A Bioethical Perspective on Oklahoma’s New Abortion Law

The percentage of college educated Americans who support legal abortion seems to have reached a new low among women under thirty and among the population as a whole,  so it should be no surprise that states are passing laws to restrict safe abortions. Before performing any abortion Oklahoma’s new 2010 law requires that the doctor do an ultrasound and describe to the woman the dimensions and gestational age of the embryo, cardiac activity if any, and appearance of external and internal structures.  A vaginal transducer must be used when doing so will display the embryo more clearly than an abdominal transducer.  Oklahoma’s law thus requires doctors to perform an ultrasound that is not medically indicated and likely to be invasive. In this era of skyrocketing medical costs and overutilization of services the new law mandates more of the same while leaving the burden of payment to the women themselves.

U.S. law requires that informed consent be obtained for treatments and diagnostic tests. This means that accurate and relevant information must be disclosed to patients. If current standards of disclosure and informed consent apply then the description of the fetus must include evidence about embryology including clinical and scientific uncertainty about when consciousness, thoughts, sensations, and life begin. This is more than some of the other commentators who are in favor of the law are advocating. Providing abortion without truthful disclosure and informed consent violates existing laws, threatens the doctor-patient relationship, and jeopardizes medical professionalism.  Mandating ultrasound, especially with out disclosing all the information -- especially where the law protects the doctor against deliberate failure to disclose --  means ignoring the need to obtain informed consent. One wonders how such a poorly crafted law ever reached the legislature. Indeed, as a result of legal challenges to the new law an Oklahoma judge has just granted a slight reprieve by delaying implementation for 45 days. 

[Guest blogging this week is Cheryl Cox Macpherson, Ph.D., Professor and the Chair of Bioethics Center at St George's University School of Medicine (SGU) in Grenada where she enjoys teaching medical and graduate students from many nations and background.]

Governor Spitzer--in this Blog?

While the current political trials of Governor Spitzer may at first appear to have no place in this Blog, a small item in the news, which is being discussed in the Feminist Law Professors Blog, caught my eye as well. Apparantly one of things caught on tape is a conversation with the woman, "Kristen", who met with Client 9--allegedly Gov. Spitzer. The New York Times reports that "After her encounter with Client 9, the prostitute told the booker for the agency that it had gone well, and the booker told her that he, in an apparent reference to Client 9, sometimes asked the women “to do things that, like, you might not think were safe.” (Link here)


While this could mean many things, it most likely means he didn't want to wear a condom. As a result, he exposed Kristen, and any other women he slept with, to the full range of STI's (including HIV and HPV) as well as unwanted pregnancy. In an interesting example of perhaps unintended coordination, another story on the NY Times' front page reports a study that 25% of U.S. teenagers (including 50% of African American teenagers) test positive for sex infections which is leading to the conclusion that treatment of boys (including vaccination against HPV) and men must be part of an effective public health strategy.

I do not believe that prostitution should be legalized. However, if there are situations where it is a transaction between consenting adults, and therefore ethically unobjectionable, there is no information here that indicates this is one of those situations. First, we only assume that Kristen is a U.S. citizen who can voluntarily leave this line of work. This is often untrue of sex workers in the U.S. There are increasing reports of foreign women lured to this country with the promise of jobs and then finding themselves forced to be sex workers. Moreover, the link between prostitution and drug addiction has been shown again and again. Is this a sound foundation for informed consent?

Moreover, whether or not it would ever be ethical to allow a sex worker to consent to exposure to an STI could there ever be informed consent by the spouse, or other partners, of a man who engages in this high risk behavior without her knowledge? (and all arguments hold the same however you would like to shuffle around the genders of the parties involved--there is quite a bit of male prostitution and it carries with it the same stigma of STI's and drug addiction).

Prostitution is a health risk for everyone, especially women, and just as we have ethical limits on the risks any individual can take, whether in the context of a drug trial or a risky surgery, we must consider them when the danger is not just to an individual woman who may or may not have consented but to all women who sleep with people who sleep with sex workers.
So is there a link between Governor Spitzer and women's bioethics? Absolutely there is and to the best of our knowledge, her name is Kristen.

