By chance, as I was writing about Atul Gawande’s New Yorker article about checklists for yesterday’s posting, the Sunday New York Times arrived with his Op Ed piece about how the Federal Office for Human Research Protections has put the project on hold for lack of informed consent from patients and clinicians.
Today I reviewed the letters sent to the research team at Johns Hopkins by OHRP on July 19 and November 6. It looks to me as if the OHRP has followed the letter of its regulations, while entirely ignoring the spirit of its mission. The letters cite numerous details that indicate that research was being done. Luckily, it was. The Johns Hopkins team was studying, in a rigorous manner, the impact of an effort to systemize good clinical care. The question was not whether an experimental drug helped or hurt research subjects, but whether a disciplined managerial approach to doing what we know is the right thing to do produced measurable improvements.
If Kristina C. Borror, Ph.D., Director of the Division of Compliance Oversight at OHRP, who wrote the letters to Johns Hopkins, reported to me, this is what I would have said:
“The purpose of our office is to protect people in the health care system. The checklists aren’t research. They are part of a managerially sophisticated effort to make ICUs accountable for doing what all ICUs agree should be done, in order to protect people in the health care system. It is great that Johns Hopkins is studying that care management process. Please show them how their application could be corrected so that we don’t erroneously subject the project to a misguided requirement for individual informed consent.”
In 2006 the Hastings Center published an excellent report on “The Ethics of Using QI Methods to Improve Health Care Quality and Safety.” The conclusions are sensible, well thought out, and practical. None of the conclusions would require individual informed consent from patients or ICU staff:
* QI is any systematic, data-guided activity that is designed to bring about the immediate improvement of care in a local setting.
* QI is both appropriate and vital to health care.
* QI is marked most distinctly by the prompt feedback of the effects of deliberate changes to the same care delivery setting that is making the changes.
* QI is intrinsic to health care delivery and obligatory for both professionals and patients.
* Though QI is often driven by a priori evidence that suggests substantial benefits are likely for the patients and/or staff involved, QI can pose some risks to some
patients.
* Not undertaking QI in the face of recognized quality deficiencies also puts patients at risk.
* QI should itself be implemented ethically.
* Low-risk QI should generally have the same review and standards as routine health care delivery.
* Higher-risk QI should undergo routine and orderly review within the usual arrangements for clinical supervision or by an advisory group.
* Some projects are correctly counted both as QI and as research involving human subjects and should meet the requirements for review of protection of human subjects
in research.
* Meeting those requirements might be more readily accomplished with a QI-IRB that met regulations, but whose policies and procedures were also tailored to the needs and expectations of QI.
* Certain issues might trigger the requirement for formal review of a proposed QI project: randomized designs, novel treatments, involvement of researchers, delayed
feedback of monitoring, or external funding.
* Federal agencies and voluntary organizations should cooperate in further developing and implementing these ideas.
We have had so many examples of the Bush administration subjugating scientific integrity to ideology that it is hard to avoid suspicion about the motives of the OHRP for scuttling the project. But whatever the motivation behind OHRP’s actions, it is important for the agency to reverse course promptly.
Monday, December 31, 2007
Sunday, December 30, 2007
Medical Ethics and Medicare Politics
Two stories earlier this month tell a David and Goliath story about the U.S. health care system. Unfortunately, Goliath is winning.
Atul Gawande’s superb and widely cited New Yorker article “The Checklist” presents the “David” story. Intensivist Peter Pronovost has created checklists for key intensive care unit functions like managing intravenous lines and maintaining ventilator function. Implementing the checklists has produced spectacular results in preventing infection and improving survival. But despite their effectiveness, the checklists have in large measure been ignored. Gawande comments:
“If someone found a new drug that could wipe out infections with anything remotely like the effectiveness of Pronovost’s lists, there would be television ads with Robert Jarvik extolling its virtues, detail men offering free lunches to get doctors to make it part of their practice, government programs to research it, and competitors jumping in to make a newer, better version. That’s what happened when manufacturers marketed central-line catheters coated with silver or other antimicrobials; they cost a third more, and reduced infections only slightly—and hospitals have spent tens of millions of dollars on them.”
In contrast to the humble checklist, nuclear particle accelerators that deliver proton therapy, as described in a recent New York Times article, are mega-Goliaths. They are housed in football field sized buildings, weigh more than 200 tons, and currently cost upward of $100 million. Prostate cancer has thus far been the main target for proton therapy. A support program, “Brotherhood of the Balloon” (named for the water-filled balloon inserted into the rectum at the time of treatment) maintains a well designed informational website. Sites that offer proton therapy – like Loma Linda in Southern California, advertise widely and effectively.
