Saturday, April 26, 2008

How the U.S. Rations "Specialty Drugs"

A recent spate of articles (here, here, here, and here) on how the U.S. rations "specialty drugs" calls for more open discussion of the taboo topic of rationing.

The term "specialty drugs" is used to refer to products that are (a) very expensive, (b) typically have no less costly equivalents, (c) often biologicals, and (d) addressed to serious conditions like cancer, rheumatoid arthritis, and multiple sclerosis. The specialty drug sector is the fastest growing segment of national expenditure for pharmaceuticals.

Faced with costs that can go above $100,000 per year, many insurers have added a fourth tier in drug benefit plans. (For readers outside of the U.S. - Tier I is for generics, Tier II for preferred brand drugs, and Tier III for non-preferred brand drugs.) Typically Tiers I - III have escalating copayments, perhaps $10, $20, & $40-$50. For low income insurees, even a $10 copayment can create a significant financial barrier.

But Tier IV is another story. Insurers are increasingly charging a coinsurance (percentage of the actual cost) - up to 20% - 30%. This level of cost sharing can mean financial ruin for a family or simply no medication.

In other words - we are rationing these drugs by the patient's ability to pay.

Market rationing is an ideal system for optional purchases. Society owes no one a BMW or a high definition TV. It is ethically appropriate for us to make decisions about optional purchases in light of our own resources. It may be unfortunate if our desires are frustrated, but it is not unjust.

But market rationing of specialty drugs is simply wrong. Most people - correctly - are horrified by the idea of making access to life saving cancer drugs, or drugs that may stop the progress of a crippling form of rheumatoid arthritis, contingent on individual wealth in a country as wealthy as the United States. But that's just what we are doing.

In the presidential campaign we will soon be hearing excoriation of "bean-counting insurers" for rationing specialty drugs this way, as if insurers could simply print more money, or charge ever more to employers and individuals.

The question isn't whether we will ration - we do and will continue to do so - but whether we do it in a more or less ethical fashion.

Because national leaders typically prefer to avoid honest talk about health care and hard choices by taxing future generations through the federal debt, we have to look to the states as the most promising sources of rational health policy. States are required to balance their budgets. The opportunity cost of double digit health care cost escalation is most apparent at the state level.

Here are four of the key things we need to do:

1. Recognize that specialty drugs are only the latest bulge in health care costs, not a silo to be squeezed without looking at the health care sector in its entirety.

2. Educate ourselves, from the ground up, as through the blogosphere, and from the top down, as through state-level leadership, about the ethical imperative to ration health care. (As an example, see my recent posting about Oregon.)

3. Speak out against rationing by wealth as an unjust and un-American way of conducting the process.

4. Interpret the fact of our (hopefully temporary) decision to ration specialty drugs by wealth as a symptom of our not having developed a comprehensive, value-based approach to spending our health care dollars.

Specialty drugs represent the best and worst of the U.S. health care "system." At its best, the sector exemplifies applying cutting edge science to major human problems. At its worst, the sector exemplifies market forces run amok, with monopolistic price gouging and rationing life by wealth.

Saturday, April 19, 2008

Oregon Health Care Reform & the Ethical Imperative to Contain Costs

Oregon is in the health policy & ethics spotlight again.

In the 1990s the Oregon Health Plan (OHP), with its (a) prioritized list, (b) unique honesty about the fact that US health care was and always will be rationed, (c) determination to ration on the basis of clinical evidence, and (d) an ethically justifiable framework of values, received worldwide attention.

OHP reduced the uninsured from 18% in 1992 to 10.7% in 1996, but a stretch of bad economic times resulted in a rise back to 16% at the end of 2006. In this context Oregon has launched a new health care reform process, embodied in Senate Bill 329, passed last spring. Senate Bill 329 extends Oregon’s explicitness about the ethical imperative to control health care costs. The preamble states:

Whereas Oregonians cannot achieve the objective of health unless the state invests not only in health care, but also in education, economic opportunity, housing, sustainable environmental stewardship…and other areas that are important contributing factors to health; and Whereas the escalating cost of health care is compromising the ability to invest in those other areas that contribute to the health of the population…Oregon cannot achieve its objective of health unless Oregonians control costs in the health care system.

