Sufficient Scruples

Bioethics, healthcare policy, and related issues.

December 29, 2005

Cynical “Consumer Protection” Law Guts Mercury-Poisoning Warnings

by @ 4:12 PM. Filed under Disability Issues, General, Global/Community Health, Healthcare Politics, Medical Science

A GOP-sponsored bill to supercede consumer-safety warning labels on food in most states will prohibit scientifically accurate warnings about mercury levels in tuna high enough to cause measurable neurological damage in fetuses. The FDA is backing the lower standards and is suing states that attempt to impose more accurate warning labels.

All 50 states have laws that require point of purchase food safety notices of one kind or another. Under the bill introduced by Republican Mike Rogers of Michigan and co-sponsored by 200 of his closest friends and accomplices (with the encouragement of numerous lobbyists), some 80 laws in 37 states would be eliminated, pre-empted by Federal authority. That will improve interstate commerce by eliminating the confusion of separate food safety warnings in the different states. You have to admire the flexibility and pragmatic attitude of “states rights” Republicans. They aren’t bound by principle.

Of course there is a little more to it. Like tuna. Because in fact the main target is California’s attempt to put strong warnings on tuna because of mercury contamination. Mercury is a known neurotoxin, and a series of landmark studies conducted in the Faroe Islands by Philippe Grandjean and his colleagues has shown that levels of mercury commonly encountered by consumers may have effects on fetal development.

California is being sued by the Tuna Foundation and their suit was joined by the FDA. And you thought the FDA was on the side of consumers? Silly you. Did you forget about Vioxx? At issue is the belief by independent scientists, the American Public Health Association and the American Medical Association that the current FDA mercury advisory is not protective and would allow exposures of an estimated 600,000 fetuses above current EPA reference levels.

Attempts by Democrats to postpone or modify the gutting of state control over food warnings were to no avail. Representative Lois Capps, a Democrat representing Santa Barbara in southern California tried to exempt state laws dealing with birth defect warnings but was defeated 32 – 31. California Democrat Henry Waxman’s amendment to permit states to help parents limit their children’s exposure to cancer-causing agents or developmental toxins was also defeated, 26 – 19.

No comment necessary.

Hat tip: Effect Measure.

December 28, 2005

Stem Cell SNAFU

by @ 5:53 PM. Filed under Biotechnology, General, General Science, Healthcare Politics, Medical Science, Provider Roles, Reproductive Ethics

I haven’t had much to say about the South Korean cloning meltdown; I don’t think it’s really very important in the long run, though of course it was a shock, and remains a kind of horror-show as it unfolds.

What we know is, essentially, that a South Korean team headed by the now-disgraced Hwang Woo-suk galvanized the world last year by announcing that they had successfully cloned a large number of human embryos – becoming the first group in the world to do so in volume. What’s more, they had made sure to do so under close IRB supervision, imposing strict protocols for how eggs were to be harvested for the attempts, and what kinds of insulation there would be between the cloning team and the egg donors to prevent coercion. Some time after that announcement, questions were raised as to whether those guidelines had been followed, as Hwang claimed they had; discrepancies were noted between the time the team’s first results were reported and the time that would have had to pass for eggs gathered under the new protocol to produce a cloned embryo (and some of the first reported results may even have dated from before the development of the new protocol). Later, it developed that at least one of the eggs used in the reported successful clonings came from one of Dr. Hwang’s research assistants, both violating the harvesting protocol and raising important questions of coercion in Korea’s highly hierarchical and authoritarian culture and academic system. This revelation prompted one of the American co-researchers to resign from the project to avoid affiliation with unethical practices. And then, most recently, it was revealed (one agonizing step at a time) that some of the reported cloning results may not have been correct, or that some of the reported clones were not in fact real, or that almost none or in fact none of the clones had been created as described. The major paper announcing the results was withdrawn, and at least one other paper was withdrawn. Finally Dr. Hwang resigned his position, and the entire episode is now regarded as contributing no reliable science at all to the field of cloning/stem-cell research, and as being in every respect a mind-boggling fiasco. Scientifically, we are back where we started, as if the Korean episode had never happened. In the court of public opinion – especially as spun by right-wing opponents of cloning and embryonic research – things are worse than before.

OK – so much, so bad. A scientific mess of the first water, with important ethical lapses thrown in: the IRB protocol was violated; material donors were subject to possibly overt, and probably implicit, coercion; the protocol breach was lied about in print and in public; research results were falsified in journals and in public statements; the falsifications were only uncovered slowly and in the face of further prevarications. Yet it played out as all such cases of scientific dishonesty always do: although opponents of science are constantly harping on the rare cases of scientific misconduct – Piltdown Man, Haeckel’s embyos – as if they invalidate science itself, or the field of science in question (always either evolution or human sexuality), the disparagers themselves have never succeeded in actually identifying or correcting any cases of scientific misconduct. To do that, they would have to understand science, which they resolutely refuse to do. In all such cases – and The Case of the Crazy Korean Cloner is merely one more example – it is scientists themselves, and in this case ethicists, who unveil the dishonesty and set the record straight.

Ethicists, and the defenders of academic honesty, do not expect that falsifications will never occur – though we may hope so. But we know that the procedures of real science, and of careful ethical oversight, will catch almost all such cases, and most especially the ones that are important enough to matter. The inherent self-correction mechanism of science – the fact that people can and will attempt to replicate, and to falsify, one’s reports – all but guarantees that the only science that remains false is the bits that no one pays attention to in the first place. Fields of heated scientific ferment are bad places to publish prominent faked papers (something Hwang must have been a fool to overlook).

Merely wrong science – and there are incalculably many good-faith wrong turns in science, it’s how the field works – will certainly be corrected by further efforts. Dishonest science in any prominent forum will very likely be uncovered. (Dishonesty usually results from thinking you can get the results you have not yet gotten, and so claiming them anyway – but if you are wrong, you will be found out, and even if you are right you are likely to be found out. Human cloning is almost certainly possible – Hwang wasn’t wrong about that – but he claimed he had the goods when he didn’t, and then couldn’t produce them as claimed.) Research ethics does not possess such a self-correction mechanism – you can’t re-run an informed-consent procedure to prove that it works – and so vigilance rather than mere good work is the necessary corrective. But in the Hwang case the ethicists did all they could to guide the process, then raised red flags when it went off the rails. A researcher resigned what was arguably the highest-profile scientific project in the world at that moment – and while the science itself was still believed to be good – over ethical violations that themselves seemed more technical than substantive. And those ethical revelations prompted widespread criticism even from supporters of the basic research project itself – partly fueling the scrutiny that eventually brought the whole thing down.

In this case, the process worked perfectly, and with amazing speed – regarding both the ethics and the science. Right-wing opponents were incensed that the project was taking place at all – that it went badly adds nothing to their objections, nor proves them right. But the fact that these lapses were found out, publicized without hesitation, and then publicly proven, by supporters of the research, demonstrates that there is a core of solid professionalism in science, and that it works to enforce the self-imposed guidelines and principles that scientists and pro-science ethicists themselves have developed. And, as said above, the fact that the scientific lapses were discovered and publicized by scientists – specifically, scientists who supported the research, only proves again that science when it goes wrong is more reliable than the anti-science crowd pretends it to be even when it goes right.

In the end, this is a riveting, but singularly uninstructive, event. We know nothing more about cloning than we did, thanks to Hwang and his boobish debacle. But we also know nothing more about science, or about research ethics. We know that the corrective processes they both impose on the substantive matter, and ethical conduct, of scientific research are remarkably effective, and the more so in prominent and important cases, and that they are driven by the devotion to good science of the scientists and ethicists themselves. But we knew that already. We see it on every (rare) occasion that one of these incidents pops up, when it is the scientists who uncover the bad science, and the pro-science ethicists who set it back on the right track.

Whatever the right-wing noise machine may make of this incident, it provides no fodder for their beliefs, and they have contributed nothing either to our scientific knowledge or our ethical infrastructure. Science will proceed, rightly for the most part, and entirely without their contributions or insight – as it always has done.

December 23, 2005

“Tiny Tim Time”

by @ 5:20 PM. Filed under Autonomy, Child-Rearing, Disability Issues, General, Healthcare Politics, Medical Science, Personhood, Provider Roles

The always-great Ragged Edge Online offers a critical look by Cal Montgomery at the Autism Society of America and its role as the self-annointed “Voice of Autism”. (The piece is prompted by a recent episode of the Donald Trump show “The Apprentice”, where the weekly task was to organize a charity fundraiser. One contestant ran a promotion for ASA that included, among other things, little plastic megaphones as a visual metaphor for the supposed “need” of autistic persons for someone else’s voice.) The piece links a really hard-hitting essay by “Kim”, the anonymous, autistic, author of the Web site “Getting the Truth Out“. This site – brilliantly done – is a response to “Getting the Word Out”, ASA’s “educational” and fundraising site.

Both writers criticize the ASA’s assumption that it knows best what persons with autism need, and that what it believes about them or their interests can be taken as definitive. “Kim” presents some common stereotypes of autistic persons and their behavior as understood from the outside, and then describes them in simple, factual terms as she understands her own behavior.

