have not been able to do this without a fatal loss of trust. By managing less, the managed care industry has bought back some trust, but the cost increases driven by reduced management will not be sustainable for long.
The pressure on Pharma is not yet at the level that was brought to bear on HMOs, but the trend is in that direction. Pharma needs new strategies to rebuild trust. Public relations campaigns won't be enough.
But what about trust in the organizations that are increasingly central to healthcare?
An article in yesterday’s Wall Street Journal Health Blog about Morgan Stanley’s “Pharmaceutical CEOs Unplugged” conference reported on CEO claims that the industry is highly trusted. But a recent Harris poll suggests that Pharma is on its way to the dustbin of trust, just as happened to managed care.
When asked "which of these industries do you think are generally honest and trustworthy – so that you normally believe a statement by a company in that industry?" about a series of 17 industries, the winner by far was “none of the above.” 11% find pharmaceutical companies trustworthy. This is better than HMOs (5%), tied with airlines and car manufacturers, and worse than hospitals (28%) and banks (30%). Pharma is trending downward: 2003 (13%); 2004 (14%); 2005 (9%); 2006 (7%); 2007 (11%). When asked "which of these industries do you think should be more regulated by government – for example for health, safety or environmental reasons – than they are now?" Pharma (53%) tied with oil for first place.
With regard to regulation, in 2003 60% of those polled felt that HMOs should be more regulated. This percentage has dropped steadily, to 45% -- the largest change for any industry. But the decreased demand for regulation has come at a high cost to the public – in the form of premium increases as HMOs have backed off from managing care.
To promote quality and efficiency, societies have to manage care. But thus far we have not been able to do this without a fatal loss of trust. By managing less, the managed care industry has bought back some trust, but the cost increases driven by reduced management will not be sustainable for long.
The pressure on Pharma is not yet at the level that was brought to bear on HMOs, but the trend is in that direction. Pharma needs new strategies to rebuild trust. Public relations campaigns won't be enough.
Thursday, January 3, 2008
Guinea-Pig Ethics
Carl Elliott’s excellent article on “Guinea-Pigging” in the forthcoming January 7 New Yorker (only the abstract is available on-line) educated me about a topic I should have known about already – the inner workings of pharmaceutical contract research organizations.
Over the past decade, pharmaceutical companies have increasingly outsourced the conduct of clinical trials to contract research organizations. CROs are big business. Revenues are estimated at close to $18 billion. The largest 10 firms enrolled more then 640,000 subjects in trials in 2004.
“Guinea-Pigging” is the insider term for the job of research subject in a CRO project. This isn’t volunteering from altruistic motives as patients of mine with HIV and cancer have done to contribute to scientific progress in an area they care about. It is a job, and not an elevated one. A guinea pig for a sleep study described the work as a form of prostitution – “I would sell my body not to slobbering johns who assail the street whore with their unkempt organs, but to slick, white coated neuropsychologists who use thrice sterilized catheters, electrodes…and invasive thermometers to get what they want.”
Readers who, like me, do not yet know in any detail about the recruitment of healthy subjects for CRO studies can visit Guinea Pig Zero, defined as a "jobzine for people who are used as medical or pharmaceutical research subjects." And, as well, websites for large CROs, such as Pharmaceutical Product Development, Charles River Laboratories, and Covance.
CROs are at the heart of the development of new treatments, but they have largely been under the radar in terms of recognizing just how important they have become. Subject recruitment is becoming a worldwide industry. I look forward to learning more about the area in the next few months. We owe Carl Elliott thanks for bringing questions about the ethics of the role -- safety, compensation, and non-exploitation, to the fore.
Over the past decade, pharmaceutical companies have increasingly outsourced the conduct of clinical trials to contract research organizations. CROs are big business. Revenues are estimated at close to $18 billion. The largest 10 firms enrolled more then 640,000 subjects in trials in 2004.
“Guinea-Pigging” is the insider term for the job of research subject in a CRO project. This isn’t volunteering from altruistic motives as patients of mine with HIV and cancer have done to contribute to scientific progress in an area they care about. It is a job, and not an elevated one. A guinea pig for a sleep study described the work as a form of prostitution – “I would sell my body not to slobbering johns who assail the street whore with their unkempt organs, but to slick, white coated neuropsychologists who use thrice sterilized catheters, electrodes…and invasive thermometers to get what they want.”
