Euthanasia and the Slippery Slope

Some of the arguments for and against what is now being called "Physician Assisted Death" (PAD)  rest on core ethical beliefs and are intractable. But the "slippery slope" argument that legalizing PAD in limited and arguably ethically acceptable circumstances, as with the Oregon "Death with Dignity Act," will inevitably lead to ethically unacceptable actions, is testable.

PAD became legal in Oregon in 1997. In the intervening 19 years there has been no significant public pressure to legalize PAD for persons who are not terminally ill, and no evidence suggesting that PAD is victimizing vulnerable populations such as the poor, ethnic minorities, or frail elderly. PAD is a relatively infrequent event, accounting for 0.4% of deaths in 2015. Further, PAD has not undermined good end-of-life-care, another slippery slope fear. In actual fact, Oregon is among the national leaders in providing good palliative and hospice care.

But although Oregon proves that the slippery slope argument against laws modeled on the Death with Dignity Act is invalid, reports from Belgium and the Netherlands are worrisome. In those countries PAD and active euthanasia occur at 10 times the rate in Oregon. What I find most disturbing is the way Belgium and the Netherlands have extended the practice beyond the terminally ill to include people described as "tired of living" and to others suffering from otherwise non-terminal psychiatric ailments.

If you're interested in PAD and the potential validity of the slippery slope concern, please read Rachel Aviv's brilliant New Yorker article from last year - "The Death Treatment," in which she tells the story of Godelieva De Troyer:

Godelieva De Troyer

At 64, De Troyer had recently been abandoned by a boyfriend and was feeling distant from her son. She sought out Dr. Wim Distelmans, an oncologist and professor of palliative medicine (!). Distelmans, who is apparently revered in Belgium for his support for euthanasia, cuts a handsome and charismatic figure:

Wim Distelmans

De Troyer had lived a roller coaster life. Her emotional states ranged from ebullience when her relationships were fulfilling to painful despair when her important attachments were disrupted. But given the clear history of relatedness during her adult life, I would wager that virtually all experienced psychiatrists in the U.S. would have seen De Troyer's wish for death when she met with Distelmans as a transient symptom, not an autonomous choice.

Rachel Aviv was able to interview Distelmans. Here's a crucial paragraph from her article:

Distelmans told me that he had no doubts about the way he handled Godelieva’s case. He explained that she was “a very nice person, a very warm person,” and that she had “wanted to do one decent thing in her life, and that is to die in a decent way, because the rest of her life was such a horrible mess.” When I asked if he worried about transference—perhaps she had idolized him or depended too much on his opinion—he laughed and said, “I’ve never met a patient who is willing to die to please someone else.”

I'd make the further wager that most experienced therapists in the U.S. would share Aviv's speculation that a "transference" was at work. And Distelmans's statement that no one is willing to die to please someone else is sheer nonsense. If we needed more proof than "psychological autopsies" conducted after suicides provide, just think of the suicide bombers who blow themselves up with heroic martyrdom as one of their motives.

Washington (2009), Vermont (2009) and California (2016), the three additional states that have passed "Death with Dignity" laws, all follow Oregon by limiting the procedure to patients with terminal conditions from which they are expected to die within 6 months. The slippery slope argument holds no water against that approach. But advocates for similar laws in other states should recognize that there appear to be real slippery slopes across the Atlantic, and must explain clearly the difference between Belgium and the Netherlands and what Oregon, Washington, Vermont and California have done.

(I've never met Rachel Aviv, but I've written about her superb work here and here.) 

Health Care in Singapore

I've had the good fortune to be invited by the Singapore Centre for Biomedical Ethics to do a week of teaching about health system ethics. Right now I'm at Heathrow airport in London, in between the Boston to|London and  London to Singapore legs of my trip.

Although there's been a lot of interest in Singapore among health policy cognoscenti, I'd been in the dark about the Singapore system until I started preparing for my visit. My impression thus far is that the People's Action Party, which has governed since independence in 1965, sees health care as (a) a crucial contributor to well-being but (b) largely an individual responsibility to provide for oneself and one's family, and (c) not a right the state is responsible for fulfilling.

When Singapore became independent in 1965 it was impoverished, with a life expectancy of not much more than 60. The government's initial emphasis was on the determinants of population health - housing, clean water, jobs, and education. On the basis of their vigorous action, health and mortality improved markedly. In 1984 they introduced a mandatory medical savings account program - "Medisave" - in which all working people, including the self employed, contributed 6-8% of income to their "Central Provident Fund" account, to be used for their own medical care and for family members (spouse, children, parents and grandparents). In the 1990s the government introduced an insurance scheme ("Medishield") and a means tested fund for low income folks ("Medifund"). But there's still a very strong emphasis on individual responsibility and paying a fair share of the cost, even for the poor. (For information about the Central Provident Fund and the system of "3 Ms", see here .)

I've been told the Singaporean government sees "insurance" in a negative light. "Insurance" connotes dependency on the state and abdication of personal responsibility. In the U.S. the frequent comment that our health system is so out of control because the population lacks "skin in the game" comes from the same moral and economic perspective. As a dyed in the wool liberal I'm a staunch believer in a universal system - either something like Medicare for all or guaranteed access to strictly regulated health plans. The framework of values in Singapore is jarring for me, but their outcomes appear to be terrific, in terms of health indices and a much less costly system than we have in the U.S.

Since I recurrently criticize conservatives for what I describe as their "theological" commitment to market solutions, to be consistent I have to challenge my own liberal theology on this visit to Singapore. Stay tuned

Psychoanalysis in China

A headline in yesterday's Washington Post caught my eye - "Freud coming into fashion in China." Until I saw the article, I'd never used "China" and "Freud" as part of the same sentence!

Through the article I learned about the China American Psychoanalytic Alliance (CAPA). Nine years ago, Dr. Elise Snyder, in her late 60s at the time, gave a paper about psychoanalysis in Beijing. She was startled at how interested young psychiatrists, psychologists and social workers were in learning about psychoanalysis. On returning home she formed CAPA, which has developed a remarkable training program for mental health clinicians in China.

In 1986, on my only trip to China, the psychiatrists I met were organically-minded, and showed little interest in psychoanalysis. It was only their politeness that kept them from describing it as a symptom of western decadence. But with the enormous social changes associated with rapid economic growth, internal migration, and a growing middle class, the anxiety and depression previously seen as western decadence have become part of Chinese life, and interest in the psychological aspects of human function has burgeoned. Incidents of suicides among workers in the economic zone and kindergarten killings have led the government to take more interest in developing access to mental health treatment.

CAPA has established a two year psychotherapy training program in which teachers in the U.S. treat the training participants via Skype and conduct supervision the same way. Faculty members travel to China for face-to-face meetings with the students and their patients. The first class will graduate in Beijing on October 24.

The CAPA program will give a window onto complex ethical questions. Freudian psychology is highly individualistic. Therapy centers on the patient's fears and desires. Societal expectations are seen through the lens of the individual psyche. Despite the extraordinary changes since Mao's death in 1976, however, China is still an authoritarian society. Challenging the state is not welcome. If psychotherapy led to intense questioning of the political structure it could create significant danger to the individual, and could lead to discrediting of the Freudian venture itself.

At a CAPA gathering in New York in January the topic of the main panel will be "Ethical Problems in Teaching and Treating in China," presented by two students in the China program. I hope it will be the start of an extensive piece of intercultural ethical inquiry. There would be much to learn from a dialogue between Freud and Mao!