Nobody told me that people would approve of this posture in childhood — even find it amusing — but be horrified by it the older I got. That’s exactly what happened, though. There are pages of my medical records dedicated to understanding why I do this. They called it regression. It’s not. There’s nothing to understand. Nothing to figure out. Nothing to fix. . . .

Flapping my hands was always ‘inappropriate’ behavior. Look at this picture. Look at all of these hand-flapping pictures. I’m happy. This whole series of ‘treatments’ designed to make me look more ‘normal’ didn’t succeed in doing that, but it did succeed in instilling shame and fear. For the way I look when I’m happy. . . .

Lack of eye contact is considered a major problem. I can either look or hear, not both. . . . But appearance is prized over functionality. . . .

I wrote earlier that this site would be about exposing the ugly realities of living with autism. The ugly realities are a little different than what Getting the Word Out means when they talk about the harsh realities of being autistic. The harshest reality is that things are set up very neatly so that we have no say in what happens to us. We’re either regarded as incapable of having a say, incapable of forming a good opinion, or not autistic enough to have an opinion. Then non-autistic people continue to make the decisions to do whatever they want, to all of us.

“Kim” is quite clear that she understands she is different from other people, though she doesn’t understand why that bothers them so much. But she rejects the – not always implicit – claim of ASA and other “advocates” that that difference means she cannot speak for herself, or that the difficulties and limitations she experiences mean that what she does say is not worthy of being taken seriously.

Both “Kim” and Cal Montgomery are suspicious of advocacy groups that set themselves before the people whose interests they are supposedly advocating. Montgomery notes:

Kim says — and this resonates with me, because this is what I thought when I first saw Getting the Truth Out — “I seem to be writing about autism and I seem to be writing about my life but I’m actually writing about how power is used and who has it and disability in general and people in general and all sorts of other generalities, just in the context of something very specific-looking.” She brings up Voice of the Retarded and the Muscular Dystrophy Association having done similar campaigns; she brings up disability rights and human rights and ethics in general; she’s not talking just about herself, or just about people who are “like her”; she’s talking about anyone whom other people have the power to define.

Hence “Tiny Tim time” – the time of year that we feel extra-sorry for those not like us and want to throw them a little something to make ourselves feel better. (The ASA promoter won the competition on “The Apprentice”.)

I must admit I feel both highly challenged by the writings of Montgomery and “Kim”, and conflicted about their message.

I recognize their claim to speak for themselves, and am certain they are right in describing the offense and the danger in condescending attempts by well-meaning organizations to take that voice away from them. (Montgomery even says, in an aside, that an obnoxious couple once attempted to confiscate her dog when they found she was a non-verbal Deaf person – apparently feeling that not only made her an unfit caretaker but gave them some sort of vigilante powers.) And their rejection of the “disability” label is powerful. “Differently abled” (a term neither of them uses – I refer to the general concept, here) in some ways makes mostsense coming from persons furthest from the mainstream who still powerfully articulate their own completeness as human beings, and refuse to see themselves as needing a “cure” or wanting to be “normal”. (Montgomery is contemptuous of Christopher Reeve.)

It is so easy to feel condescendingly pitying of persons with disabilities that to have that uncompromising sense of self-worth expressed – with all the irony and anger that it naturally draws with it – and to accept it on its own terms, without judgment or defensiveness, is a difficult challenge. It brings up all the times I have allowed myself to fall into that condescending form of thinking about disability, and forces me to confront the paradoxical-seeming need to accept everyone on their own terms – not just the photogenic, the articulate, the skilled, the presentable, the expressive, or those who otherwise draw sympathy by being the way others want or expect them to be, but also the withdrawn, the quient, the angry, the unskilled, the unattractive, and all the others whose disability – or merely whose personality – makes it impossible for them to push others’ buttons the right way, but who are no less moral persons for all that.

At the same time, I do not endorse the suggestion (briefly touched on in the links above; more common elsewhere) that it is discriminatory to see avoidable disabilities as undesirable, or even to want children without certain disabilities. Reconciling the belief that persons with disabilities are as morally worthy, and in many cases as rewarding in acquaintanceship, as those without, with the belief that one would prefer oneself or one’s children not to have such a disability, requires a very careful parsing of moral values, and a careful explication of one’s reasoning in holding such a position.

Without going into the argument in detail here, I think it is possible to want full acceptance for, support of, and social opportunities for persons with autism, and also not to want to have an autistic child, or, in the case of Down syndrome, to have similar opinions and to choose to abort a fetus known to have that condition. This is an issue I want to explore in more depth when I have the time to do it justice.

In the meantime, I recommend reading the two articles above; they are very powerful.

December 21, 2005

Creepy Operation Rescue Tactics Border on Stalking

by @ 4:46 PM. Filed under Access to Healthcare, Autonomy, General, Healthcare Politics, Provider Roles, Reproductive Ethics, Sex, Women's Issues

Operation Rescue, the extremist anti-choice organization whose modus operandi traditionally includes harassing patients at abortion clinics, also enjoys harassing abortion clinic staff in their private homes. Their tactics include parading a panel truck with the usual inflammatory images of aborted fetuses in front of the homes of clinic staff and their neighbors, and engaging in loud haranguing and religious songs or prayers. But their tactics go beyond just harassment; they also make it clear they are monitoring clinic workers’ whereabouts and their private lives.

The first stop was the neighborhood of Edna Roach. As neighbors returned home for the day, nine rescuers sang traditional Christmas hymns near Roach’s residence. It appeared that no one was at home and that Roach’s car had not been moved for several days. . . .

Next, the carolers spread Christmas cheer to the neighborhood of Sara Phares Brown, the clinic worker who drove [Dr. George] Tiller to the Emergency Room the day [a patient] died from abortion complications. Rescuers offered prayers of Brown’s repentance and salvation. “Sara has recently filed for divorce and is probably going through a difficult time in her life,” said OR spokesperson Cheryl Sullenger. . . .

The final destination on OR’s Christmas caroling tour was the neighborhood of Marguerite Reed . . . As carolers sung, Reed returned home from work and OR President Troy Newman spoke to her of [the patient's] death and her need for repentance and forgiveness thought Jesus Christ.

This is more than offensive, it’s creepy and not a little scary. Given that 7 abortion workers have been murdered in North America by anti-choice extremists, and several more severely injured, and that some of these killings have taken place in the workers’ private homes by extremists who stalked them there, these monitoring and harassing tactics have a distinctly intimidating air. At the very least they betray an intrusive and offensive obsession with the private lives of people they disagree with. Privacy has never been strongly valued by the anti-choice crowd, and harassment and personal vilification have always been high on their agenda, but that hardly excuses this behavior.

More and more the anti-choice contingent proves that its values and its standards must never be allowed to define policy for the rest of society.

Paternity Testing: Whose Interests at Stake?

by @ 1:03 PM. Filed under Autonomy, Biotechnology, Child-Rearing, General, Medical Science, Reproductive Ethics

Interesting news from Down Under: the Australian government has opposed a suggested rule-change giving teenagers the right to withhold consent for paternity testing (on themselves). This is being spun in some quarters as “forced paternity tests against their will” – which is not an unreasonable construction – but more accurately is a retention of the status quo in which courts may order testing in cases of disputed paternity.

A report by the Australian Law Reform Commission and the National Health and Medical Research Council’s Australian Health Ethics Committee recommended nearly three years ago that the government bring in laws giving young people, deemed to have sufficient maturity, the choice of saying ‘no’ to a paternity test.

“It was an empowering provision in terms of giving a children a voice in these proceedings,” says Professor Margaret Otlowski of the University of Tasmania, an expert on legal aspects of genetics.

“It’s all very well for parents to consent but if we’ve got a mature minor, 12 and up, with views about what they want, their consent should be sought as well.”

But the government has rejected this recommendation saying it would be inconsistent with the Family Law Act.

Otlowski says while one would normally expect the court to take the child’s wishes into consideration, it may make a ruling against a child who doesn’t want a blood sample taken or the issue of paternity dealt with.

“A 15 year old child could be compelled to be tested because a court thought it was in their best interest,” says Otlowski.

The issue arises in the context of paternity tests performed by court order, usually pursuant to divorce or child-custody cases. Such testing is particularly advocated by Australian “men’s rights” groups, which claim that false paternity is a common issue in such cases. (The report linked above notes that “almost a quarter” of disputed paternities turned out to be wrongly attributed in one run of cases – though this does not extrapolate to the general population for which paternity is not usually in question). The fathers seek to disclaim paternity either to weaken the mother’s legal position or to reduce their child-support obligations. (For this reason, the men’s groups have also opposed proposals that consent be required from both parents for testing of younger children. The men want an absolute right to challenge their standing as legal fathers, over the objections of either the mother or the teenage child, in all cases.)

Whatever their motivations, the basic point of the men’s groups is not irrational: it is unfair to impose unwanted obligations of fatherhood on people who are not actually fathers. This is a very far cry from a conclusion that these men’s demands are therefore justified: the practical implications of policy-making on this subject are complex. But it should be acknowledged that there is a basic point there.