On April 10-11, 100 leaders from the Oregon ethics community gathered at the Kinsman Conference, in Medford, Oregon, together with leaders of the Oregon Health Fund Board, which spearheads the health care reform process. I was honored with the opportunity to kick off the conference with a keynote talk and to participate in other ways during two days of hard work.

The conference deliberations have been summarized in a White Paper that identifies the key values underlying health care reform and pinpoints the major areas where ethical controversy may arise. Among the many conclusions, these four stand out:

1. Unlike Massachusetts, which postponed confronting the cost of its health care reform process for the first two years, the Kinsman group concluded that Oregon's effort "must meet its obligation to operate within reasonable financial boundaries, thereby preserving state resources for other public services." Focusing on the individual access without stewardship of shared resources at the same time would be ethically myopic.

2. Because stewardship of funds is a fundamental ethical requirement, "equitable distribution of resources requires acceptance of a finite global budget for health care services." The Kinsman group endorsed the use of a "prioritized list, based on the relative cost-benefit of the service."

3. The Kinsman group urged the Oregon Health Fund Board to promote "a balance between interests of self and those of society" in the reform process. Social justice values protect disadvantaged individuals by insisting on universal access. Market justice values protect efficiency by demanding value for money. The group concluded that success and sustainable reform requires "a sustainable balance between social justice and market justice."

4. Perhaps most boldly, the Kinsman group argued that compassion for those in need will require a shift in medical culture. "Current technology-dominated medical care is rewarded far out of proportion to its ability to improve population health outcomes. An explicit transfer of resources from medical care to public health will be necessary to accomplish [the goal of enhanced population health]."

As I was musing about how to end this posting, Leonard Cohen's haunting song - "Everybody Knows" - kept playing in my mind. I thought about the lyrics to see what the song was telling me:

"Everybody knows that the dice are loaded
Everybody rolls with their fingers crossed
Everybody knows that the war is over
Everybody knows the good guys lost
Everybody knows the fight was fixed
The poor stay poor, the rich get rich
That's how it goes
Everybody knows...
"

Everybody (almost) who thinks about the US health care "system" knows it is fatally broken. Oregon, more than any other state, has had the guts to say it like it is and take bold action in the health sector, as with the Oregon Health Plan prioritized list and the Death with Dignity Act. The Oregon Health Fund Board is on a tight schedule - its proposals to the Governor and Legislature are due in October/November. Let's hope that Oregon can act with the same boldness and moral clarity in 2008 that it applied in the 1990s. I'll be following its health care reform process through the eyes of the friends I made at the Kinsman Conference, and will have more to say about it in the months to come.

Tuesday, April 15, 2008

Ethics, Pharma, and the Blogosphere

An article in today's New York Times - "Citing Ethics, Some Doctors Reject Industry Pay" - will warm the heart of bloggers, present company included. Here is the key passage (I have added the emphasis):

Dr. Peter Libby, chief of cardiovascular medicine at Harvard’s Brigham and Women’s Hospital, said that when he first began receiving offers from drug companies, in the early 1980s, they seemed like a natural reflection of his burgeoning reputation.

“When you start emerging as an opinion leader or as a researcher who has knowledge and expertise, the pharmaceutical industry takes an interest in either having you consult to help them with their research or to speak,” he said.
Dr. Libby wanted to assist. Like many scientists, he feels that it is important for researchers to consult with drug companies to help develop therapies and set up studies. He never owned stock in companies that he consulted for. He always disclosed the fact that he consulted and spoke for companies. And, he added, he thought that he was protected from accusations of favoring any particular company’s products because he consulted for so many.

“I lived safely in that comfort zone for many years,” Dr. Libby said.

Then he was hit with a moment of truth. He had spent four years working without pay to help create a public television series, “The Mysterious Human Heart.” The project was, he thought, a worthy effort to educate the public about what heart disease was and how to prevent it. He was proud and pleased when the series was broadcast in October.