The Medical Council of India Sets Tough Rules about Pharma

Rema Nagarajan, a journalist friend who writes for the Times of India, brought to my attention a recent ruling of the Medical Council of India about physician relationships with Pharma and other health sector industries. On paper at least, the ruling is very tough! The rules include:

• Physicians shall not accept any gifts whatsoever
  
• Physicians (and their families) shall not accept any paid travel, whether for CME or any other purpose
  
• Physicians shall not accept any "hospitality" (such as hotel accomodations)
  
• Physicians shall not accept any cash payments whatsoever
  
• Any research funding must come through institutions, subject to a range of regulations

India is an international target for drug trials, given the size of its population and the laxness of its human subjects protections. And, many physicians are struggling financially such that attendance at educational conferences, especially outside of the country, was essentially impossible for them, making them prey to the appeal of travel funds or gifts of office equipment.

Rules are one thing and enforcement is another. It's not yet clear what the consequences of violation will be. But the Medical Council has put a strong stake in the ground, for which it deserves international recognition.

(For previous posts about pharmaceutical ethics in India see here, here, here and here. For Rema Nagarajan's article in the Times of India see here.)

Tragic Choices at Grady Hospital (2) - Undocumented Patients with End Stage Renal Disease

As I've described in a previous post (here), Grady Hospital in Atlanta closed its dialysis clinic on October 3. Grady is a prototypical safety net hospital. It cares for a large number of uninsured patients - U.S. citizens and undocumented immigrants - and has been on shaky financial footing for several years. The dialysis clinic was losing $3 million per year. On January 3 the three month extension of coverage Grady promised to patients who did not have other sources of dialysis support ended.

Kevin Sack of the New York Times, who has been doing a terrific job covering the Grady situation, recently wrote about Monica Chavarria, a 34 year old married mother of 14 and 8 year old boys, who had been on dialysis at Grady and who returned to her original home in the Mexican state of Jalisco when Grady closed the clinic:

On Dec. 22, she exhausted the 30 free dialysis sessions that Grady had provided at a gleaming private clinic in Guadalajara. On her doctor’s advice, she had been stretching out the treatments...by going two times a week instead of the recommended three. Going without dialysis can prove fatal in as little as two weeks, and the twice-a-week regimen has at times left her weak.

...Everywhere, it seems, there are roadblocks to affordable care. The dialysis unit at Guadalajara’s public hospital, which offers heavily discounted prices to the uninsured, has a waiting list that extends for months. Ms. Chavarria is not eligible for the insurance plan known here as Social Security, which is limited to salaried workers. [And] the country’s five-year-old health program for the uninsured, Seguro Popular, does not cover end-stage renal disease.

Sack's article gave a link to an article in this month's American Journal of Kidney Diseases on care for undocumented immigrants with end stage renal disease (here). The authors estimate that there may be as many as 5,500 undocumented immigrants with ESRD in the U.S. If they were U.S. citizens their care would be paid for by Medicare. But the undocumented are not eligible for the Medicare program, and in most states are not eligible for Medicaid either. Safety net facilities like Grady that undertake treatment of undocumented patients are left holding the financial bag. Grady's no-win ethical dilemma was - risk going down the tubes altogether, and depriving a large population of its services, or put some of the dialysis patients at severe risk.

Kidney physicians have addressed the ethics of the situation Grady Hospital encountered in a thoughtful manner:

1. All health care professionals and health care systems have an ethical obligation to treat the sick.

2. The federal government has the ethical and fiscal responsibility to provide care for patients within the US borders.

3. The financial burden of this care should fall not only on states that have the highest number of uninsured citizens or noncitizens, but also should be a national responsibility.

4. Because of the unique nature of ESRD, all citizens and noncitizens with ESRD should be eligible for emergency federal funding if they do not have insurance or resources to pay for renal-related care.

5. Nephrologists should not be expected to act as agents for the Immigration and Naturalization Service and should not be expected to report undocumented noncitizens because of patient confidentiality and the fiduciary nature of the patient-physician relationship.

The kidney physicians are correct in placing the ultimate ethical (and fiscal) responsibility on the federal government. Immigration is a national concern. Safety net facilities like Grady should not be put in the "hot potato" situation of having lifetime fiscal responsibility for the patients it ministers to. If we play that game the safety net will implode.

Given the national backlash against the undocumented population it's hard to imagine that the U.S. will take on open-ended responsibility for the care of undocumented immigrants. This means that addressing the problem in a humane manner requires international cooperation. It's not clinically or ethically acceptable for the U.S. to "dump" undocumented patients back on the always poorer country the patient came from. If nephrologists and public health specialists from the U.S. and Mexico worked together to create a policy and care framework for patients like Monica Chavarria their care, and the services for other patients with ESRD in Mexico, would be improved.

Should President Obama come out of the Closet on Rationing?

An editorial in yesterday's Washington Post challenges President Obama to come out of the closet about rationing and fess up to the American public about the need for limits and sacrifice. Here's the essence of the argument:

PRESIDENT OBAMA sometimes presents health-care reform as a pain-free proposition, as simple as choosing the red pill over the blue -- one that's no more effective but costs twice as much. Asked at his news conference whether "the American people are going to have to give anything up in order for this to happen," Mr. Obama's basic answer was no. "They're going to have to give up paying for things that don't make them healthier," he said...

But Mr. Obama's soothing bedside manner masks the reality that getting health costs under control will require making difficult choices about what procedures and medications to cover. It will require saying no, or having the patient pay more, at times when the extra expense is not justified by the marginal improvement in care. Mr. Obama is right that sticking with the status quo is a bad alternative, but he isn't leveling about the consequences of change...

The current system is untenable and getting worse, with employers dropping insurance and premiums rising for those who still have it. Reform is essential. But Mr. Obama does the public a disservice by acting as if it will not require anything from them in return.

Of course the editorial is correct about the need for rationing. But is its conclusion good advice for political leadership?

On May 13, 1940, Winston Churchill spoke to the British Parliament as the new Prime Minister. He didn't mince words about the need for sacrifice. Perhaps the Washington Post has Churchill in mind in their advice to President Obama:

I have nothing to offer but blood, toil, tears, and sweat. We have before us an ordeal of the most grievous kind. We have before us many, many months of struggle and suffering.

You ask, what is our policy? I say it is to wage war by land, sea, and air. War with all our might and with all the strength God has given us, and to wage war against a monstrous tyranny never surpassed in the dark and lamentable catalogue of human crime. That is our policy.

You ask, what is our aim? I can answer in one word. It is victory. Victory at all costs - Victory in spite of all terrors - Victory, however long and hard the road may be, for without victory there is no survival.

Let that be realized. No survival for the British Empire, no survival for all that the British Empire has stood for, no survival for the urge, the impulse of the ages, that mankind shall move forward toward his goal.

Metaphorically, the U.S. is facing the same situation the Brits were in 1940. Our public dream of a Garden of Eden in which all pain and illness can be banished is a "tyranny" that threatens the survival of the country as we know it. But the threat posed by an economic cancer does not galvanize society the way an external enemy does.

So how can the President align the ethics of honesty with the requirements of political effectiveness? If I were advising him I'd argue for statements like this:

My fellow Americans. Our country is facing a grave and devious threat in runaway health care costs. Health care costs are a form of virulent, but potentially treatable cancer. If we let the status quo continue health costs will strangle our economy and rob us of our strength. Al Qaeda's best strategy for weakening us would be to induce us to continue with the status quo...I know that many are afraid that change means rationing. They're 100% right to be concerned. Every other country in the world has chosen to ration health care. Unless we tackle avoidable waste we'll have to do the same thing. Making large changes can be frightening, but we have not been a nation of cowards...

President Obama needs to invoke an external enemy more effectively than he has done thus far. As wrong as they are, that enemy isn't the Republicans or the Blue Dog Democrats - it's the economic cancer of the status quo. His task is made difficult by the fact that the enemy isn't a foreign power - it's our own cowardice about facing facts in the arena of health care. As Pogo said in the 1950s - "We have met the enemy...and he is us!"