Informed Consent in Clinical Medicine as a Concern for Ethicists

The always excellent Kaiser Foundation's Daily Health Report http://www.kaisernetwork.org/daily_reports/rep_index.cfm calls attention to a startling new research finding--apparently "most patients don't read the forms they sign before undergoing surgery or medical treatment." What I find interesting, though, is that the Wall Street Journal Article that Kaiser quotes from concludes that hospitals are studyng this in an effort "to improve their informed consent processes amid 'mounting concern about patient safety and lawsuits arising from botched communications.'" At least the priorities are in that order. As a lawyer/bioethicist is is always interesting to me to see that despite the visceral hatred doctors have for the concept of civilian oversight (which is an accurate description of the current medical malpractice system which relies on lay juries for final decision making)combined with a reflexive support of any "tort reform" legislation which makes it harder for patients to sue. This support is unrelated to realities that medical malpractice litigation is not a factor in rising medical malpractice rates.

And this is of special interest to women how? Because of two phenomena. First, because women are still battling for true informed consent when it comes to issues such as breast conservation surgery and caesarian sections http://blog.healthcommunicationresearch.com/search?q=women
and second because efforts to make it harder to sue for medical malpractice ("tort reform") are harmful to women. See Professor Linda Finley (Lucinda M. Finley, Female Trouble: The Implications of Tort Reform for Women, 64 Tenn. L. Rev. 847 (1997) [hereinafter Finley, Female Trouble]; Lucinda Finley, The Hidden Victims of Tort Reform: Women, Children, and the Elderly, 53 Emory L.J. 1263 (2004) .

While bioethicists think more about the ethical issues in the informed consent process of clinical research, in fact the informed consent issues in day to day medical treatment are just as important. Although it may seem as if consent for medical treatment is less problematic because unlike areas of clinical research where the interventions may not benefit the patient these interventions seem designed only for the patient's benefit, in fact medical care is not so simple. There is always a range of options when it comes to medical treatment and one of the least understood of these options (to patients at least) is the option of doing nothing. Another frequent problem is that patients are not informed of the range of options but only those options available through their doctor or health care center.

There is an entire field devoted to communicating with patients and this blog http://blog.healthcommunicationresearch.com/search?q=women
provides many interesting examples of how the way women receive information can impact their health care decisions.

It would be ideal if the kind of improvements to informed consent such as moving away from handing over sheets of typed paper to sign towards a more interactive process that included different ways of presenting information, could be made without any need for the penalties of either civil litigation or administrative fines. However, there is nothing in recent history to show that informed consent is such a basic good that it would always be a priority without these incentives.



I would encourage all of us interested in informed consent to think more about its role in medical treatment in general and women's health care in specific from the ethics or human rights perspective rather than just to see this as yet another imposition of the legal system on the already over-burdened health care system.


Wall Street Journal Examines Efforts by U.S. Hospitals To Improve Informed Consent Processes[Feb 06, 2008]
The Wall Street Journal on Wednesday examined how U.S. hospitals have begun to improve their informed consent processes amid "mounting concern about patient safety and lawsuits arising from botched communications." According to the Journal, researchers have found that "most patients don't read the forms they sign before undergoing surgery or medical treatment." In addition, more than "half of those who do read the forms don't understand them, and only a quarter of forms include all of the data patients need to make an informed decision," the Journal reports.In response, some hospitals have begun "offering explanatory videos and diagrams" to patients when they complete consent forms, as well as "translating medical lingo into simple English" and "offering materials in other languages" to explain medical procedures and provide information about alternative treatments, according to the Journal. Some hospitals also have begun to use new technologies, such as online databases that calculate the risk of medical procedures for patients before they complete consent forms and electronic forms to address problems with lost paper forms that can delay procedures and increase costs.CMS recently issued new guidelines that require hospitals to develop "patient-friendly" informed consent processes, and facilities that do not comply could lose their eligibility to participate in Medicare. The Joint Commission, which accredits hospitals nationwide, also has advocated improvements to the informed consent processes used by the facilities (Landro, Wall Street Journal, 2/6).

More on BioBanking

According to BBC news, the UK may allow researchers to clone cells from human tissues donated for research purposes ... without the express consent of the donor.

Supporters assert that being able to clone cells from diseased tissue (eg, from tumor or other pathology samples) would allow researchers to learn more about those conditions -- and could speed the translation of basic-science research into clinically beneficial knowledge and treatments.

Opponents comment that sidestepping informed consent -- particularly for cloning, which creates copies of the donor's cells -- is a plain violation of research participants' rights to decide whether to participate in such studies. And, given the range of public opinion regarding cloning, it is conceivable that some research participants would oppose the use of their donations for this purpose.

This is another version of the question I've blogged about with regard to biobanking: just what should be the scope of allowed activities under a "blanket" or "one-time" consent? Also, should the research imperative (and perhaps the common good) outweigh individuals' preferences ion such cases?