But to his dismay, bloggers immediately attacked him and the other medical experts who appeared on the programs for having consulted for manufacturers of pharmaceuticals and medical devices, Dr. Libby said, adding: “They said we were biased. What I thought was four years of public service was impugned.

“That was a wake-up call for me. I was singed in the blogosphere.”


This year, he made his decision. He would continue speaking at forums sponsored by the pharmaceutical industry and would continue consulting for companies. But he would no longer accept payment.


I assume that Dr. Libby was troubled by postings on thoughtful, "evidence based" blogs that he respected, not by cranks. Given that assumption, the blogosphere appears to have been providing the crucial public function of "mirror, mirror, on the wall."

Dr. Libby's program may not have been influenced at all by the industry associations of its participants. When a judge has lunch with a gangster they may be discussing how best to support Mother Theresa's charity, but when a photo of the lunch is published the judge has to resign. Judges are worthless if we can't trust them. Just so with physicians and researchers.

Pharmaceutical companies are not gangsters (excepting a few), but we know that even small gifts can skew opinions. Dr. Libby made the right decision.

Bloggers - keep at it!

Sunday, April 13, 2008

The Oregon Death with Dignity Act - Democratic Deliberation Works!

The purpose of my recent trip to Oregon was to speak about the lessons Massachusetts health care reform might have for Oregon’s health care reform process, but I also used my time to explore the current state of the Death with Dignity Act (DWDA).

As most readers know, Oregon is the only state that has legalized physician assisted suicide (the state doesn’t use that term – it sees the Death with Dignity process as part of end of life care, not as suicide). In 1994, a closely contested ballot initiative (51% to 49%) established the DWDA. Its implementation was delayed by a legal injunction, but after the Supreme Court denied a petition, the Ninth Circuit Court lifted the injunction on October 27, 1997. In November 1997 a measure asking for repeal of the DWDA was put to a vote. This time voters endorsed the DWDA by 60% to 40%. As of my visit, the law had been in effect for 10½ years.

Although support for the DWDA continued strong in Oregon, the Bush administration tried to kill it. Attorneys General Ashcroft and Gonzalez argued that the Controlled Substances Act prohibited prescription of barbiturates (the medication that physicians have prescribed) for use by patients to end their lives. The Attorneys General appealed all the way to the Supreme Court. On January 17, 2006 the Supreme Court ruled (6-3) in favor of Oregon.

The DWDA allows terminally ill Oregonians to end their lives through voluntary self-administration of lethal medications prescribed by physicians for that purpose. Patients must be Oregon residents, at least 18 years old, capable of making an informed choice, and diagnosed with a terminal illness expected to lead to death within six months. The patient must make two oral requests, separated by at least 15 days. The attending physician and a consultant must confirm the patient’s diagnosis, prognosis, and capacity for making an informed choice. If either physician believes the patient’s judgment may be impaired by psychological factors (such as depression) the patient must be referred for consultation. The attending physician must inform the patient about alternatives to the DWDA, including pain control, comfort care, and hospice. Physicians must report all prescriptions under the DWDA to the Department of Human Services. Oregon tracks prescriptions and deaths, and reports trends a public website.

From the inception of the DWDA until the end of 2007, 341 patients have died through use of the lethal medication (15.6 DWDA deaths per 10,000 deaths). Approximately 1/3 of the prescriptions are not used. The commonest rationale patients give for exercising the DWDA is the loss of autonomy from the illness (100%), loss of capacity to participate in the activities they care about (86%), and loss of dignity (86%). 30% fear that pain control will be inadequate.

I interviewed 20 people during my visit, including two of my favorite informants – taxi drivers. The unanimous view was that even though many do not agree with the DWDA, Oregon is at peace with the law. There is virtually no public controversy. The population appreciates having the choice the law provides, but doesn’t use it much.