To move health care reform forward President Obama needs to channel Winston Churchill more effectively. If he doesn't create more of an external danger we'll just continue to fight with each other. That dynamic has scuttled every previous effort at meaningful reform.

Praying with and for patients

I recently attended an inspiring forum sponsored by Andover Bread Loaf, "a private, non-profit organization based at Phillips Academy in Andover that works with U.S. and international public and private school teachers and students to enhance the teaching and learning of writing and to help catalyze educational renewal in classrooms, schools, school systems, and communities."
Teachers from New Orleans described programs they are developing in an effort to rebuild education and community after the Katrina disaster. A young teacher ended her presentation by saying - "if you pray, please pray for my students."

Her request got me thinking about a patient of mine with chronic schizophrenia who I had seen intermittently for several years, a sweet man who - though quite impaired by his ailment - radiated honesty and integrity. He was going through a bad patch in which his baseline anxiety and paranoia were more severe. We reviewed stressors, coping mechanisms and medication. As he left the office he said "please remember me in your prayers." I immediately replied "I will."

I've thought a lot about my response. I don't do petitionary prayer and don't believe in a divine being who might listen and respond. But I felt that I was being truthful with my patient. I interpreted his request to mean something like "I want you to care deeply about my well being," and because I did, my reflexive response was to confirm that I would indeed remember him in my prayers. If he had said "when you go to bed tonight please go onto your knees and ask God to make me better" I would have said something like "doing that isn't my custom, but I hope you know that in my heart I wish for you to be well..."

The U.K is in the midst of a flap about the ethics of prayer in the context of clinical care. Earlier this year a nurse, Caroline Petrie, was temporarily suspended for asking a patient whether she would like to be prayed for. The incident was widely publicized. Comments were highly polarized, some attacking "absurd political correctness" and "discrimination against Christians" while others found "invoking a non-existent deity in the course of medical care is foolish at best and potentially offensive."

This month the following motion will be brought to the British Medical Association:

That this Meeting:

• (i) recognises that the NHS is committed to providing spiritual care for patients;
• (ii) notes the position on inappropriate discussion of faith matters in GMC Guidance on Personal Beliefs and Medical Practice;
• (iii) while welcoming the constructive and necessary advice in the document "Religion or belief", is concerned that some paragraphs suggest that any discussion of spiritual matters with patients or colleagues could lead to disciplinary action;
• (iv) believes that offering to pray for a patient should not be grounds for suspension;
• (v) calls on Health Departments to allow appropriate consensual discussion of spiritual matters within the NHS, when done with respect for the views and sensitivities of individuals.

My guess is that one of the paragraphs of concern to those who are bringing the motion to the BMA is the following:

Proselytising

Members of some religions, including Mormons, Jehovah’s Witnesses, evangelical Christians and Muslims, are expected to preach and to try to convert other people. In a workplace environment this can cause many problems, as non-religious people and those from other religions or beliefs could feel harassed and intimidated by this behaviour. This is especially the case when particular views on matters such as sexual orientation, gender and single parents are aired in a workplace environment, potentially causing great offence to other workers or indeed patients or visitors who are within hearing. To avoid misunderstandings and complaints on this issue, it should be made clear to everyone from the first day of training and/or employment, and regularly restated, that such behaviour, notwithstanding religious beliefs, could be construed as harassment under the disciplinary and grievance procedures. Where one or more people from the same religion are working in the same environment, an individual could be pressured to conform to certain religious practices, which is again a form of harassment. There may also be differences of opinion on conformity within groups, for example between orthodox and reformed branches of certain religions, which could cause tensions and make an individual feel under pressure because of his or her religious beliefs.

If Ms. Petrie was trying to convert her patient the suspension would have been warranted. If her patient had asked to be prayed for it would unquestionably have been reasonable to agree to do so.

But what about offering to pray, which is what Ms. Petrie did?

If I were in charge of policy for Ms. Petrie's district or for the NHS I would find it hard to make a rule about offering to pray for a patient. It's clear from multiple research studies that when patients feel that their clinician genuinely cares about them they do better. If Ms. Petrie had a gentle, unintimidating manner, knew that her patient liked to pray and said "I'm a person who likes to pray for those I care about...would you like me to include you in my prayers tonight?" I would find that acceptable. But if she asked in a strong way "would you like me to ask Jesus to touch you with his healing hand?" I would find the episode unacceptable.

It's not a matter of the clinician's freedom of speech or religion. The guiding principle is that we clinicians should shape what we bring into the care relationship based on a reasoned judgment of what's best for the individual patient. (A "reasoned judgment" can come rapidly, as for me with the patient I agreed to remember in my prayers.) It would be wrong to forbid responding to a request to be prayed for. And I would not want to legislate that no clinician should ever offer to pray for a patient, but I would want my colleagues to be capable of distinguishing between their own beliefs about what is best for others (for example, belief in Jesus, Buddha, Allah or in no god) and a thoughtful assessment of what is best for this particular patient.

That's what clinical responsibility entails. But if clinicians at a hospital or in a district were blurring the boundary between preaching and caring, a prohibition would be required.

"Skin in the Game"

Here's a story that could be the basis for a class about the U.S. health care "system." My interlaced comments are in bold italics:

When Ben Schreiner, a 62-year-old retired Bank of America executive, found out last year he would need surgery for a double hernia, he started evaluating possible doctors and hospitals.

Ben's condition - a clearly diagnosed, non-urgent, standard surgical procedure - is well-suited to the "consumer" model of health care. The procedure is done at a limited number of facilities and data on experience, complication rates and cost is usually available.

But he didn’t look into the medical center in his hometown, Camden, S.C., or the bigger hospitals in nearby Columbia. Instead, his search led him to consider surgery in such far-flung places as Ireland, Thailand and Turkey.

For the procedure Ben needed, continuity of care was a relatively secondary consideration, so "shopping" far away from home was possible. Hernia surgery can reasonably be "outsourced." This would not be the case, however, for the majority of medical interventions.

Ultimately he decided on San José, Costa Rica, where just a week or so after the outpatient procedure and initial recovery, he and his wife were sightseeing throughout the country, then relaxing at a lush resort. He was home four weeks later, with no complications.

Mr. Schreiner is what’s known in the health care world as a “medical tourist.” No longer covered under his former employer’s insurance and too young to qualify for Medicare, Mr. Schreiner has a private health insurance policy with a steep $10,000 deductible.

Ben's demographic segment - no longer having employment-based insurance and too young for Medicare - will grow as the baby boomer's age. By taking a large deductible he lowered the cost of his insurance premiums, but in all likelihood those premiums were still quite high.

Not wanting to spend all of that on the $14,000 his operation would have cost stateside, he paid only $3,900 in hospital and doctor’s bills in Costa Rica. “I didn’t have to fork over my entire deductible,” Mr. Schreiner said. “What’s more, they bent over backwards there to take care of me — no waiting, a friendly staff, everyone spoke English.”

As a former bank executive Ben is presumably adept at running the numbers. The combination of Ben's skills with a non-urgent medical need for a procedure about which information is relatively available makes this kind of comparative "shopping" possible.

Ben Schreiner is a poster person for the market model of health care. His experience shows how market forces can potentially reshape health care in the U.S. If enough of Ben's neighbors in South Carolina go out of state and out of the country for hernia surgery, local surgeons and a local facility will ultimately figure out how to provide the surgery at a lower cost.

Ben's story appeals to two deeply held American values. First, he took responsibility for himself, by (a) choosing to take on substantial financial risk for his health care choices and (b) venturing to a far away "frontier" to find what he was looking for. And, he respected and used market forces, which our culture reveres much as we revere the six-gun carried by brave cowboys.

But extrapolating Ben's experience to a comprehensive proposal for how to govern the health system as is done by market hawks in the U.S. overlooks the fact that relatively simple elective procedures that require little or no continuity of care are the exception, not the rule. Individual responsibility and market forces will certainly play a major role in the forthcoming U.S. debate about health care reform, but they can't accomplish the task on their own.