Biobanking, part 3: returning research results to participants

So: you've agreed to participate in a genetic study for health purposes, and (with or without your consent--see post #2 on biobanking) the data you've provided has been made available to the broader research community. A sample of your DNA is stored in a biobank, and researchers who have been vetted by the biobank owners are allowed to use that DNA in future studies.

The consent form you were required to sign at the time you agreed to participate in the original study stated that you would not be contacted by the research team with information about the results of the research, or of any testing or other processes they might perform as part of their study. "Ok," you thought--having been informed that most genetic research being done today isn't informative at an individual level and wouldn't be clinically useful anyway--"fair enough. I don't need the researchers to contact me with information I can't act on anyway."

Fast forward 20 years. The promise of genetic research is beginning to deliver. As research uncovers more information about how genetics interacts with environment and behavior, the DNA sitting in biobanks around the world is telling more tales than it used to. The DNA that was formerly mere data is increasingly yielding meaningful information about the health risks of individuals. So, in our imaginary scenario, let's say that--20 years after you consented to participate in a breast cancer study--researchers working on a different project discover that you carry a genetic mutation that has been definitively linked to Serious Medical Problem X.

Here are some of the questions this (not terribly far-fetched) scenario brings up for me. Do the researchers have a professional and/or moral obligation to share this information with you? Does it matter that the original consent form, which was written for a single study that the researchers truly didn't expect to provide individually meaningful information, said they would not contact you? What if the researcher contacts you with information that you didn't want? Might the researchers' obligation to re-contact participants depend on whether or not there are good risk-reduction or treatment options for Serious Medical Problem X?

Here's some additional reading for those who want to read more on return of results from genetic studies: here's a paper from the Social Science Research Network; recommendations of a working group at the National Heart, Lung, and Blood Institute; a nice list of refs from Stanford's Center for Clinical Bioethics; and the issue of the American Journal of Bioethics that features a target article and open peer commentaries on this topic.

Wanna read the first 2 posts on this topic? Here they are: 1 2

When is a Painkiller Not a Painkiller? A Patient's Right To Choose

Most patients trust their doctors. If prescribed a treatment, therapy or drug, many would not question the necessity, or authenticity of the physician's advice or prescribing strategy.

Indeed. In a study published this month in the Journal of General Internal Medicine, of 466 physicians surveyed at medical schools in the Chicago-area, 45% admitted to prescribing placebos to patients without the patient's knowledge, a practice striking at the very heart of Western medical ethics: informed consent.

Even more startling, one in five doctors admitted to actually lying to patients, claiming the placebos were medication, in clear violation of American Medical Association (AMA) guidelines, which directs its members to use placebos only if the patient is aware of and agrees to it.

Perhaps some might argue that the issue is not that significant--since placebos are viewed as harmless--but just how important is it? Particularly in terms of the doctor-patient relationship? Others might argue it raises major trust issues, and even a violation of patient rights.

See the full Time.com article here.

Religion of the Father?

AP reports that the Oregon Supreme Court has ruled that a 12 year old boy's preferences on whether or not to be circumcized should guide the decision in the dispute between his parents.

Excerpt:

The father, James Boldt, converted to Judaism in 2004 and wants the boy to be circumcised as part of the faith. The mother, Lia Boldt, appealed to the high court, saying the operation could harm her son physically and psychologically.

The state Supreme Court ruled that earlier court decisions failed to determine whether the boy wanted the circumcision, as his father contended, or opposed it, as his mother alleged.

The Supreme Court sent the case back to the trial court to answer that question.

If the trial court finds the child agrees to be circumcised, the Supreme Court said, it should deny the mother's requests. But if the trial court finds the child opposes the circumcision, the court has to determine if it will affect the father's ability to care for the child.

The custody dispute began when the child was 4 and the circumcision issue began three years ago when he was 9.

We have several interesting issues impacting this case. First: informed consent of the patient. Is a 12 year old mature and competent enough to make a decision about this permanent operation? There is a precedent in our society that denies non-medically indicated permanent procedures. For reference, most physicians deny elective sterilization operations to women even if they are of legal, consenting age (depending on the state, 25 is often used as a "no questions approval" cutoff).

Second, what is the nature of the circumcision procedure? Ought it be considered a ritual fully protected by free exercise of religion, or an elective permanent surgical procedure for non-health related reasons, thus violating the non-maleficence clause of the Hippocratic Oath? Note the sliding scale of the perceived magnitude of circumcision - from something akin to a piercing to mutilation of one's body and bodily function.