Most importantly – the vigorous debate at the time of the two referenda led the contending parties to recognize their agreement that end of life care should be as available, patient-centered, and compassionate as possible. Oregon has made great strides in pain control, hospice availability and home care. Here is how USA Today contrasted end of life in Miami compared to Portland:

If you are dying in Miami, the last six months of your life might well look like this: You'll see doctors, mostly specialists, 46 times; spend more than six days in an intensive care unit and stand a 27% chance of dying in a hospital ICU. The tab for your doctor and hospital care will run just over $23,000.

But spend those last six months in Portland, Ore., and you'll go to the doctor 18 times, half of those visits with your primary care doctor, spend one day in intensive care and stand a 13% chance of dying in an ICU. You'll likely die at home, with the support of a hospice program. Total tab: slightly more than $14,000.


The central lesson I draw from my interviews and reading is that for the DWDA, democratic deliberation is working. Everyone I spoke to who was in Oregon during the time of the referenda emphasized the robustness and depth of the public debate. A wide swath of the Oregon public thought deeply about the issue of physician assisted suicide and discussed the topic with family and friends. The DWDA can be seen as the product of extensive deliberation and two public votes. The public has educated itself through the deliberative process and given marching orders to the state government through its votes. The state has taken a continuous quality improvement approach to the DWDA, as through the POLST program (Physicians Orders for Life Sustaining Treatment) that is spearheaded by the Oregon Health Sciences University Ethics Center.

The DWDA process shows democracy at its best. Whether or not other states follow Oregon's lead with regard to the DWDA itself - and I hope that in the next decade some do - they will profit from applying Oregon's educative approach to controversial issues in their own health systems.

Sunday, April 6, 2008

On the Oregon Trail

I will be in Oregon from April 7-->April 12. On Tuesday I will speak at Oregon Health Sciences University about "The Psychology and Ethics of Health Care Cost Containment: Health Care Reform in Massachusetts and Oregon." On Thursday and Friday I will be at a statewide ethics conference in Medford, focused on health care reform. On Thursday I will try to connect the argument of Setting Limits Fairly: Learning to Share Resources for Health (second edition), written with Norman Daniels, to what the folks in Oregon are trying to do. On Friday I will try to distill some lessons for Oregon from the Massachusetts experience with health care reform.

Cost containment is the major issue for both states, and for the entire U.S. I'm not at all confident about how Massachusetts is approaching costs, any more than I am about any of the presidential candidates. I expect to learn more about Oregon's plans during my stay.

If possible, I will do some postings while in Oregon, but if that doesn't work out, I'll be back online on April 14.

Friday, April 4, 2008

Withdrawing Life-Sustaining Treatment - a Case from Colorado

Yesterday's session in the first year Harvard Medical School "Medical Ethics and Professionalism" class was exceptionally powerful. The (required) course is taught in seminar, but yesterday was a plenary session, the second of two classes focused on end-of-life care. Dr. Rick Martinez, Director of Psychiatric Emergency and Forensic Services at Denver Health, the largest safety net program in Colorado, told the class about Mr. David Drummond, and showed a video of Mr. Drummond speaking. (This is his real name - Mr. Drummond's wish, supported by his family, was to be a teacher after his death. He asked Dr. Martinez to share his full story, including his name and details of his life.)

On May 3, 2007, David Drummond, who had been homeless for three years, fell off a wall while drunk and high on crack. He sustained a high cervical fracture and spinal cord injury, leaving him quadriplegic and ventilator dependent. As soon as he was able to communicate he requested that the ventilator be removed and that he be allowed to die. Dr. Martinez was called as a consultant to assess Mr. Drummond's competence to make a decision that Colorado and federal law clearly allowed him to make, assuming decisional capacity. He orchestrated a series of meetings - with Mr. Drummond alone, with Mr. Drummond and his family, with Mr. Drummond and his pastor, and, most remarkable, with Mr. Drummond and the entire clinical team, including hospital administrators.

