Monday, December 31, 2007

Research Ethics and Quality Improvement

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
* 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.

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.)

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!

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!


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.

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.

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.

Thursday, December 13, 2007

Follow up on "A Tipping Point for Pharma Ethics?"

Three weeks ago, in what I feared might have been a fit of pathological optimism, I suggested that reaction to the way Merck and Schering-Plough were handling reporting about the trial of Zetia, their $5 billion cholesterol-lowering drug, indicated a tipping point about drug industry ethics:

"When media, legislators and their staffs, physician leaders around the country, and movies like “The Constant Gardner,” speak in unison, and when liability lawyers are waiting in the wings to hit Pharma with yet another class action suit, we have a powerful force emerging. The lure of blockbuster profits from blockbuster drugs draws out every technique of wild west capitalism, but at this point the pushback is too strong to be chilled out by a public relations campaign."

Yesterday's New York Times reported that the House Committee on Energy and Commerce is demanding information on the study. The Committee directed the companies to retain relevant documents.

Whatever ultimately emerges with regard to this particular incident, the pressure for transparency about drug trials and better information on drug perfomance is rapidly escalating. This is all to the good.

Tuesday, December 11, 2007

Health Plans and Health Care Costs

When the CEOs of two competing health plans write an op-ed together, we know that something important is cooking. Especially if they propose more regulation!

In their recent editorial “How to Control Healthcare Costs,” James Roosevelt, CEO of Tufts Health Plan, and Charlie Baker, CEO of Harvard Pilgrim Health Care, issue an important challenge. The president of the Massachusetts Senate had called for a public hearing on any proposed rate increases over 7%. In response, Roosevelt and Baker went further, and recommended “that the state’s health plans be required to participate in an annual public hearing on healthcare costs – no matter what their rate increases are – to outline the factors contributing to any changes in premiums…”

But with strings attached.

In the 1990s the U.S. asked health plans, which can be thought of as purchasing agents for the insured population, to control health care costs. They did, by managing care. But providers and patients fought back, and they largely stopped. Not surprisingly, costs are again rising rapidly.

Health plans sit in the middle of the key participants in the health care system. Enrollees need care when they are ill. Providers need to be paid. Pharmaceutical and device manufacturers want to sell their products. Employers, government, and individual enrollees, worry about the premiums they pay.

The public tends to think of health plans as bean counters with deep pockets and an insatiable thirst for profit, even in states like Massachusetts where the major plans are not-for-profit. This is where the Roosevelt/Baker proposal comes in. They want health plans brought to the table to account for their costs, but not to be in the hot seat alone: “Health insurance premiums are driven by healthcare costs, so it is important that hospitals, health centers, physician practices, and pharmacies participate in the hearings to explain the factors contributing to their rising costs…”

Our society did not accept health plan-driven management of care. Except for Kaiser Permanente and a small number of other prepaid group practices, our political process has squelched that approach. Roosevelt and Baker's proposal keep health plans in a central cost containing role, but as spotlights, not managers. Their hope is that a combination of transparency about costs on the part of all key players and public/political scrutiny will accomplish what we did not allow managed care to do.

I am skeptical about how far their proposal will go. The momentum of our health system is difficult to interrupt. Their hope is that democratic process will do what health plan management of care could not sustain. This is a good direction to go in.

(A more extended version of their proposal can be obtained from the Massachusetts Association of Health Plans.)

Sunday, December 9, 2007

Catholic & Secular Values in the British National Health Service

Four days ago I discussed the conflict over reproductive health care at Lutheran Health Center in Wheat Ridge, Colorado. This posting is about a similar conflict currently unfolding at “John and Lizzie’s” in north London.

The Hospital of St. John and St. Elizabeth, founded by the Sisters of Mercy in 1856, is known as a celebrity hospital. Cate Blanchett, Emma Thompson, Kate Moss and Heather Mills-McCartney have all had babies there. The media describes John and Lizzie’s as "the poshest place to push." The hospital is under the governance of the Catholic church, but has been operating as an independent entity, funded by the NHS, self-paying private patients, private health insurance companies, and charitable donations.

Debate about abortion has been much less virulent in the U.K. than the U.S. Last year a British journalist wrote, with some satisfaction, “Over here [in comparison to the U.S.], abortion can be a medical issue and a psychological issue; it can be an issue of social ethics.”

For reasons unclear to me on this side of the Atlantic, the tone of British debate is heating up. Cardinal Cormac Murphy O’Connor, head of the Catholic Church in England and Wales, laid down the law to John and Lizzie’s: “There must be clarity that the hospital, being a Catholic hospital with a distinct vision of what is truly in the interests of human persons, cannot offer its patients, non-Catholic or Catholic, the whole range of services routinely accepted by many in modern secular society as being in a patient's best interest."

In response, Dr Martin Scurr, founder of the Portobello Clinic in Notting Hill, and a director at the hospital, shot back a strong response: “I am convinced that the Cardinal has been badly advised, as so often has happened with the Catholic Church. Expert advisers have been chosen who give the hierarchy of the church the answers they wish to hear ... in the matter of modern medical care the cardinal has chosen to listen to individuals who have no specific expertise in that arena…we are now in an era where the Catholic Church must withdraw from involvement in frontline healthcare here in the UK, as it appears to be unable to reach the degree of tolerance that has been reached elsewhere in the world." When the hospital adopted the code of ethics demanded by the Cardinal, Scurr and another director resigned. The board chair is expected to join them next week.

Notice two things about the British debate. First, the Cardinal acknowledges that the reproductive services current church teachings preclude are “routinely accepted by many…as being in a patient’s best interest.” He acknowledges that his opponents are seeking to serve the patient’s interests, not to commit murder. And, Scurr insulates the Cardinal, by construing him as having “been badly advised.” Their positions keep the debate at the level of social ethics and leave room for further discussion.

I think the Brits, with their tradition of sharp-edged but civil debate, are likelier to advance the Catholic/Secular standoff than we Yanks are. We oscillate between politically correct vapidity and hate-laden rhetoric that encourages terrorists like James Kopp to commit murder on behalf of “right to life.” An ethically governed health system requires societal ability to debate contentious, value-laden issues, without loss of social cohesion. I hope to come back to the conflicts at Lutheran Health Center and John and Lizzie's in a future posting.

Friday, December 7, 2007

Medicare and Health Care Cost Containment

Suppose you hired a purchasing agent to represent you in making a vitally important purchase. The agent proposes making the purchase for half the quoted price. The seller protests. What would you do?

According to today’s New York Times, you take the seller’s side.

The story is complicated, and all the information is not at hand. Medicare has proposed new payment rules for Bexxar and Zevalin, two radioimmunotherapies for non-Hodkins lymphoma. Effectiveness is not in question. The agents represent an important life extending and perhaps life saving advance in treating a common form of cancer.