Euthanasia, Murder and Medical Ethics

Early this morning I read a student essay on "End-of-Life Care" for this week's medical ethics class at Harvard Medical School. The student made a thoughtful argument that (a) when physicians stop life sustaining treatments like respirators they are "killing" patients, not simply "allowing them to die," and that (b) with proper safeguards it is ethically acceptable for physicians to participate in euthanasia.

I agree with the positions the student took.

Then I turned to the New York Times, and found an article about whether a medical student in Sweden who had served time for murder should be allowed to become a doctor.

In 2000, Karl Svensson was convicted of killing Bjorn Soderberg. Soderberg had complained to his employers about neo-Nazi materials a co-worker had displayed. The co-worker, a friend of Svensson's, was fired. Svensson himself had been under surveillance for his own neo-Nazi activities.

Svensson was sentenced to 11 years in prison, but was paroled after 6 1/2 years, as is common in Sweden. While in prison he took many web-based courses and did well enough to meet the Karolinska entry requirements. When Karolinska belatedly discovered Svensson's history it found grounds for expelling him.

Now it emerges that Svensson was subsequently admitted to Uppsala medical school!

When I wrote about Svensson's expulsion from Karolinska a year ago (see here) I concluded:

People convicted of murder can be outstanding physicians. In 2001 a medical specialist to whom I had referred many patients, including a member of my own family, was sent to prison for the 1999 murder of his wife. (He maintains his innocence.) He did more than provide excellent technical care - he gave outstanding human attention as well. I was moved by my patients' description of his skill and compassion and was proud to have him as a colleague.

But the Hippocratic Oath articulates another value - "In purity and holiness I will guard my life and my art."

The classmates who wanted Svensson to stay in Karolinska were half right. People who have done their time should have the opportunity to build a new life. For all we know Svensson may have had wanted to make amends for the crime he had been convicted of. But for me the Hippocratic value is the deciding point here. Medicine has its anthropological roots in religion. Many of the prophets in all religions were healers of the body as well as the soul. The obligations the privilege of being a physician entails go beyond what we do in the office and hospital.

I hope that Svensson is committed to making up in the rest of his life for the murder the court concluded he had done. But Karolinska Institute, which expelled him last week, did the right thing.

If I'm prepared to embrace a physician who has participated in euthanasia as a respected colleague, is it consistent to favor expelling Svensson from medical school?

I believe it is. The compact between clinician and patient is central to ethical assessment of an action. When competent patients (or their surrogates) make a clear request for termination of life support, following their wishes reflects respect for their right to self determination. And although physician assistance in dying (as the process is called in Oregon and Washington, which authorize it) is controversial, with many physicians (though not a majority) opposing it, even opponents recognize that physicians of intelligence and integrity can see assistance in dying - in carefully defined circumstances - as ethically warranted.

Opponents of physician participation in euthanasia can argue that if we allow euthanasia we can't turn around and keep Svensson out of medical school. But I believe this argument is fallacious.

Removing life support, carefully defined voluntary euthanasia and murder all involve actions that bring about the end of life. But just as we can distinguish between a physical exam and sexual assault, we can distinguish between ethically justifiable actions that hasten the end of life and murder.

What Can Medical Ethics Contribute to Health and Health Care in India?

Yesterday I attended a conference at Harvard Business School - "The Indian Growth Story: Sleeping Elephant or Roaring Tiger?" I've been thinking about what medical ethics can contribute to health and health care in India since spending the month of January there, and I thought I might learn some useful things at the conference. (See as well this previous post on ethics teaching in India.)

I wasn't disappointed.

Before the conference started I had coffee with a group of young India men - some still in business school and some in their first jobs. When I told them about my interest in medical ethics, one asked "is it true that before a person (or a country) is established there is no time for ethics; when you are established then you can think about ethics?"

I told them we have to address ethical questions at every phase of personal and societal development, but the questions and expectations are different at each phase. My hunch was that early on the key job is creating an "ethics infrastructure" that will support ethically admirable health system in a later phase.

Several speakers made reference to "jugaad," a Hindi word meaning inventiveness, cleverness and ability to get things done in unorthodox ways. When I looked up the term, here's what I found:

It’s like putting two spoons of turmeric powder into your radiator if you spring a small leak. It works, it will seal the leak. In Punjab, I have seen villagers buying an agricultural water pump at government subsidised rates, cannibalising some other parts from here and there, and turning it into a vehicle. These are jugaads.

The excellent panels and plenary talks described a vibrant economy with lots of opportunity for any of the ambitious and entrepreneurial young people at the gathering who wanted to return to India. Jugaad was a common theme - finding distinctive Indian ways of addressing problems and promoting development.

As I understand it, jugaad is an attitude and set of skills that in themselves are morally neutral. In the U.S. Enron specialized in jugaad - ingenious but virulently unethical and often criminal innovations. But speakers like Dr. Pradip Kumar Sarmah, founder and executive director of the Rickshaw Bank, an enterprise that (a) makes microloans to rickshaw pullers to enable them to own their own rickshaws and (b) has supported design research to develop a new and more efficient rickshaw model showed how jugaad can promote social justice.

In U.S. medical ethics education we tend to focus on ethical nuances and conundrums - like whether a particular patient's refusal of treatment reflects decisional competence and should be respected or doesn't meet the criteria for informed choice. From what my Indian friends tell me I infer that a case like this would be premature - the teaching task would be conveying the concept of informed consent itself and working with the question of whether and why patient preferences should be respected.

My current best guess is that the key pieces of "ethics infrastructure" to focus on are (1) informed consent, (2) research ethics, especially the ethics of clinical trials, which is a booming industry in India, and (3) strengthening the expectation that health professionals must consider population health and the common good as well as their own immediate practices.

The "Beggar's Song" in "Threepenny Opera" told us that some basics must take precedence over ethical niceties - "First feed the face, and then talk right from wrong...for even saintly folk, can act like sinners, unless they've had their customary dinners!" This was behind the question I was asked at the beginning of the day, with the implication that a concern with ethics is an impediment to development.

But I think the ancient rabbis got it right when they taught "Without sustenance there is no Torah (ethics); but without Torah, there is no sustenance." With enough skill at jugaad, ethics and development can go hand in hand!

Drug Trials in India - a Video Interview with Amar Jesani

Anyone interested in the ethics of clinical trials in developing countries should look at this five minute video of an interview with Amar Jesani, a leading human rights advocate in India.

Dr. Jesani, who I had the privilege of meeting with at the Center for Studies in Ethics and Rights in Mumbai during my recent trip to India, reports the prediction that in ten years one third of all clinical trials will be done in India. The primary reason is cost reduction - trials are 50% - 75% cheaper to do in India than in the U.S. And India's huge population means that there are enough patients with the condition being studied to conduct most trials.

According to Jesani it is easier to carry out trials in India because although there are laws that ostensibly protect patients, regulation is very lax. Poor patients are desperate for care and are typically subservient to their physicians. Government inspection and ethics committee oversight is week, and the regulatory process is subject to corruption. The picture he sketches is not pretty.

Jesani explains that he and his colleagues are fighting for three things. First, clinical trials done in developing countries should be relevant to their needs. Second, in the course of the trials there should be no human rights violations. Finally, if the trial is successful the drug should be available in the developing country at an affordable price.

The video is thoughtful and constructive. The comments it received are not. Here's the most printable one: "I have been conducting clinical trials around the world for 18 years. This video is a scam this doctor is a liar...This guy is probably trying to scam a few million from the drug companies in an extortion con."

In the last few years in the U.S. we've seen a rising crescendo of criticism of the ways the pharmaceutical industry has corrupted science and clinical judgment. The ethics of international drug trials will come next in this advocacy process. If the issues are new to you, have a look at the video.