Readers who, like me, do not yet know in any detail about the recruitment of healthy subjects for CRO studies can visit Guinea Pig Zero, defined as a "jobzine for people who are used as medical or pharmaceutical research subjects." And, as well, websites for large CROs, such as Pharmaceutical Product Development, Charles River Laboratories, and Covance.
CROs are at the heart of the development of new treatments, but they have largely been under the radar in terms of recognizing just how important they have become. Subject recruitment is becoming a worldwide industry. I look forward to learning more about the area in the next few months. We owe Carl Elliott thanks for bringing questions about the ethics of the role -- safety, compensation, and non-exploitation, to the fore.
Wednesday, January 2, 2008
Outpatient Psychiatric Commitment
President Harry Truman only wanted advice from one-armed economists, to avoid being told “one the one hand…but on the other hand…”
I have tried to follow Truman’s guidance in giving talks about ethics. An “on the one hand/on the other hand” talk tends to sedate the audience. If listeners think the speaker is all wrong, at least they are awake and thinking.
But a happy article in a recent Washington Post brings up an issue for which two-armed policy advisors and ethicists are desirable. Susan Wezel, a 50 year old New York woman who suffers from a severe psychotic illness, was required to undergo outpatient treatment under a New York law (“Kendra’s law”) that allows court-mandated treatment. Despite having been hospitalized more than a dozen times in the previous ten years, she has been stable and functioning well for the past 18 months. She now takes medication regularly and credits the law with saving her life. Her husband Chris says "there was nothing I could do to get her into any help before this."
The primary political impetus for laws that allow forced outpatient treatment is fear of the rare but highly publicized acts of violence by persons with psychiatric illness. The New York State law was passed after 32 year old Kendra Webdale was killed by being pushed in front of a subway train by Andrew Goldstein, who suffered from schizophrenia. California passed “Laura’s Law” after 19 year old Laura Wilcox, who was working in a public mental health clinic during a school break, was shot to death by Scott Thorpe, who believed that the FBI was trying to poison him and force him to see an incompetent psychiatrist, and who rejected his family’s pleas that he go back onto antipsychotic medication.
Most psychiatrists have seen happy situations like Susan Wezel’s, in which a gravely impaired person regains access to their innate capacities when the psychosis that has intruded on their function is controlled. Two decades ago a patient of mine voluntarily accepted, albeit reluctantly, injections of an antipsychotic medication. These have continued every four weeks, in very low dose, to the present, and the person has been able to turn life around in a way that brings substantial fulfillment.
Lawmakers ask -- if people can be helped in this way but cannot be persuaded to participate in treatment – why not set the ball of recovery rolling by requiring treatment? Especially if the specter of preventing violence is added to the equation! The argument for outpatient commitment is powerful. But so is the critique, which is based on principle (opposition to coercion) and practice (questions about the efficacy of outpatient commitment).
I come out in favor of cautious and careful outpatient commitment programs, modeled on New York, which has not simply passed a law but has also provided funding to allow treatment of the sort that Susan Wezel has benefited from. But people of good will and good knowledge of the issues will continue to disagree.
The reason for this posting, however, is not the substantive issue, but the policy lesson that comes from the policy debate itself. Many state legislatures – like New York and California, and now Virginia, which has been activated by the Virginia Tech killings – have conducted remarkably thoughtful deliberation – involving gathering data, benchmarking other states, hearing the range of viewpoints, and educative debate.
This has been the kind of educative policy debate we need for sound governance of our health care system. The two key ingredients that allow it to happen are the (a) presence of well-informed advocates and advocacy groups for a range of perspectives and (b) absence of political posturning and virulent self-righteousness that has impeded deliberation in so many areas.
To some extent, our having such well informed advocates has helped to keep demagogues at bay. That may be the key policy lesson.
I have tried to follow Truman’s guidance in giving talks about ethics. An “on the one hand/on the other hand” talk tends to sedate the audience. If listeners think the speaker is all wrong, at least they are awake and thinking.
But a happy article in a recent Washington Post brings up an issue for which two-armed policy advisors and ethicists are desirable. Susan Wezel, a 50 year old New York woman who suffers from a severe psychotic illness, was required to undergo outpatient treatment under a New York law (“Kendra’s law”) that allows court-mandated treatment. Despite having been hospitalized more than a dozen times in the previous ten years, she has been stable and functioning well for the past 18 months. She now takes medication regularly and credits the law with saving her life. Her husband Chris says "there was nothing I could do to get her into any help before this."
