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 (3) - Brinksmanship with Human Lives

Grady Hospital has done the right thing, as I predicted it would in a post last week (here):

Clearly, a safety net provider is accountable for using the funds it receives in the most efficient manner possible. But we the public can't be allowed to turf our moral accountability to the Gradys of the world. We the public created safety net providers to care for the underserved, not to take on the burden of our sins in the manner of Jesus. I believe Grady is right to provoke a crisis over dialysis services. If some of its patients are still in limbo on January 3, Grady can't simply set them loose. It will have to continue to provide for them. But it should keep pointing the finger at its funding sources, with the message that Winston Churchill gave in World War II - "Give us the tools, and we will [do] the job," along with this corollary message - "If you choose not to give us the tools, acknowledge that you are the killers, and take responsibility for your decisions!

In his ongoing series detailing the human meaning of the Grady saga, Kevin Sack of the New York Times tells us that Grady has extended dialysis coverage for another month for 50 uninsured patients, mostly undocumented immigrants, for another month "to help give patients more time to make long-term arrangements," according to Matt Gove, who has the thankless job of speaking for Grady.

Grady is still hoping that the patients will take an active role in figuring out what to do. According to Gove “it should be clear to the patients that there’s a responsibility on their side to continue trying to find a long-term plan because at some point this care won’t be available.”

Many of the patients from Latin American countries refuse to return, since they believe - correctly - that access to dialysis of comparable quality will not be there for them. For some, the explicit plan is to go to an emergency room - quite possibly at Grady - whenever funding for dialysis at Fresenius, the private vendor Grady has contracted with, ends.

No one is suggesting that Fresenius will have any obligation when Grady stops paying. That's the difference between being a safety net provider and a private enterprise.

There are three main ways to approach the problem:

1. Send the undocumented patients back to their country of origin, let them fend for themselves with whatever help the country provides, and hope for the best. (Given the national anti-undocumented attitudes, there will be a lot of support for this option. The ethical rationale for this position is that each country is a fully separate entity responsible for its citizens. Radically different standards of health care are unfortunate, but that's the way it is. Who said life on the planet is fair?)
   
   
2. Leave Grady with the problem, which is what's happening right now. (Mother Theresa and her Missionaries of Charity could care for the dying in Calcutta as long as they had nuns who volunteered to do the work and a space in which to do it. Grady's situation is different. Dialysis was costing it $50,000 per patient per year. In its finite budget Grady has to choose which needs to serve. It can't meet them all.
   
   From an ethical perspective, this is the least justifiable alternative. Grady is a public institution, funded by a combination of county, state, and federal funds. We can't make Grady responsible for the choices we force onto it by our budgetary decisions.)
   
   
3. Address the situation internationally as part of global public health. (This won't be easy, but it's the right way to go. If our national policy is to send the undocumented patients back to their country of origin, we should work with those countries to solve the immediate needs of the individuals, but more importantly, to improve health and economic standards overall. If we continue to pretend that nation-states are self-contained islands, we'll just have more and more Grady-like crises. Sadly, this is what we're likely to do for the forseeable future.)

The U.S. created its end-stage-renal-disease program under Medicare when patients on dialysis were brought to Congress to be seen as individuals. That's what Kevin Sack is doing through his series of stories. (He's my candidate for the next round of Pulitzers!) There's no sign yet that we the public, through the higher levels of government, are paying attention. Perhaps that will happen when the one-month extension Grady has created, or the one after that, comes due.

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.

A Remarkable Health Initiative at the University of New Hampshire

Watching the federal health reform process has strengthened my conviction that the changes our health system needs will have to come from the bottom up, not the top down, and that employers play a key role.

Here's how I put this idea a month ago in a post about employer incentives:

Federal health reform is the front page news, but states and businesses are the laboratories for change. Next to Governors, who have to deal with hideous budget problems driven by declining revenues and escalating Medicaid costs, employers who offer health insurance to their employees are most directly concerned about health care costs.

Health reform requires three ingredients: (1) facing facts, (2) thinking strategically and (3) embracing individual and population concerns. Given the virulent divisiveness of current U.S. politics, employers who offer health insurance are the most promising venue for applying this triad in a "businesslike" manner!

Employer insurance covers approximately 160 million of the non-elderly U.S. population. Because the business world is way ahead of health care in its zeal for (a) casing the environment for good ideas ("benchmarking") and (b) adopting those that work well elsewhere, (c) promising innovations have the potential for rapid diffusion.

I recently came upon the website for Healthy UNH, a remarkable program launched this fall at the University of New Hampshire. The scope of the program is breathtaking, as evidenced by this statement of vision and goals:

Vision: UNH will be the healthiest campus community in the country by 2020.