Proton therapy appears to be comparable in effectiveness to alternative treatments – surgery and radiation. Not surprisingly, given its complexity, it is substantially more expensive. Although a cost-effectiveness study published four months ago concluded that proton therapy is not cost effective for most men with prostate cancer, 16 treatment centers are under development.
The checklist project costs relatively little and achieves substantial results. Proton therapy costs a lot and achieves substantially less per dollar invested. But in a health system that worships technology and avoids using cost effectiveness considerations, Goliath wins hands down.
Proton therapy is not a bad thing. But its energetic dissemination, compared to the lackluster uptake of checklists, tells a lot about why our health system costs are out of control and outcomes are mediocre relative to expenditures. Our reward systems favor Goliath. Proton therapy is glamorous and pays well. Checklists are humdrum and pay poorly.
Wringing our hands about misguided values will accomplish nothing. Controlling health costs requires structural changes. Medicare, which calls the tune for health insurance, is currently not allowed to consider cost effectiveness. Allowing Medicare to use its purchasing power wisely will require political action. Until this occurs Goliath will continue to prevail.
(P.S. Readers may have noticed Gawande's Op Ed about the checklist project and a misguided requirement for informed consent in today's New York Times. I will write about that topic tomorrow.)
Atul Gawande’s superb and widely cited New Yorker article “The Checklist” presents the “David” story. Intensivist Peter Pronovost has created checklists for key intensive care unit functions like managing intravenous lines and maintaining ventilator function. Implementing the checklists has produced spectacular results in preventing infection and improving survival. But despite their effectiveness, the checklists have in large measure been ignored. Gawande comments:
“If someone found a new drug that could wipe out infections with anything remotely like the effectiveness of Pronovost’s lists, there would be television ads with Robert Jarvik extolling its virtues, detail men offering free lunches to get doctors to make it part of their practice, government programs to research it, and competitors jumping in to make a newer, better version. That’s what happened when manufacturers marketed central-line catheters coated with silver or other antimicrobials; they cost a third more, and reduced infections only slightly—and hospitals have spent tens of millions of dollars on them.”
In contrast to the humble checklist, nuclear particle accelerators that deliver proton therapy, as described in a recent New York Times article, are mega-Goliaths. They are housed in football field sized buildings, weigh more than 200 tons, and currently cost upward of $100 million. Prostate cancer has thus far been the main target for proton therapy. A support program, “Brotherhood of the Balloon” (named for the water-filled balloon inserted into the rectum at the time of treatment) maintains a well designed informational website. Sites that offer proton therapy – like Loma Linda in Southern California, advertise widely and effectively.
Proton therapy appears to be comparable in effectiveness to alternative treatments – surgery and radiation. Not surprisingly, given its complexity, it is substantially more expensive. Although a cost-effectiveness study published four months ago concluded that proton therapy is not cost effective for most men with prostate cancer, 16 treatment centers are under development.
The checklist project costs relatively little and achieves substantial results. Proton therapy costs a lot and achieves substantially less per dollar invested. But in a health system that worships technology and avoids using cost effectiveness considerations, Goliath wins hands down.
Proton therapy is not a bad thing. But its energetic dissemination, compared to the lackluster uptake of checklists, tells a lot about why our health system costs are out of control and outcomes are mediocre relative to expenditures. Our reward systems favor Goliath. Proton therapy is glamorous and pays well. Checklists are humdrum and pay poorly.
Wringing our hands about misguided values will accomplish nothing. Controlling health costs requires structural changes. Medicare, which calls the tune for health insurance, is currently not allowed to consider cost effectiveness. Allowing Medicare to use its purchasing power wisely will require political action. Until this occurs Goliath will continue to prevail.
(P.S. Readers may have noticed Gawande's Op Ed about the checklist project and a misguided requirement for informed consent in today's New York Times. I will write about that topic tomorrow.)
Saturday, December 29, 2007
Medical Ethics and Health Care Costs
The struggle between rational thinking about health care costs and fantasy about a Lala land with no financial limits continues.
Yesterday’s New York Times reported that Aetna is planning to restrict coverage for the anesthetic propofol to high risk cases as of April 1, 2008.
