As the team lead by surgeon Stephen Chagares prepared a protocol for robotically-assisted mastectomy, the Institutional Review Board at Monmouth Medical Center provided guidance “every step of the way,” said Nicholas Fotopoulos, a research coordinator and an undergraduate at Princeton University in his sophomore year.
Fotopoulos was recruited by Chagares early in 2018 to assist him with preparing a research protocol to study the use of a robotic surgical device in nipple-sparing mastectomy procedures.
In the course of reporting a previous story April 5, an inside source informed this reporter that Chagares performed robotic mastectomy on patients without a protocol and without oversight. This, The Cancer Letter later learned, was inaccurate.
“Not only did the RNSM clinical trial get approved under the oversight of the IRB and Dr. Toesca, but the IRB committee itself worked with us pretty much in every step of the way in order to design the protocol,” Fotopoulos said. “We wanted to make sure we did everything correctly. “Monmouth Medical Center, and the IRB committee, specifically, was with us every step to make sure that this protocol was as it should be.”
Fotopoulos spoke with Matthew Ong, a reporter with The Cancer Letter.
Matthew Ong: How would you describe your involvement with Dr. Stephen Chagares, Monmouth Medical Center, and their work on robotic mastectomy? What was your role in the creation or administration of the protocol?
Nicholas Fotopoulos: I was part of the procedure pretty much from the start to where it is right now. I’ve been shadowing Dr. Chagares and we both went to Milan to observe the procedure with Dr. [Antonio] Toesca.
Dr. Toesca taught Dr. Chagares how to perform an RNSM. From there, we came back to the United States with the intention of bringing the procedure here. I was listed as a research coordinator on the clinical trial, and that gave me a whole host of responsibilities that I was involved in. I prepared the IRB documents for RNSM to gain IRB approval.
Those documents, and what was necessary, came from the IRB committee at Monmouth Medical Center. The IRB committee had their own input on revisions multiple times throughout the admission process. We made every modification they requested.
Did Dr. Chagares perform the procedures under a trial or study protocol that was approved by Monmouth?
NF: Yes. The clinical trial was approved by the IRB committee unanimously—8-0. I was there for that.
We consulted with and shared the patient’s medical records with Dr. Toesca to confirm that our first patient would be an appropriate surgical candidate for RNSM. He confirmed she was an appropriate candidate and would have included her in his trial if he had consulted with her in Italy.
What was the nature of the trial or study? Could you describe the design, target enrollment, and endpoints?
NF: It was an observational clinical trial, 10 years in total for 50 patients. Enrollment ends at the year five point, so we can follow up for the next five years into that final test year.
The study included cancer patients and high-risk patients who were candidates for traditional skin-, nipple-, and areola-sparing mastectomy. We mimicked Dr. Toesca’s clinical trial for design, target enrollment, and endpoints.
I also noticed that the study was supposed to remain active for 10 years, presumably to allow for long-term follow up?
NF: These patients, as per the study, were to return to Dr. Chagares’ office for follow up four times during the first year and then semi-annually for the following four years in order to assess how they’re doing.
We were also monitoring oncologic outcomes to make sure that, with regular follow up with Dr. Chagares, these patients were staying healthy, they were pleased with their cosmetic outcome, the cancer wasn’t returning, and the oncologic outcomes were the same or better than standard surgery.
How are the endpoints similar (or different) to the Italian RCT led by Dr. Antonio Toesca?
NF: The only difference was that ours is a single arm clinical trial. We eliminated the part that prevented patients from choosing RNSM.
The idea was to also track, through patient follow ups, any data related to adjuvant chemotherapy, radiation, hormone therapy—anything that may have been in the patient’s medical regimen prior to the procedure, or may have been necessary after the procedure, which is standard to current mastectomy procedures as well.
It appears that the IRB was in charge of the protocol design, from start to finish. Is this true? Who else provided oversight?
NF: Not only did the RNSM clinical trial get approved under the oversight of the IRB and Dr. Toesca, but the IRB committee itself worked with us pretty much every step of the way in order to design the protocol. We wanted to make sure we did everything correctly.
We were assigned a point person at Monmouth who is involved in the IRB who constantly went back and forth with us. Through this designated contact, Monmouth Medical Center made a multitude of direct edits to the protocol, consent, and other accompanying documents until they deemed them satisfactory.
Monmouth Medical Center, and the IRB committee specifically, was with us every step to make sure that this protocol was as it should be.
Did Dr. Antonio Toesca serve as a proctor for Dr. Chagares? Was Dr. Toesca’s involvement approved by the hospital?
NF: Yes. It was assumed that a proctor would be needed because it was a new procedure. Even Dr. Chagares, when he did his first hernia robotic procedures five years ago, had a proctor there for his first time.
It’s a typical procedure to have a proctor come in for something that’s relatively new to a surgeon, so it was something that the hospital signed off on, wanted him there, especially after we said we got this procedure from Dr. Toesca.
We wanted him to be the proctor. Dr. Chagares would never have performed the procedure without a proctor.
Based on what you know, was Dr. Chagares instructed by the hospital administration not to speak with The Cancer Letter? Why?
