Most notable legal developments in bioethics
Most notable legal developments in bioethics
Focus was on previous year
At this year's annual conference of the American Society of Bioethics and Humanities, held in October in Washington, DC, one of the new discussions was on the top legal developments in bioethics in 2009.
The panel discussion was conceived and organized by Thaddeus M. Pope, JD, PhD, of Widener University School of Law in Wilmington, DE.
Following are some of the topics discussed, and the panelists who presented their views:
Advance care directives:
Lois Shepherd, JD, associate professor of public health sciences and professor of law at the University of Virginia, discussed the trends in advance care planning.
While some states are putting their effort toward having citizens complete advance care directives, that is only one direction, which Shepherd believes is "continuing an older model."
"There might be some value in that, but the newer recognition is that we need to have continual conversations, consultations, and these really shouldn't be done in lawyers' offices; they should be done with a doctor's help," Shepherd tells Medical Ethics Advisor.
One reason she selected this particular topic for one of the top legal developments in bioethics is the fact that advance care planning (i.e., planning for how one will handle one's medical care if that person becomes debilitated or it is clear a long-term illness is terminal) got pegged with the tagline of "death panels" in this year's health care reform debate.
At the conference, Shepherd discussed a bill set forth by the House of Representatives during the summer, and although it didn't continue through the legislative process, Shepherd thinks the idea of planning for one's death — and having such conversations reimbursed for physicians to incent them to conduct them — gained traction.
The bill that was presented this summer would have reimbursed for advance care planning conversations every five years, or when there was a change in condition, or admission to a facility, she says.
"But it was misunderstood and politically exploited, and so that's out," she says. "But I think we will see that the idea is not over."
The idea is pertinent for those 65 and older, when planning really becomes imperative.
"So, it becomes [a situation where] a physician can talk about, 'Look, here's the prognosis, and here's the kind of choices that are going to have to be made in the future. Where are you particularly?' Not an abstract diagnosis, but where is this patient?" Shepherd notes.
Shepherd calls the heated debate that occurred surrounding this bill — with the implication that doctors just wanted to hurry up and pull the plug on very ill patients — "so overblown and wrong."
Access to investigational drugs
Shepherd also discussed the relatively new development of patients or parents or surrogates suing pharmaceutical companies to gain access to investigational drugs.
There was a case two years ago, where a nonprofit filed a lawsuit against the FDA, "saying that there was a constitutional right to save one's own life by getting access to Phase I drugs" for terminally ill patients, says Shepherd.
However, the Third Circuit Court said there was no such constitutional right.
This lawsuit was intended to gain access for an individual who is terminally ill and has no other available therapies, "except maybe a chance at a clinical trial, and for some reason they can't qualify for the clinical trial," says Shepherd.
A recent case centered around a University of Virginia student suffering from head and neck cancer, whose mother sued a pharmaceutical company. In the suit, she charged that a particular drug company had promised access to an investigational drug for her child.
"This case was decided last December [whereby] the trial judge had ordered this pharmaceutical company to give this boy an investigational or experimental drug. And then in December, the appeals court reversed it," Shepherd says.
"But it's interesting to me that even though that case did not end up winning, ultimately, with the right facts, you can make a compelling case to the manufacturer to supply drugs, if a promise has been made, for example," she says.
Free speech and physician prescribing habits
Erin Egan, MD, JD, at the University of Colorado in Denver, says she chose this topic, because each is a critical issue and also a hot topic.
Free speech, she says, is always going to garner attention politically.
"Anytime you're going to restrict free speech, people tend to feel very strongly about it," Egan notes. "And then the issue of pharmaceutical company-provider interactions is really relevant right now in medicine, because there's been a lot of push recently to limit those interactions, or redefine those interactions, to characterize those interactions far more strongly as ethical conflicts of interest."
Two of the organizations leading this effort to eliminate contact between pharmas and providers is the American Medical Student Association and the National Physicians Alliance.
"They have [both] really pushed the point that there should be no pharmaceutical rep-physician interaction," Egan tells MEA.
Such activities, she says, are "obviously designed to influence physician behavior, and companies wouldn't continue to spend the money on it if it didn't influence physicians. So, most major academic centers have actually stopped allowing any pharmaceutical company representatives to come to the school — and have even forbidden" gifts such as pens and notepads.
"The AMA [American Medical Association] has, in my mind, been disappointing in their unwillingness to take a stand on this. Instead of saying this is entirely prohibited, including sponsoring educational programs, they've been, I think, really reluctant to do that," Egan says.
Asked why she thinks this is the case, Egan responds, "Because I think that the older physicians have always done this, and I think they just don't see it as a conflict.
