Sunday, August 30, 2009

Hurricane Katrina Revisited...and Likely Consequences

If it is hurricane season, you can count on someone dredging up the story of Dr. Anna Pou and her nurse colleagues, who had been been accused of homicide for the deaths of some patients under their care during Hurricane Katrina. The New Orleans D.A. asked a grand jury to indict them; the grand jury declined. This year's second guessing begins with a disappointing ProPublica/New York Times joint exposé that really adds nothing enlightening to the debate and neglects important considerations.

In the aftermath of Katrina, these devoted healthcare workers stayed to care for their patients as best they could, despite searing temperatures and extreme humidity, lack of supplies, exhaustion, and considerable risk to themselves. As part of their care, they prioritized allocating their limited resources. “Triage” --this process of allocation-- is a long-standing practice in medical care, and will be more visible when we are faced with the next disaster or epidemic. The concept of triage, which has it's roots in battlefield medicine, in it's simplest form involves sorting patients into three groups – those who are likely to survive with no medical care, those that are unlikely to survive given the level of care available at the site, and those that likely will survive if treated at the site. The limited care that is available is then provided first to the group that is deemed most likely to benefit from it, and only when that group has been treated, is it provided to the others. Dr. Pou and her colleagues were faced with a situation that was, in many ways, similar to a battlefield situation, in that their resources were extremely limited, to the point where they couldn't save everyone. Thus it seems that the most sensible thing for them to have done was to focus their efforts on those who were likely to survive, and do whatever they could to make those who were unlikely to survive as comfortable as possible in their remaining hours.

There are unintended consequences of the homicide accusations that were not addressed by this article. For example, many patients currently receive inadequate pain medications because of physicians' concern about criminal liability and accusations against them of crossing the line between comfort care and euthanasia. My elderly mother was one such victim, and I am still haunted by her death last year. After a number of admissions over a period of a year during which time her quality of life continued to decline, she had elected to be removed from a ventilator, knowing that she would die. The hospital's ICU physician did not explain to her or me that they were going to insist on a “breathing trial” rather than sedating her with morphine or other drugs before they removed the breathing support. After their trial failed, as expected, they began to titrate morphine intended to “keep her comfortable.” When, after hours of watching her twitch while waiting at her bedside for her to die, I called the doctor in and asked him to increase the morphine as she appeared aware and uncomfortable to me, he refused, saying that he did not want the appearance of having hastened her death. What if someone audited her chart? This, even though mom was 95, had a living will, had granted me medical power of attorney, and had requested being removed from life support and allowed to die in peace. While I would argue that any physician's first duty is to his patient, this physician chose to put himself first and my mother second. His behavior, allowing my mother to experience unnecessary pain for a period of several hours as she lay dying, was despicable and inexcusable... yet sadly still somewhat understandable given the justified fear medical professionals have of being second-guessed by “reviewers” after the fact.

Another pressing concern is health care workers' potential response to future disasters. We are currently faced with the influenza season approaching and the continued concerns about a severe “swine flu” epidemic. I am an Infectious Diseases physician and likely will be working long, hard hours should an influenza epidemic occur. This week, I received an e-mail from my state's medical association asking me to register as a volunteer in case of a bioterrorism or natural disaster emergency. I reflexively signed up. After all, I was raised to help others, and chose to enter a “helping' profession. Now, reminded of the persecution of this fine physician and two nurses, I feel ambivalent.

Dr. Daniel Sokol discussed the ethics of healthcare workers “duty of care” in responding to virulent epidemics. While no clear conclusion can be made, I appreciate Dr. Sokol’s discussing the multiple roles that physicians have that may be in conflict. For while a doctor has an obligation to patients, they also have:
“a duty to care for their own children by protecting them (and hence themselves) from infection. So a further problem with the duty to care, aside from its vagueness, is that it fails to consider the holder of the duty as a multiple agent belonging to a broader community. Doctors and other medical professionals, in such situations, play several incompatible roles—health care worker, spouse, parent, for example—and they must deal with them as best they can. The limits of the duty of care are thus also defined by the strengths of competing "rights and duties.”

Add to that burden of responsibility the possibility of criminal prosecution for triaging patients and allocating the scarce resources that are likely to be available, be it medication or access to ventilators and ICU care, and you can anticipate the most likely outcome.

The irresponsible charges brought against Dr. Pou and her colleagues will have a chilling effect on other health care workers in the future, who will be loathe to respond to disasters. First, there is the risk of malpractice for caring for patients outside our specialties or beyond our experience. Now there is the risk of the destruction of one's reputation and career, not to mention crippling legal defense bills and even prison from attacks from Monday morning quarterbacks.

Enough of the attacks from the protection of the sidelines. Their attackers are, in effect, tying to impose 21st Century legal, moral and ethical obligations on a staff that was forced to operate for several days under 16th Century conditions. Dr. Pou and her nurse colleagues should be hailed for their heroism and devotion to their patients.

Given the conditions that are likely to exist during the next emergency, be it a natural disaster, an epidemic or an attack – limited or no power, lack of equipment and supplies, shortage of staff and no relief staff – would you want to stay and help? Who will be willing to risk his or her career and incur thousands upon thousands of dollars in legal fees defending herself? Who will care for you during the next disaster or epidemic?

Let us put this entire story into perspective by recalling that the true guilty parties in the Katrina debacle were the incompetent and irresponsible officials—most notably Bush and his “Heck-of-a-job, Brownie” FEMA head who failed to protect New Orleans and then further betrayed it's citizens with falsehoods – and not the healthcare workers who devotedly stayed and provided the best care they could under almost unimaginable conditions.

Saturday, August 29, 2009

Comparative Effectiveness Research-Rational Healthcare or Healthcare Rationing?

I've been reading about the comparative effectiveness research debate and found my understated quote of the week in the normally staid New England Journal: "Developers face few incentives to conduct active-comparator superiority trials and understand that they benefit from the unacknowledged deficiency of evidence. The development or marketing of me-too drugs and devices may provide a greater return on investment than research aimed at true clinical innovation."

For those who might not have been able to keep up, the focus on comparative effectiveness became more urgent, given soaring healthcare costs, enormous budget deficits, and the strained economy.

While traditional trials usually centered on establishing the efficacy of a drug or device compared to a placebo (a non-inferiority trial), the new focus is on comparing the effectiveness between available therapies. This research is a congressional mandate as part of the American Recovery and Reinvestment Act (ARRA) of 2009. The law provided that the Institute of Medicine (IOM) should make recommendations for national priorities for CER funding—which they did in remarkably short time.

Not surprisingly, the CER plan has come under attack by pharmaceutical companies, despite the assurance, for now, that the research will not be used to restrict physician prescribing choices based on cost-effectiveness data. Others are concerned that, rather than supporting rational healthcare decision-making, the CER initiative is the first step down the slippery slope towards healthcare rationing. An interesting proposal—intended to close the evidence gap and more directly benefit prescribers and consumers—is to have the FDA require comparative effectiveness labeling on their products, to make the benefits and risks of each product clearly evident.

While the two sides are not evenly matched, making the likely outcome predictable, barring an upset, it will be interesting to watch this debate evolve.