A Mental Health Tragedy Revisited

On December 11 I did a post on the tragic story in which Marci Thibault, in a state of psychosis, took actions that led to her death and the death of her twin sister's two children.

Marci's sister and brother-in-law have a letter in today's Boston Globe. I quote it in full. It has a lot to teach us about tragedy, ethics and heroism:

Family coping with tragedy responds to its critics
December 31, 2008

WE ARE the parents whose two children were killed last January in traffic along with their mentally ill aunt. After being made aware of numerous online and in-print reader comments that were less than gracious, we wanted to clarify a few points and add to our public statements. Note that there is no pending lawsuit, and we are unsure whether there will be one. If there is ever one, and if there is any monetary judgment, proceeds would go directly toward the goals of our nonprofit, Keep Sound Minds.

We started this organization to improve awareness and education about mental illness to hopefully prevent another tragedy such as the one that befell our family. We will not personally profit as a result of this tragedy or any potential lawsuit.

An article was written about our story ("Finding words at last for an unspeakable loss," Dec. 7), and it seems many people are quick to crucify us as parents and people. We realized that was a possibility when we opened up to the public. That is unfortunate, but in our minds, the greater good of shining light on mental health issues far outweighs receiving backlash from people who don't know us.

We are similar to most of the readers of your paper. We loved and cared about our children deeply. They meant the world to us. If we believed Kaleigh and Shane would be in any danger that night, we never would have let them go. While we had some understanding of mental illness, we learned through the most painful way possible that we did not know everything. Our goal of Keep Sound Minds is to provide the public with better tools and knowledge to protect further innocent lives from being lost as a result of mental illness.

We pray that none of your readers will have to go through a similar tragedy, and we hope that people would be more understanding of the complexities of our case instead of immediately judging us as careless, self-centered people.

Ken and Danielle Lambert
Brentwood, N.H.

My first reactions to the letter were pain about the Lambert's suffering and fear that I might inadvertently have written something that added to their distress. On re-reading the December 11 post I was relieved to see that I had been very clear about my view of their conduct, as in the final sentence - "Danielle and Ken Lambert deserve admiration and respect for their efforts to transform private grief into public altruism."

In their letter to the Globe Danielle and Ken continue to teach us, this time about advocacy. For every tragic story like Danielle and Ken's, in which a normal appearing but deeply ill person like Danielle's sister Marci takes actions leading to terrible consequences, there are 10,000 stories about unjustified discrimination against people with a history of mental illness. And even if there is no simple guidance for police who are called to make evaluations of odd behavior, as happened when Marci was on her way to Danielle and Ken's home, the story they allowed the public to learn about will be used for police education all around the country.

If there's an award for ethical advocacy in mental health, I nominate Danielle and Ken Lambert!

The Sad Case of Nataline Sarkisyan Continues

Almost a year ago, in the context of the New Hampshire primary, I criticised John Edwards for politicizing the death of seventeen year old Nataline Sarkisyan, who experienced liver failure after a bone marrow transplant for leukemia, and whose insurer refused to cover liver transplantation. Here are the concluding paragraphs from that post:

Every health system has to set limits. This would be true even if Mother Theresa were the health czar. It is entirely reasonable to question the evidence basis for UCLA’s proposal or Cigna’s denial. Similarly, it is entirely reasonable to argue that the bar for evidence should be lower in last chance situations than in other domains of care. But Edwards, who I admire and largely agree with politically, does the public a disservice by presenting the denial as a moral crime.

Edwards favors extending Medicare to a wider range of citizens. If he ends up as president, it will be interesting to see how he addresses the issue of limits. As Oregon Governor John Kitzhaber recognized 20 years ago, universal coverage is impossible without limits. No limits, no universality. It is that simple.

True leaders must be educators. Understanding the ethical necessity for limits is counter-intuitive for those who are not familiar with the health sector. Edwards may have done an effective piece of campaigning yesterday, but he was not providing the kind of ethical leadership that improvement of our health system requires.

This is especially unfortunate. Edwards is a superb communicator -- just the kind of voice we need to help us come to grips with the sad fact that health care limits, well set, are an ethical necessity, not a moral abomination.

