Ethical and Legal Aspects in the Treatment of Autism Spectrum Disorder

The term “autism” has been used historically to refer to a heterogeneous range of neurological and psychological conditions, but the current usage of the term dates from the pioneering work of psychiatrist Leo Kanner in the United States and pediatrician Hans Asperger in Austria in the 1940s (1). Relying upon a series of case histories, Kanner described “autistic disturbance of affective contact” as a syndrome in which “children have come into the world with the innate inability to form the usual, biologically provided contact with people. . .” that is characterized by “aloneness” and “an obsessive insistence on the preservation of sameness” (2). The current version of the Diagnostic and Statistical Manual of Mental Disorders uses the term “autism spectrum disorder” (ASD), which it defines as a neurodevelopmental disorder characterized by “deficits in social communication and the presence of restricted interests and repetitive behaviors” (3). Achieving scientific consensus regarding the causes, parameters, and best treatment methods for the phenomenon has proven problematic—even by the standards of contemporary psychiatry. Thought leaders in the field, such as Allen Frances, have expressed concerns that looser criteria have led to overdiagnosis (4). In light of the wide range of presentations, even whether ASD is a “disease” or a “variation of normal” remains contentious (5). The history of autism is scarred by unfounded and discredited claims such as that the condition is the product of detached parenting (Bettelheim’s debunked “refrigerator mother” theory) and that it stems from childhood exposure to vaccinations (6).

The Centers for Disease Control and Prevention estimates that ASD in the United States occurs in approximately one in every 36 children, with the total number of Americans affected by the condition exceeding five million (7, 8). In addition to challenges related to resource allocation and access to effective interventions, care of both children and adults diagnosed as having ASD can be complicated by widespread misinformation. For example, well-intentioned parents may seek complementary or alternative treatments that either lack an evidence base or, in extreme cases, actually pose an increased risk to the welfare of their children. Disagreements over the best course of management may lead to conflict between providers and families. Ensuring that both the autonomy and interests of adults with ASD are protected can also prove challenging, both in clinical decision-making and in human subject research (9). As prenatal genetic testing has advanced to be able to detect genes associated with increased rates of ASD, the issue of whether fetal screening should be offered—and publicly funded—has also generated controversy (10).

Case 1, Part 1

You are a child psychiatrist in private practice. Ms. A brings her 16-year-old son, B, to your office for a consultation. B was diagnosed as having ASD a decade earlier, and since that time, has “failed” multiple treatments including behavioral and communication-based interventions. He can only say a few words to express basic needs and cannot speak in full sentences. He is chronically irritable, becomes easily agitated at home, and has displayed several violent outbursts over the past few months, all directed at Ms. A. Ms. A, who is a single parent, has homeschooled her son. She appears deeply devoted to his welfare.

• 1.1. Ms. A explains to you that she has read about two forms of treatment that she believes may benefit her son: chelation therapy and leuprolide injections. She read online that a child psychiatrist might help her gain access to these therapies. In response to her request for such assistance, you should do which of the following?

  1. Assist Ms. A in gaining access to these complementary treatments, as she is her son’s legal decision-maker and has the right to make medical decisions on his behalf.

  2. Explain to Ms. A that these are not evidence-based treatments, and although you do not see any harm in trying them, you also cannot support her in pursuing treatments that are unsupported by any significant scientific data.

  3. Express concern to Ms. A that these interventions might be harmful to her son’s health, but that other inventions might be available to reduce her son’s violent outbursts.

  4. Arrange for B to be admitted to the hospital prior to treatment in light of the potential risks involved in both of these interventions.

  5. Determine that B lacks capacity to make decisions about these treatments and then encourage Ms. A to obtain legal guardianship so that she will have the power to authorize them.

• 1.2. Ms. A inquires about what intervention you would recommend to treat her son’s irritability and you suggest risperidone, which is approved by the U.S. Food and Drug Administration (FDA) for this purpose. Approval by the FDA for this purpose indicates that the intervention

  1. Is safe only, but not necessarily effective

  2. Is both safe and effective

  3. Has a medical use and a low potential for abuse

  4. Has a medical use and a low potential for both abuse or dependence

  5. Cannot be used as the basis for liability in the federal courts

• 1.3. Ms. A is unwilling to have her son try risperidone, because she has read online that risperidone may cause galactorrhea. She is willing to have him try olanzapine, which has also shown efficacy in clinical trials, but may have greater side effects. Olanzapine is not approved by the FDA for this purpose but is approved to treat other psychiatric conditions. If you believe that olanzapine is an acceptable intervention, you

  1. May still not prescribe it because this use falls outside FDA parameters

  2. May still not prescribe it because risperidone has fewer side effects

  3. May only prescribe it if the FDA has approved an Investigational New Drug (IND) application

  4. May prescribe it legally as a result of the “respectable minority” rule

  5. May prescribe it legally as an off-label drug use (OLDU)

Case 1, Part 2

Ms. A agrees to try olanzapine for her son and to return for a follow-up appointment with B in a week. When they do return, she reports that she has not picked up the prescription for olanzapine, because she read more about the side effects and was deterred. Instead, she purchased leuprolide without a prescription from a foreign web-based pharmacy and gave B his first dose of the hormone that morning. You believe that such a course of treatment places B’s health in danger.