In terms of policy-making, this area is famously contentious. The standard Western common-law approach is that the man who is recognized as the father of a child at birth is the legal father thereafter. Thus it becomes especially difficult to renounce paternity once you have acted as a child’s father at any point – even if you can prove you are biologically unrelated. This flies in the face of the common-sense “fairness” objection noted above, but it makes its own kind of sense from a different perspective. Children benefit from family stability, and children must be provided for – thus it is more important that a child have a father than that the child have the particular person who was their biological father as a father – especially if the latter cannot be identified, or doing so would require a lengthy and contentious battle in which it is obvious that whoever gets stuck with the child views himself as the “loser”. For this reason, whoever the mother named as the father on a child’s birth certificate was commonly assigned the legal obligations of fatherhood unless he could prove unambiguously that he was not the father, and whoever acted as father in the child’s early life was commonly recognized as the legal father even when it actually was proved that he was not – for the sake of ensuring that somebody would be around to take care of the child, and that that relationship would be as stable as possible once it was established. This was a straightforward valuation of security and stability much higher than factual accuracy or even fairness to the non-father.

The proposal to give teen children a veto of paternity testing was much in keeping with this tradition: preventing unilateral abrogation of the parent/child relationship and withdrawal of support from the child, even when it can be proven biologically that the presumed “father” is not the actual father. There are other considerations as well – unconsented testing exposes the subject to information they may not be prepared to deal with or which is unwelcome, it may force teens to face changes in their relationship with their parents resulting from the parent’s or the teen’s knowledge of facts which had previously been hidden, and, from a general-principles perspective, it represents unconsented testing on a third party for someone else’s (the father’s) benefit. Any of these may be undesirable from the teen’s perspective, and it is the teen’s body and genetic information that is at the center of the issue. The proposal essentially gives teens the right to demand that any such testing must wait until they – the teen – are comfortable with it and willing to face the outcome that may result. It also means that the teens are given the right to demand that the father’s interests in knowing and acting on their own paternity status be held secondary to the teen’s interest in self-determination – which is not that surprising, given that we do make such demands in almost all other cases of third-party conflict (potential live organ donors may withhold or even revoke consent for donation whether or not anyone else needs those organs; patients have so far been allowed to refuse to be informed of their HIV status, and automatic testing of newborns’ HIV status was opposed in the names of the mothers; testing of doctors’ and prisoners’ HIV status, for the peace of mind of patients or police officers, was also opposed on privacy grounds; etc.).

So, the government’s rejection of that proposal in this case represents an encroachment on self-determination for teens, and an advance of the claim of “fathers’ rights” against the traditional understanding of the obligations of parenthood. Most significantly, it represents a claim that third parties’ privacy may be violated to satisfy the interests of others – a significant rollback of privacy and autonomy doctrine that is ameliorated somewhat by the fact that the subjects in this case are legal minors who are understood not to have full autonomy to begin with. At any rate, it is an important development.

December 20, 2005

Malpractice or Bad Luck?

by @ 2:53 PM. Filed under Access to Healthcare, Autonomy, Biotechnology, General, Healthcare Politics, Provider Roles

Dr. Joe Pellicer reports witnessing the malpractice trial of a physician friend. Without giving details, he asserts that the adverse incident in question was unavoidable. He reports that his friend was able to convince the jury of this, despite the plaintiffs’ lawyers insinuations, and that “[a]fter just minutes, the verdict came back: The jury absolved my friend of any wrongdoing.”

This would seem to be a showcase legal proceeding, then: a grieving family, whose relative died after treatment and discharge from the local ER, feared that something was amiss. (And why not? Patients are supposed to get better after treatment; it’s not surprising when a patient dies in the ER, but it’s surprising when a patient is discharged as healthy and then dies at home.) They brought action in the only authoritative forum our society provides for assessing facts in situations of that kind, and assessing fault and assigning damages. The jury heard arguments from both sides, weighed complicated technical information that the defendant himself presented to them as part of his defense, and arrived at a conclusion – one that Pellicer declares was correct on the facts. What’s the problem?
(more…)

December 16, 2005

Health Policy by Adversarial Combat

by @ 4:25 PM. Filed under Access to Healthcare, Autonomy, Biotechnology, General, Global/Community Health, Healthcare Politics, Medical Science, Provider Roles, Reproductive Ethics, Sex, Theory, Women's Issues

Ema of The Well-Timed Period comments on the plan by the Wisconsin Attorney General to sue the FDA for failure to authorize OTC sales of emergency contraceptive “Plan B”:

In my opinion this is like treating the symptoms without addressing the cause. A court of law (or, for that matter, the political arena) is not the appropriate venue to decide whether Plan B should, or shouldn’t be available OTC. Alternatively, if you really must go the lawsuit way, I say do it the right way. Start making Plan B available OTC immediately, in defiance of the FDA’s political ruling, and force the politicians who object to make a [scientifically sound] case against it.

[brackets original]

Her concern about courts of law is that they are simply another way for non-scientific rulemaking to enter the health-policy field. She appears to regard trial-based health-policy rulings as no more preferable than ideologically-driven legislation or regulatory stonewalling. I think she has a point in this (the history of “junk-science” cases in the courtrooms bears her out).

However, I am not convinced that it is as simple as simply opting for “science-based” policy-making. Any bioethicist will immediately respond that policy decisions are inherently value-based – they take scientific fact as one relevant consideration, but no scientific fact stands on its own, or dictates the one, true, obvious policy that must follow from it.

I am not endorsing the FDA’s shameless politicking with Plan B, or the right wing’s constant obstructionism and misogynist intrusiveness over abortion, but it is also true that neither Plan B distribution nor abortion are justified simply because they are very safe, or even because they are safer than their likely alternatives. However loudly those facts speak, they do not “speak for themselves” – they must be placed in the context of whatever values are served by policy-making. If abortion really were “murder”, it wouldn’t be justified even if it was safer than childbirth (as in fact it is); if teen sex really were as icky as the Bush Administration’s evangelical medical corps believes, OTC availability of Plan B might not be justified even if it prevented unwanted full-term pregnancies. We must have some sense of where we stand on the moral values implicated by certain behavior in order to make policy for that behavior – and in that kind of decisionmaking, scientific fact creates the practical context which must be taken into account, but it does not dictate answers. This is why we cannot simply leave policymaking to scientists, even if we dare not leave it to politicians. (And why we must engage the moral debate over sex and abortion in a way that the pro-choice contingent largely has not so far.)

For similar reasons, I think her plan to force the FDA’s hand is commendably bold, and might bring salutary political results, but as a matter of proper regulatory approach it is misguided. It is important to have prior review of major healthcare policy decisions such as the introduction of powerful new drugs. Drug-safety regulation has brought incalculable benefits to the US and the world, and back when we had a professional and scientific regulatory agency the system – for all its flaws – was both necessary and effective. We cannot put the burden on the FDA to “rule out” dangerous drugs after they have been introduced in the marketplace – that is their regulatory mandate regarding “health supplements”, which is proof enough of what a disaster it would be for prescription drugs. We also cannot allow manufacturers to simply vacate the regulatory review requirement whenever they determine that the FDA has not behaved responsibly – it requires no imagination to see what the result of that policy would be. If the FDA has behaved in bad faith regarding one drug or class of drugs – as it unquestionably has – that problem must be addressed directly, preferably by turning the entire pack of pinheads and fanatics out of office at the first opportunity. It might even be useful to impose limits on the FDA’s discretion to overrule the advice of its scientific review committees. But there are few legal grounds for challenging a policy decision simply because it is discriminatory or hostile to a group’s interests. The protest move Ema recommends would necessarily be a challenge to the FDA’s internal procedures – the fact that it is stonewalling – not to the fact that the agency is now held captive by right-wing religious fanatics who hate women and sex. The latter is not – in the absence of a women’s Equal Rights Amendment – a legally-cognizable reason for violating a regulation; the former is procedurally weak, but more important would open the floodgates to any commercial manufacturer who wanted to claim they had been harmed by the FDA’s review process – something we definitely do not want.

As much as I share Ema’s frustration, I think this is a fight we have to win on the merits, not by claiming legal rights to do what other drug makers should not be allowed to do.

December 15, 2005

Absurd South Dakota Propaganda Document on Abortion is Released

by @ 10:43 AM. Filed under Access to Healthcare, Autonomy, General, Global/Community Health, Healthcare Politics, Medical Science, Personhood, Provider Roles, Reproductive Ethics, Sex, Theory, Women's Issues

The state of South Dakota established a “Task Force to Study Abortion”, mandated to issue a report on abortion in general, and policy recommendations for South Dakota. Ann at Feministing notes that almost half of the Task Force’s 17 members were anti-abortion activists, and only 2 were identified as pro-choice.

The Report itself is a hack job of anti-choice rhetoric: literally every paragraph is framed to comment negatively on abortion, without the slightest recognition of the role sexual autonomy plays in women’s lives or arguments in favor of abortion rights. It is filled with absurd anti-choice tropes, such as extensive “DNA evidence” that a fetus is a “human being” in the biological sense, and no discussion whatsoever of reasons why or how that corresponds to moral personhood; the report actually notes that the latter is distinct from the former, then explicitly conflates the two on the very next page without discussion. It quotes extensively from the egregiously mendacious Bernard Nathanson, as well as a parade of anti-choice witnesses who claim they were “harmed by abortion”. (The report actually notes that “in every instance” these witnesses were anti-abortion, without noting that they were recruited as anti-abortion witnesses. Yes – the Task Force discovered that 100% of anti-abortion activists are anti-abortion, and actually cited that fact as a finding! This is the level of intellectual work the group turned in.) No mention whatsoever is made of pro-choice witnesses.