This morning the Associated Press reported that the Sarkisyan's attorney, Mark Garagos, is suing Cigna:

Insurer Is Sued Over Liver Transplant

The family of a 17-year-old leukemia patient has sued the health insurance giant Cigna over her death in 2007 after the company initially refused to pay for a liver transplant.

The lawsuit, filed last week in Los Angeles County Superior Court by the family’s lawyer, Mark Geragos, accuses the company of breach of contract, unfair business practices and intentional infliction of emotional distress. It accuses Cigna of delaying and rejecting valid claims, which resulted in the wrongful death of the girl, Nataline Sarkisyan.

The insurer, based in Philadelphia, eventually approved the transplant after Nataline’s family held a rally outside its office in suburban Los Angeles. Nataline, however, died hours after the approval was secured.

Chris Curran, a spokesman for Cigna, said the company felt that the lawsuit was without merit. Mr. Curran said the company had volunteered to pay for the procedure out of its own pocket.

Mortality is sad, but the death of a seventeen year old is tragic. For any health system, deciding about coverage in a situation like that of Nataline Sarkisyan, is the most difficult challenge imaginable. While I have no expertise on liver transplantation for patients with leukemia, my impression is that a strong case can be made that not covering the transplant was a fair and justifiable decision. If the case comes to trial that's what the jury will be asked to decide. And if the verdict is appealed the Appellate Court(s) will have to address the issue the U.S. has tried so hard to avoid - rationing.

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.

Hatred of Insurance Companies

The Obama transition team is sponsoring 4,200 house party-based grass roots discussions of health care in December. Today's New York Times reported on one of them.

In my work on health system ethics I've often invoked the need for a "societal learning curve" with regard to the health system. The Obama health care house parties will provide HHS Secretary Tom Daschle with a huge opportunity to see where the U.S. public is coming from in its understanding of the health system.

Here are some excerpts from the account of the health care house party, followed by my comments in italics. The report suggests just how much teaching and leadership we need from Secretary Daschle and President Obama:

"When a dozen consumers gathered over the weekend to discuss health care at the behest of President-elect Barack Obama, they quickly agreed on one point: they despise health insurance companies.

They also agreed that health care was a right; that insurance should cover 'everything,' not just some services..."

I run the ethics program at Harvard Pilgrim Health Care. It's a not for profit health insurance company that insures a million people. For the past four years it has been rated #1 in member satisfaction and quality of care by U.S. News and World Report and the National Committee for Quality Assurance. I respect and admire the organization.

That said, health insurance companies are in an unenviable and perhaps impossible position, poised between (a) employers and government agencies frantic to control what they pay for health insurance (b) providers who are largely not held accountable for costs, (c) insurees who want "everything" covered, in a context of (d) severely limited public and political understanding of how health care really works.

"Dr. Lawrence M. Nelson, a scientist at the National Institutes of Health who emphasized that he was speaking as a private citizen, said: 'The incentives in the current health insurance system are upside down. The less care you provide, the bigger your profits.'"

In the 1990s, public policy asked insurers to mediate the gap between what payers wanted to pay, providers wanted to provide and patients wanted to receive by determining which proposed interventions were "medically necessary." That role wouldn't be easy for anyone - even Mother Theresa or Dr. Schweitzer. Insurance companies, especially for profit companies, were ultimately pilloried for setting limits. They've backed off from taking that role. Costs, of course, are skyrocketing again.

But Dr. Nelson's comment suggests just how tough a teaching job Secretary Daschle will face. Less care is often (a) as good as more care or (b) better. That's a counterintuitive lesson for much of the public. Entities that profit from providing less care aren't able to teach it. The Secretary has to find ways to help us learn.

The Obama transition team did not ask people how a new health care system should be financed, but several people here said that individuals and businesses should have to pay a small health care tax — some preferred to call it a “contribution” — so that everyone could be covered.

Not asking how the health system should be financed strikes me as a major error. There is no way we will come to grips with health care costs until we set a true budget for the health system. The idea that "small contributions" might get us to where we need to go suggests how much we are still living in lala land with regard to health care finances.