Under the new rules Medicare will reimburse hospitals approximately $16,000 for the treatment, which patients receive only once. GlaxoSmithKline, which markets Bexxar, says it is priced around $30,000 per treatment. Biogen Idec prices Zevalin similarly.

The drug companies, the physicians who administer the treatment, and patient advocacy groups, have all attacked Medicare. One especially powerful article in Newsweek – “How Washington Is Nixing a Cancer Cure” – portrays Medicare as an uncaring, devious bureaucracy, peopled by “bean counters.”

It may turn out that Medicare’s analysis, according to which $16,000 is a fair payment, is incorrect. But two things in the story as it has unfolded so far bother me.

First, none of the protesters say anything about the ethical duty to support Medicare cost containment. Medicare is our purchasing agent. We all contribute to it through payroll taxes. If we (all stakeholders) do not support its cost containment efforts, Medicare will go down the tubes, but only after it siphons vast sums away from other socially important uses. Medicare cost containment is an ethical duty, not a shameful action by “bean counters.” Perhaps Medicare has made a mistake, but it is fighting the good fight here.

Second, the sad fact is that health sector trust has eroded. Drug companies deserve to be thanked for developing effective treatments like Bexxar and Zevalin. But the multiple Pharma scandals make it hard to take company protests about unfair reimbursement at face value. Perhaps worst of all, Pharma’s efforts to co-opt patient advocacy groups lead to uneasiness about the advocates’ position on what the price should be.

From what I glean about the two drugs, I have no doubt that in a country as wealthy as the U.S. they should be available to patients with non-Hodgkins lymphoma. But I also have no doubt that we all need to support Medicare’s efforts to rein in health care costs.

Thursday, December 6, 2007

Is Making Employees Pay for Bad Health Habits Ethical?

Employers are desperate about health care costs. Some are dropping health insurance altogether. Some are making employees put more “skin in the game” with increased deductibles. And some are starting to make employees pay for bad health habits.

A Harris poll reported in the Wall Street Journal in October showed that a majority believe that employers should not make employees who smoke, are seriously overweight, or do not exercise, pay more for their health insurance,

But starting next month, the Tribune Company in Chicago will charge employees who smoke $100/month. And the Kellogg Company is raising the premium for non union employees $360 for those who decline to take a health risk assessment. Other companies will follow their lead.

How ethical are programs like these?

I believe for a behavior like smoking that, while addictive, is potentially controllable, charging a small fee is ethically justifiable. The fee should be modest at the start. The aim is to attract attention and make the point that smoking doesn’t just harm ourselves – it taxes others by the health costs we generate. For that reason, the fee should be used to offset overall insurance costs. The $100/month the Tribune Company plans to charge would be punitive for most employees and seems too high. But the Tribune has addressed this by waiving the fee for employees who complete a smoking cessation course.

A teamster official who works for the Chicago Tribune asked “What are you going to do next? Say a guy who has history of heart disease has to pay more? Where’s it going to stop?” This is the right question. Charging more for people who are sick is not justifiable. But charging for a modifiable habit that contributes to higher costs for the whole group is.

We Americans worship financial fixes. What the Tribune and Kellogg are doing is justifiable if thought of as part of a broad attempt to help us recognize that we will only tame runaway health costs if we pull together as a population and self-prescribe some painful medications. A carefully planned charge for bad health habits can play a small part in the large educative process we need to carry out.

Wednesday, December 5, 2007

Religious Hospitals, Secular Hospitals, and Democratic Process

A fascinating hospital purchase drama with medieval undertones is unfolding in Wheat Ridge, Colorado.

The Sisters of Charity of Leavenworth Health Systems is seeking to purchase Exempla Lutheran Medical Center. If the Attorney General approves the transfer of ownership, procedures prohibited under Catholic health care rules – such as abortion and tubal ligation – will no longer be permitted at Lutheran. A group of Lutheran doctors, supported by the ACLU, Planned Parenthood, NARAL, and other organizations, are lobbying against the sale.

The contending parties have rich histories. The Sisters of Charity opened the first private hospital in Kansas in 1864. Lutheran was founded in 1905 as a tent colony for tuberculosis patients. Both entities are mission-driven and committed to care of the poor.

The issue of merger between secular and religious hospitals is common enough to be the single focus of an activist organization, MergerWatch. The secular/religious conflict in Colorado is a vintage good vs good ethical dilemma. Catholic health care has a noble history of devotion to the poor and vulnerable. But in our pluralistic society, many do not share Catholic views on reproductive ethics. Lutheran, with its own noble history, has provided these services to its community.

Two days ago the Rocky Mountain News carried a moving plea for compromise from Dr. Lawrence Rust, a retired trauma surgeon who had practiced at Lutheran. Dr. Rust seeks a path whereby “both sides of this dispute can salvage their most important principles.” Specifically “the medical staff at Lutheran needs assurance that they will be free to practice on a daily basis without interference,” and “the Sisters of Charity need to know that the organization that they own faithfully represents their core values.”

I am committed to deliberative discussion as a key process for ethical governance of the health system. I would sorely love to believe Dr. Rust’s proposal could work:

“When a physician disagrees with a policy, the disagreement would be handled openly by peers. The Catholic voice would be joined with other professional voices in committees, and the resulting decisions would be forged from reason and discussion. If the decision disagreed with the Catholic approach (such as allowing tubal ligations) both sides would have had the opportunity to fully present their side, but the consensus approach would prevail.”

Unfortunately, this won't work. The Catholic perspective on reproductive services does not arise from particular facts about individual situations. The Conference of Bishops "Ethical and Religious Directives for Catholic Health Services" prohibit abortion and sterilization under all circumstances. If the Directives are to be followed the hope that "decisions would be forged from reason and discussion" is, alas, entirely quixotic.

Hospitals drop "service lines" all the time, especially if the service in question is a money loser. In Wheat Ridge the issue is principle, not money. It is hard to see how the Sisters of Charity could respect pluralism and allow the prohibited procedures to be done, say, by a nominally independent portion of the hospital. Apart from logistical complexities, the Bishops are clear: "Catholic health institutions are not to provide abortion services, even based upon the principle of material cooperation."

So what should be done? If I were the Sisters of Charity I would not want to be seen as imposing my moral perspective -- even though I fervently believed it was absolute truth -- on those who did not share it. But that is exactly how buying Lutheran and dropping the forbidden services would appear. But if I were a physician at Lutheran I would want to be sure that I was protesting because the purchase would make the services significantly less available to those who want them, and not because, like Martin Luther himself, I was opposing "Catholic power" on principle.

The decision is in the lap of the Attorney General. In my view, if the purchase would significantly reduce access to services that are legal and, by a majority of the population, seen as ethically acceptable as well, I would not allow it to go through. But if I concluded that the services were readily available I would allow it to go ahead.

