publication date: Apr. 7, 2019

Stephen Chagares initially declined to speak with The Cancer Letter. However, following publication of this story on April 5, 2019, Chagares sent the following email to Matthew Ong, a reporter with The Cancer Letter:

Dear Matthew,

I read your article in the online publication, The Cancer Letter. 

I understand, with anything new in medical advancement, non-medical journalists can encounter inaccuracies. Leaving the debate about Robotic Mastectomy aside, when you state “hospital insiders” as your source that a clinical trial was NOT performed, you assert  a major error in your article that can cause great harm to my hospital (Monmouth Medical Center/ RWJBARNABAS), our IRB Committee/Process, the Department of Surgery, the Department of Credentialing, my colleague Dr. Elkwood, Dr. Toesca, and myself.  Please see screenshots of your article attached. 

I DID perform Robotic Mastectomy under a clinical trial at Monmouth Medical Center. After my training in June 2018 with Dr. Toesca, he supplied me with his clinical trial protocol which is currently being performed throughout Europe and Asia.  After countless hours of research and hundreds of emails with hospital administration and the IRB committee, a revised clinical trial IRB was submitted. Dr. Toesca reviewed and edited the IRB as he is an investigator on my study. The data collected under my IRB will be submitted with data collected worldwide. In addition, all CITI modules were completed and proper authority was requested from Memorial Sloan Kettering Cancer Center for their Clinical trial Breast Questionnaire, the same one used in the other studies worldwide.  MSKCC granted approval for me to use it in my trial as a non-funded academic user. The Chief of Surgery issued a letter of confidence and the head of Credentialing decided there was no additional privileging needed due to my years of extensive mastectomy and robotic proficiency. I presented my trial to the IRB Committee in August 2018 and received a unanimous approval from all IRB members. 

In your article, you mention that I didn’t obtain FDA approval for this operation. I am not sure if you understand FDA and robotic off label operations. Off label operations are performed every day. This would have been a task for the hospital to obtain if they so desired an approval as they own the robot. In my communications with Research and Development at Intuitive, we discussed the facilities that are launching off-label robotic mastectomy and the “only” pathway for FDA approval is through the hospital, not through the surgeon. It was not something Monmouth Medical Center wanted to explore before or after either of the operations I performed. This is a choice all facilities make and it should be mentioned accurately without opinion as it is commonplace in every hospital every day in our country.  

By copy of this email, the above listed people are the hospital administrators, physicians and IRB members with whom I communicated and corresponded since May 2018.  The hospital administrators and I had been communicating prior to, during and after my return from training to perform robotic mastectomy with Dr. Toesca.  At all times, communication was positive/encouraging and upon return, we all worked together and I followed every request set forth by multiple departments and the IRB Committee.  These are factual documented emails showing collaboration over many months.

While your “unnamed source” sounds exciting, they are either in this email and not telling you the truth or they are not in this email and therefore are unaware of the process from beginning to end.  So, I respectfully request that you communicate with the above appropriate parties and immediately redact/clarify your article to accurately reflect the course of events to protect the interests of all parties involved.

Thank you. 
Dr. Chagares

 

Paul Goldberg, the editor and publisher of The Cancer Letter, responded to Chagares’s email:

Dear Dr. Chagares,

Thank you for your email.

As Matt’s editor, I have been on this story from the beginning. Our goal at The Cancer Letter is to get all stories right. This means we are always open to the idea of clarifying stories we have published. 

Information you bring to our attention now requires some processing on our part, and please accept my assurances that we will get going on it first thing Monday. To help us hit the ground running tomorrow morning I ask that you send us the documents to which you refer in your email.

I am all the more appreciative of hearing from you because Matt, who is on this email, made several attempts to reach out to you, most recently last week. Matt has also reached out to the hospital and Dr. Toesca. 

Sincerely,

Paul Goldberg

 

Chagares forwarded Goldberg’s email to members of the Institutional Review Board and officials at Monmouth Medical Center. Goldberg responded in an email containing a list of questions to Chagares and the institution. The Cancer Letter has not received answers or formal acknowledgement of receipt. Goldberg’s April 7 email follows:

Hi All,

As the editor on this story, I want to assure everyone that The Cancer Letter is committed to presenting accurate information.

For your convenience, I am attaching the PDF edition of last Friday’s issue. If a clarification or a followup story is required, we stand poised to go forward with that.