Propofol acts rapidly. It allows people undergoing colonoscopy to be relaxed and sedated more speedily than the alternatives. And, after the procedure, to wake up more quickly as well. Colonoscopists like propofol for the depth of anesthesia it gives and the fact that it allows them to complete the procedure in less time, which increases productivity.
But propofol can depress respiration and even cause respiratory arrest. Many believe that handling propofol safely requires an anesthesiologist to be part of the colonoscopy process. This drives the cost of the test up substantially.
The article is revealing about the social learning curve U.S. society must progress on to get a grip on health care costs. Dr. Douglas Rex, a colonoscopy expert at Indiana University, gets it right: “It’s perfectly appropriate to say this doesn’t look like a good place to spend health care dollars.” Even if you disagree with Rex’s conclusion, you have to acknowledge that he is right to think about value and opportunity cost. It isn’t harmful to use propofol and have an anesthetist present – but is it worth it, compared to other uses of the same money? This would be a productive debate.
In contrast, the article quotes “many doctors” who “say that the freedom to choose the treatments used is an important principle to preserve no matter what the cost to insurers…” This is vintage Lala land talk. The “many doctors” who indulge in this form of magical thinking invite us to believe that insurance companies are trees that grow money. There is no recognition that insurance funds come from employers, who take it out of the wages that would otherwise go to employees, or from taxpayers, whose money could be used for other priorities.
In growing up we learn self control through repetitive encounters with reality. We can spend our allowance on candy bars now, or save it and get a basketball later. Sadly, we can’t do both.
As a society we need to grow up with regard to health care. I don’t know enough to have a strong position on how valuable it is to use propofol routinely for colonoscopy, as apparently happens in New York City, where 77% of the Aetna enrollees receive it, compared to 10% elsewhere. Maybe New York gets it right, and spending our money on propofol (and the like) is better than providing more home care or raising wages.
Our society needs to have debates like this one again and again. We need to school ourselves in recognizing limits and deliberating about value. If we can teach our children about candy bars versus basketballs, we can teach ourselves to think about what matters most to us in health care and what we will choose to forgo.
Physicians who tell their patients and the public that “the freedom to choose the treatments used is an important principle to preserve no matter what the cost to insurers” are like parents who bring up spoiled kids. The medical profession has to move beyond this kind of magical thinking.
Let’s get more real about health care costs and value in 2008!
Yesterday’s New York Times reported that Aetna is planning to restrict coverage for the anesthetic propofol to high risk cases as of April 1, 2008.
Propofol acts rapidly. It allows people undergoing colonoscopy to be relaxed and sedated more speedily than the alternatives. And, after the procedure, to wake up more quickly as well. Colonoscopists like propofol for the depth of anesthesia it gives and the fact that it allows them to complete the procedure in less time, which increases productivity.
But propofol can depress respiration and even cause respiratory arrest. Many believe that handling propofol safely requires an anesthesiologist to be part of the colonoscopy process. This drives the cost of the test up substantially.
The article is revealing about the social learning curve U.S. society must progress on to get a grip on health care costs. Dr. Douglas Rex, a colonoscopy expert at Indiana University, gets it right: “It’s perfectly appropriate to say this doesn’t look like a good place to spend health care dollars.” Even if you disagree with Rex’s conclusion, you have to acknowledge that he is right to think about value and opportunity cost. It isn’t harmful to use propofol and have an anesthetist present – but is it worth it, compared to other uses of the same money? This would be a productive debate.
In contrast, the article quotes “many doctors” who “say that the freedom to choose the treatments used is an important principle to preserve no matter what the cost to insurers…” This is vintage Lala land talk. The “many doctors” who indulge in this form of magical thinking invite us to believe that insurance companies are trees that grow money. There is no recognition that insurance funds come from employers, who take it out of the wages that would otherwise go to employees, or from taxpayers, whose money could be used for other priorities.
In growing up we learn self control through repetitive encounters with reality. We can spend our allowance on candy bars now, or save it and get a basketball later. Sadly, we can’t do both.
As a society we need to grow up with regard to health care. I don’t know enough to have a strong position on how valuable it is to use propofol routinely for colonoscopy, as apparently happens in New York City, where 77% of the Aetna enrollees receive it, compared to 10% elsewhere. Maybe New York gets it right, and spending our money on propofol (and the like) is better than providing more home care or raising wages.