Pluralism does not come easily. We need to learn all we can about how to respect principles and pluralism from cases like Wheat Ridge. I hope to be able to follow the story, and invite readers to comment.

Monday, December 3, 2007

The Ethics of the Hospital Safety Net

Yesterday the Galveston County Daily News published an educative but heartbreaking story about the ethics of the hospital safety net.

The University of Texas Medical Branch (UTMB), the oldest medical school west of the Mississippi, has been known for its commitment to treating the medically underserved. It is now, however, considering refusing to provide cancer care to indigent, undocumented immigrants.

They must be monsters. Right? No. Wrong!

Almost 25% of the Texas population is uninsured. Medical costs are going up, the number of uninsured is rising, and state funding has been cut. In an effort to control costs the hospital laid off 381 workers last year.

This is, alas, a recurrent challenge for safety net hospitals. We look to them to be the caretaker of last resort, cut their funds, and then blame them for heartlessness.

UTMB is doing citizens and decision-makers a service by bringing the ethical challenge to center stage. Of the action they may take, their own spokesperson says – “it doesn’t feel right!”

Howard Brody, the distinguished director of the UTMB Institute for Medical Humanities, put the ethics cards on the table:

“If what voters of Texas want is Harris County [which would receive patients UTMB did not care for] shouting at Galveston and Galveston shouting at Harris County and everybody pointing fingers and saying ‘You should be doing more than you’re doing,’ then they can have that…If they want indigent folks to get care and want everybody in Texas to at least have a chance to have more access to medical care, then voters of Texas should step up and provide more resources.”

We ask safety net hospitals to turn somersaults on behalf of needy patients. That mission draws idealistic young physicians and nurses to work at safety net sites. But a point comes when trying to do the impossible turns into enabling. That is what UTMB must have concluded.

The Texas public is the legitimate decider about safety net funding. It is entitled to cut funds to the point where people with cancer will be turned away. But if it chooses to do this it should acknowledge the actions it is taking and the consequences of these actions. UTMB’s actions clarify the ethical dimensions of the policy debate and forces the public to own up to the implications of its funding decisions.

Sunday, December 2, 2007

Alternative Medicine & Hospital Ethics

In today's New York Times "The Ethicist" column, the always engaging Randy Cohen provides a model terse analysis of a complex organizational ethics question:

I work at a hospital where several nurses practice therapies like healing touch and therapeutic touch, said to adjust a patient’s energy field and thereby decrease pain and improve healing, although there is no significant evidence for this. If those nurses believe in these treatments, may they tell the patient they are effective? If the treatments provide merely a placebo effect, telling patients about this lack of evidence might undermine that benefit. Would that justify withholding the information?

Cohen starts by making the obvious point about informed consent: if the alternative treatments are offered, the nurses must inform the patients that the treatments are based on "non-standard" theories and have not been validated by research. Their personal conviction that the treatments work is just that -- personal conviction -- not evidence.

What I like most in Cohen's response is the way he thinks about individuals and the organization. Here is his concluding paragraph, with my comments in boldface:

What the nurses could do is explain that their techniques are unproved and unendorsed by the hospital (if this is the case; hospitals vary), offering patients, in effect, the sort of supplemental treatment available outside the hospital. But this approach is not without risk. A therapy provided in the hospital by its staff carries a sense of official approval, no matter what disclaimers are offered. [Cohen is right -- both the nurses as individuals and the hospital as an organizational entity have ethical obligations to the patient. The perspectives of both parties -- nurses and hospital -- must be presented to the patient.] In any case, these nurses must alert their colleagues and hospital administrators about such things. Both groups need to know how patients are being treated if they are to do their jobs well. [Cohen believes, correctly, that a well-functioning hospital can be a big tent. Patients can be offered science-based "western" care and tradition-based alternative "eastern" care if the nurses, their colleagues, and the hospital leadership, can allow their different perspectives to live side-by-side.]

Hospitals, like orchestras, benefit from having players with a wide range of talents and styles. Ethically excellent hospitals learn how to harness this variety on behalf of their patients. If in the future I were in a hospital for chemotherapy, I would hope to have "healing touch" available as well.

Saturday, December 1, 2007

The FDA Considers Giving Away the Shop

The FDA is considering allowing pharmaceutical companies to advertise off label uses of drugs by sending articles to physicians. The proposed new regulations would sell-out on FDA responsibilities and further skew the ethical landscape for drug use in the U.S.

I can’t believe the proposed change will go through. The ethical quality of our health care system depends on whether we can achieve a balanced deliberative process to consider the multiple values involved in steering the system. We depend on the FDA to play a role in checking Pharma’s marketing juggernaut.

It is right and proper for drug companies to market their products vigorously, but only within the boundaries created by law, regulation, and ethics. The FDA has slapped multiple fines on pharmaceutical companies for illegally marketing off label uses for their products, but these fines are treated as an ordinary cost of doing business.

Now the FDA proposes to lower the bar for marketing of off label prescribing. I doubt that I am alone in assuming that the FDA and its administrative masters are being bought off.

Marketing isn’t an evil activity. But for the FDA to abdicate its responsibilities to the public is.

Friday, November 30, 2007

The Ethics of the Appeals Process

From time to time (here and here) I write about tools that organizations can use to strengthen the ethics of their enterprise. For medical ethics to be more than an engaging classroom exercise, we need to connect deliberation to effective action.

Yesterday I conducted a seminar at a large pharmacy benefits management company, focused on their experience handling appeals about drug coverage. My “assignment” was to help the group put the appeals work into an ethical framework.

I used a framework developed by the American Medical Association Institute for Ethics Ethical Force Program. The Ethical Force Program convenes multi-stakeholder working groups to develop consensus-based frameworks of values for central areas of health care and to derive measurable performance expectations. The framework I used with the PBM group comes from “Ensuring Fairness in Health Care Coverage Decisions.” It performed superbly.

The Ethical Force Work Group (I was a member) identified five key values for designing and administering health benefits:

Transparent: The processes for designing and administering health benefits should be fully transparent to those affected by these processes.
Participatory: Stakeholders should be involved in a meaningful way in creating and overseeing health benefits.
Equitable and Consistent: Design and administration of health benefits should result in similar decisions under similar circumstances.
Sensitive to Value: Design and administration of health benefits should consider the relationship between health outcomes and resource use.
Compassionate: Design and administration of health benefits should be flexible, responsive to individual values and priorities, and attentive to the most vulnerable individuals and those with critical needs.

I confess to feeling bored when I see lists of values. On first glance a list can look like a compendium of platitudes. Yawn.

But in yesterday's seminar the framework came to life. Everyone who had participated in the actual process of addressing appeals about drug coverage had experienced the pull of each of the five values and the conflict among them.