Teaching Medical Ethics in India

During the four weeks I've just spent in India (I'm at the Amsterdam airport now, on my way home) I asked two questions about ethics and ethics education: 1) Can the field of medical ethics, which is so well established in the west, contribute to improving health in India? 2) Insofar as the answer is yes - how?

Medical ethics is not well developed as an academic field in India. To the best of my knowledge there are no medical school departments of ethics. Minimal curricular hours are devoted to the subject.

I believe that ethics education can make important contributions to health care systems and ultimately to health itself. But I formed this view in the U.S. In India I challenged myself with my favorite question - "so what?" So what that ethics education in India is rudimentary? What difference could more attention to ethics education make in a country with more than a billion people including a rural and urban population barely living at a subsistance level that is larger than the entire U.S.?

I was able to have a series of meetings with people who were generous with their time and thoughts. They delineated four major areas of concern:

1. Improving health status and access to care for the poor - both rural and urban. Several people feared that in its zeal for economic development the Indian government is starving the public sector and overly relying on a private health system. One described a vicious cycle in which as the public lost confidence in the poorly funded public system that loss of confidence was cited as justification for further reliance on private and for profit "solutions."

2. Dealing with environmental health hazards. As an example, yesterday's Times of India descibed staggeringly high levels of multiple drugs in the Andra Pradesh water supply - a result of dumping by pharmaceutical manufacturers. An activist physician stated "It's a global concern - European countries and the US are protecting their environment and importing the drugs at the cost of the people in developing countries." A village woman added -"When the local leaders come, we offer them water and they won't take it."

3. Addressing continuing stigma and ostracism of people living with HIV/AIDS. The National AIDS Control Organization (NACO) and its state branches and multiple NGOs have worked hard in this area, but stigma and ostracism continue to be major problems. (If you're interested in this area, the Yahoo AIDS India e-Forum is a great place to start.)

4. Responding to the torrent of clinical trials from the U.S. and Europe. India has an enormous population of poor people who have thus far been relatively easy to enroll in drug trials that are often poorly regulated (see here for a previous posting on this topic).

These aren't subtle or obscure issues. Like India itself - they're big. Does ethics education have anything of value to offer? I think it does.

If I were consulting to a medical school in India about establishing an ethics curriculum, here are three of the suggestions I would make:

1. I like to think of ethics in terms of three As - Analysis ("what is the right thing to do in this situation?"), Advocacy ("let's do the right thing"), and Administration ("what systems and procedures do we need to help the right thing happen?"). The analytic component , which is dominant in U.S. ethics education, would be less central at the start in India. The key goal of the program should be to encourage health professionals (and other stakeholders) to include responsibility for promoting population health as part of their professional identity, and to suggest ways in which they (whatever else they do) can (a) advocate for improved population health and (b) contribute to administrative measures that support positive actions.

2. Words in a lecture (a more central mode of teaching in India than in the U.S.) or on a page won't foster advocacy skills or administrative understanding. The new ethics education program should be guided by Albert Schweitzer's famous precept: "Example is not the main thing in influencing others - it is the only thing." Students should be exposed to health professionals who have found ways to put population health ideals into action. If the medical school were in proximity to the Vivekananda Memorial Hospital in Saragur, in the state of Karnataka, I would want them to meet with the staff I encountered there (see my posting on the Vivekananda hospital) and for interested students to work there, even for a short time.

3. Finally, I would want the program to be linked to an important area of population health in the local community. If the school was in Chennai, in the state of Tamil Nadu, where the headquarters of the Indian Network of People Living with HIV/AIDS, an NGO founded and run by HIV+ people, is located, learning about the difficulties HIV+ people - especially the poor - enounter in seeking work, accessing care, and maintaining ties with family and community, would be a rich learning opportunity. I would hope that faculty would not simply profess ethics but would put their professions into action, and take students with them in doing so.

Responding to Medical Mistakes in India

For anyone interested in (a) India and (b) medical ethics, (c) the Indian Journal of Medical Ethics (IJME), which is available online, is the key resource.

During my recent stay in Mumbai (I'm in Bhopal now) I met with Sandhya Srinivasan, the executive editor. I learned that IJME was born out of activism. In 1992 a group of reform-minded physicians contested the Maharashtra state medical council election on a platform of "ethical medical practice." The slate lost badly. But the reformers created a newsletter for discussion of ethical issues and promotion of ethical practice. Over time the newsletter became the IJME.

I am especially interested in how the interplay of modernization and tradition in Indian medicine affects ethical norms. By U.S. standards Indian physicians are on a pedestal. I was told that many of the poor see the doctor as "a God on earth." But at the same time western values embodied in concepts like informed consent, physician-patient collaboration, and open acknowledgment of medical mistakes are increasingly part of public discourse.

What happens when "physician as God on earth" meets "physician as collaborator"? The most recent issue of IJME provides a window onto this question.

Dr. Ashok Sinha, a private practitioner in Agartala, the capital of Tripura (a small northeastern state bordering on Bangladesh) discusses - in thoughtful and personal terms - how to respond to poor practice on the part of colleagues. Here are the first two paragraphs of his engaging commentary:

"One of the major ethical issues that I face very often in my practice is whether to criticise my colleagues or not. Complaints, criticism and condemnation lead to terrible consequences and never help anyone, they say. I am told that my colleagues are to be treated like my siblings and I should never criticise them in front of patients.

That seems logical enough. We may or may not agree with a particular diagnosis offered by fellow physicians, and it is not necessary that either of us would be right every time. But to criticise him or her in front of the patient would degrade the whole medical community. Even the patient would be in doubt about whom to trust. Moreover, very often this criticism is fuelled by competitive one-upmanship. Rather than bettering our performance to get ahead, we used the tactic of putting the other fellow down..."

Dr. Sinha reports that "sometimes I spoke out and made myself unpopular, and sometimes I did not, and hated myself for it." But his dominant ethical perspective is that "while we must have loyalty to the profession and the medical community, what about loyalty to patients?"

Dr. Sinha's discussion is followed by two commentaries. Ann Sommerville, head of ethics at the British Medical Association, argues that "in case individual integrity is not enough, doctors also have a duty to take action if they witness evidence of colleagues failing...lessons should be learned, future errors avoided and natural justice dispensed to patients who have been inadvertently harmed." Prabha Chandra, Professor of Psychiatry at the National Institute of Mental Health and Neuro Sciences in Bangalore, concurs. His emphasis, however, is on the need for a practical learning curve regarding how to talk with physicians and patients about mistakes.

The trio of articles strike me as precisely on target. The broad values of honesty with patients and professional responsibility for assessment of practice and self-regulation, do not appear to be culture-bound or limited in their relevance to the west. But values require practical implementation. There is currently very little teaching of medical ethics at medical schools in India, and professional societies do not have strong traditions of self-regulation. I expect the medical community to endorse Dr. Sinha's framework of values, but as Dr. Chandra points out, there is substantial research and skill-development to be done to put that framework into action.

Ethics at the Swami Vivekananda Hospital

I'm in Mysore, in the South Indian state of Karnataka, for eight days, at the Vivekananda Institute of Indian Studies. The Institute is part of a remarkable twenty five year old non-governmental organization - Swami Vivekananda Youth Movement (SVYM).

I visited for two days at the hospital the NGO runs in Saragur, a rural community forty miles southwest of Mysore. The visit provided a rich perspective on the ethics of health care and health organizations. I've organized my initial thoughts around two questions, both involving the concept of health care as a calling:

1. If health care is a calling, where does the call come from? Dr. R. Balasubramianiam ("Balu"), currently president of the NGO, led a group of medical students at Mysore Medical College who founded SVYM in 1984. Balu described how at 17 he was "ragged" so harshly by the senior students at the engineering college he had enrolled in that he decided not to go back. Since simply staying at home wasn't an option, to cover up the fact that he wasn't at school he started to spend the hours he would have been at the engineering college at an ashram, where he encountered the teachings of Swami Vivekananda (1863 - 1902) and was inspired by Vivekananda's vision of service to the rural poor and of making India an educated, healthy, harmonious society. Medicine, in the form of service to the rural poor, became his calling.

