I remember having a worrisome conversation with a patient and friend of mine around the time that the agenda and speaker list for an FDA Public Hearing on Draft Guidance for HCTPs were reaching final form. It was difficult to see my friend palpably afraid that the therapy he was getting for his chronic immune system condition would be scuttled by the FDA. The concern was that if his provider was shut down, he would lose access to the therapy and thus any chances of benefitting from its effective amelioration of his symptoms.
My friend isn’t the activist type, and I was curious why he had become so concerned. He had been seeing his stem cell treatment provider for some months prior. It was within the time period that hearing preparations were underway. There was a rancorous debate surrounding the prospect of FDA regulation impacting what they had mobilized themselves to argue was “practice of medicine," which is not regulated by the agency.
Recently he had become quite impassioned, often siding with the arguments he saw posited by clinics.
He had become a fierce advocate for minimum regulation, maximum access.He had also become exhausted, not doing so well at home, and depending more on his wife to get him in and out of bed.
As the hearing approached, my friend doubled down on his efforts to sway anybody who would listen, to mobilize against the FDA. His commitment was truly inspiring, and his knowledge of the issues, along with the terminology was impressive as well. He wrote, blogged, and emailed everybody he knew.
One of his emails came to me, and while reading it, my heart sunk to the point of pain. I recognized phrases I had heard his provider use weeks before during a joint conversation we were having with another physician. They were distinctive and verbatim.
I knew that he was justified in being afraid of losing control of his health. His email cast many fine points of light on our recent talks and late-night telephone calls and helped me fully recognize what had happened to him. The fact that it came at the hands of his provider enraged me.
His provider had exploited her position of power and was using him as currency to sway public opinion. All the while, she was convincing him that doing so was in his best interest. Now he was deteriorating right in front of me, trying to protect her, and concerned for her well-being rather than his own.
My friend was suffering, not only from his life-limiting disease but from needless pain and perplexity that threatened his objectivity and contaminated his decision-making. It was devastating to watch.
It reminded me of a concept we were all introduced to in 1973, when four hostages were taken during a bank robbery in Stockholm, Sweden. After the days-long standoff, the hostages were released. During the weeks that followed, the world witnessed the hostages talking with reporters, and defending their captors’ actions. It was as if the hostages had formed a curious, but obvious bond with them. This was later witnessed when all four victims refused to testify in court against their captors.
The dramatic story was profound, and the name given to the phenomenon was “Stockholm Syndrome”. Stockholm Syndrome is defined as “feelings of trust or affection felt in certain cases of kidnapping or hostage-taking by a victim toward a captor.” The irony is that the victim cannot see this distortion in their reality, even while it is obvious to others.
The cognitive dissonance that is achievable when basic needs are threatened is tortuous. It is a natural human inclination to protect at all costs that which we believe to be in our best interest. This is true for patients, providers, regulators, and legislators. Unfortunately, patients are sometimes unwittingly used as currency to make that happen.
I believe the reason why the FDA, academic bioethicists, researchers, stem cell clinic critics, and many patients are outraged by these stories of exploited patient loyalty is that there is simply no way to totally mitigate the power imbalance between a broker of healing and the person needing to be healed. The greater the needs of the patient, the greater the power imbalance.
In the case of my friend’s provider, his loyalty was positively reinforced, even directed, by her support and strategically-placed compassion. She had carefully exploited his dependency on her help by instilling the belief that his mission was hers as well.
Sadly, it worked. Even though she spoke of my friend and some of her other patients using language like “community” and “common sense,” she was really using them as leverage-by-proxy against her nemesis, the FDA.
She had transformed my friend into a defender-sympathizer--a “more-than-minimally-manipulated” patient.
The next morning I called my friend. We discussed his long night and told him how I felt; half-joking about my ad hoc diagnosis of him having “Stockholm Syndrome.” We laughed--but I was also firm. My message was clear: I wanted him to advocate for his own needs, not those of his provider. She would eventually move her attention to other patients and other lobbying efforts anyway. I told him that he was a much better advocate for himself than she could ever be.
While comparing patients unwittingly enlisted in the defense of a provider (a “more-than-minimally-manipulated” patient) to a victim of a life-threatening hostage situation, is obvious hyperbole, suggesting the presence of a similar phenomenon to Stockholm Syndrome is not. Such patients are products of serious ethical misjudgments. These ethical infringements not only harm patients but also place providers very squarely in the crosshairs of the FDA and other regulators.
I’m betting that most of the cases of this type of unethical behavior are inadvertent. Perhaps they stem from a belief that the patients they coax to advocacy are always empowered by it. Unfortunately, the opposite is true.
A wise friend, and Vanderbilt University’s Director of Religious Life, Rev. Mark Forrester, describes eloquently the reason for this. The following statement has been paraphrased with permission.
While I am not trying to psychologize or diagnose this problem an actual case of Stockholm Syndrome, I do believe that the lesson we can draw from this story is that unhealthy attachments run deep and, if not examined under the light of prayerful discernment and critical reason, they will impede and distract us from a true partnership in the wilderness of the here and now.
The scrutiny that belies today’s regulatory environment means that stem cell clinics simply cannot risk creating “more-than-minimally-manipulated” patients. Even if it is inadvertent.
How do providers with good and idealistic intentions determine if this ethical problem affects them and their patients? How can they reverse it? How do they begin peeling away the onion and get to an ethical core that both honors the helping relationship and protects their clinical practice and reputation? How do they change their approach and keep regulators from forcing this issue that is clearly capable of placing a target on their back?
My suggestion is to consider a Practices Compliance Assessment (PCA); one of our RMAT Spectrum Services that is aimed at bringing cell therapy practices into compliance. A PCA will help practitioners recognize and integrate the “spirit” of regulatory rules, not just the “letter” of their detail.
The RMAT Spectrum Services PCA is a comprehensive and multi-domain evaluation of provider compliance strengths and weaknesses in an extensive list of essential operations, including web content, social media platforms, informed consent procedures, follow up care practices, data modeling and security, billing policies, HIPAA compliance, patient engagement, GMP, CGTP, 361 vs. 351, product sourcing, and more.
Assessment from a professional, knowledgeable third-party consultant can protect the shared provider-patient experience and can mean the difference between “more-than-minimally-manipulated” patients and FDA-compliant practices.