Values:

1. Transforming health care delivery
2. Creating value for the money we invest in medical care
3. Ensuring that the care we purchase is the right care at the right time
4. Following medical care practices that are evidence-based
5. Improving the health of our entire community, spanning multiple locations and audiences
6. Sustaining health and health care
7. Collaborating across our community
8. Engaging and educating our community
9. Advancing mental and physical well-being
10. Promoting work/life balance

The website includes action plans for changing the way care is delivered to the UNH community, educating the community about what's driving the cost trend, encouraging the use of evidence-based cost effective care, and increasing wellness-promoting behaviors. It's a comprehensive program about enhancing the bang for the bucks the University invests in health insurance (for approximately 2,800 faculty and staff) and improving the health of the entire community, which includes 15,000 students.

It's too early to know what the Healthy UNH program will accomplish. But the way the program is conceptualized can show other employers how worksites can become a force for health literacy, promotion of wellness, and delivery system change.

Over time, as more employers take a holistic approach to promoting health, reforming health care delivery, and getting a grip on runaway costs, state and federal legislators will get the message. Our leaders will lead us better when the front lines show them what needs to be done and how to do it!

(Additional posts about worksite initiatives are available via the "Employer Insurance Ethics" tab. See also a New England Journal of Medicine article - "The Employer as Health Coach.")

Tragic Choices at Grady Hospital

On October 3, Grady Hospital in Atlanta closed its dialysis clinic. Grady committed itself to cover the cost of dialysis for three months for any of the 96 patients under its care who did not have an alternative source of dialysis. The three month extension is up on January 3. An undetermined number of patients - possibly as many as 50 - do not yet have a settled plan for continued treatment.

Grady has been serving the poor in Atlanta since 1892. A quarter of Georgia’s physicians have had at least part of their training at Grady. The hospital has 953 beds. The Grady Health System, which includes nine neighborhood health centers, does 921,000 outpatient visits per year, but has been in dire financial straits for many years.

In 2007, in the context of massive financial losses, the board voted to turn Grady over to an independent 501(c)(3) corporation, hoping that a more business-like board could bring managerial discipline to the hospital and make tough decisions the more political board was not willing to make.

This past summer the board showed it could make tough decisions when it voted to close the dialysis clinic, which was losing $2.5 million each year.

The dialysis clinic is a prototypic safety net program. 35% of the patients are undocumented and uninsured. Another 30% are documented but uninsured. 8% are prisoners. The facility itself is old, with outmoded equipment.

In a September ruling as to whether Grady should be allowed to close the clinic, Judge Ural Glanville of the Fulton County Superior Court recognized the severity of the trade off between Grady's stability and the importance of the clinic to the patients it served:

"Indeed, no value can be placed on human life. Nevertheless, when contemplating the use of injunctive authority, the court is required to balance relative equities, even in cases involving issues of life and death. If the court were to require [Grady] to maintain...the services forming the basis of the complaint, it would likely result in an adverse effect on the services offered to other individuals and the public at-large."

A group of plaintiff's brought a class action suit to block the January 3 funding cutoff, but on December 15 the suit was dismissed.

Predictably, Grady is being vilified as an uncaring killer. When confronted by a City Council member the chair of the Grady board responded by accusing the Council of grandstanding - demanding that the clinic be continued without providing funds to do it. I think this was a useful confrontation.

Uninsured patients, most notably immigrants, and especially undocumented immigrants, are caught in the middle of a life-and-death form of the game of "hot potato." Grady Hospital, as a safety net provider, inevitably loses, since its mission is to care for those who have nowhere else to go. When the public, through its government, stints on funding, safety net programs like Grady are left holding human lives in their care. What is a safety net provider to do if the funds allocated to it by the public don't allow it to meet the needs of its patients?

Clearly, a safety net provider is accountable for using the funds it receives in the most efficient manner possible. But we the public can't be allowed to turf our moral accountability to the Gradys of the world. We the public created safety net providers to care for the underserved, not to take on the burden of our sins in the manner of Jesus. I believe Grady is right to provoke a crisis over dialysis services. If some of its patients are still in limbo on January 3, Grady can't simply set them loose. It will have to continue to provide for them. But it should keep pointing the finger at its funding sources, with the message that Winston Churchill gave in World War II - "Give us the tools, and we will [do] the job," along with this corollary message - "If you choose not to give us the tools, acknowledge that you are the killers, and take responsibility for your decisions!"

(For a previous post on Grady Hospital, see here.)

The Ethics of Virtual Medical Visits

OptumHealth, a division of UnitedHealthGroup, will soon be offering a web-based platform for connecting patients and doctors by video. When the largest health insurer enters the E-visit space we know a change is coming. The Optum program will roll out in Texas in 2010.

I think virtual visits are a great step forward. But I'm chastened by this critique in the article about Optum:

"This is a pale imitation of a doctor visit. It’s basically saying, ‘We’re going to give up any pretense of examining the patient and most of the nonverbal clues that doctors use.'"