The Report concludes, from its “scientific fact” that a fetus is biologically distinct from its parents, that it constitutes a “second patient” and that a doctor violates a professional obligation to that fetus in performing an abortion. This is a mangling of ethical reasoning that not even the rankest anti-choice hack would attempt: it is, technically, a circular argument, but more than that it is simply an argument that contains no argumentation at all – simply a definitive assumption about the moral status of the fetus that is in fact the center of the abortion controversy to begin with. It also expends extensive energy explicitly criticizing Planned Parenthood – the only abortion provider they studied – with such gems as:

We find first that Planned Parenthood fails to inform the pregnant mother in any language that her unborn child is in existence. It is impossible for a woman to give informed consent to an abortion if she does not fully understand that her child is in existence, and that she is consenting to the termination of the life of her child.

Do they seriously believe that Planned Parenthood has deceived pregnant women as to the existence of their fetus? Do they seriously believe women who seek abortions are doing so in ignorance of the existence of their own fetuses? (These women, presumably, want an abortion . . . for no reason whatsoever?) This is not merely a bizarre and manufactured complaint, but it exhibits all the infantilization and contempt for women that characterizes the anti-choice position.

Bizarrely, it even makes the complaint that:

We find that Planned Parenthood has confused the objective biological fact that the procedure terminates the life of a live human being with the moral or value judgment of what respect or value should be placed upon the life of that human being. . . . [T]he pregnant mother can apply her own discrete personal, moral or religious values to her circumstance only after accurate biological facts concerning the existence and nature of her unborn child are disclosed.

This is a bit rich coming from the authors of this report. But it is also very confused: the most-controversial moral question associated with abortion is whether the fetus holds any distinct moral status sufficient to override the woman’s desire to terminate her pregnancy. As the Task Force notes, this is a moral, not a biological question. But they themselves – not PP – confuse those two issues by insisting that the moral question can only be determined by consideration of the fact that the fetus is “a human being” in the biological sense. Their complaint, in fact, hinges on language in PP brochures and videos that refers to “the contents of the uterus”, and so forth – that is, on PP’s failure to use the particular term “human being” to refer to the fetus. But that term can have moral significance only if one has previously determined – on moral grounds – that it does. It can hardly be claimed (though – as above, the Task Force seems to claim it) that the women don’t know they are actually pregnant. Despite their language, it is not the “existence” of the fetus that the Task Force thinks the women are confused about; it is the fact that that fetus occupies a status the Task Force members regard as morally significant, and PP has not cooperated in using the language the Task Force feels most reflects their particular moral beliefs about that fact, that they object to. But objecting on that ground is precisely to invade the realm of decisionmaking they themselves have said – and the Roe v. Wade decision mandates – must be the woman’s alone.

The Task Force also relies upon hoary myths of post-abortion psychosis, and criticizes Planned Parenthood for making factually accurate statements such as:

1. “Early abortion by vacuum aspiration is one of the safest procedures in all
medicine.”
2. “A legal abortion, as it is performed in the United States today, is a very safe procedure and complications are rare.”
3. “The emotion most women experience after having had an abortion is relief.”

There’s more: the nonsense goes on for over 70 pages, and ends with a lengthy pro-life rant and a recommendation for a complete ban on abortion. In a telling footnote, they blithely disclose that:

The Task Force has not examined the question of whether any exceptions are necessary – i.e., whether an abortion is ever medically necessary, even to save the life of the mother.

The pro-choice members of the committee were prohibited from releasing a minority report. The Task Force also makes a number of slanted and, often, extremist recommendations, including:

1. Amend the State Constitution to include provisions that provide the unborn child, from the moment of conception, with the same protection of the law that the child receives after birth and also provide protections for the mother-child relationship.

2. Require the abortion doctor to personally complete, while questioning the woman in confidence, a written form provided by the State that specifically asks the woman if she is being pressured into having the abortion. If she indicates that she is being pressured, require that the abortion shall not be performed.

3. Require the abortion doctor to verify the age of the patient and the father of the unborn child, and require the abortion doctor to report to the appropriate authorities any sexual activity that is contrary to South Dakota law.

4. Require strict reporting requirements concerning the reasons a woman is seeking an abortion. The report must contain a written disclosure by the doctor as to whether or not continuing the pregnancy threatens the health or life of the woman. If the threat exists, the doctor must detail the nature of the threat.

5. Require that the State create a written disclosure form that requires the abortion doctor to provide the mother, in person, with all of the risks of abortion to the mother and her unborn child. Require that this disclosure take place before the woman pays for the abortion and before she is taken to the procedure room. Require that the mother must also be provided sufficient time for personal review and discernment.

6. Require that no abortion can be performed unless the pregnant mother, prior to making an appointment for an abortion, receives counseling and disclosures about the nature of the risks and the alternatives to abortion by a pregnancy care center that does not perform abortions.

7. Require that the abortion doctor show the pregnant mother a quality ultrasound image of her unborn child before the procedure is performed and prior to her signing the consent form on which she indicates that she viewed the ultrasound.

8. Require the abortion doctor to have hospital privileges at a hospital within 30 miles of the location where the abortion is performed.

9. Require that the South Dakota Vital Statistics include disclosure of all facilities that perform abortions in South Dakota as well as the number of abortions performed per year at each facility.

10. Strengthen laws so that abortion facilities are thoroughly regulated and regularly inspected by the South Dakota Department of Health or other proper authority.

11. Strengthen the child support laws, including the requirement that the father of an unborn child support the mother and their unborn child during the pregnancy and thereafter. 12. Strengthen laws that provide financial and other support to pregnant women so that lack of support no longer compels a woman to seek an abortion.

13. Strengthen and clarify existing public policy regarding character development education pursuant to SDCL 13-33-6.1. Such clarifications should include a definition of sexual abstinence and a statement that abstinence education in South Dakota is to exclude contraceptive-based sexuality education.50 14. Any other legislation that has as its goal to decrease the number of abortions in our State.

Recall that these recommendations come after a recommendation of a complete ban on all abortions across the board. Many of these suggestions are obviously designed to intimidate or manipulate patients seeking abortions; others are designed to burden abortion providers to the point that they cannot actually practice. Others serve to intrude the state further into women’s privacy and autonomy – demanding reasons and justifications for abortions that the Task Force previously had sanctimoniously said were the woman’s decision alone; requiring unnecessary and manipulative “informed consent” procedures that the woman is not allowed not to submit to, while making her supposedly private and personal decision; requiring submission to “informed consent” counseling at an anti-choice facility, and so on.

The Report, and its recommendations, are a parody of healthcare policy-making. They say nothing useful, or even rational, about abortion, and will stand as a laughingstock among medical and bioethics professionals forever. The Report will provide fodder for that division of the anti-choice wing that has taken up war against Planned Parenthood as its distinct struggle, but that group hardly requires factual or rational material t0 ground its activities on.

More than anything, this Report exemplifies the highly partisan, wholly ideological nature of “medical ethics” on the right wing. This is an extremist version of the absurdities of the President’s Council on Bioethics and so many other right-wing advocacy organizations. It may be a sign of the kinds of “bioethics” we can expect from them in the future – the kinds of “analysis” that, as in the case of global warming, tobacco, handguns, and other pet right-wing causes, serve only to provide professional-seeming cover for wholly non-rational and irresponsible activism. If so, this is a sad day for bioethics.

Hat tip: Ann at Feministing.

UPDATE: Echidne of the Snakes has some good commentary on the report also, noting further absurdities such as one physician’s testimony that abortion in cases of incest was not necessary because incest does not usually result in genetic defects, while offering the bizarre speculation that incest could also result in “the genius range of intellect” by combining “good genes”; the fact that not only was almost half the Task Force pre-committed anti-choicers, but 16 of its 17 members were men; and one of the anti-choice members defended the obviously one-sided Report and the exclusion of pro-choice supporters by stating explicitly that they had been limited because the express purpose of the committee was to “gain freedom for the unborn and all those who have been victims of abortion”.

December 13, 2005

Divergent Approaches to EC in Different States

by @ 3:54 PM. Filed under Access to Healthcare, Autonomy, General, Global/Community Health, Healthcare Politics, Provider Roles, Reproductive Ethics, Sex, Women's Issues

Stateline.org, of the Pew Research Center, has a good review of the various actions taken in different states in regard to making emergency contraception more widely available. Some states have moved decisively to make the medication easily obtainable; others have seen roadblocks thrown up by conservative governors or legislators. One state – Wisconsin – announced last week it will be suing the FDA to force approval of OTC availability of Plan B.

While the Food and Drug Administration delays a decision on whether to allow the “morning-after pill” to be sold over the counter, officials in several states are mounting efforts to make the emergency contraceptive easier to get.

In recent weeks, the stakes have increased in the contentious policy debate over the pill, which is sold under the name Plan B, with four pharmacists losing their jobs in Illinois, state attorneys preparing a lawsuit against the FDA in Wisconsin and tempers flaring in Massachusetts. . . .

In Illinois, four Walgreens pharmacists who said they wouldn’t fill prescriptions for the morning-after pill were suspended without pay because of a one-of-a-kind Illinois rule put in place by Gov. Rod Blagojevich (D) requiring pharmacies to sell the drug.