The primary political impetus for laws that allow forced outpatient treatment is fear of the rare but highly publicized acts of violence by persons with psychiatric illness. The New York State law was passed after 32 year old Kendra Webdale was killed by being pushed in front of a subway train by Andrew Goldstein, who suffered from schizophrenia. California passed “Laura’s Law” after 19 year old Laura Wilcox, who was working in a public mental health clinic during a school break, was shot to death by Scott Thorpe, who believed that the FBI was trying to poison him and force him to see an incompetent psychiatrist, and who rejected his family’s pleas that he go back onto antipsychotic medication.
Most psychiatrists have seen happy situations like Susan Wezel’s, in which a gravely impaired person regains access to their innate capacities when the psychosis that has intruded on their function is controlled. Two decades ago a patient of mine voluntarily accepted, albeit reluctantly, injections of an antipsychotic medication. These have continued every four weeks, in very low dose, to the present, and the person has been able to turn life around in a way that brings substantial fulfillment.
Lawmakers ask -- if people can be helped in this way but cannot be persuaded to participate in treatment – why not set the ball of recovery rolling by requiring treatment? Especially if the specter of preventing violence is added to the equation! The argument for outpatient commitment is powerful. But so is the critique, which is based on principle (opposition to coercion) and practice (questions about the efficacy of outpatient commitment).
I come out in favor of cautious and careful outpatient commitment programs, modeled on New York, which has not simply passed a law but has also provided funding to allow treatment of the sort that Susan Wezel has benefited from. But people of good will and good knowledge of the issues will continue to disagree.
The reason for this posting, however, is not the substantive issue, but the policy lesson that comes from the policy debate itself. Many state legislatures – like New York and California, and now Virginia, which has been activated by the Virginia Tech killings – have conducted remarkably thoughtful deliberation – involving gathering data, benchmarking other states, hearing the range of viewpoints, and educative debate.
This has been the kind of educative policy debate we need for sound governance of our health care system. The two key ingredients that allow it to happen are the (a) presence of well-informed advocates and advocacy groups for a range of perspectives and (b) absence of political posturning and virulent self-righteousness that has impeded deliberation in so many areas.
To some extent, our having such well informed advocates has helped to keep demagogues at bay. That may be the key policy lesson.
Tuesday, January 1, 2008
AIDS, Global Health Priorities, and Ethics
How could it possibly be ethical to recommend spending less money on AIDS in Africa and other underdeveloped areas?
In today’s New York Times, Daniel Halpern of the Harvard School of Public Health, gives the answer.
Halpern describes how as bad as the AIDS epidemic is, in many countries the lack of clean water, absent sewage systems, and poverty, combine to make easily treatable diarrheal diseases an even larger source of mortality. In Botswana more funds are available than can be assimilated into the AIDS treatment system. And not surprisingly, many of the best health practitioners are leaving lower paying jobs in basic health services to take better paid opportunities in the AIDS sector.
The degree to which we in the developed world have finally accepted responsibility for helping our brethren in Africa and elsewhere represents moral progress. But Halpern argues that we can do better by fine tuning our moral sensitivities:
“It is [important], especially for the United States, the world’s largest donor, to re-examine the epidemiological and moral foundations of its global health priorities. With 10 million children and a half million mothers in developing countries dying annually of largely preventable conditions, should we multiply AIDS spending while giving only a pittance for initiatives like safe-water projects?
If one were to ask the people of virtually any African village (outside some 10 countries devastated by AIDS) what their greatest concerns are, the answer would undoubtedly be the less sensational but more ubiquitous ravages of hunger, dirty water and environmental devastation. The real-world needs of Africans struggling to survive should not continue to be subsumed by the favorite causes du jour of well-meaning yet often uninformed Western donors.”
In January, 2005, when my wife and I visited Mahindra United World College, a school Pune, India, for 11th and 12th graders from around the world, I taught classes on AIDS and ethics. One of the mini-cases I used touched on the topics Halpern discusses so cogently. Here is the case I used with the students:
“The World Health Organization has set a target of treating 3 million persons with AIDS in the developing world by the end of 2005 – the “3 x 5” program. The WHO regards AIDS as an ethical as well as clinical and humanitarian crisis. Since antiretroviral treatment is available how can it be acceptable not to offer it throughout the world?