"I think part of that is just human psychology — if they acknowledge that it's a conflict, they've been engaging in conflicted behavior for a long period of time. But I really don't think that's the issue. I think that they're just so used to this that they really think that it's insignificant," Egan says.
H1N1 flu and disaster planning ethics issues
Egan also spoke on the topic of mandatory vaccines as it relates to H1N1 flu and disaster ethics issues. She notes that mandatory vaccines were pushed most recently in the early part of this century — and primarily toward the immigrant population.
"I would say we've seen an increase in people's unwillingness to get vaccines," Egan notes. "If you look at the childhood vaccines, they're all designed to prevent illnesses that kill kids, and yet you see parents saying that they're not willing to accept the small risk to their children of an adverse event from a vaccine. And then, theoretically, at least, [they are] perpetuating the active viruses and putting other children at risk for their refusal.
"And we've allowed that refusal, because we haven't seen a major epidemic," she says.
She notes that while the U.S. has had "episodes" of both pertussis and measles, they've never been widespread or become epidemics.
"Every time they've happened, we've talked about how preventable these things could be with vaccination, but we're never talking about a large amount of children," she says.
"Then, you come up with the idea that there's this precedence that people don't have to participate in public health, and that it's something that's entirely optional," she says. "An example of that would be [when] they came out with a recommendation not so long ago that health care workers get the smallpox vaccine, but it was optional. And almost no providers did that."
It was a "low-tension issue," simply because there was not actual smallpox present.
Since the Karen Ann Quinlan case, she says, "our current legal precedent sets a very strong precedent that people can refuse medical treatment that they don't want."
"While those things are in conflict, we've never really had to deal up-front with the conflict that that exemplifies," she says. "And when we do, you know, when we come to this point where we have to tell people they have to be vaccinated . . . that's going to be a major conflict, and I'm not sure how we're going to negotiate that."
Parental non-consent to medical treatment
Mary Anderlik Majumder, JD, PhD, an assistant professor of medicine with the Center for Medical Ethics and Health Policy at Baylor College of Medicine in Houston, says that the committee decided on this topic as one of the top developments, "because there has been just another slew of cases that have made it into the national media."
For example, there was the case of Daniel Hauser in Minnesota this summer, a 13-year-old boy with Hodgkins lymphoma, whose mother took him on the run rather than consent to continuing medical treatment, even though the treatment was working.
It was, she says, "pretty clear that the judge had authority to order treatment," and the really difficult decision that he had to make was to continue the boy in the custody of his parents after his mother took him on the run. Ultimately, the judge decided to leave him in the parents' care, and he received appropriate treatment for his illness.
The background to that is complex, however, Majumder notes, and it sometimes creates confusion.
In 1974, the Department of Health and Human Services regulated that states that received federal money for child protection services came with the requirement that the states that received money had to have a religious exemption in their law.
"So, you couldn't go after parents for neglect if they were not treating their child medically for religious reasons," she says.
Still, that didn't prevent the court from ordering medical services if a child needed it — you just couldn't charge the parents with neglect, Majumder says.
"So, not many states had religious exemptions related to their child neglect or their criminal laws, " she says. "And most of the states [added] them, because that was one of the strings attached to getting federal money."
In 1983, the federal government changed its policy, "but the states haven't necessarily removed those provisions."
Regarding the ethical considerations of parental non-consent for their children to receive medical treatment, Majumder thinks the "American Academy of Pediatrics got it right when it said there shouldn't be religious exemptions to these laws. On the other hand, you should always try to negotiate with parents, and going to court should be a last resort."
"So, whether it's a religious reason or a cultural reason, if parents are refusing treatment, you should try to understand where they're coming from; you should be open to negotiation — you know, what's essential, what's not," Majumder tells MEA. "You shouldn't immediately call [Child Protective Services]."
There were also two cases discussed — one in Oregon involving a 15-month-old child with a blood infection, she says.
"The parents were charged with second-degree manslaughter and second-degree criminal mistreatment. The wife was totally acquitted, and the father was found guilty of criminal mistreatment, which is a misdemeanor — manslaughter is a felony, so it was a lesser charge," she says.
The father was sentenced to 60 days in jail and five years' probation.
[Editor's note: See the January 2010 issue for more of the top legal developments in bioethics for 2009.]
Sources
- Erin A. Egan, MD, JD, Assistant Professor, Hospital Medicine, Director of Quality Improvement, Hospital Medicine Group. University of Colorado, Denver. E-mail: [email protected].
- Mary Anderlik Majumder, JD, PhD, Assistant Professor of Medicine with the Center for Medical Ethics and Health Policy at Baylor College of Medicine, Houston. E-mail: [email protected].
- Lois Shepherd, JD, Associate Professor of Public Health Sciences, Professor of Law, University of Virginia, Charlottesville, VA. E-mail: [email protected].
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