Three of the pharmacists filed a complaint Dec. 7 with the Equal Employment Opportunity Commission, arguing their employer “effectively fired” them for their moral beliefs. Blagojevich’s order requires all pharmacies that sell birth control pills also to stock the morning-after pill, a set of two pills that contain a higher dose of hormones than standard oral contraceptives. . . .

Right now, Illinois is the only state with such a requirement, but it won’t be for long. California lawmakers pushed through a similar law, effective in January, that differs in one key aspect: It also would give pharmacists with moral objections to dispensing the pill a way to opt out. The compromise won the endorsement of pharmacists, though the more ardent anti-abortion groups still objected.

Wisconsin Attorney General Peg Lautenschlager (D) last week took the first steps toward filing a lawsuit to force the FDA to let the drug be sold without a prescription. Under Wisconsin law, Lautenschlager needs the permission of Gov. Jim Doyle (D) before suing the federal government. Doyle gave his approval on Thursday, Dec. 9. . . .

As a legal matter, she said the FDA’s repeated delays – without an outright rejection of the application — are “political” and violate the federal Administrative Practice Act, which governs how federal agencies must operate.

Next week, Massachusetts will begin allowing pharmacists to dispense the morning-after pill without a doctor’s prescription. The Democratic-controlled Legislature overrode a July veto by Gov. Mitt Romney (R) to make the Bay State the eighth to let patients buy the drug without visiting a physician. The law allows specially trained pharmacists who partner with doctors to write and fill the prescriptions themselves.

It also requires hospitals to offer the drug to rape victims. Earlier this week, Romney’s administration ruled that the mandate did not apply to Catholic hospitals, touching off a furor among politicians who say the administration’s stance undermines the purpose of the law. But Romney reversed course Dec. 9 after speaking to his lawyers and said that the law will be applied to all hospitals, according to the Boston Globe.

Legislators in New York didn’t have the votes to overcome Republican Gov. George Pataki’s veto of a similar measure there, but the legislation did clear the Republican-controlled Senate before ending up on Pataki’s desk.

In reaction to the emergency contraception controversy, the American Medical Association passed a resolution this summer calling on pharmacists to fill all prescriptions. It even suggested that, if no pharmacist within 30 miles of a patient would fill a script, the patient should be able to buy the drug from the doctor instead. . . .

Mississippi enacted a broad law meant to protect pharmacists and other health-care professionals who have moral objections to administering certain drugs, including the morning-after pill. It joins Arkansas, Georgia and South Dakota in giving pharmacists the right to refuse to dispense emergency contraception.

In Indiana and Texas, lawmakers passed measures designed to limit Medicaid funding for emergency contraception.

And when Arkansas legislators told health insurance companies they had to cover contraception, the lawmakers explicitly excluded emergency contraception.

[emphases added]

Good Beginning on “OTC” Emergency Contraception

by @ 2:55 PM. Filed under Access to Healthcare, Autonomy, General, Healthcare Politics, Provider Roles, Reproductive Ethics, Sex, Women's Issues

New Hampshire has begun a program to allow dispensing of EC without prescription by pharmacists who have taken a two-day special training. This is not quite the same thing as OTC availability (and finding yet another way to make EC availability dependent on pharmacists’ cooperation, though a positive step in some ways, is not completely a step forward). However, it is a major advance in making this medication available at the time of need.

Six months after Gov. John Lynch signed a bill that would make “morning-after” pills available to women hoping to prevent unwanted pregnancies, about 200 pharmacists have received training in dispensing the drug.

The law allows pharmacists who have volunteered for the training to provide women with an elevated dose of birth-control hormones without a doctor’s prescription. The drug, if taken within 72 hours of unprotected sex, can cut a woman’s chance of pregnancy by up to 89 percent. . . .

Two training sessions for pharmacists were held this past weekend. Once trained, pharmacists need to partner with a doctor or nurse practitioner to be able to prescribe the pill.

One problem with this approach is that, by putting the responsibility on pharmacists to dispense this medication, it unavoidably puts on them the responsibility to deal with issues that are fundamentally the woman’s concern alone:

The training sessions address such issues as a pharmacist’s personal views on emergency contraception and the medical side effects or liability that comes with dispensing the drugs.

Part of the protocol is to prescribe the pill first, then ask questions afterward, said Don Downing, a pharmacist and associate professor at the University of Washington School of Pharmacy.

Any woman, regardless of her age, can have the pill if she’s had unprotected sex in the past five days and has had her period in the past four weeks, which means she’s not pregnant. She must also sign a consent form.

If a pharmacist suspects that a woman has been raped, he or she can refer the woman to a hospital or to one of the state’s 14 crisis centers.

It is not mandatory that the pharmacist report the assault unless the woman is under 18. If that is the case, Downing suggested that a pharmacist dispense the drug, then tell the girl about his or her intention to call authorities.

“You never hold them hostage,” he said. “They’ve just been held hostage.”

Though this training seems to have been designed to be as empowering of women as possible, questions about the pharmacists’ personal views, whether the medication will be dispensed, who must be notified, and whether notification will be conducted against the woman’s wishes would not arise if states could just trust women to make their own decisions about their own bodies, with a medication that has proven to be highly safe and effective for all age groups. There is no reason for pharmacists to “address” these issues at all, let alone allow them to stand as explicit – or even implicit – barriers to women’s healthcare. European practice, and the studies resulting in a near-unanimous approval for OTC sale of Plan B by the FDA’s scientific advisory panel, show that women can use this medication safely on their own initiative, without submitting their decisionmaking to someone else’s review.

New Hampshire is to be commended for taking a large step toward increasing availability of Plan B, but it would be much easier, and better for the women, if the FDA would simply let women have what they need without anyone else’s intervention.

December 12, 2005

The Accidental Misogynist

by @ 7:32 PM. Filed under Autonomy, General, Healthcare Politics, Reproductive Ethics, Sex, Women's Issues

Allah has picked a fight with several feminist bloggers over his perception of their perception of anti-woman sex politics.

As we’ve discussed here before, nearly every argument that comes out of the feminist camp depends on bad-faith assumptions about their opponents’ motives. Jill, for example, never tires of reminding us that what the pro-life movement is really all “about” is controlling women. Concerns about dead babies? Just a big smokescreen for misogyny and uterus-harvesting. . . .

The more doctrinaire or powerful a conservative is, the more conscious his misogyny is assumed to be. For those less doctrinaire and powerful—well, they might not be evil per se, but at the very least they’re acting according to a false consciousness. . . . If you could dig deep into our unconsciousness, you’d see we’re all just cheerleaders for the patriarchy too.

I suspect, however, he and his cohort would not be accused of controlling women and hating women’s sexuality if they didn’t consistently take positions that served invariably, and often exclusively, to control women and punish their sexuality, irrespective of any impact on, or relation to, the issue of “dead babies”.

The anti-sex right is consistently anti-contraception and anti-sex-education no matter how much evidence mounts up that that contributes to unplanned pregnancies, and to abortion. Many of them are opposed to condoms and HPV vaccines, because they are beside themselves at the thought of actual sex and are not moved from that position by little things like AIDS and cervical cancer. They demand the right both to control and to judge women’s sexual behavior, not merely determining how and whether women can prevent or terminate unwanted pregnances, but also whether they (the right-wingers) personally will allow women to have access to legal medications for doing so. Prominent anti-sex activists refer to women as “murderers” and “baby-killers” for having abortions; some have proposed criminal penalties for women aborting unwanted pregnancies. Some have actively promoted “shaming” for unapproved sex as a cultural practice; others – including the recent past Director of the President’s Council on Bioethics – have encouraged “courting” and fathers’ determination of daughters’ marriage choices for adult women. Right-wing organizations often actively distort information about sex (James Dobson’s Web site claims that rape cannot result in pregnancy), and actively seek to prevent young people from learning simple facts about sex and contraception. More and more legal efforts are made every day not only to prohibit abortion but to intervene in pregnancy, forcing women to carry pregnancies to term even when abortion is legal, or punishing women for their behavior while pregnant. Right-wing groups are promoting “covenant marriage” to prevent straight women from leaving bad marriages, and “defense of marriage bills” to prevent lesbians from entering into good ones. They have demanded fathers’ vetos over abortion, and abandoning careers for full-time homemaking as a preferred life for mothers.

It’s possible that the people who do all these things are sincerely concerned about fetuses – in fact it seems clear they like them far more than they like the women in whose bodies the fetuses reside – but every one of their policies can be explained by hostility to women and women’s sexuality, while many of them are irrelevant to sex, and many of them are actively counterproductive from the perspective of reducing abortions. The only reasonable conclusion is that they hate women more than they hate abortion, and in fact there is little evidence that they really hate abortion anyway (since all their anti-abortion positions can also be explained by misogyny, while some of their anti-woman positions are incompatible with a strong commitment against abortion).

When they stop acting like misogynists, they’ll stop being accused of misogyny.

December 7, 2005

“Professional Ethics” Means No Snarky Blog Posts? Uh-Oh.

by @ 1:32 PM. Filed under General, Provider Roles, Theory

Marquette University’s dental school has just suspended a student (with forfeiture of his $14,000 tuition and all credit earned that semester) for insulting comments about (unnamed) school students and faculty posted on his blog. Their grounds are that such remarks constitute “professional misconduct in violation of the dental school’s Code of Ethics and Professional Conduct” and a violation of a rule against “stalking, hazing or harassments”.