Balu's narration of his traumatic experience at the engineering college teaches one lesson about the origins of medical calling. It typically has strong personal roots. Virtually all of the physicians, nurses and other health care professionals who (a) I admire and (b) I know well enough to ask about their path to health care (c) cite meaningful personal origins of their calling. These vary tremendously, but have in common being intensely important to the individual.

Pictures of Swami Vivekananda and placards with his most quotable sayings are all around the hospital. When an associate of the NGO told me that he himself was an atheist I asked him "if Swami Vivekananda were here and heard you say that - what would he say?" The response was - "the Swami was an atheist himself - he thought that any god who allowed so much suffering didn't deserve to be worshipped. He taught that the religious spirit was shown in service, not in ritual practices."

Dr. Sridevi Seetharam, a physician deeply involved with medical ethics, explained that in Sanskrit terms, the gentleman I quoted in the previous paragraph was talking about the devotional path known as Karma Yoga - "selfless service to others in one's chosen profession or area of work." Vivekananda was Hindu by birth, but taught that all religions are in some sense "true." In addition to the personal origins of each person's calling to health care, the hospital's inspiration, Swami Vivekananda, and the ancient tradition of devotion through a Karma Yoga, which can be entirely non-sectarian and non-theistic, provides an external pillar for the calling.

In the U.S. people of faith can, if they choose, base their calling on their religious beliefs. But the kind of framework the doctrine of Karma Yoga provides, is not part of our secular ethos. The professionals I most admire act as if they were carrying out a devotional process, but if asked to explain the foundation that underlies their care giving, they're often at a loss to articulate it, or say something like "this may sound like a cliche but..."

2. How does calling manifest itself at the organizational level? My time at the Vivekananda Hospital was limited, but:

* The hospital and its outpatient clinic serve a rural population that includes tribal people who are only recently out of the forest. There is a huge social gap between many of the patients and the well educated professional staff. But the professionals evinced an interest in and warmth towards the people they serve that seemed more like love than technical "cultural competence." The physicians we spoke with evinced deep empathy with the patients. One manifestation of this empathy was creation of a strong role for "patient care managers" who come from the rural population and guide patients through their interaction with the care program in a side by side manner. Empathy is also manifested by providing free lodging for family members who cannot go back to their villages at night because there are no buses after 5:00 PM.

* Physicians were remarkably knowledgeable about traditional Ayurvedic treatment methods and Ayurvedic clinicians were part of the staff. Patients whose traditions and beliefs included Ayurveda had access to this approach in a way that was integrated with the allopathic services they received.

* A holistic view of health as involving more than medical relief of pathological states led the hospital staff to initiate a range of other activities including health and hygiene education in the villages, support for school improvement, and promotion of a clean water supply.

* Finally, and most remarkable from an American perspective, the hospital holds a twice a week non-sectarian prayer meeting attended by all of the staff and all of the patients. I was not present for a prayer meeting, and I do not see it as a format that would fit into a secular U.S. institution, but finding acceptable ways of recognizing the calling that all are participating in is a desirable path to follow.

A Mild Wrist Slap for Pharma in India

Last month, before coming to India (where I am now) I wrote about the drug marketing scene. The posting gave a link to an article in the Times of India that suggested to me that the Indian media were on the trail of the Pharma-Medicine story that is currently exploding in the U.S.

In Delhi I met with Rema Nagarajan, the reporter who wrote the Times of India story. Rema is well-informed about developments in the U.S., such as medical schools banning all gifts to medical students, house officers and faculty. Yesterday she had a followup article in the Times of India that suggests that the exposure of excessive pharmaceutical company influence over medical practice is heating up in India. India does not have the same level of consumer advocacy and consumer protection that has been developed in the U.S., but India is on its way in that direction.

Here are excerpts from Rema Nagarajan's article:

If you thought the government would crack the whip on pharmaceutical companies offering freebies to doctors for prescribing their products, think again. The department of pharmaceuticals has indeed taken note of the dubious practices reported by TOI on December 15, but in a surprisingly mild, almost apologetic tone.

Joint secretary Devendra Chaudhury wrote to the various associations of drug manufacturers on December 18 citing the TOI report, but the letter suggests he would be "grateful" if the associations acted on suggestions made by the department.

...The mild tone is despite the fact that the December 18 letter admits: "The allegations cannot be in any way treated as ethical and something that could be endorsed by society in general. This also puts the pharma industry in a bad light since the enhanced promotional expenditure of the pharmaceutical companies result in enhanced market price of the drugs, which has to be borne by the consumer."

Yet, it says the department would be "grateful if you (pharma associations) could kindly take action" on its suggestions and also take steps to "prevent such perception in the mind of the public and other bodies to obviate misuse of promotional expenditure" and to kindly "prevent allegations as well as media reports on this subject as have appeared".

The joint secretary says in the letter that "the matter being extremely sensitive and of great public importance I am constrained to write to you". With such a mild and apologetic tone from the government it is anyone's guess whether the pharma industry would feel the need to take any action.

Both the Organisation of Pharmaceutical Associations of India (OPPI) and the Indian Drug Manufacturers Association (IDMA) had released their own codes of conduct at the beginning of 2007. However, there is no single code applicable to all drug manufacturers, a fact that the letter points out. But again, this is followed up by a gentle nudge: "You may like to consider having such a code for your members"...

Establishing an ethical balance between medicine and commercialism in India will not be easy. Two very strong forces push against efforts to spotlight the problems and suggest solutions. Fist, there is tremendous trust in physicians, beyond what the profession deserves. (Rema quoted a Hindi saying in our discussion - "A doctor is like a God come down to earth.") Second, Pharma is a substantial component of the national thrust for rapid economic development. Successful enterprises aren't totally untouchable, but they are harder to tame than comparable enterprises in the U.S.

Preaching doesn't create an ethical health system. Public understanding of what constitutes good health system ethics and public demand for accountable performance are required. The media and political leaders are key "educators" for the public. I'll try to glean more about the societal learning process in India while I'm here.

Psychiatric Ethics in Mumbai

Because of (a) my clinical specialty (psychiatry) and (b) the fact that I'll be spending time in Mumbai next month, the headline "Psychiatrists work overtime with traumatized in Mumbai" in yesterday's Boston Globe caught my eye.

Here's the gist of the story:

"Since the gruesome Mumbai terrorist attacks, mental health specialists have been in big demand here.

But India, with 1.1 billion people, has only 4,000 psychiatrists, and efforts to provide adequate professional help for those traumatized by the rampage that left more than 170 dead and hundreds wounded is proving a daunting task.

Psychiatrists say it's not unusual to arrive at rural clinics and find 300 people waiting to see them. Each patient receives a scant few minutes of attention. Many give up and go in search of more traditional forms of assistance.

Evening "relaxation and breathing" workshops, for example, are being held in the immediate environs of the Chabad Jewish center that came under prolonged attack late last month and in other neighborhoods around Mumbai.

"We help ease people's tension through breathing techniques," said Ami Patel, an instructor with the Art of Living Foundation, which offers the sessions. "And people appreciate the feeling that someone cares."

...Mumbai psychiatrist Anukant Mittal is a case in point. He shuttles among city hospitals, suburban clinics, and primitive rural facilities, all part of a catchment area of 26 million people.

On any given day, Mittal sees patients ranging from chief executives of high-tech multinationals, who pay $50 per visit, to illiterate villagers wearing nothing but strips of cloth over their loins, and pay a subsidized 5-cent fee.

