Sufficient Scruples

Bioethics, healthcare policy, and related issues.

January 11, 2006

FDA “Plan B” Suit Continues

by @ 3:19 pm. Filed under General, Women's Issues, Access to Healthcare, Reproductive Ethics, Sex, Biotechnology, Healthcare Politics, Medical Science

Medical News Today reports that the lawsuit by the Center for Reproductive Rights against the FDA to force OTC sales of “Plan B” emergency contraception - against the FDA’s lengthy stalling tactics - can continue. The Bush administration had argued that the Center had no standing to file suit (i.e., it wasn’t a pregnant woman), but:

[Federal Judge Edward] Korman disagreed with Amanat, saying, “There’s a serious issue here as to whether [FDA is] acting in good faith”

This suit is separate from an attempt on the part of the Wisconsin Attorney General to force the FDA to release Plan B under a different legal theory.

The legal issues surrounding this case are somewhat muddled - whether anyone can sue the government because it is running inefficiently, without a showing of direct harm, is a novel question. (Surely the FDA’s behavior in this case has been execrable, but it makes equal sense to, say, sue the Post Office for being slow, sue the EPA for being useless, and sue NASA for constantly blowing up their own rockets. Citizens have an interest in seeing those agencies perform their duties conscientiously and effectively, just as they do with the FDA - so why cannot we sue them all?) However the legal issue falls out, though, the country does have a huge stake in not having its science-based policy-making apparatus corrupted by ideological or religious zealots. There are avenues for inserting political values into science-related policy, but to have the underlying science itself distorted, or simply swept aside as in the case of Plan B, leaves the community with no protection against patent dangers that require careful and accurate evaluation.

Time and again the Bush administration has not merely ignored scientific fact, but deliberately poisoned science itself, on the issues of globabl warming, pollution, reproductive health, forestry management, endangered species protection, toxic waste, and almost anything you can name. They have lent the weight of the government itself to an entrenched assault on factual reality by the religious right wing and the corporate world - the battle to invalidate science so as to avoid accountability for the scientifically-provable harms they cause with their values and policies, or the scientific falseness of their beliefs. (Michael Behe testified in the “intelligent design” schoolbook trial that “science” does not require a focus on natural phenomena - that it could embrace astrology or . . . oh, say . . . religion as well as confirmable facts. The Kansas state school board almost immediately thereafter redefined science in precisely this way. This is the intellectual standard to which the ideological right adheres.) The greatest incursion has been in the area of sexual health policy, where not merely misguided policies such as “abstinence only”, but sheer distortion of fact regarding sexual and reproductive issues, permeates Bush administration policy-making. Judge Korman grossly understates the issue: there is little question that the FDA has not been acting in good faith on Plan B, but has been carrying out a calculated campaign of obfuscation and foot-dragging - including an outright double-cross on its promise to two Senators that action would be forthcoming on the certification - for a period of years.

Whether lawsuits like this one are the appropriate resolution of this case, some resolution is necessary. Whatever policies and values the incumbent administration may bring to government, the country has a right to expect its governmental bodies will act fairly, professionally, and in a forthright manner - that they will not lie to citizens or other members of government, falsify or distort the factual basis on which policy is made, or run roughshod over their own operational procedures (or the Constitution, it should pointedly be noted in respect of many Bush policies) to ensure the outcome they unilaterally prefer.

Standards of Care: Heavy Hangs the Head that Wears the Crown

by @ 11:10 am. Filed under General, Autonomy, Provider Roles, Healthcare Politics, Theory

Maurice Bernstein, MD, at Bioethics Discussion Blog, raises the question whether the standard of care changes in respect of a patient’s perceived public responsibilities. We are all familiar with “VIP care” - the extra attention, special privileges, and more-aggressive treatments that well-kn0wn or influential patients get, sometimes to their disadvantage. Such practices often arise in the context, as above, of “extra” care or privileges for the privileged, or in the context of scarcity, in which some patients are favored in the treatment lottery over others (as in the early use of “social worth” criteria for determining access to kidney dialysis machines). There has been much negative commentary on this tendency. Bernstein is asking a different question, however: whether the approach to treatment should be different for someone with important responsibilities, for instance to keep them alert longer but at a greater risk of death, to maintain the appearance of health rather than debility for PR purposes, or to help them manage some looming crisis.

If other factors are equal, such as ability to afford the medical care, should standard and accepted therapy be trumped by a “do everything and anything” attempts at therapy simply because the patient is a king or a prime minister and not a plain citizen?

Note that Bernstein is not talking about extra resources under conditions of scarcity - he is talking about a presumptively aggressive treatment strategy when the patient is a high public official. The idea, presumably, would be that prolonging that person’s life would be worth almost any hardship or risk, because they have public responsibilities or personal political goals that private patients would not have. (I’m not sure why Bernstein assumes the “different standard” would be a more aggressive standard in all cases. As I suggest above, there may be different ways of serving political patients’ goals other than aggressive treatment - trading more consciousness for shorter lifespan, for instance, or sacrificing health for false energy in the short term. But the general point is clear enough.)