The conclusion was that Mr. Drummond clearly understood his condition, the recommendations for rehabilitation, and the fact that most people with spinal cord injuries, including quadriplegia, ultimately adapt and experience a better quality of life than they predict for themselves shortly after the accident. He consistently expressed the wish for his life to end, emphasizing that being physically active was a central component of who he was as a person. Interestingly, once he was told that the decision about continuing or withdrawing the ventilator was in his hands he briefly asked "is my life's work done?" But once he had effected some reconciliations within his family he said he was ready. His family and pastor supported his decision. On September 24, surrounded by people who loved him, the ventilator was turned off, and he died.

I am writing about the class in this blog about organizational/health system ethics because of the way David Drummond, supported by Dr. Martinez, turned a personal tragedy into an opportunity for societal learning. The staff meetings at Denver Health - with more than 25 people (including Mr. Drummond) participating, were remarkable examples of collaborative deliberation. Organizations tend to fall into silos. Silos see issues from their own narrow perspective. The meetings Dr. Martinez orchestrated brought the partial perspectives of the multiple silos into thoughtful, deliberative exchange, leading to a decision that Mr. Drummond, his family, and most of the caretakers, felt at peace with. And, even those who saw the situation differently agreed that all points of view had been listened to respectfully.

The students focused on what it meant that if Mr. Drummond continued with the rehabilitation process, an imagined future self might look back and say "I sounded as if I knew what I was talking about then, but I wasn't ready or able to see what my life's mission turned out to be." Did that mean that the decision he made was not "autonomous," that it was not his "true self" speaking? The predominant view was that the possibility that a future self might disagree with the present self did not mean that the decision was not competent (autonomous).

Like the staff sessions at Denver Health, the Harvard Medical School class was very deliberative. Mr. Drummond's wish to be a teacher is being realized. In the videotape, when he was asked if he had any final advice to give, he thought for a moment, smiled, and said "remember to eat lots of ice cream and cookies."

Wednesday, April 2, 2008

The Organizational Costs of Ethical Conflicts

Everyone who writes knows the feeling – “I wish I had written that!” That was my reaction to “The Organizational Costs of Ethical Conflicts,” by Nelson, Weeks and Campfield in the January/February issue of the Journal of Healthcare Management.

Nelson and his colleagues present vignettes illustrating common ethical problems - end-of-life decisions, conflicts of interest (as about a preferential nursing home admission), and truth telling after an adverse event. The distinctive aspect of the article is that the analysis is managerial, not "philosophical."

The authors delineate three areas of organizational function for which the ethical conflicts created new costs. The cost implications are remarkably broad:

Operating costs include staff time spent dealing with the ethical issue, opportunity costs of the diverted time, and - perhaps most important - potential for decreased staff morale from chronic or recurrent ethical conflict, leading to burnout and even increased turnover.

Legal costs include risk management staff time, legal fees, and the potential for litigation, settlement costs, and even long term increase in malpractice premiums.

Public relations costs include staff time dealing with adverse publicity, the cost of rebuilding a damaged public image, and the potential for loss of referrals and political/philanthropic support.

Nelson and his colleagues recommend the health organizations move from what is typically a "reactive" approach to ethics - consultation after an ethical problem has hit the fan - to a "proactive" stance. This would involve two main strategies. First, after an ethics committee or ethics consultant responds to a conflict, a process of root cause analysis should be conducted, to determine what could be done to prevent similar problems in the future. Second, organizations should proactively identify areas of likely ethical conflict so that policy development, skill training, and guideline dissemination can be conducted in advance.

I have seen first hand how on target Nelson and his colleagues are. In 2000, Harvard Pilgrim Health Care, a not-for-profit health insurer that has been rated top in the nation for the past three years, got into financial diffuculties, and was briefly put into receivership by the Massachusetts Attorney General. At a meeting of the Harvard Pilgrim Ethics Advisory Group, a body that includes purchasers, physicians from the network, consumers, and public leaders, as well as Harvard Pilgrim staff, a public official stated - "you have to get back to being an effective insurance company...but if that's all you are you aren't worth saving...what makes you special is your commitment to activities like this!"

Nelson and his colleagues teach us that ethics activities aren't just a goody two-shoes, politically correct pursuit. Ethics is properly seen as part of quality improvement, patient safety and strategic management as well.