A dental student at Marquette University has been suspended for the rest of the academic year and ordered to repeat a semester after a committee of professors, administrators and students determined that he violated professional conduct codes when he posted negative comments about unnamed students and professors on a blog.

Scott Taylor, the student’s attorney, said his client, a 22-year-old in Marquette’s School of Dentistry, was brought before the committee for a conduct hearing last week after a classmate complained about his blog, a Web site that contained musings about topics ranging from his education to videogames and drinking.

The focus of the hearing, Taylor said, were half a dozen postings including one describing a professor as “a (expletive) of a teacher” and another that described 20 classmates as having the “intellectual/maturity of a three-year-old.” . . .

In a letter to the student dated Dec. 2, Denis Lynch, the dental school’s associate dean for academic affairs, said the committee had found the student “guilty of professional misconduct in violation of the dental school’s Code of Ethics and Professional Conduct.”

The student also violated a universitywide code that subjects students to disciplinary action if they participate in “stalking, hazing or harassments,” the letter stated.

In addition to informing the student of his suspension and his need to repeat his fall semester, which costs $14,000 in tuition, Lynch threatened the student with expulsion if he continued to post material on “any blog sites that contain crude, demeaning and unprofessional remarks.”

Interestingly, the dental school acted against the advice of one of the university’s own ethicists and (apparently) the dental school’s own bioethics director:

Daniel D’Angelo, an adjunct associate professor of behavioral sciences in School of Dentistry, agreed. He reviewed the student’s blog entries at the request of his parents before the conduct hearing. D’Angelo, who is a co-director of Marquette’s Ethics and Professionalism curriculum, determined that the postings did not justify disciplinary action.

“What he wrote was imprudent, immature and oftentimes distasteful,” D’Angelo wrote in a letter to Anthony Ziebert, a professor who chaired the student-faculty review committee that heard the case. “But no matter how much I or anyone else find these entries, rude, distasteful and imprudent, it doesn’t make these entries unethical or immoral.”

D’Angelo said he made the decision after consulting with the director of bioethics at the Medical College of Wisconsin [Robyn S. Shapiro, JD] and a legal ethicist.

The dental school notes that they have disciplined this student, while other students with potentially offensive blogs have gone unmolested, because students in the professions are held to distinct codes of ethics that general students are not. And they have a point there. But the standards apparently incorporated in their professional code are – like so many professional codes of ethics – indecipherably vague. (For one thing, the committee that relied on these professional standards to discipline this student also managed to find him guilty of “stalking, hazing, or harassments” for the same blog posts – which is asinine. There is no apparent reason why their findings under the professional code should be regarded as any more reasonable.) As with most such “standards of professionalism” actions, the code appears merely to be a convenient excuse for controlling behavior the enforcers find distasteful or embarrassing.

This incident underscores the problems with vague and broadly-worded codes of professional ethics, and more generally with the notion of “professional standards” as a substantive ethical concept. It also points up the ways such concepts can be used punitively and to enforce conformism. One can certainly make a case that juvenile behavior is not in keeping with membership in a responsible profession. But it is surely far from coincidental in this case that the behavior that prompted punishment was explicit criticism of the university – the student would almost undoubtedly not have been punished if he had criticized the faculty of another school, or merely exhibited immature behavior in another sphere (say, excessive drinking or sexist jokes). It’s too much to imagine that a sincere concern for professionalism motivated this action.

So, how can we hold students and trainees to professional standards if (a) we cannot articulate a set of clear and explicit standards that meets consensus among professionals, (b) we cannot distinguish unprofessional behavior from mere bad behavior, and (c) we cannot trust ourselves to impose professional standards in a reasonable and disinterested manner?

One answer is to jetison the concept of professional standards as traditionally understood, and simply adopt explicit codes – statutory, perhaps – of required and prohibited behavior. This would take “professionalism” out of the hands of the professions, making them just another regulated industry and eliminating one central sphere of authority that has traditionally marked them as professions. But this may not be such a bad thing, and it may also be the only honest way to resolve conflicts such as are present in this case. (It would also resolve conflicts over such matters as “conscience clauses”, wherein professionals demand the right to impose barriers to professional service on grounds of “professional ethics”. If we addressed this through the law rather than the professions, at least we’d have a clear answer, yes or no, as to whether they should be allowed to behave in that way.)

I am not pleased to see professional students behaving like silly frat boys. But I’m even less pleased to see them failing to wash their hands between patient visits, bringing their racist and sexist attitudes into the treatment environment, and imposing their beliefs and preferences on their patients – all lapses of professional conduct that are commonplace and never the grounds for disciplinary action. That a professional school can unilaterally fine a student $14,000, delay his education by up to a year, and threaten to destroy his career over insulting remarks suggests that “professionalism” may not be all it’s cracked up to be.

December 6, 2005

Pentagon Falsified Data on Adverse Incidents Following Non-Voluntary Anthrax Vaccinations

by @ 12:59 PM. Filed under Autonomy, Biotechnology, General, Global/Community Health, Healthcare Politics, Medical Science, Provider Roles

The Hampton Roads, VA, Daily Press is beginning a four-part series on a deliberate misinformation campaign by the Department of Defense regarding adverse health incidents among troops who were given controversial anthrax vaccinations.

The Pentagon never told Congress about more than 20,000 hospitalizations involving troops who’d taken the anthrax vaccine, despite repeated promises that such cases would be publicly disclosed.

Instead, a parade of generals and Defense Department officials told Congress and the public that fewer than 100 people were hospitalized or became seriously ill after receiving the shot from 1998 through 2000.

They also showed Congress written policies that required public reports to be filed for hospitalizations, serious illnesses and cases where someone missed 24 hours or more of duty.

But only a sliver of those cases were reported, while the rest were withheld from Congress and the public, records obtained by the Daily Press show.

Critics of the vaccine, veterans’ advocates and congressional staffers say the Pentagon’s deliberate low-balling of hospitalizations helped persuade Congress and the public that the vaccine was safe.

Keeping the actual number of illnesses secret contributed to a shorter list of government-recognized side effects for the drug, giving patients and physicians a false idea of what might constitute a vaccine-related illness or problem. Doctors are expected to know the full list of side effects and alert federal drug safety officials whenever they see a repeat of those symptoms.

Repeated evidence of the same adverse side effect after a vaccination is one of the most telling signs of a systematic problem with a drug or vaccine, as opposed to a coincidental relationship, vaccine safety experts say.

(It should be noted that these are all hospitalizations among people who had taken the vaccine. There is no reason to believe these are all due to effects of the vaccine. But that’s not the point.)

The comments that can and should be made about this are all too obvious. What’s depressing is that making them will have absolutely no effect – on this case, on future behavior by the Pentagon and the Bush administration, or on the right of citizens, including the military, to control their own healthcare and to exercise their liberty free of governmental control.

Hat tip: HealthLawProf Blog.

Moral Intuitions – An Empirical(?) Study

by @ 12:42 PM. Filed under General, General Science, Theory

A researcher from Georgetown U. Law School has published a paper arguing that data from studies of people’s intuitive reactions to “trolley problem” scenarios (a classic ethical hypothetical first posed by Philippa Foot, in which one has the option of either allowing a runaway trolley to hit a group of people in its path, or stopping it in a way that involves killing just one person who would otherwise have lived if you hadn’t intervened) demonstrates that they have similar sets of intuitive moral principles that reside below the level of cognitive awareness.

Aspects of the Theory of Moral Cognition: Investigating Intuitive Knowledge of the Prohibition of Intentional Battery and the Principle of Double Effect

Abstract:
Where do our moral intuitions come from? Are they innate? Does the brain contain a module specialized for moral judgment? Does the human genetic program contain instructions for the acquisition of a sense of justice or moral sense? Questions like these have been asked in one form or another for centuries. In this paper we take them up again, with the aim of clarifying them and developing a specific proposal for how they can be empirically investigated. The paper presents data from six trolley problem studies of over five hundred individuals, including one group of Chinese adults and one group of American children, which suggest that both adults and children ages 8-12 rely on intuitive knowledge of moral principles, including the prohibition of intentional battery and the principle of double effect, to determine the permissibility of actions that require harming one individual in order to prevent harm to others. Significantly, the knowledge in question appears to be merely tacit: when asked to explain or justify their judgments, subjects were consistently incapable of articulating the operative principles on which their judgments appear to have been based. We explain these findings with reference to an analogy to human linguistic competence. Just as normal persons are typically unaware of the principles guiding their linguistic intuitions, so too are they often unaware of the principles guiding their moral intuitions. These studies pave the way for future research by raising the possibility that specific poverty of the stimulus arguments can be formulated in the moral domain. Differences between our approach to moral cognition and those of Piaget (1932), Kohlberg (1981), and Greene et al. (2001) are also discussed.