If Secretary Daschle uses the health care house parties as an opportunity to refine his agenda for leadership they will provide valuable insight. But if the house parties are used to define the content of proposals we'll just continue down the same path of inexorable cost increases we are on now. Our political leaders - always excepting former Oregon Governor John Kitzhaber - haven't had the guts to help us face the need for limits and to begin to understand health care in a more nuanced way. It remains to be seen whether the new administration is up to the task.

The Invisibleness of Money

Here's a letter to the editor from today's New York Times:

December 22, 2008
Generic Drugs: Let Patients and Doctors Decide
To the Editor:

Your Dec. 10 editorial “(Generic) Drug Resistance” doesn’t mention a critical fact: nearly 7 out of 10 prescriptions in America are now filled with a generic drug.

In New York, pharmaceutical companies cooperated with state officials in fashioning policies for Medicaid and the state employee health plans that have driven generic substitution to more than 90 percent, according to the Department of Health, while protecting patients whose circumstances necessitate brand medications.

The assertion that physicians are “bought off” by pharmaceutical companies insults both the medical profession and the scientists who are working to develop new treatments for patients suffering from chronic and life-threatening illnesses.

America’s pharmaceutical research companies support patients receiving the treatments that are best for them — including brand-name medicines and generics. That said, without innovative medicines there would be no generics.

In the end, these decisions should be made by patients and their doctors, not dictated by pharmaceutical companies or editorial writers.

Ken Johnson
Senior Vice President
Pharmaceutical Research
and Manufacturers of America
Washington, Dec. 15, 2008

The assertion that physicians have often been "bought off" by the drug industry is, alas, all too true. My own specialty, psychiatry, is currently the focus of recurrent revelations about the unseemly conduct of leaders in our field.

What stands out in Mr. Johnson's letter is the absence of any reference to money. It is easy to agree that clinical decisions "should be made by patients and their doctors." But Mr. Johnson avoids the question of who will pay for the conclusions the patient and physician reach.

When drugs are paid for by the individual, preference for a branded product is quite rightly up to the individual. But when drugs are paid for by funds a population puts together for collective benefit - whether via taxes as with Medicare and Medicaid, or via a combination of employer and employee payment as with most private insurance - the collective voice quite properly has a role in allocating the the shared resources.

Note the word "dictated" in Mr. Johnson's final sentence. His rhetoric is subtle. The implication is that any interference with decisions made in the physician-patient dyad would be "dictatorship." But smooth PhRMA rhetoric doesn't print money. Collective funds are limited. Physician and patient autonomy does not, and should not, include the right to commandeer the funds of the commons without any accountability.

Mayo Clinic Skipped Written Informed Consent - Bravo!

A headline caught my eye this morning - "Mayo Skipped Written Consent."

Before I say more I have to acknowledge a conflict of interest. I admire the Mayo Clinic. I've never been there, but I respect the thoughtfulness of the medical program as reflected in documented outcomes and publications, and the values Mayo has been known for.

Here's the story. George R. Studnicka, a federal prisoner, developed lymphatic cancer. He was referred to the Mayo Clinic for treatment. Mr. Studnicka subsequently claimed that Dr. Daniel Pinheiro operated on him without consent and Dr. Yolanda Garces performed radiation therapy on him, also without consent. (See here for the US District Court Appeal opinion.) Mr. Studnicka's lawyer found no signed informed consent form in the record and complained to the state. An on-site inspection of 12 records showed that none contained signed consent forms.

Mayo wasn't defensive. An administrator told the inspectors "There is no written surgical consent...We don't use them here." The state inspectors reported that Mayo officials told them they "didn't agree with the federal definition of written consent."

Bravo!

