Roles and Responsibilities of Physicians in Patients Decisions about Unproven Stem Cell Therapies
Stem cell science, using embryonic and tissue-specific stem cells, is advancing rapidly and promises future medical care improvements. Effective therapy is likely a long way off, although numerous clinics worldwide offer stem cell “therapies,” most of which are not regulated and may not even be stem cells.
Anecdotal reports suggest a substantial number are willing to try stem cell-based interventions (SCBIs), despite questions about safety and efficacy and even some examples of serious harm. Because patients typically travel abroad to receive these unproven SCBIs, the practice is commonly known as “stem cell tourism.”
Potential harm and negative effects from SCBI research has discouraged some patients from engaging in stem cell tourism. These concerns raise questions about the role physician play in patients decision-making related to unproven SCBIs.
Legal Responsibilities for Healthcare Providers
A physician’s legal duty to a patient begins when a relationship is established, such as examining to evaluate, diagnose, or treat. The relationship – and, thus, the duty – may arise in other ways, such as on call or through consultation. Once formed, the duty is typically continuous.
Because most SCBI conversations take place in existing physician-patient relationships where legal duty is clear, I focus this discussion on what is required within those relationships concerning SCBIs.
Obligation to Inform
Legal requirements to obtain informed consent from patients for treatment is based on the principle, famously articulated by Justice Cardozo, that “every human being of adult years and sound mind has a right to determine what shall be done with his/ (her) own body.” To exercise that right, patients must understand their condition and options.
Thus, the informed consent doctrine requires physicians to disclose material information about the patient’s diagnosis and prognosis, risks, benefits and consequences of the proposed treatment, as well as any alternative measures. In addition, physicians must respond to patient questions.
Failure to obtain informed consent can give rise to legal liability. With this background, we can consider likely physician disclosure obligations regarding SCBIs.
Is there obligation to disclose SCBI as treatment alternative?
Because informed consent doctrine requires physicians to discuss alternative treatments, the question arises whether physicians proposing a treatment must inform patients about the availability of unproven SCBIs, especially as patient interest in SCBIs grows for at least some conditions.
Case law suggests the duty of disclosure extends only to “available choices.” Thus, there does not appear to be an obligation to inform about non-FDA approved, experimental treatment unavailable in the host country. Lending further support to this conclusion is that courts typically require disclosure only for recommended treatments.
Because reasonable physicians are unlikely to consider unproven SCBIs as legitimate alternative treatments, they appear to have no legal duty to tell patients about them. However, because the evaluation of recommended treatments is based on the reasonable physician standard, an obligation regarding SCBI disclosure may change to the extent evidence develops about effectiveness of at least some SC Is.
Is there obligation to inform in response to patient inquiries or decisions?
SCBI discussions most likely arise when patients ask about them. A patient may ask a physician for information about a SCBI, for example, in response to a news story or while conducting Internet research about treatment alternatives.
A patient may also ask a physician for advice after deciding to pursue a SCBI. In either case, the physician is providing medical advice subject to malpractice standards. Thus, physicians must respond, as would reasonable providers with experience and expertise.
Physicians should provide accurate information about what is currently known about SCBIs when asked. The challenge for physicians is to know what information to provide. Information provided by the International Society for Stem Cell Research to help patients and physicians evaluate SCBIs (http://www.closerlookatstemcells.org/) may be particularly helpful.
Referring the patient to other reputable websites, such as the National Institutes of Health, for information about stem cell research could also be helpful (http://stemcells.nih. gov/info/faqs.asp). However, patients may need physicians’ help interpreting SCBI information including any clinical trial data and recommendations to guide decision-making.
There is limited data regarding how patients make decisions about SCBIs. Existing data suggests failure to make a clear recommendation may confuse patients. Physicians should be cautious about referring patients to providers or clinics offering SCBIs.
A physician could be liable for referring an incompetent practitioner, an unaccredited clinic lacking proper staff, equipment or facilities, or SCBI was ineffective and risky. The American Medical Association’s guidance on medical tourism (http://www.ama-assn.org/ama1/pub/upload/mm/31/ medicaltourism.pdf) speaks of referring only to accredited facilities, which can reduce the risk of negligence.
However, the ISSCR guidelines suggest physicians should also inquire about the practitioner’s qualifications and evidence of SCBI safety and efficacy before making any referral.
Every human being of adult years and sound mind has a right to determine what shall be done with his (her) own body.
When a patient chooses an unproven SCBI, the physician should inquire into the decision and suggest reconsideration. Physicians have ongoing, fiduciary obligations to patients and, thus, to act in their best interests. In the case presented, the physician could relinquish this duty by presenting risks, benefits, and uncertainties to persuade the patient from selecting the unproven SCBI.
AMA and ISSCR guidelines may determine what specific information to provide to these patient inquiries. In particular, the ISSCR patient handbook describes information that patients may need and is a good source of about SCBIs and the state of research.
Importantly, the physician is not required to prevent a competent adult patient from pursuing an SCBI that appears fruitless (at best) or harmful (at worst) after attempts to dissuade the patient have failed. The “right to determine what shall be done with [one’s] own body,” is a broad one, extending to refusal of life sustaining treatment.