Our society needs to have debates like this one again and again. We need to school ourselves in recognizing limits and deliberating about value. If we can teach our children about candy bars versus basketballs, we can teach ourselves to think about what matters most to us in health care and what we will choose to forgo.
Physicians who tell their patients and the public that “the freedom to choose the treatments used is an important principle to preserve no matter what the cost to insurers” are like parents who bring up spoiled kids. The medical profession has to move beyond this kind of magical thinking.
Let’s get more real about health care costs and value in 2008!
Thursday, December 20, 2007
Happy Holidays
I will not be posting again until Friday 12/28. I have very much enjoyed the first four months of "Health Care Organizational Ethics" and look forward to returning soon.
Warm best wishes to all for a happy and healthy 2008!
Jim
Warm best wishes to all for a happy and healthy 2008!
Jim
Tuesday, December 18, 2007
Physician Review by Patients
Physician review is a front burner policy issue. The hope is to provide prospective patients with guidance of the sort most of us seek out in Consumer Reports for purchases large and small, to give quality-improving feedback to physicians, and, sometimes, to inform pay for performance schemes.
This is a personal story about physician review. One patient reviewing one physician.
Today I had a final appointment with someone who has been my psychiatric patient for 13 years. The treatment has been relatively successful. Major symptoms have gone into remission and the person’s capacity for health-promoting self-management has improved markedly.
For many years we have done an “annual review” as a humorous but serious practice. Since perfectionism had been a VERY problematic symptom, we created a constructive paradox. The only way to get an outstanding “review” was to be “less than perfect.”
At this final meeting we set out to do a final review. In accord with good review practices, my patient had done a very thoughtful self review, and we drew together the large themes of the treatment, where things stand now, and plans for the future, which involves a new treatment setting.
At this point I said, “We should be reviewing me as well.” My patient said, “of course,” and took out a typed review addressed to me, divided into meaningful categories.
The review was largely quite positive, as the treatment had gone well. But the positive feedback was not simply pleasing. In its details, it was useful. Under the “prescriber” category my patient wrote: “I’ll miss your telephone calls to tell me that the clozapine white blood count was fine [clozapine requires a regular blood check, and under our arrangement I left a phone message about the results]. To hear from you was a highlight for my weeks.” Sometimes little, low tech things that we do – here a 15 second telephone message every four weeks – matter more than we realize. This was action-relevant, educative feedback.
But what made the review most meaningful to me is that not every category was uniformly laudatory. Under the “Positive Thinker” heading my rating was “”satisfactory,” not “excellent.” Here is the comment: “For the most part it has been great to have your positive thoughts, but at times I have called you “PollyAndy” because you always see the good side. At times I just wanted you to see my negative side and to acknowledge my pain.”
I told my patient that I knew this area was a vulnerability and that when they were growing up my sons used the term “poptimism” for this trait. Insofar as I had not conveyed acknowledgement of pain I apologized for that in retrospect.
Not all people are prepared to give candid feedback to their physicians, and among those who are, not all have the skill at giving feedback that my patient displayed. But whatever happens in the arcane realm of physician review and pay-for-performance, direct 1:1 feedback is more valuable by far.
Perhaps if the medical profession had been more diligent in seeking meaningful patient (and collegial) feedback over the years, the tidal wave of effort to establish formal review mechanisms would not seem so urgent.
This is a personal story about physician review. One patient reviewing one physician.
Today I had a final appointment with someone who has been my psychiatric patient for 13 years. The treatment has been relatively successful. Major symptoms have gone into remission and the person’s capacity for health-promoting self-management has improved markedly.
For many years we have done an “annual review” as a humorous but serious practice. Since perfectionism had been a VERY problematic symptom, we created a constructive paradox. The only way to get an outstanding “review” was to be “less than perfect.”
At this final meeting we set out to do a final review. In accord with good review practices, my patient had done a very thoughtful self review, and we drew together the large themes of the treatment, where things stand now, and plans for the future, which involves a new treatment setting.
At this point I said, “We should be reviewing me as well.” My patient said, “of course,” and took out a typed review addressed to me, divided into meaningful categories.
The review was largely quite positive, as the treatment had gone well. But the positive feedback was not simply pleasing. In its details, it was useful. Under the “prescriber” category my patient wrote: “I’ll miss your telephone calls to tell me that the clozapine white blood count was fine [clozapine requires a regular blood check, and under our arrangement I left a phone message about the results]. To hear from you was a highlight for my weeks.” Sometimes little, low tech things that we do – here a 15 second telephone message every four weeks – matter more than we realize. This was action-relevant, educative feedback.