The March 2008 issue of the "Proceedings of the Mayo Clinic" had an article on "Medical Informed Consent:General Considerations for Physicians." I don't know whether the timing of the article was coincidental or whether it was meant to present Mayo's philosophy of informed consent. Here's the key summary table from the article:

TABLE 2. Prudent Behaviors of Physicians Engaged in the Process of Medical Informed Consent
* The physician directly involved in the proposed treatment should conduct the informed consent discussion. The discussion should include the treatment, the risks and benefits of treatment, and alternative therapies with associated risks and benefits
* The physician directly involved in the proposed treatment should discuss the most likely outcome with no treatment, on the basis of the best available medical or surgical evidence
* The physician directly involved in the proposed treatment should always discuss the severe risks, such as death, paralysis, loss of cognition, or loss of a limb, even if the probability of occurrences is negligible
* The physician involved in the proposed treatment should always disclose less severe risks that occur frequently. Courts do not place emphasis solely on consequences; they recognize frequency as an important component of risk
* The physician directly involved in the proposed treatment should discuss informed consent in language the patient can understand, and treatment should not proceed until the physician believes the patient understands the risks and benefits and has made a rational decision
* The physician directly involved in the proposed treatment must understand that the medical consent form is not medical consent; it represents evidence that the consent process occurred. The dialogue between the patient and physician is the essence of the consent process (emphasis added)
* The physician directly involved in the proposed treatment should document all patient-imposed restrictions in the medical record and the discussion with the patient about how the restrictions limit the physician’s ability to provide standard medical care...
* When physicians and patients take medical informed consent seriously, the patient-physician relationship becomes a partnership, with shared authority, decision making, and responsibility for outcomes The physician directly involved in the proposed treatment can enhance the informed consent process through appropriate use of additional learning materials, such as pamphlets and video, and through involvement of support staff, such as physician assistants, in providing information that can be discussed by the responsible physician

In my view this represents an exemplary approach to informed consent. The recurrent reference to "the physician directly involved..." and the concluding bullet correctly portray informed consent as a crucial clinical process between clinician and patient, not as a bureaucratic event between pen and paper. Sadly, medical students I've taught have described being sent onto the hospital ward to "consent the patient" - i.e., get the patient to sign a document, which demeans informed consent and invites the student to become cynical.

Apparently, and not surprisingly, the level of documentation in Mayo charts was variable. That's not acceptable. And apparently federal regulations require signed forms in certain circumstances. Mayo agreed to implement a written consent form. I hope the Clinic does this in the clinically sensitive spirit embodied in the passage I quoted.

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.

Why Ethics Has a Bad Name

Here's an excerpt from an article about Illinois Governor Blagojevich I read over coffee in this morning's New York Times:

The moment could not have been more welcoming for a Democrat. Gov. George Ryan, a Republican who was by then engulfed in a corruption scandal, did not run for re-election, and the Republican who did had a long record of public service but an unfortunate last name: Ryan.

Mr. Blagojevich focused his campaign on pledges of reform and clean government, and won. Once in office, even amid accusations of campaign donations being exchanged for state jobs, Mr. Blagojevich continued to promote himself as a lonely fighter against the gargantuan pressures of lobbyists and lawmakers — pressing for tougher ethics laws, appointing inspectors general and sending state employees to “ethics training.”

In an earlier posting about "A Ridiculous Use of Medical Ethics Teaching" I speculated about why a state ethics board ordered a physician whose multiple offenses suggested incorrigibility to take an ethics course. The three possibilities I came up with were cynicism (avoid meaningful action by appearing to do something), optimism (the multiple offender means well - an ethics course will show him the true path) and magic (like divine intervention, the ethics class will pierce the miscreant's evil self and bring about transformation).

Governor Blagojevich, who is now the toast of late night comedy shows, provides a fourth reason ethics can have a bad name - duplicity. This is the technique the hungry wolf used in hope of eating Little Red Riding Hood. Disguising himself as the kindly grandmother is like the Illinois governor presenting himself as the candidate of reform.

Ethics education and ethics committees can be enormously valuable, but only as a support for the objectives set by ethical leaders. As grandma probably told Little Red Riding Hood - actions speak louder than words.

A Mental Health Tragedy

At 8:00 PM on Friday January 11, 2008, Marci Thibault came to her twin sister's home to pick up her 4 year old nephew Shane and 5 year old niece Kaleigh for a sleepover at her own home in Bellingham MA. On the way home she pulled her car into the median of the highway, undressed herself and the children, and carried the children into the oncoming traffic. All three were killed.

Four months earlier Thibault had been treated at McLean Hospital for a psychotic episode. She was discharged after six days with medication and a referral for outpatient treatment. Between her discharge and her death she was said to be "95 percent back to her old self."