The Ethical Force framework proposes no algorithm for weighing the five values or adjudicating among them. Its usefulness for the group came from the encouragement it gives for accepting the tension among values and deliberating about alternative options. There is a natural tendency to avoid conflict, either by rigid adherence to rules ("bean counters") or rigid commitment to the desires of the individual appellant ("bleeding hearts").

Organizations have to give lip service to the importance of ethics. Even Enron had a well worded ethics code! But even at the best organizations “ethics” has negative connotations – either self righteous preaching or wishy-washy “on the one hand/on the other hand” inconclusiveness. In other words, tunnel vision adherence to single values or paralysis among multiple values.

But if those of us concerned with the ethics of organizations can link skillful ethical deliberation with skillful organizational leadership, we will have a powerful combination. As Muhammad Ali taught us: "float like a butterfly, sting like a bee."

Monday, November 26, 2007

Accountability for Reasonableness in Tanzania

Starting in the early 1990s, Norman Daniels and I conducted a series of studies on how U.S. health organizations made decisions about priorities and limits. On the basis of those empirical observations and normative perspectives derived from philosophy and political science, we proposed a framework – “accountability for reasonableness” – as an account of fairness in setting priorities and limits and a broad how-to-do-it approach.

The accountability for reasonableness framework identifies four conditions for seeking fairness in health priorities:

Relevance – the rationales for priority setting decisions must be based on reasons (evidence and values) that stakeholders can agree are relevant. Procedurally, having a wide range of stakeholders participate in deliberation ensures that the full range of relevant reasons will be considered.

Publicity – priority setting decisions and their rationales must be publicly accessible, not just on demand, but through various forms of active communication outreach.

Revisability – there must be processes for revising decisions and policies in response to new evidence, individual considerations, and public reactions.

Enforcement – local systems and leaders must ensure that the above three conditions are met.

The field studies that informed the accountability for reasonableness framework were done in settings responsible for individual patients who were part of a larger population for which there was a total budget for care: not-for-profit HMOs; Medicaid programs; and, the VA. In the ten years since we did the major fieldwork, however, the U.S. backlash against managed care has led to fewer budgeted care systems.

As a result, the framework has had much more application outside of the U.S. – in countries like Canada, England, New Zealand, Norway, and Sweden, where the principle of solidarity is stronger, the entire population is insured, and the health system has an overall budget.

In recent years, Doug Martin and his colleagues at the University of Toronto Center for Bioethics have asked whether accountability for reasonableness, with its emphasis on openness, democratic process, and deliberation, could be relevant in less wealthy settings with different cultural traditions.

Earlier this month, Martin and colleagues from Denmark and Africa published “What do District Health Planners in Tanzania think about improving priority setting using ‘Accountability for Reasonableness’”? They presented the framework to local stakeholders in a series of capacity building workshops. Participants liked the framework, especially the extensive participation it calls for, the strong expectation for transparency, and the potential for including a wider range of values than current approaches did. Their major concerns had to do with the learning curve required for participation in the kind of reason-based deliberation the framework envisions.

From a global perspective, the hyper-individualistic approach we in the U.S. have built into our health care system -- as in Republican dread of expanding public SCHIP coverage and politicans' knee jerk horor when the words "socialized medicine" are spoken -- is increasingly aberrant. Virtually all other societies see basic health care as a collective responsibility we owe to each other, not as an individual responsibility to shop for as solitary consumers.

It isn't surprising that Tanzanians responded to the same values and approaches that prevail in Commonwealth countries, Scandanavia, and elsewhere. Illness, disability, and mortality are part of common humanity. We know that just as well as the Tanzanians do. When we become familiar with a communitarian program like Medicare we are able to think in terms of collective concerns. But for most of the adult population, our fragmented health system and our almost theological devotion to governing health care via market competition lead us away from thinking in terms of how to care for a population.

Health care appears to be high on the agenda of concerns for the 2008 election. It will be interesting to see if we are ready for a deeper and more thoughtful national debate than we have thus far been able to muster.

Sunday, November 25, 2007

Physicians should not be Drug Company "Educators"

Psychiatrist Daniel Carlat’s article in today’s New York Times Magazine provides valuable insight into the ethics of drug marketing.

Carlat tells how he became an “educator” for Wyeth in 2001. He visited primary care and psychiatric offices to talk about Effexor XR, Wyeth’s antidepressant. Carlat was paid $500 for a one hour “Lunch and Learn” talk; $750 if he had to drive an hour. His narrative forms a five-step morality play:

1. Carlat began the role with naïve optimism that he could be a well-paid but objective educator for a drug that he liked to use in his own practice.
2. After a rosy start he moved into a phase of rationalizing the distortions he recognized he was building into his presentations.
3. There is then a moment of epiphany, when a psychiatrist in a group he is speaking to challenges his playing down of the hypertension risk the drug creates: “He looked at me, frowned, and shook his head…I felt rattled. [The] frown stayed with me – a mixture of skepticism and contempt. I wondered if he saw me for what I feared I had become – a drug rep with an M.D.”
4. After the epiphany, Carlat made his presentations more balanced and objective. Here is what happened: “I was visited by the same district manager who first offered me the speaking job. Pleasant as always, he said: 'My reps told me that you weren’t as enthusiastic about our product at your last talk. I told them that even Dr. Carlat can’t hit a home run every time. Have you been sick?’ At that moment, I decided my career as an industry-sponsored speaker was over. The manager’s message couldn’t be clearer: I was being paid to enthusiastically endorse their drug. Once I stopped doing that, I was of little value to them, no matter how much “medical education” I provided.”
5. The final phase, embodied by the New York Times article, is public confession and a pledge to abstain from drug company funding in the future.

I don’t fault Wyeth for its marketing strategy. Capitalism is about selling. If we physicians turn up our noses at the mores of commerce we are being hypocritical. After all, we market our own services to patients and colleagues every day.

But I agree with Carlat that physicians should not carry out the marketing function for drug companies. To do what he found himself doing violates at least two of the nine principles in the AMA code of ethics: “A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception” and “A physician shall continue to study, apply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public…”

So what should be done? Carlat’s candid narrative makes clear that disclosure isn’t enough. “Caveat emptor” – let the buyer beware – is an appropriate guide for commerce. It is not, however, compatible with professionalism. The story Carlat tells shows how the “educator for the drug company” role shifts the clinician’s primary commitment to scientific objectivity and advancing patient interests to a marketing function.

When patients, physicians, and the public suspected that managed care incentives were corrupting clinical judgment an enormous backlash emerged. The conflicts created by the “educator” role are at least as severe. The medical profession needs to push back against physicians taking on the role of drug marketers with the same vigor it brought to bear on managed care. Marketing by drug companies is part of the way our economy works. But as Carlat shows so clearly in his personal testimony, having physicians participate in the marketing effort as “educators” is incompatible with professional ethics.