Mikhail, John, “Aspects of the Theory of Moral Cognition: Investigating Intuitive Knowledge of the Prohibition of Intentional Battery and the Principle of Double Effect” (May 2002). Georgetown Public Law Research Paper No. 762385

Without reading the whole paper, it’s hard to tell exactly what argument is being made here. However, this seems to me to smack of the common sociobiological strategy of observing a behavioral pattern and then asserting that the fact that it is common proves it must have a biological origin. In particular, statements such as “data from six trolley problem studies . . . suggest that both adults and children ages 8-12 rely on intuitive knowledge of moral principles” implies both that there are such things as intuitive moral principles and that they are relied on in making the decisions the respondents make to the problems. But even if moral responses are hardwired, as sociobiologists tell us, and even if these responses cover such scenarios as the trolley problem, it is unlikely they take the form of “principles” except in the sense in which they result in behavior patterns that could be predicted by reference to moral principles. That is to say, the brain doesn’t work by way of principles, but by way of a network of mutually-reinforcing weighted signals; there is no more “principle” consulted by the brain in adducing an intuitive response to a moral problem than there is a rule saying “be aroused by attractive persons” that results in sexual excitation, or a rule that says “swing now” that results in hitting a baseball.

It is common to describe empirically-observed behavior as if it was rational-rule-driven (“the subordinate ape engages in submissive posturing to avoid conflict with the dominant ape”), but this has to be understood as an abstraction from the actual phenomenon in question. That’s fine in most cases. But when you are attempting to infer, from observed behavior, general behavior-guiding principles for the purpose of establishing a behavior-guiding system of principles, i.e., a moral theory, then the reification of the “principle” analogy becomes a problem.

It seems even more apparent that that is what Mikhail is doing when he says “Just as normal persons are typically unaware of the principles guiding their linguistic intuitions, so too are they often unaware of the principles guiding their moral intuitions.” Again, the assumption is made that “principles” are somehow consulted in the brain, both to produce effective linguistic behavior and to drive intuition-guided responses to moral scenarios. But they are not. In the linguistic case, the inference of principles contributes to the development of a theory that describes how language can be said to work – as long as we don’t believe the brain actually works by way of the same rules that structure the theory we use to describe what the brain does. In the moral case, however, we construct moral theories not to describe human behavior, but to prescribe it. Mikhail is observing behavior to craft a rule-based system to model that behavior, which he then apparently regards as the correct system for determining that behavior where it is not automatic (e.g., among persons with “defective” intuitions, or in scenarios that do not immediately generate any governing intuition).

This is a perilous enterprise for two reasons, one obvious and one less so. The obvious one is a variation of the “is/ought” problem – the fact that certain behavior is what people do has nothing to do with whether it is what they ought to do. The less obvious reason is the one I have been emphasizing above: it is a form of circular reasoning to assume the brain works by way of moral principles, infer those principles from the way the brain works, and then declare that those are the principles by which the brain ought to work. And, aside from circularity, it is false on its face because the brain does not work by way of principles except in a metaphorical sense.

There is certainly a place for prescriptive moral principles – it is the place of normative ethics. But we must find or create the right ethical principles ourselves – not merely observe them in the modal intuitive responses of random persons to moral hypotheticals. Those responses neither encode moral principles nor establish moral norms. The local maxima of psycho-physiological signalling networks, Mr. Mikhail, are what we are put on this earth to rise above.

Hat tip: HealthLawProf Blog (in an interesting roundup of articles on “the principle of double effect” in various contexts).

December 5, 2005

Hawaiian Supreme Court Invokes “Personhood” Standard in Fetal-Death Case

by @ 7:08 PM. Filed under Autonomy, General, Healthcare Politics, LGBTQ Issues

The State Supreme Court of Hawaii has taken a refreshing approach to fetal-injury issues by squarely confronting the question of fetal personhood as a pre-requisite to any finding of legal liability for harm to a fetus. Specifically, in a case involving a woman who admitted using methamphetamine shortly before giving birth to a baby who died two days later from the effects of meth, the Court held unanimously (though with three separate opinions) that the fetus prior to birth is not a legal person, and thus the woman cannot be convicted of manslaughter – there being no “man” in question at the time of her actions leading to the death of the baby.

The main opinion in the case makes for good reading. It offers an interesting survey of practices on this issue nationwide, noting that most jurisdictions do not allow prosecution of pregnant women for harms to the fetus accruing prenatally, but that most jurisdictions do allow such prosecutions against third parties (other parties who injure the woman while she is pregnant). It then goes on to note that the ABA Model Penal Code requires that “the defendant’s conduct must occur at a time when the victim is within the class contemplated by the legislature” – meaning that the victim must be the kind of entity covered by the law, at the time the alleged crime occurs, for the results of the action in question to count as a crime against that victim. And since a fetus is not a legal person, acts against a fetus are not crimes against a person (except where expressly stipulated to be so by legislation, as many states have done).

Having established that the offense of reckless manslaughter contains a conduct element and that the conduct must be directed against a “person,” the final sub-issue is whether the HPC’s definition of “person” includes a fetus. We hold that it does not.

According to HRS § 701-104 (1993), “[t]he provisions of [the HPC] cannot be extended by analogy so as to create crimes not provided for herein; however, in order to promote justice and effect the objects of the law, all of its provisions shall be given a genuine construction, according to the fair import of the words, taken in their usual sense, in connection with the context, and with reference to the purpose of the provision.” . . . Thus, in the present case, we interpret the relevant provisions of the HPC in accordance with the foregoing maxims of statutory construction.

According to the “fair import of the words, taken in their usual sense,” HRS § 701-104, a fetus is clearly not one “who has been born and is alive.” HRS § 707-700. The plain language of the statute is clear and unambiguous, and therefore we need not go any further

A concurring opinion by Justice Acoba puts it precisely (and even invokes “strict construction” to explain why expansive reading of “person” cannot be permitted):

[A]t the time of [the] offending acts there is simply no person (i.e. one who has been born and is alive) in existence as to whom the conduct can be said to have been directed. . . .

[A] strict construction of the statute would preclude the interpretation that HRS § 707-702(1)(a) applies when a woman’s prenatal conduct causes injury to a fetus later born alive. [emphasis original]

Much of this case hinges on the fact that Hawaii law expressly defines a “person” as “a human being who has been born and is alive.” Thus, the dispute was a somewhat technical one over whether certain acts – that would be crimes if perpetrated on “persons” – constitute crimes when perpetrated on beings who are not persons under the legal definition but who later become persons and then suffer from those acts. This decision thus provides little protection against the growing wave of inflation of fetal legal standing and protection. The coordinated move to write fetal protection into every possible aspect of the law is sweeping away the long-standing common-sense definition of fetuses as non-persons, and this decision will not roll back that tide.

However, it is worthwhile to see the Court taking seriously this distinction anyway, and to see that there is still room within the law for a more reasonable view of the relative moral standing of persons and fetuses, especially of women and the fetuses who inhabit their bodies. I suspect this case will spark a backlash (already visible in the right-wing blogosphere) in the direction of granting personhood to fetuses in Hawaii and the other fiew states in which this is not yet done. But for now, Hawaiian law seems to recognize an obvious biological fact, which puts prenatal there on a much-welcome footing.

Canadian Pharmacies Creating Database of Women’s Sexual Practices as Prerequisite to Dispensing EC

by @ 6:30 PM. Filed under Access to Healthcare, Autonomy, General, Healthcare Politics, Provider Roles, Reproductive Ethics, Sex, Women's Issues

The Toronto Star reports that Candian pharmacies are requiring women to fill out questionnaires about their sexual activity, sexual history, and pesonal identifying information – to be stored permanently in the pharmacy computers – before dispensing emergency contraception. They charge an extra fee for this non-optional service, doubling the cost of the prescription. They claim the information is to be used to monitor women’s patterns of use of EC “for counseling purposes.”

Canadian pharmacists are being advised to collect a woman’s name, address, phone number and sensitive details about her sexual activity before dispensing the so-called morning-after pill.

The guidelines, put out by the Canadian Pharmacists Association, have drawn concern from women’s health groups, which say the rules are discriminatory and raise privacy issues. . . .

Janet Cooper, senior director of professional affairs for the pharmacists’ association, said the information is necessary to determine whether the pill will be used appropriately and effectively, since it doesn’t work if taken more than three days after intercourse.

She said the information is to be kept in the pharmacy’s computer “so that if she came in a month later for another one, that would mean she probably needs to be advised to get better contraception.”

The medication is OTC in Canada, so pharmacists are the most direct source of information about its use. But the need to ensure informed decision-making has nothing to do with requiring unrequested “advice to get better contraception”. And the informational program is highly intrusive, while storage of the information for lookup on the pharmacy computer is simply creepy. (There is no explanation of how this information will be protected or who will have access to it.)

Health Canada moved the emergency contraceptive levonorgestrel, or Plan B, from being a prescription to a behind-the-counter drug in April, making it available to women of any age. A woman is required to ask the pharmacist for it so she can be counselled about its use.

The pharmacists’ association immediately posted guidelines on its website. They include giving women a screening form to fill out that asks for personal identification, the time when they last had unprotected sex, the number of times they have had unprotected sex since their last menstrual period, and what form of birth control they use. The information should be stored in the pharmacy’s computer, the guidelines state.

“These are highly personal, interrogative questions, and it’s disturbing,” [Anne Rochord] Ford [a drug-safety activist]said. Women taking this pill are already under stress, and “the last thing they need is this kind of interrogation,” she said.

“We are a bit stumped why they have gone to this degree,” she said. “This is just so over the top, unnecessary and unproductive.”

Most pharmacies don’t have a private place to counsel women, so it must be done in public.