Although patients may not have a right of access to them nor to require that physicians provide them, they may choose unproven treatments. If the adult patient lacks decision-making capacity, there may be an obligation to intervene as described below for pediatric patients.
Physician obligations to patients continue even when patients pursue SCBIs against physician advice. Patients returning after receiving from a SCBI abroad will likely turn to their physicians for post-intervention follow-up care, treatment of SCBI-related complications and continued medical care.
Accordingly, physicians should explain that they will continue to provide care for their patients. In rare circumstances, a physician may feel unable to provide care because the patient pursues unproven SCBI. In such cases, the physician must formally terminate the relationship with sufficient notice to allow the patient to find another practitioner.
Failure to do so could lead to a claim for abandonment.
Are obligations different for pediatric patients?
While a physician does not have a legal obligation to prevent competent adult patients from seeking SCBIs, they may have a duty to prevent parents from pursuing SCBIs for their children. The situation is different for children because they cannot protect themselves and must rely on others to make decisions on their behalf. Given the patients’ vulnerability, pediatricians typically place stronger emphasis on the obligation to advocate on their patients’ behalf, even against the patients’ parents.
Physicians should provide accurate information about what is currently known about SCBIs… the challenge is to know what information to provide.
While parents typically have wide latitude to make decisions for children under the assumption they will act in their best interests, if a child is at risk of serious harm or death, that authority may be restricted. If the parent persists in pursing an action that the physician believes is harmful to the child, the doctor may seek a court order for the recommended treatment.
The quintessential case where physicians seek to override parental decision-making is when a Jehovah’s Witness’s child suffers a trauma requiring a blood transfusion – a highly effective treatment posing very little risk. While the Constitution protects parents’ right to raise children within their religious faith, children may not embrace those beliefs as adults.
Accordingly, courts have been willing to intervene to allow the child to reach adulthood and exercise choice. Courts intervene most often when the likelihood of success is very high, the risks are low, and the intervention is of short duration.
As the risks increase and the levl of interference increases (e.g., intervention of months or years), courts are more hesitant to intervene. Courts have been willing to order some cancer treatments, despite negative side effects and typically long duration of treatment, when the likelihood of cure is very high.
Thus, the pediatric physician’s obligation will depend on the proposed SCBI and the child’s condition. The obligation to intervene is strongest when evidence suggests the SCBI is likely to harm and delay effective therapy. Even evidence of harm alone would provide strong justification for intervening to avert damage.
The obligation to intervene will be weakest when there is no evidence that SCBI is harmful, even if ineffective and no available alternative therapy is available. In evaluating whether to intervene on the child’s behalf, the physician may also consider what that action may do to the relationship with the family.
The child’s physician may be concerned that the physician-family relationship will not survive court intervention and could potentially drive the parents away from conventional medicine, resulting in negative consequences for the child’s health. In such circumstances, the physician should balance SCBI risks against losing the opportunity to provide care and advocate for the child in the future.
The pediatric physician must also consider legal obligations to report a parent’s decision to pursue SCBIs as child abuse or neglect. All states mandate physician reporting of child abuse, in part, because children are vulnerable and unable to protect themselves. Accordingly, physicians need to consider reporting requirements in connection with SCBIs.
Like the decision about court intervention, the physician should consider what is known about the SCBI’s potential risks and benefits and what alternatives, if any, are available to the child. If there are no alternatives and risks from intervention, there would be no obligation to report.
The child will not be harmed either by the SCBI or any delay in receiving conventional therapy. However, if the SCBI has known, serious harms without known benefits, there may be an obligation to report, particularly if the SCBI would replace effective alternatives.
The more challenging SCBI situation is also the more common one, where harms are uncertain, but plausible. In such cases, a physician must ultimately rely on medical judgment.
As with the decision whether to seek court intervention, a pediatrician also should consider what reporting could do to the relationship with the patient’s family. When the physician learns about the SCBI only after intervention, reporting will not avert any harm, but could disrupt the physician-patient relationship and chance to protect the child in the future. There could be legal repercussions from not fulfilling reporting obligations.
In recent years, patient pursuit of unproven SCBIs has inspired substantial policy interest because of the risks they pose to individual patients and stem cell research. Although not all patients will discuss their interest in SCBIs with physicians, medical personnel needs to be prepared to respond.
There is some evidence that suggests physician behavior differs from these legal obligations and professional expectations. This article may help physicians better understand obligations and counsel patients about a range of alternative and unproven interventions.
About the Author
Leslie E. Wolf, professor of law at Georgia State University’s College of Law, researches health and public health law and ethics, with a particular focus on research ethics. She has conducted empirical research on conflicts of interest, stored biological materials, certificates of confidentiality, IRB web guidance, and HIV-related laws and policies.
Prior to joining the law school, Wolf taught medical and research ethics at the University of California, San Francisco, where she also served on the UCSF institutional review board and advisory committee regarding stem cell research. She also was selected a Greenwall Fellow in Bioethics and Health Policy and a Greenwall Faculty Scholar.