Wednesday, November 21, 2007

A Tipping Point for Pharma Ethics?

Pharma is the Jekyll and Hyde of health care. At their best, drug companies develop research-based treatment breakthroughs and do well by doing good. At their worst, as described in the Senate Finance Committee report on Avandia that I discussed in yesterday’s posting, greed strangles ethics.

A story on the front page of the business section in today’s New York Times leads me to believe that we are approaching a tipping point for Pharma ethics. The headline reads: “After a Trial, Silence – Cardiologists Question Delay of Data on 2 Cholesterol Drugs.” The story describes vigorous pushback from cardiologists against Merck and Schering-Plough for a suspicious delay in reporting the findings from a drug trial and for changing the criteria for evaluating outcomes in midstream.

The doctors who are quoted – including the chief of cardiology at Walter Reed – fear that pharmaceutical companies are, once again, cooking the books. The words “fraud” and “deceit” do not enter the story, but the implication is there.

There is nothing complicated about the ethical issues involved. Either the cannons of openness and scientific honesty are being followed or they are not. What stands out for me is the degree to which the reporter understands that this could be another Avandia or Vioxx story in the making, and how much space the Times devotes to it. The Senate Finance Committee report on Avandia was similarly blunt and hard hitting.

When media, legislators and their staffs, physician leaders around the country, and movies like “The Constant Gardner,” speak in unison, and when liability lawyers are waiting in the wings to hit Pharma with yet another class action suit, we have a powerful force emerging. The lure of blockbuster profits from blockbuster drugs draws out every technique of wild west capitalism, but at this point the pushback is too strong to be chilled out by a public relations campaign.

The pharmaceutical industry has a history and traditions to be proud of. Polls of public trust put pharmacists near the top. The fact that massive profit potential has led to corrupt practices isn’t surprising. But more drug scandals would be bad ethics and bad business, and would irrevocably taint the industry.

I predict that the pharmaceutical industry feeding frenzy is coming to an end. If we are truly at a tipping point we have to thank the whistle-blowers and determined activists who have fought so vigorously for good health system ethics.

Tuesday, November 20, 2007

The Intimidation of Dr. John Buse

The Senate Finance Committee has jurisdiction over Medicare, Medicaid and the FDA. This makes it an important player in health policy and oversight of the health system. While the Committee’s recent report on “The Intimidation of Dr. John Buse and the Diabetes Drug Avandia” is not as dramatic as John Le Carre’s “The Constant Gardner” (or the excellent film version with Ralph Fiennes), it doesn’t miss by much.

The Committee’s investigation was triggered by a June 14, 2007 New England Journal of Medicine article “Effect of [Avandia] on the Risk of Myocardial Infarction and Death from Cardiovascular Causes.” The article sounded an alarm about the manufacturer (GlaxoSmithKline) and the FDA as well as the drug:

“The manufacturer’s public disclosure of summary results for [Avandia] clinical trials is not sufficient to enable a robust assessment of cardiovascular risks. The manufacturer has all the source data for completed clinical trials and should make these data available to an external academic coordinating center for systematic analysis. The FDA also has access to study reports and other clinical-trial data not within the public domain…”

Six weeks after publication of the New England Journal article, Senators Grassley (R) and Baucus (D) wrote a strong letter to the FDA Commissioner expressing concern about suppression of dissent regarding Avandia. In a statement accompanying release of the letter, Senator Baucus said:

“…under Commissioner von Eschenbach’s leadership it seems that drug manufacturers’ interests may be allowed to trump science. Based on our ongoing investigation, it appears that FDA staff who voiced safety concerns about Avandia were removed from the very jobs that are supposed to protect the American public…”

Happily, someone inside the FDA must have been spilling the beans to Committee staffers.

The November report clearly draws on whistle-blower tips as well. It describes in detail how GlaxoSmithKline sought to silence Dr. Buse, currently president of the American Diabetes Association, who in 1999 was the first to raise concern about increased cardiovascular risk from Avandia. This internal email shows how executives at the company reacted:

“Mention was made of John Buse from UNC who apparently has repeatedly and intentionally misrepresented Avandia data from the speaker’s dias in various fora…the sentiment of the SB [what later became GlaxoSmithKline was then SmithKlineBeecham, i.e., “SB”] group was to write him a firm letter that would warn him about doing this again…with the punishment being that we will complain up his academic line…”

It is probably not often that a Senate Committee Report can be described as a "great read." This one can. Here is another juicy quote -- this one from an email from Dr. Buse to Dr. Steven Nissen, first author of the New England Journal article, describing what happened after he expressed his concerns about Avandia and cardiovascular risk:

"Immediately the company's leadership contact[ed] my chairman and a short and ugly set of interchanges occurred over a period of about a week ending in my having to sign some legal document in which I agreed not to discuss this issue further in public...It makes me embarrassed to have caved in several years ago."

The pharmaceutical industry is once again shooting itself in the foot. This sorry story -- so well set forth by the Senate Finance Committee -- puts another nail in the coffin of Pharma's reputation. It won't be long before lawsuits start to emerge, just as has happened with Vioxx. We can only wonder how many billions of dollars will have to go into settlements and fines before the pharmaceutical industry cleans up its act.

The happy part of this story is the role of the Senate Finance Committee and the whistle blowers who helped them do their important work. We owe them thanks!

Wednesday, November 14, 2007

Barriers to Serving Vulnerable Populations

Anyone interested in the politics and ethics of health care resource allocation should read Christine Ferguson’s recent Health Affairs article “Barriers to Serving the Vulnerable: Thoughts of a Former Public Official.”

Ferguson writes from her experience in numerous state and federal public health roles, including seven years as director of human services in Rhode Island and two years as commissioner of public health in Massachusetts. The question she asks is -- why is it so difficult to fund services for vulnerable populations?

In Ferguson's view, the problem isn't just money. She believes that the chronic budget problems have two generally unspoken issues in the background: “[1] policymakers’ perceptions and biases about vulnerable populations and [2] their disbelief in the likelihood of a successful outcome once a service or treatment is offered.”

With regard to 'biases about vulnerable populations" Ferguson writes that public and private decision makers divide vulnerable populations into three categories: " (1) those with health care problems that are the equivalent of an 'act of God,' such as most forms of cancer, premature birth...(2) those with health care problems that are viewed as being their own fault, resulting from behavior that could be reversed...such as the obese, substance abusers, prisoners, the homeless...and (3) the offspring of parents who made 'bad' choices, such as illegal immigrants...My observation has been that the first group is considered 'deserving'; the second, clearly 'undeserving'; and the third, the children of the undeserving, occupying a middle ground."

In other words, Ferguson believes that the centuries old distinction between the "worthy" or "deserving" poor and the "unworthy" and "undeserving" poor is alive and well in health policy and governance.