NF: As I recall, after the first robotic mastectomy procedure of September 2018, Dr. Chagares initially presented his patient at a breast conference at Monmouth Medical Center and at a second breast conference in Pennsylvania.
When you first reached out, Dr. Chagares referred to the hospital administration, and they said there were very strict media guidelines for IRB clinical trials and he was told not to speak with the Cancer Letter.
I believe you reached out to Dr. Chagares again, and he was again told not to speak with the media, specifically The Cancer Letter, as per the hospital administration’s instruction.
Ultimately, was the hospital responsible for determining whether the study required IDE review by FDA? What was the hospital’s decision?
NF: The hospital gave us a checklist of everything you need for the protocol to be approved, and one of those items was an IDE. In the initial consultation meeting, the question of whether an IDE was necessary came up, and we were advised that an IDE was not required. The answer to the question became “Not Applicable” on the application from there forward.
What were the hospital’s initial concerns that led to the splitting of the study? I.e. only non-cancer patients were subsequently allowed to be enrolled to the protocol?
NF: Shortly after the first mastectomy, Dr. Chagares received a call from the hospital to separate the current clinical trial into two research groups—cancer patients and risk-reducing/non-cancer patients. There wasn’t anything alarming about this request.
Monmouth Medical Center confirmed via email that we would pause the cancer patient trial until the new protocol was submitted, but the non-cancer patient clinical trial would remain intact and active. We got the impression that they just wanted the two separated for logistical/reporting purposes.
When the hospital decided to end the study in its entirety and place a moratorium on the procedure, how were you and Dr. Chagares’s team informed of the decision? A patient had reached out and said she never received an explanation from the hospital. Did administration officials provide written justification for the moratorium?
NF: In November 2018, Dr. Chagares’ surgical coordinator tried to schedule an RNSM procedure for a risk-reducing patient. That was the first verbal notification where the hospital informed our group that the procedure was put on hold, without any written confirmation.
The patient had to be informed impromptu and without written confirmation as to why they could not receive the procedure they wanted to have. Dr. Chagares had to explain this to the patient without hospital correspondence, informing them that there were safety concerns with the current procedure.
The nurse manager then confirmed the coordinator could not schedule any RNSM. Dr. Chagares sent multiple emails and put out calls to the hospital. They confirmed via telephone to Dr. Chagares that all RNSM’s are completely halted, with no specifics as to why.
I received from that point a phone call from Dr. Chagares informing me what he had just been told, he said the hospital was concerned by a letter from Dr. Hooman Noorchasm, and I also read the news and the article that was published in the Asbury Park Press. To my knowledge, no one has received written notification of that decision by the hospital and we did not receive a copy of Dr. Noorchasm’s letter.
With every change to a clinical trial, typical protocol dictates that you should be given written notification of the change. We were never provided with any written official communication as to why a complete moratorium was placed on the procedure, or why the protocol was initially split between the two patient populations.
Have patients been notified that the trial was shut down?
NF: Yes, only by Dr. Chagares. He has a policy of full disclosure with all details with his patients.
The patients received no communication from the hospital. I think you can see from the emails from the patient that reached out to you that they were frustrated, knowing very little about the reason behind any of this, wanting to undergo RNSM, and completely being shut off from that opportunity.
Based on documents obtained by The Cancer Letter, on April 15, the hospital instructed Dr. Chagares to stop “collection of any additional data on the subjects already enrolled.” Does this go against the design of the trial and any follow-up that was promised to the patients?
NF: Yes. That was part of the plan, as we said, with the clinical trial, to follow up regularly as Dr. Chagares does with all of his patients. We were told to not follow up with those patients, no additional collection of data. That’s greatly concerning. It’s definitely a threat to patients’ health.
Despite these instructions, Dr. Chagares is still following the patients very closely, as he does with all his mastectomy patients, as is the medical standard of care.
If Dr. Chagares were to follow through with those instructions, collect no more data, to not observe the health outcomes of your patients—that would be totally inexcusable.
For patients to see that the hospital is saying, “We’re not going to follow up with you anymore, we want to cut you off,” the patients were largely frustrated that all this was happening and there was so much confusion about it. There was very little transparency as to why certain things were happening. I believe that not following up with the patients, as per the protocol they signed up for, would be completely wrong.
Does this moratorium on follow-up go against standard practice and principles of medical ethics?
NF: Looking back now, I experienced Monmouth Medical Center being very enthusiastic about RNSM. They were instrumental in the extensive IRB clinical trial approval process. With all the work that went into development of this clinical trial to obtain their IRB approval, to be very quickly halted—it doesn’t make sense.
To see the hospital behaving like this, it alarms me that there’s a potential for a different administrative goal in light of The Cancer Letter’s article. I was shocked to read the inaccuracies. I can only conclude that “Multiple sources with direct knowledge of the situation who spoke on the condition that their names would not be used” lied to you about Dr. Chagares.
So, I’m at a loss to explain how this is actually happening or what’s going on behind the scene, because we just don’t know, but it seems more of an orchestrated hospital administrative agenda behind all of this.