Third, the dispute between the parents should be considered carefully, and both parties' motives must be separated from what is in the best interest of the teenager. However, the "father's ability to care for the child" should not be used as a factor, as it should be categorically seen as a sign of unfit parenting to abuse or neglect one's child for not conforming to religious practice.

In my opinion, a case would be made for supporting such a procedure on someone not legally competent only if 1) there were a medical indication or 2) there were a time-sensitive factor to the procedure in terms of reducing side effects or discomfort. Thus, there is potential for supporting circumcision of infants over children or teenagers because some believe less pain is felt at that time (I do not endorse this position, I simply present it for argument) than would be felt later on. And there are rare cases where a circumcision is medically indicated in a child or a teenager due to developmental or other impairments.

However, this situation does not fulfill either criterion - a 12 year old does not have time-sensitive reasons for seeking a circumcision, there is no medical indication, and even the religious argument falls short due to the father's recent conversion. I do not see a reduction in suffering that would result from the operation occuring now or occuring six years from now, but the difference legally, cognitively, and ethically would be significant. Therefore, while I applaud the court's intent to look to the teenager's wishes, I do not feel that he is able to ethically consent to such a procedure at this time, and there should not be a circumcision until he comes of legal age of consent.

Addendum: Upon further reflection, I suspect that this is an attempt by the court to foist responsibility for the act (or non-act) onto the teenager so they do not have to risk appearing to be anti-religion. If so, that is an irresponsible course of action.

NYS Supreme Court Case Stirs Ethical Debate

As is being being reported in numerous outlets, the NYS Supreme Court will be hearing a civil case filed against NewYork-Presbyterian Hospital by a construction worker who underwent an involuntary rectal examination as part of his trauma assessment. The plaintiff is claiming assault, battery, and false imprisonment for being restrained, sedated, and examined against his wishes. The hospital's response, of course limited due to HIPAA requirements, is that the plaintiff was brought to the ER with head trauma, was combative, and needed to have severe head trauma ruled out. (Apparently a rapid way to assess injury to the nerves of the spinal cord is to check rectal sphincter tone.) The plaintiff resisted, was sedated, and when brought out of sedated, punched a doctor in anger, and was arrested for assault.

None of this in itself is particularly new or newsworthy; it is a continuing debate of what constitutes emergency care, standard care, informed consent, and what it means to have decision making capacity. These debates have been going on for years, and will likely continue for as long as any of us can envision.



No, the interesting thing actually comes from the commentary at City Room, the NYTimes local blog. Reading through the comments gives an eye-opening view into the way the general public perceives medicine, emergency medical care, and doctors. The most fascinating, and oft-repeated claim, is that if the patient (plaintiff) could be be arrested for assault, then he was obviously competent to decide his medical care - that, as one commenter put it,

if the patient’s competence is questioned regarding his ability to make an informed decision, then it’s inconsistent to charge that same incompetent person with assault.

Of course, the best retort to that (also brought up in comments) is that a drunk person is not competent to make decisions - yet is still responsible for the actions they take while drunk. (Also of note is that no one claiming specific background and training in medical ethics has spoken up in the thread. For those of you reading this, with the limited information available, what's your take on the situation?)

Obviously the message of personal autonomy and the basic idea of informed consent has permeated our society, but at a very simplistic level that might actually cause more misunderstanding and difficulty when treating emergency medical cases than potential good. The question becomes then, how do we increase the general knowledge level of the lay person while still emphasizing autonomy, while simultaneously acknowledging the education and superior knowledge of the physician without falling back on paternalism?

For anyone interested in this line of thought, the comments in that thread are well worth the read, and the contemplation.
-Kelly

Should Children be Vaccinated against Addiction?

blog.bioethics.net points to an article in Time on the new "cocaine vaccine" and asks whether it should be given preemptively to children.

Basically, the "cocaine vaccine" works by stimulating the body to produce antibodies that bind to cocaine molecules, preventing them from binding to the receptors in the brain that, when activated, produce the "high" from the drug. As a result, the "high" is negated or greatly reduced, which removes the incentive to continue to use the drug.