In addition to the unspoken sentiments about the worthiness/unworthiness of vulnerable populations, Ferguson describes "cynicism about whether treatment will lead to a successful outcome...(1) the belief that on an individual basis, seldom will an intervention or service lead to a successful outcome...and (2) the belief that on a population wide basis, the number of people who fall into a given vulnerable group is never reduced..."

Ferguson has no magic bullets to propose. She makes four policy recommendations to those who are concerned with the needs of vulnerable populations. First, to be open to new program approaches. Simply advocating for more of the same "demonstrates a lack of appreciation of the very real problems faced by decision makers..." Second, the biases that policy makers hold need to be confronted openly and discussed. Third, criteria for success must be realistic. Finally, advocates should identify the ways in which health programs impact dimensions like productivity, educational attainment, and quality of life, as well as the direct impacts on health.

I beat the drums for Ferguson's article because of its experience-based realism, not simply for the recommendations she makes, sound as they are. There is a tendency to approach resource allocation issues too much from the head and too little from the heart. I believe that Ferguson is correct in identifying bias about populations and despair about success as major underlying barriers to meeting the needs of the underserved. To achieve more equitable allocation of our health resources we have to address these deep attitudinal factors. Simply marshaling more facts and raising our voices won't do the job.

Tuesday, November 13, 2007

Eureka – A High Quality Public Debate on a Hot Medical Ethics Issue!

A page 1 article on the selling of kidneys in today’s Wall Street Journal is sure to trigger extensive public discussion. We will soon see the panels of reporters that pose questions in the 2007-2008 presidential “debates” pop questions about kidney sale to the candidates.

The underlying issues are clear. Four thousand people per year in the U.S. die while on the waiting list for kidney transplant. The surgery and post surgical treatment has improved, but we do not have enough living and post-mortem donors to meet the demand. Quality of life and survival are better with transplant than dialysis. How are we to get more kidneys? Allowing sale of kidneys is an obvious possibility.

My aim in this posting is not to concentrate on the issue itself but on the quality of the Wall Street Journal article and the debate between two economists that accompanies the article. What stands out is the thoughtfulness of the arguments and the genuine debate between the economists. My own position is clear (I am firmly against organ sale) and yours may be too. But the physicians quoted in the article and the dueling economists that accompany it are truly talking to each other in a thoughtful manner.

Democratic process requires public deliberation. This has been sadly lacking in our increasingly polarized political climate. Hate-laden sound bites too often replace the reflective clash of ideas that a well governed polity needs.

The issue of kidney sale has a lot going for it as a training ground for public deliberation. The need for more kidneys is easy to understand. The question of organ sale is obviously important. But while it touches deep, theologically-connected values (the “sacredness” of market solutions on the one hand and the "sacredness” of the body on the other), there is more room for real thinking than the abortion question allows. (See my recent posting on that topic.) And it is not likely to become a playground for political pandering the way the tragedy of Terri Schiavo did.

Ethically sound governance of our health system isn’t simply a matter of coming up with the “right” answers. For many of the complex questions a health system must address, reasonable people will come to different conclusions. Improving our collective skill at thoughtful deliberation will abet two important outcomes. First, in the course of deliberation, new and better options often arise. (There is evidence for this in the exchange between the two economists.) Second, when a policy decision is finally made, those who are disappointed can more readily see the outcome as fair and move on.

At their best, journalists are not simply “reporters.” They can be “educators” as well. The Wall Street Journal’s coverage of the kidney sale issue is educative. I encourage readers to go to the site to read the article and accompanying materials, and to cast your vote in the yes/no survey. (When I voted at 12:45 the tally was 482 yeses to 260 nos.)

Monday, November 12, 2007

Organizational Ethics and Patient-Centered Care

I recently reviewed a Commonwealth Fund report on “Patient-Centered Care: What Does it Take?” Although the word “ethics” appears only once in 34 pages, the report makes a substantial contribution to organizational ethics.

There is a vast literature on the concept of patient-centered care, defined in the 2001 Institute of Medicine "Crossing the Quality Chasm" report as:

"Health care that establishes a partnership among practitioners, patients, and their families (when appropriate) to ensure that decisions respect patients’ wants, needs, and preferences and that patients have the education and support they need to make decisions and participate in their own care."

Unfortunately, there is an equally vast literature documenting the degree to which our health system falls short of this vision.

The very practical Commonwealth Fund discussion identifies seven factors as most important for achieving patient-centered care:

• Leadership at the level of the CEO and board of directors
• A strategic vision clearly and constantly communicated
• Involvement of patients and families at multiple levels
• Care for the caregivers through a supportive work environment
• Systematic measurement and feedback
• Quality of the built environment
• Supportive technology

In classes and consultations I have often been asked “what is ethics?” I have found it useful to distinguish between three components: analysis, advocacy, and administration. (Three “A” words – what a coincidence!)

Analysis is what is required when our question is – “what is the right thing to do in this situation?” When we are clear about what (we believe to be) the right course of action, advocacy is the key activity – “patient-centered care really matters – let’s embrace it!” When we are aligned in our values, administration is the needed component – “let’s make sure we consistently provide patient-centered care and let’s make it as easy as possible to do it.”

“Patient-Centered Care: What Does it Take?” speaks to the administrative side of ethics. The ideals of patient-centered care are (quite properly) taken as the starting point. The seven factors provide an organizational strategy for making it happen.

I believe that anyone who has practiced medicine will understand the importance of the seven factors. While they are conceptualized for organizations, they are relevant for a solo practitioner as well.

Applying the factors doesn't necessarily require rocket science skills. In my psychiatric practice a crucial part of the “built environment” is having enough room for three chairs in addition to mine to make it easy to see family members with my individual patients. And with regard to supportive technology, when voice mail became available, being able to give patients a telephone number they could call 24/7 and know I would get the message no later than the next day made a big difference.

“Just do it!” has been a great slogan for Nike, but it doesn’t cut the mustard for promoting patient-centered care. The Commonwealth Fund report gives us a better game plan.

Saturday, November 10, 2007

Why Incentives Will Not Control Health Care Costs

On November 1 and November 8 the New England Journal of Medicine published two important articles on rising health care costs by Peter Orszag, director of the Congressional Budget Office. (The November 8 article is available to non-subscribers.)

Orszag and Phillip Ellis (his coauthor) don’t beat around the bush about the importance of controlling health care costs: “The long-term fiscal balance of the United States will be determined primarily by the future rate of growth of health care costs.”

Their analysis and proposals are sound. They argue that we don’t have enough information on comparative effectiveness and that our payment systems provide no incentives to patients or providers to choose treatments that offer the best quality at the lowest cost. They endorse a value-based approach to insurance design.

But these excellent ideas aren’t new. Proposing them will accomplish nothing without public understanding and public support. And we will not get understanding and support without a form of educative political leadership that -- with the exception of former Oregon governor John Kitzhaber -- has been almost altogether lacking. (Also see the speech I proposed for the Vermont governor in my October 27 post.)