But what made the review most meaningful to me is that not every category was uniformly laudatory. Under the “Positive Thinker” heading my rating was “”satisfactory,” not “excellent.” Here is the comment: “For the most part it has been great to have your positive thoughts, but at times I have called you “PollyAndy” because you always see the good side. At times I just wanted you to see my negative side and to acknowledge my pain.”
I told my patient that I knew this area was a vulnerability and that when they were growing up my sons used the term “poptimism” for this trait. Insofar as I had not conveyed acknowledgement of pain I apologized for that in retrospect.
Not all people are prepared to give candid feedback to their physicians, and among those who are, not all have the skill at giving feedback that my patient displayed. But whatever happens in the arcane realm of physician review and pay-for-performance, direct 1:1 feedback is more valuable by far.
Perhaps if the medical profession had been more diligent in seeking meaningful patient (and collegial) feedback over the years, the tidal wave of effort to establish formal review mechanisms would not seem so urgent.
Sunday, December 16, 2007
Business Ethics and the Developing World
Consumers International, which defines itself as “the global voice for consumers,” has just published an important report: “Drugs, Doctors, and Dinners: How Drug Companies Influence Health in the Developing World.” (For a summary of the report, see IndUS Business Journal.)
Drug company profits are declining in the west. For big Pharma, the developing world represents a desperately needed growth opportunity. Not surprisingly, Asia, Africa, and Latin America are seeing intensified drug marketing. “Drugs, Doctors, and Dinners” describes an ethical free-for-all, in which doctors are rewarded with dinners, trips to conferences, and even air conditioners, for their prescribing practices.
The situation is ethically complex. A young physician friend of mine in South Asia, well educated and highly intelligent, told me that he is the only member of the group of “top students” in his program who has remained at home. All the rest have migrated to England, Canada and the U.S. Earning capacity at home is limited, and achieving a middle class life style is difficult. Travel to a conference is a rare perk. An air conditioner can make office or home tolerable in the hot season.
In the U.S. we have powerful consumer organizations, increasing media sophistication about negative drug marketing practices, and relatively strong regulation. I recently speculated that we are approaching a tipping point for pharmaceutical ethics.
These counter forces are weak in the developing world. Regulation of marketing practices is limited. Enforcement is feeble. Industry self-regulation looks great on paper does little on the ground. The Consumers International report recommends banning drug company gifts to doctors. This, alas, is not likely to happen.
According to the Indian National Commission on Macroeconomics and Health 2005 report “ten of the top 25 drugs sold in India are non-essential, irrational, or hazardous.” Expensive drugs draw down the limited public and private funds. If the drugs are not needed the funds are simply being wasted. Searching the document for the word “irrational” will give a rich sense of the scope of the problem.
What should we expect and what can be done? I anticipate that as the pressure for more rational, cost-effective prescribing practices increases in western countries, the developing world market will get progressively more marketing attention from the drug companies, much as tobacco sales are shifting from the developed to the developing world. Organizations like INRUD (International Network for the Rational Use of Drugs) and the World Health Organization Essential Medicines Program play a crucial role in recommending positive actions and increasing developing world drug policy infrastructure.
But the economic forces are VERY powerful. Recommendations alone will not lead to improved pharmaceutical practices. If economic incentives can be altered, as the Gates Foundation and others have begun to work on, drug companies will shift their marketing efforts more in accord with population needs. But direct citizen advocacy in both developed and developing worlds will be needed as well.
Drug company profits are declining in the west. For big Pharma, the developing world represents a desperately needed growth opportunity. Not surprisingly, Asia, Africa, and Latin America are seeing intensified drug marketing. “Drugs, Doctors, and Dinners” describes an ethical free-for-all, in which doctors are rewarded with dinners, trips to conferences, and even air conditioners, for their prescribing practices.
The situation is ethically complex. A young physician friend of mine in South Asia, well educated and highly intelligent, told me that he is the only member of the group of “top students” in his program who has remained at home. All the rest have migrated to England, Canada and the U.S. Earning capacity at home is limited, and achieving a middle class life style is difficult. Travel to a conference is a rare perk. An air conditioner can make office or home tolerable in the hot season.
In the U.S. we have powerful consumer organizations, increasing media sophistication about negative drug marketing practices, and relatively strong regulation. I recently speculated that we are approaching a tipping point for pharmaceutical ethics.