Leaders in the west are surprised to get pushback on the 3 x 5 program. As a hypothetical example, imagine that an Indian doctor has said the following to the WHO: ‘For you in the west AIDS is the one and only epidemic. For us it is one of many problems. In the health sector we have malaria, tuberculosis, diarrheal diseases and more. If you are so eager to help us why aren’t you paying as much attention to poverty, hunger and unemployment? You want to help us with AIDS but you also want to stop outsourcing which brings us jobs and lets us help ourselves. I believe you are thinking about yourselves with this policy, not about us!’”
Students from developing countries understood the hypothetical pushback immediately. A student from Africa said “this is another example of the west deciding what it thinks is wrong in our countries and what is best for us.” A number of students from India commented, in effect – “we have serious challenges in health and other sectors. AIDS is just one of many serious problems. If the west focuses urgently on AIDS without comparable attention to other needs, it makes it seem that the outsiders do not understand Indian realities.”
I liked the tone of Halpern’s Op Ed piece. He is coaching, not scolding. He gives us credit for the moral progess we have made. Then, as a good coach should do, he asks us to stretch further! Looking back to my visit with the students in Pune, I admire their tone as well. If other young people can coach their elders as wisely the world will be a better place.
In today’s New York Times, Daniel Halpern of the Harvard School of Public Health, gives the answer.
Halpern describes how as bad as the AIDS epidemic is, in many countries the lack of clean water, absent sewage systems, and poverty, combine to make easily treatable diarrheal diseases an even larger source of mortality. In Botswana more funds are available than can be assimilated into the AIDS treatment system. And not surprisingly, many of the best health practitioners are leaving lower paying jobs in basic health services to take better paid opportunities in the AIDS sector.
The degree to which we in the developed world have finally accepted responsibility for helping our brethren in Africa and elsewhere represents moral progress. But Halpern argues that we can do better by fine tuning our moral sensitivities:
“It is [important], especially for the United States, the world’s largest donor, to re-examine the epidemiological and moral foundations of its global health priorities. With 10 million children and a half million mothers in developing countries dying annually of largely preventable conditions, should we multiply AIDS spending while giving only a pittance for initiatives like safe-water projects?
If one were to ask the people of virtually any African village (outside some 10 countries devastated by AIDS) what their greatest concerns are, the answer would undoubtedly be the less sensational but more ubiquitous ravages of hunger, dirty water and environmental devastation. The real-world needs of Africans struggling to survive should not continue to be subsumed by the favorite causes du jour of well-meaning yet often uninformed Western donors.”
In January, 2005, when my wife and I visited Mahindra United World College, a school Pune, India, for 11th and 12th graders from around the world, I taught classes on AIDS and ethics. One of the mini-cases I used touched on the topics Halpern discusses so cogently. Here is the case I used with the students:
“The World Health Organization has set a target of treating 3 million persons with AIDS in the developing world by the end of 2005 – the “3 x 5” program. The WHO regards AIDS as an ethical as well as clinical and humanitarian crisis. Since antiretroviral treatment is available how can it be acceptable not to offer it throughout the world?
Leaders in the west are surprised to get pushback on the 3 x 5 program. As a hypothetical example, imagine that an Indian doctor has said the following to the WHO: ‘For you in the west AIDS is the one and only epidemic. For us it is one of many problems. In the health sector we have malaria, tuberculosis, diarrheal diseases and more. If you are so eager to help us why aren’t you paying as much attention to poverty, hunger and unemployment? You want to help us with AIDS but you also want to stop outsourcing which brings us jobs and lets us help ourselves. I believe you are thinking about yourselves with this policy, not about us!’”
Students from developing countries understood the hypothetical pushback immediately. A student from Africa said “this is another example of the west deciding what it thinks is wrong in our countries and what is best for us.” A number of students from India commented, in effect – “we have serious challenges in health and other sectors. AIDS is just one of many serious problems. If the west focuses urgently on AIDS without comparable attention to other needs, it makes it seem that the outsiders do not understand Indian realities.”
I liked the tone of Halpern’s Op Ed piece. He is coaching, not scolding. He gives us credit for the moral progess we have made. Then, as a good coach should do, he asks us to stretch further! Looking back to my visit with the students in Pune, I admire their tone as well. If other young people can coach their elders as wisely the world will be a better place.
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