While I see the potential for this treatment to help addicts overcome cocaine addiction, the talk of giving this preemptively to children worries me. Beyond the issues of informed consent mentioned, I have concerns about using any treatments that could affect brain receptors in children unless it is medically indicated. Psychoactive drugs affect us because our brains have receptors that respond to particular drug molecules; these receptors probably have some other function in normal life. Stimulating the body to produce antibodies that bind to drug molecules to inhibit them from binding to our receptors could have adverse impacts on the natural auto-stimulation and regulation from our bodies. In children whose brains are still developing (and will go into overdrive during puberty), we cannot safely anticipate what the long-term effects on neurotransmitters and brain activity could be.

Because the vaccine has been show to be effective on adults, and because there is usually sufficient time to respond to cocaine addiction, I do not feel that vaccinating children in this case is justified.

And because I still am bitter about the controversy over the HPV vaccine: aren't moralists worried that giving the cocaine vaccine to children will tell them it's okay to start doing drugs?

Big Pharma and Informed Consent

A colleague asked me to post this entry under the nom de plume J. E. Cochran -- a thought provoking post, I thought:

Informed consent, in a clinical trial, requires that a clinical trial subject be fully informed of all the risks and the benefits of taking part in the trial before participation. The goal of informed consent is that the subjects should have all relevant information, and be able to make their own decisions as to whether they should participate in the clinical trial. This approach is complicated not only because of the complicated information that must be presented to the subject,
which can rarely be fully understood, but also the fact that the information must be kept a secret for business reasons.

The requirement of informed consent, was proposed by physicians, ethicists, and even the US Food and Drug Agency (FDA) and the International Committee on Harmonization (ICH). However, while informed consent does invoke a warm fuzzy feeling and is great PR for
the pharmaceutical industry, the practical procedures and implicationsare far from having been completely worked out.

Pharmaceutical companies spend hundreds of thousands of dollars a year protecting their intellectual property by using patents, trade secrets, copyrights, etc. Accordingly, the investigators, subjects, institutions and all other related personnel who would have access to
the drug or its data are subject to strict confidentiality provisions. Practically speaking, however, it is commonly known that researchers talk amongst themselves and patients routinely discuss their treatment protocols with each other. Drug companies hope to curtails this
practice but realize that they have little choice but to "play along." The research industry chooses from only 3-5% of the entire practicing physician population. This population not only does the required research to approve a drug, but consists of key opinion leaders and a
significant portion of the initial prescribing population. In light of the clout of this researcher population, the industry prefers not to antagonize this population by the stringent enforcement of the confidentiality provisions. The practice of stringent enforcement of confidentiality provisions becomes even murkier when we talk about allowing patients to see the Investigator's Brochure (IB).

The IB is a grouping of the significant scientific data, in the original scientific language, which is made available to the investigator so that the investigator knows all the relevant risks
and benefits when enrolling patients. Conversely, the informed consent form is a significantly simplified document that hopes to inform patients, in a language that they can understand, of only the most important risks and benefits. The trade-off, caused by the use of this simplified language, is that a lot of the risks are not completely addressed in the standard informed consent form.

The question therefore arises: Considering the private and proprietary nature of new chemicals entities (NCEs), and the possible lack of complete information in the typical informed consent form, can a potential subject, request to have access to not only the informed consent form (which the subject is usually required to sign or acknowledge), but also the investigator's brochure?

Pro Business and intellectual property (IP) advocates, as advised by their lawyers, err on the side of protection of the data. They believe that the data generated from the drug can save lives, if only given a chance, and provided a profit can be made on the drug. They believe that this profit can only be made if their drug remains unique and the data generated from their studies is not mis characterized. They hence assert that the patient should only have access to the data that is meant for them and provided since that information has been customized for them such that it is easy for them to understand and difficult to mis-characterize. On the other hand, the drug companies believe that the data provided in an IB is difficult for the lay person to understand, and easy to mis characterize. Furthermore, if that data is provided to competitors, it can serve as a source of erosion of profits since the competitors will either mis-characterize
the data or develop me-too products. To avoid all these complications, pro business and intellectual property advocates err on the side of protection of the data.

On the other hand, patient rights advocates believe that despite the confidentiality provisions, the subject must have access to all data. These advocates believe that the understandability of the data is a significant goal, but should not be a barrier to access to this data. They point out that informed consent cannot occur in the absence of complete information. They also assert that the fact that subjects may not understand the data is an inadequate explanation since the
information should be phrased such that it can be easily understood. (IP advocates point to the inherent risks in over warning and the lack of focus present in 40 page informed consent forms.)

Both sides have valid concerns, each of which must be addressed. However, these concerns must not only be addressed in the vacuum of academia but in the bustling streets of commerce with true capitalism testing what the market supports.

For more info on this subject, click here.