• 1.4. When you explain your concerns to Ms. A, she becomes upset and says that B is her son and that, until he turns 18, it is her right to make medical decisions for him. She has no intention of stopping the hormone treatments. Instead, she tells you that she wishes to terminate her son’s care with you. If you genuinely believe that the leuprolide injections place B’s health in grave danger and report your concerns to your state’s child protection agency, that decision most reflects the legal approach in the case of which of the following?

  1. Georgetown College v Jones

  2. Jacobson v Massachusetts

  3. Prince v Massachusetts

  4. In re Gault

  5. Roy v Hartogs

Case 2, Part 1

Dr. W, a consultation-liaison psychiatrist, is asked to conduct a psychiatric evaluation of X, who wishes to donate a kidney to a stranger. In particular, X self-identifies as suffering from “high-functioning autism,” and the transplant team is concerned that his wish to become an altruistic donor stems directly from this condition. Dr. W conducts a 3-hour evaluation of X, during which X explains, “I don’t understand why everyone doesn’t donate a kidney to a stranger. Not doing so doesn’t make any sense to me.”

• 2.1. Dr. W determines that X understands the risks of the procedure and is not acting under duress. If X is allowed to proceed with donation, this will reflect the ethical principle of which of the following?

  1. Fidelity

  2. Autonomy

  3. Nonmaleficence

  4. Paternalism

  5. Veracity

• 2.2. If Dr. W determines that X’s wish to donate is a direct result of a diagnosis of ASD, how should this affect the decision of whether to allow X to donate his kidney to a stranger?

  1. X should not be permitted to donate, as DSM disorders are contraindications for altruistic organ donations.

  2. X should not be permitted to donate because his decision is the direct result of a psychiatric condition.

  3. X should be able to donate as long as he understands the risks, is not operating under duress, and meets the other established criteria for altruistic donation.

  4. X should be able to donate because competent adults have a legal right to donate their organs.

  5. Dr. W should defer a determination on the issue of donation until X undergoes a course of treatment for his ASD.

Case 2, Part 2

Dr W determines at the conclusion of his evaluation that X displays no psychiatric contraindications to donating a kidney. The surgery takes place several weeks later and the transplant appears to be a success. X is discharged home after 2 days. However, 4 days following the operation, X returns to the emergency room, having developed severe pain in his right calf. A Doppler ultrasound reveals a blood clot. The medical team wishes to place X on a blood-thinning medication and to admit him to the hospital for further monitoring. X is willing to take an oral blood-thinning agent at home, but demands to leave the hospital. He acknowledges that his mood has recently been low, but explains that he misses his pets, and also does not wish to miss any more workdays. He states, “I can accept some risks in order to get back to my daily home routine.”

• 2.3. Dr W is called upon to determine whether X has the decisional capacity to leave the hospital against medical advice (AMA). He chooses to use the well-established criteria of Appelbaum and Grisso to determine capacity. Which of these statements would suggest that X does not have capacity to leave AMA?

  1. “Even if I’m going to die, I’d rather die than spend another day in this hospital.”

  2. “I understand there are risks in leaving the hospital prematurely, and I’ve weighed them out in my mind, but I’m willing to take my chances.”

  3. “Other people might die of a blood clot, but I’m in great shape, so I’m not at any risk.”

  4. “Work has to be my priority right now. I need the money.”

  5. “I’ve been feeling terribly depressed all day, but I’m sure my mood will improve once I’m back home.”

• 2.4. Under which circumstances would the Appelbaum and Grisso criteria be least suited to determine X’s capacity to leave the hospital AMA?

  1. X suffers from delirium.

  2. X is a Jehovah’s Witness.

  3. X cannot speak English.

  4. X does not believe in allopathic medicine at baseline.

  5. X does not understand the risks of leaving the hospital with a blood clot.

Answers

• 1.1. The answer is C. A range of complementary therapies are commonly used as treatments for autism. Data suggest that some of these may help address the “abnormal physiology in autism” (11). Others, which lack an evidence base, may include “dietary supplements, vitamins, hyperbaric oxygen, hormone injections, swimming with dolphins, horseback riding, yoga, and massage” (12). Chelation therapy, which has been associated with “hypocalcemia, renal impairment, and reported death” (13), and injections of the hormone leuprolide, which may cause “numbness, weakness, difficulty breathing, trouble swallowing, hives, blood in the urine, bone pain, testicular pain, and osteoporosis” (12), are likely deleterious. The psychiatrist’s duty is to inform the patient of these known dangers, not to express indifference (choice B). A physician should not play a role in helping a patient obtain a harmful, noneffective treatment (choice A), nor does this change if the patient is hospitalized (choice D). As B’s sole parent, Ms. A is likely B’s legal decision-maker, whether or not she obtains a court order, but that does not entitle her to authorize treatments that run against his best interest (choice E).