Rural residents sometimes turn instead to a shaman for help.

'You know very well they're going to go from your clinic to a witch doctor who will do black magic,' Mittal said. "So you have to say: 'I know you're going to need someone to exorcise this, but at the same time don't stop taking my medicine.'"

...Psychiatrists must grapple with their own anger, which can hamper their ability to help others. Recognizing this, hundreds of counseling professionals across India started an e-mail 'anger discussion group.'

'Psychiatrists are human, too, so we express our anger and try to heal ourselves,' said Harish Shetty, a social psychiatrist with Mumbai's Hiranandani Hospital.

'It's not always politically correct to admit anger, but in our epics, the Ramayana and Mahabharata, good kills evil,' Shetty said. 'It's part of our ethos.'"

For me, three aspects of the story exemplify admirable medical ethics.

First, Dr. Mittal's comment to his patient - "I know you're going to need someone to exorcise this, but at the same time don't stop taking my medicine" - embodies cultural awareness at its best. He recognizes his patient's beliefs, sees how they can be integrated with the treatment he is recommending, and presents a respectful synthesis of traditional healing and allopathic medicine.

Second, when "hundreds of counseling professionals across India started an e-mail 'anger discussion group'" we're seeing the kind of self awareness and self discipline that all health care professionals should apply. Whatever area of health care we're in, our attitudes and values are part of the clinical equation, and we have to do all we can to make sure they don't distort the care we offer.

Finally, Dr. Shetty's citing of the Ramayana and Mahabharata places health care where it belongs - in the context of wider culture. Practicing evidence-based medicine is a necessary part of excellent practice, but isn't sufficient in itself.

Health Care Rights in India and the U.S.

In yesterday's post on "Drug Marketing in Mumbai" I mentioned that I'm reading ethics literature from India in preparation for a visit I'll be making soon.

In the most recent issue of the Indian Journal of Medical Ethics, Dr. Helen Sheehan from the South Asia Studies Department at the University of Pennsylvania has a fascinating article on "Cancer, access to investigational drugs, and patient rights in the USA and India."

Dr. Sheehan tells a story from the U.S. (the Abigail Alliance case, which I discussed in "Access to Experimental Drugs - the Supreme Court Gets it Right") and a story from India (a cancer drug trial carried out at the Regional Cancer Center in Thiruvanathapuram in Kerala).

What's most striking in the story is that the rights at stake are polar opposites. Interestingly, both situations involve Johns Hopkins.

The Abigail Alliance case was brought on behalf of Abigail Burroughs, a young woman who contracted a rare head and neck cancer that did not respond to standard treatment. Her Johns Hopkins physician wanted to give her an experimental medication, not yet approved by the FDA. The legal action claimed a right for dying patients to have access to experimental drugs. The drug was not made available. Abigail died in 2001. The drug was subsequently approved by the FDA.

The posthumous appeal claimed a constitutional right to the drug, based on the fifth amendment guarantee that no person shall “be deprived of life, liberty, or property, without due process of law.” Patients in “last chance” situations, when standard treatment offers no hope – are facing death. The Abagail Alliance argued that by not facilitating access to drugs that have passed through Phase 1 trials, the FDA is depriving them of the right to opt for a potentially life-saving intervention. The District of Columbia Circuit Court ruled against the Alliance.

The situation at the Regional Cancer Center in Kerala involved trial of an experimental drug on 27 oral cancer patients from November 1999 to April 2000. The agent had only been tested in mice. Without approval from any IRB, a scientist from Johns Hopkins contracted with the Regional Cancer Center and brought the drug to India. In July 2001 a physician at the Regional Cancer Center blew the whistle on the study, claiming that no approval had been given and that the informed consent process was a sham. Johns Hopkins conducted its own investigation and concluded:

* The scientist was negligent for failing to submit a proposal for the clinical trial to a Johns Hopkins University institutional review board. Under university policy and federally mandated procedures, faculty experiments involving human subjects must have prior IRB approval, whether conducted in the United States or abroad.

* The trial did not meet Johns Hopkins standards for research with human subjects. For example, the committee found there was inadequate safety testing of the drugs in animals before they were injected into human patients. The committee also said that consent forms used to recruit patients for the study were inadequate.

* The scientist carried drugs used in the study to India without either an "investigative new drug" approval from the Food and Drug Administration or explicit FDA export permission.

* The scientist, without authority, signed several versions of a document committing the university to collaboration with the RCC.

In the U.S., the Abigail Alliance claimed (unsuccessfully) that the FDA regulations were too strict and abrogated Abigail's rights by preventing her and her physicians from protecting her against avoidable death. In India critics concluded that the Regional Cancer Center was too lax in its oversight of research, and that the drug trial abrogated participants' rights to adequate protection.

It isn't surprising that a country with strict research regulations (the U.S.) pushes drug research to sites where the regulation is more lax (such as India).
A New England Journal article discusses the risks to India as "A New Colonialism."

I hope we are in the process of seeing a global re-equilibration with regard to "rights" in health care. In the U.S. our expectations are excessive - as evidenced by our belief that we have a right to anything we or our doctors hope might provide benefit. In India, at least as seen by an outsider, expectations for what each individual deserves are too low, as evidenced by the way poor patients at the Regional Cancer Center were herded into a study. The disputed drug trial in India reflects the dark side of both countries - U.S. entitlement to join in the exploiting of poor citizens in India.

We owe thanks to the whistleblowers and journalists who give both countries opportunity to look in the mirror and see our failings.

Drug Marketing in Mumbai

I'll be in India for a month in 2009. One purpose of the trip is to learn about medical ethics education, ethics committees and the broad landscape of health system ethics, so I've been reading ethics literature from India itself. An article on "Drug promotional practices in Mumbai: a qualitative study" in the Indian Journal of Medical Ethics caught my attention.

The authors interviewed 15 senior executives from multinational (4) and Indian (11) drug companies, 25 pharmacists - 5 wholesalers and 20 retailers (5 attached to large hospitals and 5 stand alone shops each in rich, middle class and slum neighborhoods), 26 medical representatives from Indian (9) and multinational (27) companies, and 25 physicians - 13 GPs and 12 specialists who practiced in rich, middle class and slum neighborhoods.

Here are some excerpts from the article - with my comments in italics:

1. Information and brand reminders.
"Doctors stated that they received information on new drugs primarily through visits by MRs who use flip charts for this purpose. 'These flipcharts show the benefits of their drugs over the drugs of other companies. They also provide results of studies carried out by them on the drug's efficacy.' (general practitioner in slum)

According to the doctors, MRs rarely mentioned drug interactions and adverse reactions but they were otherwise generally satisfied with the information provided and accepted the MR's role. 'Everything is told in a precise way... medical representatives are well versed with their products and quite capable of answering the doctor's questions.' (senior general practitioner in middle-class neighbourhood)"

I saw this same system in action in 1989 when I spent a day with a psychiatrist in a public clinic. He let medical representatives join him when patients and their families (no one came in alone) were in the consulting room. As described in the 2007 article, the MRs pulled flip charts out of their valises and used them to demonstrate the virtues of their products.

"The doctors did state that MRs took up time that could be spent attending to patients and MRs were aware of this. "Doctors always perceive MRs' visits as an intrusion. Every minute taken up by the MR is time which could have been spent seeing patients and making money in the clinic. Often, MRs queue up early in the morning for doctors who allow only the first three MRs to see them." (from focus group discussion with medical representatives)"

The physicians I've spent time with in the public sector were treated like Gods. After the appointment patients touched the physician's shoe as a gesture of respect. It sounds as if the medical representatives had to come as supplicants in a similar fashion.