To be able to assess the issues Dr. Chagares brings up in his emails to The Cancer Letter, we would need to obtain answers to a series of questions, which are consistent with the questions we sought to address from the time months ago, when we started reporting the story.

Dr. Chagares had declined to speak with Matt, and the institution provided no on-record response beyond an initial statement that didn’t address many of the key questions. This is an excellent opportunity for all parties to establish the facts.

Here are the questions that we at The Cancer Letter believe are relevant today:

1. Did Dr. Chagares present a protocol for a clinical trial studying robotic mastectomies to the IRB at Monmouth Medical Center? If so, would you share that protocol with The Cancer Letter?

2. Alternatively, was Dr. Chagares’s use of the da Vinci robot in mastectomy considered off-label?

3. If this was a clinical study, what were the endpoints?

4. Who was the PI?

5. What were the enrollment targets?

6. Did the endpoints include long-term oncologic endpoints?

7. Were there stop and start rules? What were these rules?

8. Was there monitoring for adverse events?

9. Were there any other institutions engaged in Dr. Chagares’s trial, if there was one?

10. What role—if any—did Dr. Antonio Toesca play in this study? What is his relationship with your institution?

11. If this was a trial, was Dr. Toesca’s protocol identical to the protocol that may have been approved by the Monmouth IRB? Did. Dr. Toesca review and edit the Monmouth protocol, as Dr. Chagares states in his email to The Cancer Letter? We respectfully request both protocols.

12. In that email, Dr. Chagares states: “The Chief of Surgery issued a letter of confidence and the head of Credentialing decided there was no additional privileging needed due to my years of extensive mastectomy and robotic proficiency. I presented my trial to the IRB Committee in August 2018 and received a unanimous approval from all IRB members.”

Is this correct? Could you provide these documents to The Cancer Letter?

13. Did the robotic mastectomy patients who were operated on by Dr. Chagares at your institution sign an IRB-approved consent form indicating that they were being enrolled in a clinical trial?

14. Did this clinical trial protocol—if indeed this was a clinical trial—adequately reflect the risks and potential benefits?

15. Whether this was a clinical trial or not, were the patients informed about the fact that there are no long-term data demonstrating either superiority or non-inferiority of the robotic procedure in terms of cancer-related outcomes, compared to standard of care “open” procedures?

16. Did the institution or Dr. Chagares obtain an Investigational Device Exemption from FDA prior to conducting the robotic mastectomies?

17. Would an IDE have been required? If not, why not?

18. In his email to The Cancer Letter, Dr. Chagares states: “Off label operations are performed every day. This would have been a task for the hospital to obtain if they so desired an approval as they own the robot. In my communications with Research and Development at Intuitive, we discussed the facilities that are launching off-label robotic mastectomy and the “only” pathway for FDA approval is through the hospital, not through the surgeon. It was not something Monmouth Medical Center wanted to explore before or after either of the operations I performed.”

Is this correct? Did your hospital decide not to seek an IDE?

19. If an IDE was required, who would have been responsible for obtaining it—the hospital or Dr. Chagares?

20. Did Dr. Chagares receive oversight and surgical proctoring when the robotic mastectomy procedures were conducted?

21. Would this have been normally required or expected to happen?

22. It is publicly known—as a result of Dr. Chagares’s press announcements—that Dr. Chagares had performed two robotic mastectomies. Were there additional robotic mastectomies performed at your institution by Dr. Chagares or other surgeons in situations where no press releases were issued?

23. The manufacturer of the device—Intuitive Surgical—said to The Cancer Letter that it cautioned “a surgeon” about using its da Vinci robot to perform mastectomies in an off-label setting. Were you aware of this expression of concern from the company?

24. Are you aware of the identity of that surgeon? If you are, we respectfully request that you identify him or her.

25. Was the company informed of Dr. Chagares’s off-label use of the robotic device?

26. If not, should the company have been informed?

27. Why did the hospital ultimately decide to suspend robotic mastectomies? What were the “safety concern” and how did they emerge?

28. Has the hospital conducted further review regarding the safety of the procedure?

If so, what are the hospital’s conclusions?

29. In his email to The Cancer Letter, Dr. Chagares states: “At all times, communication was positive/encouraging and upon return, we all worked together and I followed every request set forth by multiple departments and the IRB Committee.  These are factual documented emails showing collaboration over many months.”