These counter forces are weak in the developing world. Regulation of marketing practices is limited. Enforcement is feeble. Industry self-regulation looks great on paper does little on the ground. The Consumers International report recommends banning drug company gifts to doctors. This, alas, is not likely to happen.
According to the Indian National Commission on Macroeconomics and Health 2005 report “ten of the top 25 drugs sold in India are non-essential, irrational, or hazardous.” Expensive drugs draw down the limited public and private funds. If the drugs are not needed the funds are simply being wasted. Searching the document for the word “irrational” will give a rich sense of the scope of the problem.
What should we expect and what can be done? I anticipate that as the pressure for more rational, cost-effective prescribing practices increases in western countries, the developing world market will get progressively more marketing attention from the drug companies, much as tobacco sales are shifting from the developed to the developing world. Organizations like INRUD (International Network for the Rational Use of Drugs) and the World Health Organization Essential Medicines Program play a crucial role in recommending positive actions and increasing developing world drug policy infrastructure.
But the economic forces are VERY powerful. Recommendations alone will not lead to improved pharmaceutical practices. If economic incentives can be altered, as the Gates Foundation and others have begun to work on, drug companies will shift their marketing efforts more in accord with population needs. But direct citizen advocacy in both developed and developing worlds will be needed as well.
Saturday, December 15, 2007
Good Ethics/Bad Law in Massachusetts
Last week the Massachusetts Supreme Judicial Court published its decision on Coombes vs Florio, a case with important implications for medical liability law. The case is also deeply interesting from the perspective of medical ethics.
On March 22, 2002, David Sacca, a 75 year old patient of Dr. Roland Florio, suffering from cancer of the lung and several other ailments, lost consciousness while driving and hit and killed a 10 year old boy, Kevin Coombes. The Coombes family sued Dr. Florio, claiming that he failed to inform David Sacca about the side effects of the many medications he was taking, and failed to warn him against driving.
A lower court found that Dr. Florio owed no duty to Kevin Coombes, and therefore could not be sued for the alleged failures. The Massachusetts Supreme Court was asked to review the lower court’s decision to dismiss the case. The question was whether Kevin Coombes's estate had standing to sue Dr. Florio.
By a 4-2 decision, the court concluded that Dr. Florio owed a “duty of care” to Kevin Coombes. On reading the decision and viewing a video of the Supreme Court session, I believe the decision was bad law but good ethics.
Judge Ireland, joined fully by two colleagues, and in part by a third, concluded that Dr. Florio owed any and all of those who might be injured by David Sacca’s driving a “duty of care,” with the result that Coombes was entitled to bring the suit. I agree with the ethical perspective the finding is based on. We physicians should consider our patients as part of a social world, not as isolated atoms. When we discuss, for example, a medication we are prescribing, we should refer to the potential for harm to others as well as to the patient, just as with a patient infected with HIV we counsel against unprotected sexual contact, not just for harms that might come to the patient, but for the harm the patient could cause to others.
Justices Cordy and Marshall, in dissent, argue persuasively that the majority finding is not justified by the precedents the majority cites. Further, they point out significant harms that can come from the finding, including a massive increase in litigation, violation of patient-doctor confidentiality from suits brought by third parties, and more defensive medicine. In my view, they show that the finding is bad law. Here is some of Justice Cordy's reasoning:
"There is no debate that it is foreseeable that the victims of an impaired driver are not only the driver but other drivers, pedestrians, or cyclists. The impaired driver plainly has a duty to all potential (foreseeable) victims. But extending the duty of the driver's physician, grounded in the doctor-patient relationship, to all those whom the driver encounters is entirely different. Because A has a duty to B, and B has a duty to C, it does not necessarily follow that A has a duty to C. The duty of A to C must be established on its own terms."
Unfortunately, the dissenting justices base their conclusion, in part, on bad ethics. Justice Cordy argues that the doctor-patient relationship should be:
"…autonomous, free from the influence of concerns beyond the patient's well-being. This reflects long-held norms about the relationship between doctor and patient and the sound social policy that a doctor's interest be solely in the well-being of his patient."
This perspective, widely held in the U.S. but much less so elsewhere, is patently wrong. If we took it seriously, if our HIV positive patient says "I know about the risks unprotected sex poses for me, and I am not daunted by them," we would keep silent about the risks created for others. Of course we wouldn't do this -- we would weasel out of the inconsistency by saying "it would be harmful to you to expose others to risk."