I’m not a politician. I can’t claim to know how a political leader could pursue this kind of educative strategy and win votes. The political challenge, however, is like a clinical challenge that nurses and doctors deal with every day. Hectoring patients about losing weight or cutting down on tobacco or alcohol doesn’t work. But motivational interviewing, which involves meeting patients where they are in their understanding and readiness for change, and helping them take the next step, however small, often does. Skillful clinicians do this well with individual patients. Skillful political leaders can do the same with populations.

The fact that the two New England Journal articles come from the non-partisan Congressional Budget Office is important. Orszag and Ellis lay out the extent of the problem posed by health care costs in a careful, hard-to-challenge manner. They suggest many of the steps we will have to take. What they don’t do is make any mention of the need for political leaders to take the analysis and run with it. Let’s hope that some the Representatives and Senators they advise take the baton from them.

Friday, November 9, 2007

What Counts More for Organizational Ethics – Infrastructure or Leadership?

This is a trick question. The answer is – both. In my view, infrastructure and leadership pretty much tie.

Albert Schweitzer’s teaching – “example is not the main thing in influencing others…it is the only thing” – is my starting point for thinking about organizational ethics. The key question for developing an organization’s ethical culture is how to harness the power of “example.”

The American College of Healthcare Executives (ACHE) has developed and disseminated a 53 question ethics self-assessment tool. It well organized and easy to use. (Also see the posting about the excellent ACHE ethics decision-making process.) Here are some questions I especially liked:

* My statements and actions are honest even when circumstances would allow me to confuse the issue
* I demonstrate that my organization’s vision, mission, and value statements are living documents
* I ensure equitable treatment of patients regardless of socioeconomic group or payor category
* I promote Board discussion of resource allocation issues, particularly those where organizational and community interest may appear to be incompatible
* I demonstrate that incompetent supervision is not tolerated and make timely decisions regarding marginally performing managers
* My staffing plan minimizes the need for sudden layoffs or other crisis-driven responses to external financial factors

To my reading, the first two questions address personal leadership, the last two focus on management systems, and the middle two are betwixt and between. By my count 31 of the 53 questions are primarily about promoting ethics via personal example while 22 emphasize promoting ethics via the values embodied in infrastructure. ACHE is wise in solidly emphasizing both.

While I was writing this posting my email chimed and a Los Angeles Times story titled "Health Insurer Tied Bonuses to Dropping Sick Policy Holders" appeared. In our system of competing insurance programs insurers must monitor for fraud. But setting numerical goals for disenrollments and paying bonuses for financial savings creates a powerful counter-example to the insurer's (Health Net) self-definition as "people helping people to be healthy, secure, and comfortable."

Nurturing a positive ethical climate is a delicate process. Personal integrity on the part of leadership is necessary but not sufficient. Infrastructure must support and reinforce the values that executives endorse and model. Organizations become ethically admirable through a combination of inspiring leadership and obsessive attention to the ethical "lessons" taught by structures and systems.

Thursday, November 8, 2007

The Ethics of Medical Tourism

In July, the Harvard Pilgrim Health Care Ethics Advisory Group (which I chair) discussed the ethics of health plan involvement with medical tourism. (A summary of the discussion is available in the “Medical Travel Today” newsletter.) Although out-of-U.S. treatment is not yet a large issue for U.S. health insurers, Harvard Pilgrim had received a few appeals for medical travel, and wanted to scope out potential ethical concerns in advance.

Ripples of change are emerging, like the self-insured construction company in Albuquerque that charges its employees 50% of the cost of procedures done in the U.S. but only 25% of the overseas cost. And last night National Public Radio began a series on the internationalization of medicine.

Out-of-the-U.S. travel for treatment will grow. The phenomenon raises some significant ethical issues. We should try to anticipate these issues and plan for them before too many problems hit the fan.

There are five main reasons why Americans travel abroad for treatment. Most commonly the target is cosmetic treatment or other services, such as surrogacy, not covered by health insurance. Second, individuals who are uninsured or whose insurance has substantial deductions or coinsurance may seek treatment in Thailand, India or elsewhere to save money – the treatment may cost 10 – 20 % of what they would pay in the US. Third, individuals may seek treatments that are unavailable in the US, such as cancer treatments or surgical devices that have not received FDA approval. Fourth, as good as medical care can be in the US, individuals may believe that a higher quality of care is available elsewhere, as for surgical procedures where surgeons in other countries may have significantly more experience. Finally, individuals on transplant waiting lists may seek transplantation in countries where the wait may be shorter.

The primary challenges are assuring the quality of the out-of-U.S. treatment, planning for continuity of care on returning, and creating mechanisms to address the liability concerns of all parties. Quality, continuity, and accountability, are core ethical commitments in health care. In these areas we know what we are aiming for. The challenge is making our ideals real.

The most perplexing ethical concerns for medical tourism are the impacts on the host country. In economically less developed societies health professionals are already being lost to the home country through “brain drain.” Nurses and physicians could easily be further diverted away from the home population by catering to better paying foreign patients. And in the area of transplantation there is reason to believe that organs are being sold (and sometimes taken by force, as from prisoners). Stuart Rennie has a passionate posting on this topic in his excellent “Global Bioethics Blog.”

Medical tourism will expand. Done right it could provide benefits for all parties – patients receiving treatment, the “exporting” country, and the medical “host.” But if we allow an unbridled free market to govern the expansion we will also see ethically unacceptable developments as well.

It wasn’t the free market that ended the slave trade.

Tuesday, November 6, 2007

Gary Wills on Abortion

Gary Wills, one of my favorite writers, has thrown a constructive bomb into the abortion debate.

In a Los Angeles Times column “Abortion isn’t a Religious Issue” Wills argues learnedly that there is no scriptural authority for concluding that religion forbids abortion. He sees abortion as a moral concern that should be thought about in light of “natural law.” To Wills this means “we must turn to reason and science,” and look for insights from philosophers, neurobiologists, embryologists, and others, not scripture.

Here is the heart of Wills’s argument. While I agree with his conclusions, I present the argument as a model of the way we need to conduct thoughtful public deliberation about difficult topics:

"These [abortion decisions] are difficult matters, on which qualified people differ. It is not enough to say that whatever the woman wants should go. She has a responsibility to consider whether and when she may have a child inside her, not just a fetus. Certainly by the late stages of her pregnancy, a child is ready to respond with miraculous celerity to all the personal interchanges with the mother that show a brain in great working order.

