I just spent a week at Wake Forest University Institute for Regenerative Medicine. I enjoyed the experience of being immersed in all things tissue-regeneration, bio-printing, scaffold development, and, especially, the unique collaboration model they have with private industry to co-develop, co-innovate, and co-trial technologies and treatments in hopes of getting cures out to patients sooner.

For me, this week was all about the patient. I was able to ask questions about how global manufacturing design changes for mass distribution of regen products might affect those wanting, or depending upon personalized medicine delivered at point of service.

I also asked questions about intellectual property and the common good, calling the race between gene-editing and stem cell transplant. And about the Regenerative Medicine Advanced Therapy (RMAT) Designation, and new time frames for the development of needed cell therapies.

 

“a next logical step we should expect from the paradigm shift that we call the “personalized medicine movement” is a diagnosis-specific, individualized informed consent model that reflects the new challenges for patients’ experience”

This visit also reminded me that, in spite of the phrenetic pace of innovation, our ethical scaffold has not kept pace, and is nowhere near where it needs to be, even today. We need to work quickly and aggressively to change that, or, as it has with all innovations in our healthcare past, including our current state of clinical translational practice, patients will get hurt, if not physically, then emotionally or spiritually.

My personal story and deep interest in ethics and justice for patients has led me to call for development of a standardized core of hybrid ethical principles for the regenerative medicine patient who is entering in relationship with a cell therapy provider.

We need such a hybrid model badly. And soon.

With the substantial help of two esteemed colleagues of mine, Waymon Hinson, Ph.D., and Robbie Hutchens, MMFT, we plan to produce a white paper and accompanying model representation of what we are calling a “Translational Ethic”. We should be ready to deliver this to all of you within a few weeks. It’s very exciting, and designed to catalyze a conversation about the need for an ethical framework based upon patient rights and provider self-regulation.

So, a “next logical step” we should expect from the paradigm shift that we call the “personalized medicine movement” is a diagnosis-specific, individualized informed consent model that reflects the new challenges for patients’ experience making decisions in an environment of constantly emerging data, retro-engineered clinical information, and regulatory flux that characterize the current state of the stem cell industry.

 

informed consent should be designed to reflect and describe the possible risks of getting better, sometimes dramatically over a short time, as well as the risks of getting worse

As a patient who has experienced the good, bad and ugly when it comes to the relevance and delivery of informed consent, I have a few things to suggest. Over the next few months, I will be working with another colleague to explain these ideas further, but, to share a bit of the love now, here is a peek of where we’re headed:

  1. In an age capable of propelling and sustaining a movement and infrastructure for delivering personalized medicine, we are obligated to each other to provide an equally customized approach to informing patients being asked to grant consent.
  2. Advanced cellular therapies are capable of reversing the known sequelae for any number of diseases for which we know a dim prognosis and outcome is all but certain. For that reason, informed consent should be designed to reflect and describe the possible risks of getting better, sometimes dramatically over a short time, as well as the risks of getting worse. We should be able to assign risks to a bipolar model of possible outcome(s) of treatment. Impact from both positive and negative.
  3. Technology is heavily embraced in order to deliver advanced treatments successfully. It should be heavily embraced in the delivery of informed consent as well, providing information in creative formats that can be consumed and understood by a patient, again based upon their experience, stage of condition, and specific diagnosis.
  4. Taking into account the possible informational, cultural, and professional gaps in knowledge surrounding the mechanisms by which treatments actually work or not, it is a given that practitioners, especially specialists, are assumed to be aware of what patients need for adequate consent, how they need it explained and agreed upon so that it has meaning to them, and how to reinforce that knowledge in a way that overcomes any functional deficiencies or barriers.
  5. Informed consent must integrate a hybrid of the current research, experimentation, and treatment consent requirements, because what we want to sometimes call “research”, is more objectively determined in a court as more resembling “treatment”. Unless we integrate to a standard, the patient will be underserved at the point of the needle, and protections of informed consent will be lost to confusion.
  6. Health care lawyers need to begin developing alternative ways to an 11-page checkbox generic consent form that has the sole purpose of eliminating provider liability. They need to revisit and infuse patient needs and experience into their mitigation model.

I hope, that these thinking points become talking points among those of us interested in taking responsibility for the necessary adjustments in our care delivery system, especially with regenerative medicine.

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Doug Oliver, Founder and Chair of The Regenerative Outcomes Foundation in Nashville, TN, was legally blind for 10 years, and had his sight restored after autologous stem cell therapy in 2015. He has since inspired millions with his story of emerging hope in regenerative medicine, and helped Senator Lamar Alexander craft key patient provisions included in the 21st Century Cures Act, which passed with historic bipartisan support, and was signed into law in December 2016.