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Policy Discussions

Licensee Use of Innovative or New Treatment

Discussion Ends on 08/23/2019

NCMB is considering adopting a new position statement entitlted Licensee Use of Innovative or New Treatment.

The Board will accept feedback on the proprosed position statement through close of business on Friday, Aug. 23.

The full text of the proposed position statement is below:

Licensee Use of Innovative or New Treatment

The North Carolina Medical Board (“Board”) recognizes that progress in medical science, advances in patient care, and improved outcomes require exploration of innovative treatment and new technology. The Board is also cognizant that the promise of innovative treatments may be marketed by naïve or misguided (but often well-meaning) innovators or even unscrupulous entrepreneurs. While the Board encourages licensee participation in scientifically valid research and innovation, the Board has a responsibility to protect the public and prevent patient exploitation or harm. Licensees must guard against: (1) overpromising the benefits of a particular treatment without sufficient data to support such claims; and (2) the exploitation of patients who are often in desperate circumstances and willing to try any proposed therapy in spite of excessive costs and scant evidence of a treatment’s efficacy. Licensees must balance respect for patients’ autonomy in seeking treatment options against the need to safeguard patients from the risks of novel, but often unproven, and potentially dangerous interventions. Concepts licensees should consider when offering or promoting innovative or novel treatments include:

• The treatment or procedure must be for the patient’s benefit (beneficence).
• There should be suitable informed consent and shared decision-making where the licensee honestly discusses the risks and benefits of such treatment.
• Emphasis on data purportedly supporting a novel or unproven intervention to minimize risk and overemphasize benefits should be avoided.
• Licensees should be prepared to support any claims made about the benefits of treatments or devices with peer reviewed and reproducible documented evidence.
• Shared decision-making should include at a minimum: (1) an explanation, discussion, and comparison of treatment options with the patient; (2) an assessment of the patient’s values and preferences; and (3) decisions that are made in partnership with the patient. There should be patient autonomy and voluntary noncoercive participation.
• Avoidance of promotional “tokens of legitimacy” which might include patient or celebrity endorsements, marketing using various certifications, awards, or citations of physician affiliations or memberships in academic or professional societies.
• Advertisements should not contain claims that may be deceptive or are false or misleading. Licensees are responsible for ensuring that all information, especially in terms of risks, benefits, and efficacy, is presented in an objective manner.
• Licensees must understand the relevant clinical issues of the treatment offered and should have received sufficient education and training. Licensees must be accurate and not misleading in providing patients descriptions of their training or skills for the treatments they recommend or offer.
• Licensees should consider consulting with an Institutional Review Board (IRB) to clarify processes and safe guards and seek IRB approval, where necessary.
• There must be a clear understanding by the patient of why the new treatment or technology is recommended. What is its purpose and how is it different from current or conventional treatment? The availability of traditional or established treatment alternatives should be discussed with the patient.
• There should be thoughtful consideration of the decision-making capacity of the patient (children, mentally ill, prison populations, etc.).
• When unconventional, new, or innovative treatment is employed, there is a greater need for thorough, detailed, accurate medical record documentation of the course of treatment and outcomes.
• Errors and adverse outcomes, identified both during and after treatment, should be timely communicated to patients.
• Licensees must comply with relevant federal and state laws and applicable professional society guidelines.

Comments

I strongly believe that the proposed policy statement be completely rewritten! As one who conducted clinical trials at Duke for several decades- I find it incredulous that in only the Second sentence of the policy- it chooses to imply the widespread misappropriation of clinical trials to somehow cause the public harm. Do the writers of this policy really believe that the majority of us engaged in the development of life changing new treatments are motivated by the long shopping list of sins outlined in your policy? Scrap this policy and write one which celebrates the current explosion of outstanding new safer, more effective treatments and at the end- remind the principal investigators that they should continue to follow the IRB/FDA guidelines which have served us so well for many decades! My field of rheumatology has been totally enlightened by the multitude of life changing treatments which have evolved over the last 20 years. Let us celebrate this success and not overly react to the less than 0.1%!

By G Radford Moeller MD Clinical Professor of Medicin on Aug 8th, 2019 at 9:20am

I have been the chair of an IRB for about 20 years and served on that IRB another 10 or so, and I compliment the Board on this detailed list of issues that come up with innovative or new treatments.  I would like to make three comments (and I will only comment about drugs, since I don’t have enough experience with devices to feel comfortable talking about them).  First, the threshold question is whether the physician wants to refer a patient to a clinical trial of an unapproved new drug or wants to make off-label use of an approved drug or use an integrated or alternative therapy such as herbs or vitamins.  If it is the former, then the process of enrolling the patient in the trial gives the clinician a lot of protection.  But when the clinician is suggesting an off-label use, or some sort of alternative or integrated medical treatment, then the clinician has to work through the ethical issues alone. Second, it will be problematic to offer a new or innovative drug in lieu of conventional treatment until there is good scientific evidence that the new or innovative drug is likely better than the conventional treatment.  It may often be appropriate to offer the new drug if conventional treatment has failed (but even here the new treatment may have harmful side effects), but if conventional treatment has not failed, it would seem problematic to offer something new before there are good Phase III studies to support it.  Third, when a physician is seeking to place a patient in a clinical trial, the physician should discuss the issue of “therapeutic misconception.”  Studies are research, not treatment; research subjects are subjects, not patients, and the new drug might prove worse than nothing at all.  The referring physician should be the first person to make this clear.

By Steven Shaber, JD on Aug 6th, 2019 at 2:54pm

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