Given these uncertainties, who is to make the individual decision to have an abortion? Religious leaders? They have no special authority in the matter, which is not subject to theological norms or guidance. The state? Its authority is given by the people it represents, and the people are divided on this. Doctors? They too differ. The woman is the one closest to the decision. Under Roe vs. Wade, no woman is forced to have an abortion. But those who have decided to have one are able to

Not surprisingly, Wills has been attacked vehemently, as in ProLifeBlogs:

"Wills, a dissident Catholic liberal, has made a living attacking the church of his parents. In this article he attempts to sound intellectual, all the while presenting false, misleading bits of history along with half-truths designed to give the reader both an intellectual as well as religions reason not to care about the abortion debate."

Wills’s column is lucid and important. I presume the same is true for “Head and Heart: American Christianities,” the recently published book it comes from. His argument has implications for health policy, not just abortion.
The major impediment to serious consideration of a single payer system in the U.S. is the vexing question of whether our political discourse can tolerate the kind of thoughtful deliberation that managing a health system and setting limits would require. As much as I prefer a health system based on universal coverage financed by collective funds, grotesqueries like Senator Bill Frist’s March 17, 2005 speech contesting the diagnosis of Terry Schiavo on the basis of his review of family videotapes make me doubt our potential for rational oversight of the health system.

Wills provides an antidote to the kind of knee jerk moralizing Senator Frist evinced. Perhaps the fact that Frist’s political aspirations have crashed and burned mean that Wills’s brand of thoughtful moral and scientific analysis is not just pie in the sky. Wills’s discussion of abortion provides a model for the kind of public reasoning we must learn to do about health care.

Sunday, November 4, 2007

The Ethics of "Skin in the Game" Thinking

An article on “How Much ‘Skin in the Game’ do Medicare Beneficiaries Have?” in the November-December issue of Health Affairs presents important findings about the Medicare population. It also invites attention to the health policy expression de jour “skin in the game.”

The authors analyzed out of pocket spending for 1997 – 2003 from the Medicare Current Beneficiary Survey (a survey of 12,000 representative Medicare beneficiaries). Median spending as a percentage of income increased steadily, from 11.9% in 1997 to 15.5% in 2003. Those with income below 200% of the federal poverty level spent 22% of their income on health care. Those over 400% spent less than 8%. As a share of income the poorest, sickest, and oldest, paid most. Four in ten Medicare recipients spent more than 20% of their income on health care.

The authors let the numbers speak for themselves, right up to their concluding sentence: “Our findings suggest that giving elderly and disabled Medicare beneficiaries more ‘skin in the game’ could make health care less affordable and accessible for all but the highest-income beneficiaries.”

Of course they are right. Having the oldest, sickest, and poorest, spending relatively so much more than others for their health care is not – from the perspective of equity and fairness – acceptable system performance.

But what about the phrase “skin in the game” itself? The fact that the Health Affairs authors put the phrase into quotes makes me believe that they agree with me in finding it a singularly repugnant way to talk about the economic side of how we deal with frailty, illness, and mortality itself. These aspects of human experience would appear to represent significant skin in life’s game!

The phrase is meant to convey that individuals should be concerned with the efficiency of medical care. It is true that the structure of health insurance currently gives patients and providers few external incentives to care about efficiency. And even for those who want to promote a more cost effective system, useful information on cost and quality is hard to come by.

To my ear “skin in the game” has a scolding quality, as if unless patients are at risk for the cost of their care their default position will be selfishness and economic profligacy. My experience suggests otherwise. In my clinical practice I have found that when patients understand that expenditures that produce limited or no benefit impoverish the health system and ultimately deprive others of access to care, most want to promote cost effectiveness. Human solidarity in the face of illness provides a motive for efficiency.

A Google search will tell you that Warren Buffett coined the phrase to make the point that high ranking company officials should own stock in the enterprise, to ensure that their interests are aligned with that of outside investors. Buffett’s reputation lends respectability to the phrase, but he denies having anything to do with its coinage! I would like to think that he is distressed by the overuse of the phrase in the health policy world.

At the Consumer Driven Healthcare Summit held in Washington DC September 26 -28, Jamie Robinson, an economist with a strong commitment to the social mission of health care, advocated for a nuanced combination of “individual responsibility with social accountability.” A 25 minute videotape of his talk is well worth listening to. Your will hear Robinson talk about the importance of incentives that support needed care and make patients responsible for deciding whether low value interventions are worthwhile to them. But you won't hear the kind of ham handed use of "skin in the game" thinking that is currently too widespread in health policy circles.

Thursday, November 1, 2007

Globalization, Mental Health Ethics, and Woody Allen

Three words in an article about outsourcing in yesterday’s New York Times got me thinking about globalization, mental health ethics, and Woody Allen.

The article predicts that consumer services will be the next wave of offshoring, using tutoring and personal assistant services as examples. But it quotes Nandan M. Nilekani, co-chairman of Infosys, a leading outsourcing company, as bullish about additional opportunities – “even psychological counseling.”

This is sure to happen soon. To get a sense of what is already happening enter “internet based psychological counseling” in your favorite search engine and look at the sponsored links. Counselors are actively marketing themselves and their services. Prices are posted clearly. 24/7 access is a major selling point.

During my psychiatry residency a patient voiced this fantasy: “You met me in the clinic, introduced yourself as ‘Dr. Sabin,’ and took me into an office. How do I know that you are not a bum off the street who put on a tie and is pulling off a hoax?” At least my patient could see me and know that I existed, whether bona fide resident or bum off the street.

As a medical student I had learned of an experiment that could never get by an Institutional Review Board now. Subjects were offered “psychotherapy” via speaking into a tape recorder. They were told that a “therapist,” who they would never meet, would listen to their recordings. At the end of the experimental “treatment” they were quizzed about outcome and feelings about their “therapist.” Many had improved and voiced positive attitudes towards their “therapist.” The web offers an ideal way to put this unethical experiment into practice.

I have used email in my work with patients (who I also see in the office) for at least ten years. Some people can express themselves more fully and listen better without face to face contact. (That is why Freud initially sat behind the couch.) For others, convenience is key. And for people with limited mobility, the Internet can be a savior.

As enthusiastic as I am about the ways in which web-based applications can support mental health practice, I worry about the Wild West ethics that will emerge. Psychiatry, psychology, social work and other mental health professions have developed robust ethical frameworks. Clinicians may not adhere to their profession’s code, but expectations are clear, and there are mechanisms for enforcement.

Not so with the web. A medium that brings together clients with depression, anxiety, and the full range of mental health problems, with invisible and unaccountable vendors of therapy, is ripe for exploitation and abuse.

Because offshore counseling services will elicit a higher level of wariness then the friendly looking U.S. based online counselors who tell us about their families and church affiliations, they may impose a higher level of quality control and transparency.

The best educators about the risks in online therapy will probably be our comedians. We can look forward to seeing what Woody Allen – the master satirist of psychotherapy – comes up with. It won't be long before comedians riff about the rights and wrongs of therapists having telephone sex with their patients!