If the quote were anonymous I might have dismissed it as fuddy-duddyism. But it's from Dr. David Himmelstein, a friend, a superb primary care physician, a brilliant policy researcher, and co-founder of Physicians for a National Health Program (PNHP - the single payer advocacy group) - the opposite of a fuddy-duddy!

Experience with E-care is just beginning to emerge. In January, the Hawaii Medical Service Association (HMSA - Hawaii's Blue Cross Blue Shield) began offering 24/7 access via telephone and the web to physicians in its network who sign up to provide the service. Hawaii is a natural place to start, since for a number of patients, seeing a doctor in person would require flying to another island. If I were a primary care physician in Hawaii, I'd sign up to do it!

The infrastructure is provided by American Well, a Boston-based company that provides secure infrastructure for web visits, automated billing, and care coordination. The technologies involved aren't new, but packaging them to create tools easy for patients and clinicians to use is a valuable step forward.

I write about Optum and American Well on an ethics site becuse the fundamental step of trying to meet "constructive," "health promoting" patient preferences evinces an ethical focus on patient and public values. Even in my dark ages psychiatry practice I had patients who were VERY grateful for the opportunity to use email to monitor and manage the medications we were using, or to use email to discuss issues we had initially opened up in the office. And when email served my patients' needs it was a win/win tool, since I could access it from home at times that were convenient for me as well.

David Himmelstein is absolutely correct in noting the ways in which E-visits fall short of what an expert physician can transact in the office. But there is a segment of the public that places more value on convenience and timeliness than on a high quality in-person relationship. I have less of a sense of the pros and cons of E-visits for this segment, but it's an experiment worth conducting, on the hypothesis that E-access is better than no access!

(More information on the HMSA program is available from a Fortune article here and a Business Week article here.

Medical Culture and Costs at UCLA

An article about the cost of end-of-life care in this morning's New York Times focuses on the Ronald Reagan UCLA Medical Center. UCLA has a national reputation for high quality/high tech care, but also for high costs. According to the Dartmouth studies, Medicare pays UCLA $50,000 during the last 6 months of a patient's life compared to $25,000 at the Mayo Clinic.

The article quoted CEO David Feinberg as saying “If you come into this hospital, we’re not going to let you die”!

I have memories that shed light on the story.

From July 1964 to June 1965 I was a medical intern at UCLA, before returning to Boston to train in psychiatry. I don't remember any limits being set on the tests we ordered until the chief resident came to us in the spring to say "folks, we're running out of money for tests, so cut back where you can." He was apologetic for having to cramp our style. The question of when tests were medically important to do, when they were wasteful, and when the risk of false positive results or otherwise misleading findings was so great that doing the test would be, in medical jargon, "contraindicated," was never discussed. UCLA was probably not unusual in that era, but in retrospect it seems that a cost-unconscious ethos was already part of the culture.

The article in the Times also discussed UCLA's ethic of doing everything possible for patients - sometimes with extraordinarily beneficial results. I experienced this in a very positive way as an intern. During one of my ward rotations a young professor was admitted for a heart attack. He was stable, but the physician in charge had me sleep in the same room with him as an additional element of safety. My skills at cardiology were, to put it politely, "developing" at best. But the message of concern and caution embodied in my assignment made a strong impression on me. (I was also aware of the absence of equity - we didn't have interns sleeping in the rooms of our other heart attack patients.)

Dr. Feinberg, the CEO, is a child psychiatrist. Prior to becoming CEO of the UCLA hospitals he was medical director for the Neuropsychiatric Hospital there. Psychiatry has always been subject to limits in ways the rest of medicine hasn't. In addition to his medical training, Dr. Feinberg has an MBA. I trust that his comment about how UCLA is "not going to let you die" is a wry way of tweaking a culture that has been overly technology-driven and underattentive to the ethics of medical costs.

(See here for a profile of Dr. Feinberg, here for the New York Times story, and here for "Caring about patients and caring about money: the American Psychiatric Association code of ethics meets managed care," a paper I wrote in 1994.)

Patient Safety, Ethics, and Psychiatry

This fall I was asked to discuss a case for the Agency for Healthcare Research and Quality Mortality and Morbidity Rounds - a web-based patient safety education site.

At first I thought they were writing to the wrong Dr. Sabin. Patient safety isn't an area of my expertise. But the case they asked me to discuss had major issues of ethics and psychiatry that arose in the care of a homeless man with a history of IV drug use, admitted to a hospital with a methicillin-resistant Staphylococcus aureus (MRSA) abscess near the spine. The patient left the hospital against medical advice (AMA) with bad aftereffects.

I won't recapitulate the case and my discussion here. The moral of the story in the case I discussed was that homeless IV drug users are more "foreign" to most hospital staff than patients from "foreign" countries. Caring for people who we may see as "other" calls for distinctive cultural competence skills. When an institution lacks those skills safety is jeopardized. Ethics and psychiatric consultation can often be helpful.

(I read a number of cases on the website and found them uniformly engaging and informative. The AHRQ site is well worth visiting.)