It should be up to the woman to ask for advice about taking it, Ford said.

Canada has not been as plagued with right-wing hysteria over sex as has America. It would be sad to see the kind of hostility and intrusiveness that US women face in getting their sexual-health needs met start to take root up north. Let us hope this is just a bad idea, not the beginning of yet another war on women.

December 2, 2005

Developing Criticisms of French Face Transplant

by @ 6:29 PM. Filed under Access to Healthcare, Autonomy, Biotechnology, General, Medical Science, Provider Roles

When it was announced earlier this week that a French surgical team had performed the first partial face transplant, there was widespread commentary. The face-transplant issue is one that has gotten a lot of attention lately as several teams around the world have announced they are moving toward the procedure. AJOB devoted a special issue to the subject just a couple of months ago.

The problems with face transplants are manifold: the procedure is highly intricate and may have limited success in producing realistic facial muscle control; the risk of rejection raises the horrifying possibility that a patient could sacrifice a damaged facial surface for, literally, no face at all; there is the difficulty of complying with a lifelong regimen of immunosuppressants, with no alternative option in the case of a face transplant (there is no “fallback” position for patients who do not tolerate the drugs); and many have also raised the question of the patient’s psychological reaction to altered facial appearance. (It is understood that the patient will look more like their old self than like the tissue donor, because it is the underlying architecture that contributes most to appearance, not the outer tissue – but there would certainly be changes in appearance that could carry great psychological weight, given the emphasis people place on facial appearance.)

For all these reasons, ethics committees have demanded a “go-slow” approach, and the surgical teams contemplating these procedures have undertaken extensive pre-screening of possible candidates for the first such procedure. Now the news from France is that a partial face transplant has been performed on a patient who was disfigured and disabled by dogbite, but who was only 6 months past the accident itself and on whom no conventional reconstructive surgery had been attempted. This has raised questions whether this case was appropriate for such a radical therapeutic procedure. The New York Times reports:

Surgeons in France have for the first time performed a partial face transplant, a surgeon who led one of the two teams that performed the operation said yesterday.

The recipient of the transplant was a 38-year-old woman who had been severely disfigured in an attack by a dog, said the surgeon, Dr. Jean-Michel Dubernard of Lyon. The operation was carried out in Amiens on Sunday.

In a brief telephone interview, Dr. Dubernard said the two surgical teams had grafted a nose, lips and chin from a donor who had been declared brain dead onto the woman’s face. . . .

Face transplants are among the most disputed frontiers in transplantation science because they are so risky and no one can say what a patient will look like afterward.

Ethics committees in France and England have rejected proposals to perform full face transplants until more research is done. The committees were concerned about the unknown risks of the long-term use of large doses of immunosuppressive drugs for a procedure that does not save lives. The aim of face transplants is to improve the quality of life for patients who have suffered severe injuries from burns, accidents and shootings, for example.

The French committee did approve partial face transplants of the type performed on the woman in Amiens. But the committee cautioned in a report last year that even a partial transplant – the mouth and the nose, for example – was “high-risk experimentation.” . . .

The relatively short interval of about six months between the dog bite and the surgery raised questions among some experts about what, if any, efforts had been made to perform reconstructive surgery first. “The major question is: what were the indications” for the transplant, said Dr. Maria Siemionow, a surgeon at the Cleveland Clinic who plans to perform a full face transplant.

Dr. Laurent Lantieri, a surgeon who was not directly connected with the French woman’s surgery but who has reviewed some of her records, said he was puzzled about why she was put on the list for a face transplant in June or July, so soon after she received her injuries. Dr. Lantieri has published articles about his intention to perform partial face transplants, and was a consultant to the ethics committee in France that approves such procedures.

Face transplants, the committee said, should not be performed on an emergency basis. One reason, it said, is because “the very notion of informed consent is an illusion,” even if all standard techniques have been exhausted, a candidate patient insists on receiving the transplant and a donor is available. “The surgeon cannot make any promises regarding the results of his restorative efforts, which are always dubious,” the committee said. The report continued, “Authentic consent, therefore, will never exist.” . . .

Dr. Lantieri said he had reviewed a summary of the woman’s medical record and examined a photograph of her damaged face. The woman’s type of injury seemed consistent with proposals to do a partial facial transplant, he said. “She had very strong psychological problems,” Dr. Lantieri said. “I said I would not go further if I did not have more examinations by additional psychiatrists to know that she would be able to pursue lifelong immunosuppression therapy.” Dr. Lantieri said he believed that Dr. Dubernard “wanted to be first” to do a face transplant, as he had done a hand transplant.

However, the AP notes today that:

An ethics debate broke out over the world’s first partial face transplant Thursday with one surgeon challenging the decision to operate, while others suggested a bit of jealousy might be at play.

At the same time, several doctors raised concerns about the psychological health of the French woman who received a transplanted nose, lips and chin on Sunday. She had been brutally mauled by a dog in May, and her identity remains unknown.

Dr. Laurent Lantieri, an adviser to the French medical ethics panel, said the surgeons who operated violated the panel’s advice because they failed to try reconstructive surgery first. He said a transplant donor was immediately sought without trying to repair the woman’s face with more conventional surgery.

Lantieri, who had seen a picture of the woman, said, “She had a complete amputation of both lips. The tip of the nose was amputated.” Her new donated facial parts came from a brain-dead woman whose family gave consent.

The panel had previously objected to full face transplants but said partial ones could be considered under strict circumstances, which included first trying normal surgery.

“The ethics committee said this kind of transplant should never be considered as an emergency procedure,” Lantieri said.

However, surgeon Denys Pellerin, of the National Consultative Ethics Committee advised by Lantieri said, “as long as the transplant is not total, it is not unethical.”

And Dr. Jean-Pierre Chavoin, secretary general of the French society of plastic surgery, noted that Lantieri had planned to do a face transplant himself and had been beaten.

Carine Camby, director general of the agency under the French Health Ministry that coordinates organ procurement, said normal reconstructive surgery could not have been used in this case.

“It is precisely because there was no way to restore the functions of this patient by normal plastic surgery that we attempted this transplant,” Camby said. “She could no longer eat normally, she had great difficulty speaking and there is no possibility with plastic surgery today to repair the muscles around the mouth which allow people to articulate when they speak and not spit out food when they eat.”

There are certainly grave questions to be considered about this case, but I suspect, too, that this is something of a manufactured controversy. Outside doctors weighing in on the psychological state of patients they have not met, while challenging the treating physicians’ clinical judgment in light of their own preconceptions about the propriety of the treatments . . . where have we seen that before? Did the Schiavo case teach us nothing? Uninformed second-guessing of patients’ (direct or by-proxy) decisions out of personal prejudice should be a thoroughly discredited procedure by now – but apparently anyone is free to inject their opinion into others’ healthcare decision-making if they masquerade a sufficient degree of outrage.

As for the question of unfavorable outcomes, I do not minimize the difficulties these procedures give rise to. I am puzzled, though, by the French board’s claim that “authentic informed consent will never exist” in these cases. Their reason – that one cannot predict outcomes exactly – is applicable to any risky procedure of any kind, and would tend to the conclusion that true consent can never be given in any case – if one believes that predicting outcomes is a prerequisite to an informed consent to undergo a treatment. But, of course, the risk of the procedure is part of what one consents to when one gives consent, and that risk consists, precisely, in the fact that the possible outcomes are various and unpredictable.

It’s true that there are different types of unpredictability: the kind that arises from not knowing which of several possible outcomes – e.g., cure or death – will result, and the kind that arises from not knowing what some of the various possible outcomes would even be like – e.g., how one’s face will look after a transplant, or how bad a ventilator really feels. The French committee may be pointing to the fact that, in face transplants, we not only do not know whether the transplant will be successful or not, but we do not know what it will be like even if it is successful. But this, again, is a familiar uncertainty – exactly the same problem attends most major decisions, including, for instance, getting married, choosing a career, or having a diseased organ resected. We find that our chosen futures often turn out differently from our hopes and expectations – with experience, we even learn to take that fact into account, and to discount our expectations when weighing alternatives in making major decisions. But nothing about this undercuts our right to consider and accept these risks if we choose, or invalidates the decisions we make about them.

Informed consent is not a matter of choosing between carefully-explained outcomes with perfect certainty, or even of choosing the relative risks we are willing to undergo of differnt, easily-predictable outcomes . It is a matter of choosing between the available alternatives, using as much knowledge as is available about, and relevant to, the decision at hand. Often, such choices focus on the relative risks of outcomes that themselves each harbor some degree of variability, or some range of possible manifestations. But such is the stuff of life: you can choose to vacation in the mountains or at the sea, but you cannot know in advance whether it will snow in the mountains or rain at the seaside. Perhaps you prefer the sea to the mountains, but only if it does not rain – all you can do is work out, and rank-order, the desirability of all the possible outcomes, acknowledging that you have no control over which will come about, but there is no reason you cannot make a rational choice among them even if you cannot control them. You must choose the alternative that seems most likely to please you, taking into account the uncertainties that will remain after you have made the choice. We do this every day. We can do it, if we choose, with more personally-fraught decisions. We cannot eliminate risk from the choices we make, but we can make rational choices about risks. The French committee seems to think that informed consent requires the former, but it has never required more than the latter.

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