On her way to her sister's home Marci Thibault came to the attention of the state police. She apparently drove into the median area at full speed. When a motorist stopped to offer help she began to punch him. State police came to the site and questioned her. She told them she was having "a debate between good and evil." The troopers considered committing her to a psychiatric hospital, but she calmed down, and they concluded they did not have enough evidence to do so.

By the time Marci arrived at her sister and brother in law's home, however, "she was acting like the normal Marci I knew all my life," her twin sister Danielle Lambert, a pediatric nurse practitioner, reported.

In the aftermath of the tragic event, Danielle and Ken Lambert, Kaleigh and Shane's parents, have started a nonprofit group "to improve the mental health system by educating the public and promoting practical solutions."

I'm writing about this story on a blog devoted to health system ethics for two reasons.

First, the way Danielle and Ken Lambert have channeled their grief is ethically admirable. By devoting themselves to "prevent[ing]similar incidents from occurring by improving society's understanding and management of mental health issues" they are transforming private tragedy into public benevolence. And, the fact that they portray Marci Thibault, the agent of their childrens' death, as a victim of mental illness and not as a perpetrator, shows an admirable capacity for not blunting grief through blame.

Second, the excellent Boston Globe article from which I learned about this tragic event, is unusually clear about the ethical trade off between public protection and civil liberties:

Dr. Alberto M. Goldwaser, a forensic psychiatrist who teaches at New York University's medical school, said it is understandable that the Lamberts are second-guessing the State Police and McLean. But he said the couple's criticisms are probably unrealistic.

"Right now, we know the police should have taken her to a hospital, and then this tragic event wouldn't have happened. But that's in hindsight," said Goldwaser, who is not involved in the case. "So, yeah, [Thibault] was peculiar. We're talking about taking her liberties, taking her freedom"...

Thibault's husband, Michael, an EMC Corp. employee who met his wife at Bellingham High School, said it might be a good idea for police to have access to a database of individuals who had been committed to psychiatric hospitals, despite the inherent privacy concerns. He said the State Police "had Marci in their hands on the way up" to New Hampshire.

But Dr. Mark Goldblatt, a Cambridge psychiatrist and president of the New England chapter of the American Foundation for Suicide Prevention, said Americans are ambivalent about how to respond to people with mental illness.

"Society wants it both ways," he said. "We want to have complete freedom and liberty and not be restrained by government, not have people's names in databases. And at the same time, we want to control people who live a certain way with mental illness. It's hard to have both."

The Boston Globe deserves gratitude for the kind of journalism that contributes to public understanding of complex ethical issues. And, most notably, Danielle and Ken Lambert deserve admiration and respect for their efforts to transform private grief into public altruism.

MRI and CT - the Curse of Incidentalomas

In 2001, 225 leading general internists were asked to rank 30 medical innovations in terms of their importance for patient care (see Health Affairs article here). By a large margin the group judged magnetic resonance imaging (MRI) and computed tomography (CT) scanning to be the most important. For physicians like me who entered medicine before the new imaging techniques were developed, the information MRI and CT provide seems miraculous!

But as physicians know all-too-well and as an excellent New York Times article by Gina Kolata today describes especially clearly - as scans rapidly improve, the frequency of "incidentalomas" increases just as fast.

Incidentalomas are scan findings that get labeled "abnormal" but actually have no clinical significance and are not causing a problem for the patient. The Kolata article describes Cheryl Weinstein, a healthy 64 year old with knee pain. Here's her story:

When she started looking up her symptoms on the Internet, she decided she probably had a meniscus tear. “I was very forceful in asking for an M.R.I.,” she said.

And when the scan showed that her meniscus was torn, she went to a surgeon expecting an operation.

He X-rayed her knee and told her she had arthritis. Then, Mrs. Weinstein said, the surgeon looked at her and said, “Let me get this straight. Are you here for a knee replacement?”

She said no, of course not. She skis, she does aerobics, she was nowhere near ready for something so drastic.

Then the surgeon told her that there was no point in repairing her meniscus because that was not her problem. And if he repaired the cartilage, her arthritic bones would just grind it down again.

For now, Mrs. Weinstein says she is finished with her medical odyssey.