From the perspective of patient autonomy, the issue is simple: if the patient has goals that are dictated in part by their political role or responsibilities, it is far from irrational for the patient to act toward those goals. And healthcare, on the strong-autonomy model, is guided by the patient’s goals and values. Presumably Teddy Roosevelt’s doctors didn’t want him grandstanding on the campaign trail and repeatedly bursting open his stitches from a failed assassination attempt, but the crowds ate it up and Roosevelt seemed to like doing it. Whose business was it but his? Similarly, if a dying leader needs an unhealthy but opportune shot of stimulant to make a last TV appearance, whose business is that? We often speak of the elderly vent-dependent patient who wants to hang on just long enough for the family to gather around them, or for a grandchild to finish school - and easily endorse those heartwarming goals as valid determinants of aggressive treatment in otherwise-hopeless cases; there is no principled reason not to take the same stance toward the cagey old pol who wants to hang around long enough to swing one more election or launch one more plot.

And, considering the patient’s role itself, clearly a strong argument can be made that leaders must sometimes take risks that ordinary citizens may avoid. It was considered commendable for the British royal family to remain resident in London during the WWII Blitz, even as many citizens fled to the countryside. Similarly, leaders may sometimes need resources and protections that ordinary citizens do not have. Few begrudge the special travel and security arrangements enjoyed by high political leaders, even though ordinary citizens have just as much right to safety and no similar indulgences. In short, leaders’ lives and the burden of risk and privilege they enjoy are different from those of regular citizens, for reasons that make sense. And if this is so in so many other areas of their lives, why should it not be so in the case of healthcare as well?

Alternatively, from an objective “normal species functioning” model, there is nothing about leaders or VIPs that makes their bodies work differently from others’, so there is no reason to change the preferred treatment in their cases. Ordinary patients’ treatment decisions are not made by reference to their social responsibilities or how they spend their time outside the hospital - these issues have little bearing on physiology - and there is no greater reason to make decisions that way for VIPs. We would expect purely evidence-based standards of care for all patients if this decisionmaking model is the one we endorse.

The question thus becomes not one of whether there are any good reasons for treating leaders differently from other citizens, but whether we conceive of healthcare as the sort of thing - among many others - by way of which we do treat leaders differently. In other words, it is a question of what model of decisionmaking we adopt for healthcare. And this question is a familiar one - a mainstay of introductory bioethics courses everywhere. Autonomy-centered models, or “holistic” (for want of a better word) models that see the patient situated in their life context, clearly accept political goals as equally-valid patient values as the more homey ones of private citizens. Only a model of decision-making that grants healthcare providers veto power over patient goals can reject political goals as determinants of treatment.

This discussion takes it as granted that a “standard of treatment” does not equate to mandatory treatment - that a VIP or politician who did not want exceptional care would be entitled to decline it. But there is one final consideration: Bernstein’s question seems to imply that aggressive or life-prolonging treatment, as a standard of care for VIPs, would be the presumptive mode of care even if not mandatory. That is, that VIP patients could opt out of aggressive treatment, but would otherwise be expected to accept it by virtue of their social role.

This presumption is difficult to situate in a patient-centered ethic of care, because, in such a context there essentially is no standard of care, or at least no presumptive treatment in any given situation. Clinical facts do not dictate treatment decisions if the patient’s goals and values are truly decisive - not even in seemingly obvious cases, because the patient may still always have some divergent values that favor a different treatment path. This, essentially, is the autonomy-based defense of non-standard treatment for VIPs, above: that their values incorporate political goals that private citizens do not have, and thus lead to treatment decisions different from those of the average private citizen. But if so there is no need to adopt a “standard of care” that presumes, or even permits, aggressive treatment for VIPs, since autonomy-centered care simply interrogates each patient in each situation and then authorizes aggressive care for those who desire it, VIP or not, and supportive care for those who desire it, VIP or not.

So it seems that even asking the question what the standard of care should be presumes a non-autonomy-based decisionmaking model. That raises the spectre that, not only would VIP patients be given more aggressive treatment when they want it, but they could conceivably be required to take it when they do not, as part of their duty to their country. (Similarly to the non-legal but presumptive obligation of Presidential candidates to reveal their health records.) Caregivers for VIP patients would be seen as serving the public good rather than their patients’ interests. (This suggestion has been made regarding Presidential physicians’ concealing of their patients’ health threats, but it has not yet been made, to my knowledge, regarding actual treatment modalities for VIP patients.)

This would be not merely a different standard of care for such patients, but a different ethic and decisionmaking model entirely for their care. That seems like quite a stretch to be making.

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