Ethics of Experimental Treatments for Patients

Problems such as accessibility of knowledge about experimental procedures as well as their availability in certain areas are two types of ethical dilemmas about such treatments, according to a new briefing note on ethical issues in experimental treatment.

The Nuffield Council on Bioethics, an independent advisory body to policy makers on ethical issues in bioscience, based in the United Kingdom, issued a briefing note to highlight the ethical issues that can surround experimental treatments for both patients and doctors. They classified some experimental treatments into 3 categories: advanced therapies, such as gene and stem cell treatments; surgeries; and fertility treatments.

Advanced therapies, they said, are often used in conditions where there is no other existing cure. These stem cell and gene therapies can be used in cancers, multiple sclerosis, muscular dystrophy, and other diseases. One benefit of this type of treatment is the individuality of each personalized treatment. However, these advanced therapies are criticized for their sometimes-questionable marketing practices and the way that messaging might influence patients’ expectations of success. Furthermore, the influence of public campaigns for these treatments may reach the public too soon, and the treatments may just be in the early stages.

Surgical procedures can present a “lack of clarity,” the Council explained. Sometimes a surgery is simply a modified approach to an existing type of surgery or technique, and patients may be unaware that the type of surgery they are pursuing is not routine.

Fertility treatments offer patients “add-ons” in the private sector, according to the briefing. The aim of these bonuses is to improve the chance for a successful pregnancy; however, there is limited evidence to support these claims. These “add-ons” can cost anywhere from £50 and £8,000 (about $65 to $10,250) according to the Council, and a recent study in the United Kingdom found that some clinics provide clients with misleading information about the evidence.

This was prompted by several recent medical controversies reported in the media recently, the Nuffield Council authors said, which included additional, secretive expenses in fertility treatment costs, deaths from stem cell transplants, and parents who hoped to seek or receive experimental treatment for their children abroad. The authors said they hope their briefing note addresses how experimental treatments are regulated and summarizes the ethical issues that all parties, including patients, families and healthcare professionals need to be aware of.

“Often, experimental medical treatments are considered as the last hope, when all other options have been exhausted,” Hugh Whittall, director of the Nuffield Council on Bioethics said in a press release. “It is completely understandable that people in this position might be willing to try anything and everything they can, despite uncertainties about the efficacy or safety of the treatment, and the likelihood of there being significant costs involved. A key challenge is balancing the interests of patients with ensuring they are protected from harm, particularly if treatments are offered outside of United Kingdom regulation.”

Some of the ethical issues that pop up during the use of experimental treatments, according to the Council, are:

• Assessing how safe and effective a treatment could be, especially in the face of an absence of research evidence or previous experience to draw on.
• Making an informed decision and giving consent, particularly when treatments are being searched out for children or people unable to provide consent.
• Being influenced by online information. The Council said online information about experimental treatments “can empower patients,” but it could miss alerting patients to the limitations or risks of the possible treatments
• Ensuring healthcare professionals act responsibly and that any treatment offered to a patient is in their best interest, rather than being driven by other incentives.
• Inequality of access, and affordability of experimental treatments, can be a challenge. Plus, availability can vary even within the United Kingdom compared to other countries.
• Negative impacts on knowledge… The Council explained that reports about the efficacy and adverse events surrounding an experimental treatment might not be disseminated as it should be or as if it were a clinical trial.

“It is important that patients and their families have access to impartial and accurate information, and are made aware of uncertainties about possible outcomes when making a decision about trying an experimental treatment,” Whittall continued. “We will be raising these issues with Government and working with regulators, and we are following up this piece of work with a new project exploring how disagreements can develop about the care of critically ill children, and how those disagreements are being resolved.”