2. Incentives.
"Some MRs said incentives had become less cost-effective over the years as each company tried to offer more expensive gifts than the others. Incentives did not work to build a doctors' loyalty to a particular brand as all companies offered incentives. So they were now increasingly based on the prescriptions generated. Two doctors practising in slum areas showed printed handouts from a drug manufacturer giving targets and incentives to meet them. They were offered a cell phone handset for prescribing 1,000 tablets, an air cooler for prescribing 5,000 tablets and a motorcycle after 10,000 tablets were prescribed."

This direct "payment" for the number of pills of prescribed is a form of fee splitting. The practice should be seen as unambiguously unethical. There's no way a patient could, or should, trust the prescribing practices of a physician who receives direct payments for prescribing a specific medication.

"Another promotional practice was to finance educational programmes and conferences. Individual doctors' travel, stay and conference fees were also paid for by drug companies. Most doctors had no objection to such support and said they could not otherwise afford these meetings that they described as informative. A small minority felt that the lack of transparency in the funding of medical programmes by drug companies was unacceptable. Nearly half the doctors and all the MRs felt that over the past decade conferences had moved out academic college auditoria to five-star hotels which served lavish cocktail dinners, all with an accompanying increase in budgets."

All of the physicians I know who work in the public sector in India have difficulty paying for educational programs and conferences. If pharmaceutical companies gave money to a central body that administered a fund independently the practice would be acceptable. But paying for specified conferences where slanted presentations may be given is marketing, not education. And while we should not begrudge five-star hotel dinners or overseas conferences for hard working physicians - they deserve R&R - for drug companies give vacations and motorcycles it creates a clear conflict of interest for the physician.

"Drug companies stated that funding medical conferences had become less cost-effective; they suggested that doctors as a group had begun to pressurise pharmaceutical companies into financing their associations' programmes and would even boycott drug companies that did not give in to their demands. 'Things have got to such a stage now with doctors actually demanding sponsorship from companies. This year (an Indian drug company) had zero participation in (a specialist association's) conference. The company is now feeling the heat in the form of infrequent prescriptions.'(senior executive of an Indian drug company)"

This form of frontier capitalism would be funny if the problem weren't so serious. Drug companies give motorcycles for prescribing 10,000 pills. Professional societies boycott medications if the drug company doesn't pay up for their conferences. This is reciprocal bribery and strongarming!

3. Trade Practices.
"Retail chemists said that the multiplicity of brands made it difficult for them to stock all drugs and they risked being left with unsold stock. They therefore stocked the drugs of those companies which were promoted well both with the chemists as well as the doctors. Hence, it made sense for MRs to be consistent in promotion with doctors as well as chemists.

It was also reported by drug companies that chemists associations [demanded]...a charge of Rs 5,000 to Rs 10,000 to the association of wholesale chemists to stock a new product. Drug companies also gave other incentives to chemists to stock their own products."

Paying physicians to prescribe their medications and pharmacies to stock them has the elegance of a military pincer attack! All that is lacking is getting the patients to ask for the product.

"...Screening camps were used to influence public knowledge about a disease and also expand the market for the drug for that disease."

With direct outreach to the public, all the marketing bases are covered - patients, pharmacies and physicians. Since few medications are paid for by insurance, that sector, which would be important in the U.S., is currently not central in India.

All of the issues described in Mumbai are present in the U.S., but in India the pharmaceutical practices are more brazen. Federal and state regulatory capacity is significantly less in India than in the U.S. Perhaps more important, organizations - medical schools, hospitals, medical societies, and more - currently have less capacity to push back against commercial forces than comparable institutions in the U.S.

But the Indian media is sinking its teeth into the issue of commercial corruption of medical decision making (see, for example, "Are your drugs boosting your doctor's lifestyle?" in yesterday's Times of India here). The same ethical drama is playing out globally, just with different timing.

NICE is teaching the world about health care limits

Today's New York Times has a fascinating article about the firestorm triggered by NICE's decision not to cover Sutent, an cancer drug that may extend life of kidney cancer patients for 6 months, but at a cost of $54,000.

The article shows that NICE is the world's leading teacher about the ethical imperative for societies to set health care limits. I've quoted some excerpts from the article (in italics) followed by my comments.

"'Everybody should be allowed to have as much life as they can,' Joy Hardy [wife of Michael Hardy, who has kidney cancer] said...'It's hard to know that there is something out there that could help but they're saying you can't have it because of cost...What price is life?'"

Mrs. Hardy is profoundly right - deciding not to cover Sutent is a tragic choice. In terms of Albert Schweitzer's concept of reverence for life, the answer to the question "what price is life?" is - "it's priceless." But in economic terms, it's not.

Some years ago, Lester Thurow, then Dean of MIT's Sloan School of Management, suggested that we think about this kind of decision in terms of how much human labor the cost represents. $54,000 is a bit more than the average annual wage in the U.K. Asking "is it right to require John Doe to turn over his entire year's earnings to give Mr. Hardy a chance to live 6 more months?" feels significantly different than asking "should we allow a bureaucrat to sacrifice Mr. Hardy for $54,000?" Money isn't paper - it's ultimately human labor. We should have reverence for John Doe's life as well as Mr. Hardy's.

"Even in the United States, rising costs have led some in Congress to propose an institute that would compare the effectiveness of new medical technologies, although the proposals so far would not allow for price considerations...the idea of using price to determine which drugs or devices Medicare or Medicaid provides has provoked fierce protests."

The idea that we would forbid our government to consider cost - in other words, say that even if 100 or 1,000 John Does had to sacrifice their entire annual income they would have to do so to provide a chance for 6 more months of life - is so preposterous that it calls to mind Schopenhauer's famous comment about a philosophical assertion he found equally preposterous: "As a serious conviction it could be found only in a madhouse; as such it would then need not so much a refutation as a cure."

With regard to our public discourse about health policy, the U.S. is indeed a madhouse!

Robert Goldberg, vice president of the Center for Medicine in the Public Interest, an advocacy group financed by drug makers, likened Dr. Rawlins (director of NICE) and his institute to terrorists..."

This kind of Karl Rove take-no-prisoners rhetoric from a well paid PhRMA shill shows what NICE and its leadership is up against. I hope Michael Rawlins has a thick skin and a good sense of humor.

"Dr. Rawlins said he was frustrated that his institute had been censured instead of the drug company executives who set sky-high prices."

He's right to be frustrated!

Anyone who has brought up children knows how difficult it is to teach about limits and sharing. It takes patience, firmness, love and understanding the cost to the child of not learning. Children don't thank us. Like the hypocritically named "Center for Medicine in the Public Interest" they call us the equivalent of terrorists.

NICE is the kind of teacher the developed world - especially the U.S. - needs. Let's hope Michael Rawlins and his colleagues can keep up the good work!

More About the "Engage with Grace" Project

Yesterday I joined with other bloggers in a "blog rally" to (a) encourage ourselves and our readers to talk with those we are closest to about our wishes for end of life care and (b) to present a simple tool that could facilitate these discussions.

I learned from yesterday's Boston Globe that I'd gotten the story of the Engage with Grace project wrong in an important way. When Rosaria Vandenberg was close to the end of her life the hospital recommended that she stay. Although her brother did not know what Rosaria's wishes would have been - they hadn't had the kind of conversation Engage with Grace encourages - he took her home. Her two year old daughter, who had been afraid to touch her in the hospital, snuggled up to her in bed at home. Rosaria, opened her eyes for the first time in a week and gazed at her daughter. She died peacefully the next night at home.

Rosaria's family family felt it had made the right decision bringing her home, but wished they had talked openly with Rosaria about the values that were important for making the decision. Alexandra Drane, her sister-in-law, launched the Engage with Grace website to encourage others to have the kinds of conversations they wished they had had with Rosaria.

So many contributions to health care ethics come from individuals and families who learn deep lessons from their encounters with illness and mortality! These are gifts we can be thankful for.