But the atomistic view of the physician's moral responsibilities is a major contributor to our ongoing paralysis with regard to managing health care costs. If our sole responsibility is to the patient, with no regard whatsoever for the impact of our actions on wider society, the sole basis for not offering an intervention is that it would harm the patient. However useless it might be, if it is not harmful, and the patient wants it, the view that "the doctor's interest [should] be solely in the well-being of his patient" requires us to offer it. Societal opportunity costs be damned.
My speculation is that the four justices who reached a faulty legal conclusion may have been swayed by the correct ethical argument that physicians should think about all of those who their interventions affect, not "solely" about their patients. Unfortunately, in Coombes vs. Florio, good ethics may have encouraged a bad legal decision.
On March 22, 2002, David Sacca, a 75 year old patient of Dr. Roland Florio, suffering from cancer of the lung and several other ailments, lost consciousness while driving and hit and killed a 10 year old boy, Kevin Coombes. The Coombes family sued Dr. Florio, claiming that he failed to inform David Sacca about the side effects of the many medications he was taking, and failed to warn him against driving.
A lower court found that Dr. Florio owed no duty to Kevin Coombes, and therefore could not be sued for the alleged failures. The Massachusetts Supreme Court was asked to review the lower court’s decision to dismiss the case. The question was whether Kevin Coombes's estate had standing to sue Dr. Florio.
By a 4-2 decision, the court concluded that Dr. Florio owed a “duty of care” to Kevin Coombes. On reading the decision and viewing a video of the Supreme Court session, I believe the decision was bad law but good ethics.
Judge Ireland, joined fully by two colleagues, and in part by a third, concluded that Dr. Florio owed any and all of those who might be injured by David Sacca’s driving a “duty of care,” with the result that Coombes was entitled to bring the suit. I agree with the ethical perspective the finding is based on. We physicians should consider our patients as part of a social world, not as isolated atoms. When we discuss, for example, a medication we are prescribing, we should refer to the potential for harm to others as well as to the patient, just as with a patient infected with HIV we counsel against unprotected sexual contact, not just for harms that might come to the patient, but for the harm the patient could cause to others.
Justices Cordy and Marshall, in dissent, argue persuasively that the majority finding is not justified by the precedents the majority cites. Further, they point out significant harms that can come from the finding, including a massive increase in litigation, violation of patient-doctor confidentiality from suits brought by third parties, and more defensive medicine. In my view, they show that the finding is bad law. Here is some of Justice Cordy's reasoning:
"There is no debate that it is foreseeable that the victims of an impaired driver are not only the driver but other drivers, pedestrians, or cyclists. The impaired driver plainly has a duty to all potential (foreseeable) victims. But extending the duty of the driver's physician, grounded in the doctor-patient relationship, to all those whom the driver encounters is entirely different. Because A has a duty to B, and B has a duty to C, it does not necessarily follow that A has a duty to C. The duty of A to C must be established on its own terms."
Unfortunately, the dissenting justices base their conclusion, in part, on bad ethics. Justice Cordy argues that the doctor-patient relationship should be:
"…autonomous, free from the influence of concerns beyond the patient's well-being. This reflects long-held norms about the relationship between doctor and patient and the sound social policy that a doctor's interest be solely in the well-being of his patient."
This perspective, widely held in the U.S. but much less so elsewhere, is patently wrong. If we took it seriously, if our HIV positive patient says "I know about the risks unprotected sex poses for me, and I am not daunted by them," we would keep silent about the risks created for others. Of course we wouldn't do this -- we would weasel out of the inconsistency by saying "it would be harmful to you to expose others to risk."
But the atomistic view of the physician's moral responsibilities is a major contributor to our ongoing paralysis with regard to managing health care costs. If our sole responsibility is to the patient, with no regard whatsoever for the impact of our actions on wider society, the sole basis for not offering an intervention is that it would harm the patient. However useless it might be, if it is not harmful, and the patient wants it, the view that "the doctor's interest [should] be solely in the well-being of his patient" requires us to offer it. Societal opportunity costs be damned.
My speculation is that the four justices who reached a faulty legal conclusion may have been swayed by the correct ethical argument that physicians should think about all of those who their interventions affect, not "solely" about their patients. Unfortunately, in Coombes vs. Florio, good ethics may have encouraged a bad legal decision.
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