Luckily the surgeon Mrs. Weinstein saw knew that cartilage tears are as common in people with arthritis of the knee who have no pain as they are for people with knee arthritis who do have pain. Otherwise she might have had an unnecessary operation. She would have risked complications for no potential upside gain. And all of those whose funds created the insurance pool that paid for the surgery would have wasted money.

The situation is much the same with herniated discs. Kolata reports on research demonstrating that routine scans for back pain do not improve outcomes. And the large number of "false positives" (scans interpreted as abnormal where the "abnormal" findings are not causing a problem) create psychological distress for the patients and may lead to unnecessary and potentially harmful tests and procedures.

MRI and CT are spectacular medical advances, but like everything in medicine they have potentially negative side effects. A substantial number of scans done in the U.S. should not be done. (Estimates vary, but all the estimates I've seen are more than 10%.) Unnecessary scans cause clinical and economic harm. Gina Kolata's article can be useful in public education - to help us better understand the limits of technology and the need to tolerate uncertainty.

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!

Shared Medical Appointments - a Clinical and Ethical Innovation

Yesterday's Boston Globe had a fascinating article about shared medical appointments at Harvard Vanguard Medical Associates (HVMA), the group I practiced with for 32 years before retiring from clinical practice last year.

As implemented at HVMA and the Cleveland Clinic, shared medical appointments are 90 minute visits with one's own physician along with perhaps 8 - 10 other patients (see here for HVMA and here for the Cleveland Clinic). In shared appointments physicians do what they would do in a typical 15 minute visit - listen to the patient's story, ask questions, do the necessary physical examination, order tests and prescribe medications. (The intimate components of the physical exam are done outside of the group.)

The literature about shared appointments emphasizes productivity gains, improvement in access, and patient and physician satisfaction with the format. But from historical research I did on an earlier version of the shared appointment and my own experience with a related format in psychiatry, I believe there is an ethical or even spiritual dimension as well.

In 1905 Dr. Joseph Hersey Pratt, then at the Massachusetts General Hospital and later at the New England Medical Center, began to hold what he called the "tuberculosis class" at the Emmanuel Church in Boston. Pratt thought of the class as an efficient way of encouraging patients to follow a rigidly defined regimen of out-of-doors rest, the only treatment for TB at the time. Patients were directed to spend day and night in tents erected on the roofs and balconies of Boston tenements. A "friendly visitor," the prototype of the medical social worker - made regular visits to the home to provide supervision and support, and to assist the family in making the needed practical arrangements. A subsidy provided by Dr. Elwood Worcester, rector of the Emmanuel Church, paid the salary of the friendly visitor and aided in purchasing tents, blankets and other necessities. Pratt ran the class for 18 years. His results with poor patients from Boston appeared to be similar to the results achieved at the best sanataria.

In 1975 I had the privilige of starting an outpatient program for patients with chronic mental illness at the Harvard Community Health Plan (which later became Harvard Vanguard Medical Associates). The medical literature suggested that group-based programs were as effective as individual appointments (see here), so with the same productivity rationale we established a "continuing care group." The group, staffed by a psychiatrist and a psychiatric nurse met weekly, with 5 - 20 patients attending. We met for 90 minutes and discussed medications, managing symptoms, and life.

The group format was indeed efficient. But over time I observed that for many of the patients, as well as for myself, it was more than that. A closeness and sense of shared humanity gradually emerged. It helped patients see themselves as people with illnesses, not as "schizophrenics" and "manic depressives." People were able to help and support each other. Although I had to work hard at the meetings I found the rich human exchange exhilarating and deeply rewarding. It was a thoroughly secular exchange, but I believe a cultural anthropologist would have seen the group as having many elements in common with religious settings.

When I went to the Harvard Vanguard website I saw that my own primary care physician is among those who are offering shared medical appointments. I'm happiest when I have no need to see a health professional, but when I do I look forward to experiencing the format from the patient's perspective!

(The Boston Globe article gives access to a short video clip of a shared medical appointment, with background comments by Dr. Gene Lindsey, who'se leading the shared appointment. I encourage readers to make a two minute investment to watch the video - it's very informative.)