• 1.2. The answer is B. Approval from the FDA indicates that a medication is both safe and effective for the purpose indicated (14). Before 1962, the 1938 Food, Drug, and Cosmetic Act only required that manufacturers demonstrate safety, not efficacy (choice A). Since risperidone is one of the two antipsychotic medications approved for treating irritability in ASD—aripiprazole is the other—it is believed to be both safe and effective for this purpose (15). Whether a substance has the potential for abuse or dependence is relevant to its scheduling under the Controlled Substances Act of 1970 and is unrelated to FDA approval (choices C and D). Although the FDA authorizes medications as safe and effective, this does not shield physicians from liability if they are prescribed inappropriately (choice E).

• 1.3. The answer is E. The FDA approves medications for the marketplace, but does not determine the manner in which physicians may use them, so FDA parameters are not relevant (choice A). Prescribing olanzapine in these circumstances would constitute an OLDU. Such use is consistent with available data for the efficacy of the medication for this purpose (16) and physicians are not bound to prescribe the optimal medication in all circumstances if patients will only accept another, effective but less optimal, intervention (choice B). The “respectable minority” rule shields physicians from malpractice if they use an intervention embraced by a sufficient number of thought leaders in the field, even if it is not the standard of care; it bears on liability, not legality (choice D). INDs are required for experimental drugs in human subject research, but do not apply to clinical applications of medications already approved for public use (choice C).

• 1.4. The answer is C. Prince v Massachusetts (1944) is a United States Supreme Court decision that allows states to require that parents serve the best interests of their children even when doing so violates parental autonomy. The case is best remembered for Justice Wiley Rutledge’s warning that, “Parents may be free to become martyrs themselves. But it does not follow they are free, in identical circumstances, to make martyrs of their children. . .” (17). Georgetown College v Jones (1963) is a federal Court of Appeals case in which Judge Skelly Wright limited the authority of individuals to make decisions for themselves, not their children; the underlying principle is no longer widely followed. In Jacobson v Massachusetts (1905), the United States Supreme Court permitted states to require vaccinations against smallpox; the rationale was to protect the general public, not the person being vaccinated. In re Gault (1967) is a landmark criminal law case that extends the protections of the 14th Amendment to juveniles. Roy v Hartogs (1975) is a New York State case that upheld liability for sexual relations between psychiatrists and their patients, heralding an era of stricter boundary enforcement in physician-patient relations (18).

• 2.1. The answer is B. The principle of autonomy is a “core value” in Western health care ethics (19). It ensures that competent patients are empowered to effectuate their personal wishes through their medical decisions. The principle of nonmaleficence, or “do no harm,” refers to the duty of the physician not to cause injury to the patient. As donating an organ involves risk to the donor, even if small, it is inconsistent with this principle (choice C). Fidelity, often considered a key value in nursing, refers to the duty of loyalty to the patient and may require both nonmaleficence and confidentiality as well (choice A). Paternalism is in many ways the opposite of autonomy and involves protecting the patient from his own interests in favor of a third party’s perception of his welfare (choice D). It was a key element of medical practice in the United States in an earlier era. Veracity, or truth telling, the duty to be honest with a patient, is an important value but is not directly related to the decision to allow X to donate an organ (choice E).

• 2.2. The answer is C. Although certain psychiatric conditions may prevent a person from meeting the criteria for altruistic organ donation, a DSM disorder is not an automatic contraindication (choice A). The fact that the patient is motivated by his disorder might be a barrier to donation—for instance, if he were manic or psychotic—but is not necessarily an obstacle (choice B). Since X’s condition is not relevant to his ability to qualify as an altruistic donor, no reason exists to require treatment prior to evaluation, nor it is even clear that X would either desire or benefit from any proposed treatment (choice E). Although organ donation is a public service that helps other human beings, even those who are qualified to donate do not have a legal right to do so (choice D).

• 2.3. The answer is C. One of the crucial aspects of meeting the Appelbaum and Grisso criteria is understanding the risks and benefits of any proposed intervention and “what it means for them” personally (20). If X cannot appreciate that his blood clot poses a risk, he does meet this standard. In contrast, recognizing that he faces a risk (choice B) and even that this risk might be fatal (choice A) is not inconsistent with decisional capacity. Experiencing psychiatric symptoms may diminish or impair capacity, but only if these symptoms are encouraging irrational choices (choice E). Nonmedical goals, such as economic needs, are legitimate reasons for medical decisions as long as patients can otherwise meet the established criteria for decisional capacity (choice D).

• 2.4. The answer is D. Appelbaum and Grisso designed their criteria for people who share allopathic values at baseline. Recently, critiques of how their model has been implemented have emphasized that it should not be used with patients who adhere to values that are, at baseline, incompatible with the proposed medical intervention (21). Both patients experiencing delirium (choice A) and those not appreciating risks (choice E) are well suited for the Appelbaum and Grisso model—although they will likely not meet its standards. The model can be applied with a translator, so language should not be a barrier to its use (choice C). Jehovah’s Witnesses may reject certain features of allopathic medicine at baseline (namely, blood transfusions), yet this belief alone does not preclude them from meeting capacity standards, which they often do, so the Appelbaum and Grisso approach can work with such patients.