Is this correct? Could you provide all documents Dr. Chagares is referring to?

30. In his email to The Cancer Letter, Dr. Chagares states: “All CITI modules were completed and proper authority was requested from Memorial Sloan Kettering Cancer Center for their Clinical trial Breast Questionnaire, the same one used in the other studies worldwide.  MSKCC granted approval for me to use it in my trial as a non-funded academic user.”

Do you regard MSK as supportive of Dr. Chagares’s clinical trial and concurring with its design—if this was indeed a clinical trial?

31. On his website, Dr. Chagares states that he has “obtained specialty training in breast surgery” at MSKCC. Is this correct? MSKCC officials stated to The Cancer Letter that Dr. Chagares had been a non-employee rotating surgery resident from Monmouth Medical Center in 1990, and that this was a two-month rotation. Is this an appropriate use of the MSKCC link?

32. Dr. Chagares’s website identifies him as a “board certified breast surgeon.” What does this mean? The Cancer Letter is not aware of any “board certified breast surgeons.” There are, however, general surgeons who specialize in breast surgery. Should this be corrected?

We look forward to your response.

Sincerely,

Paul

 

Monmouth officials responded April 10 with the following statement:

“Of paramount concern to Monmouth Medical Center (MMC) is patient safety. After an evaluation of the robotic mastectomy procedure, MMC promptly suspended the procedure, pending additional investigation of its risks and benefits.”

 

Before publication of a May 31 follow-up story, The Cancer Letter sent an email containing another list of questions to Chagares and the institution. The text of the May 30 email follows:

Hi all,

It’s Matt and Paul from The Cancer Letter. We are working on a story that follows up on our previous reportage about robotically-assisted mastectomies at Monmouth. We have obtained in-depth information, and would like to give the hospital administration, the IRB, and Dr. Chagares the opportunity to respond to another series of questions.    

Please note that our story is scheduled to run tomorrow (Friday, May 31) morning. Our deadline is close of business at 6 p.m. ET for receiving any response.

Thanks,

Matt & Paul 

1. Did Monmouth Medical Center perform robotic mastectomies on a surgical protocol?

2. If so, how many patients was MMC aiming to enroll, and over what period of time?

3. Was the protocol approved by MMC’s IRB designed to test safety and efficacy of the da Vinci robot in mastectomy procedures?

4. If so, was this a randomized surgical trial?

5. Were members of MMC’s administration and IRB aware of the fact that the da Vinci robot has not been cleared by FDA for mastectomy or the treatment or prevention of breast cancer?

6. Was the protocol approved by MMC’s IRB limited to collecting patient satisfaction data after the procedure has been performed at MMC?

7. How many patients was MMC aiming to enroll, and over what period of time? How many were enrolled before the study was shut down?

8. What were the hypotheses that the study was intended to test?

9. Were hypotheses related to oncologic outcomes a part of the study?

10. Were the criteria for stopping the study pre-specified in the protocol?

11. Did MMC and its IRB oversee and vet all edits that were made to the protocol before it was approved by the IRB on Aug. 15, 2018?

12. Has Dr. Stephen Chagares ever created a protocol or conducted research before this protocol? 

13. Did Dr. Chagares at any time hold himself out to be knowledgeable about creating a protocol or did he rely on the guidance of MMC?

14. What role did MMC play in the creation of the protocol?

15. Did MMC instruct Dr. Chagares to make changes to wording and location of wording in the protocol? 

16. Did MMC have any concerns during the process? 

17. How many times did MMC review the protocol—ending in approval or decision to reverse the approval? 

18. Prior to ending enrollment, did MMC split up the study into separate studies—one for prophylaxis, the other for treatment of breast cancer? If so, what was the rationale?

19. What was the trigger for stopping enrollment? What was MMC’s rationale for ending enrollment?

20. Did local newspaper coverage of robotic mastectomy at MMC play a role in the hospital’s decision to implement a moratorium on the procedure and end the study? If so, how?

21. Is MMC continuing to conduct follow-up on patients who were enrolled?

22. Has MMC instructed Dr. Chagares or anyone else to stop follow-up and collection of data on patients who were enrolled?

23. Has MMC provided written justification for the moratorium on the procedure as well as ending the study to Dr. Chagares?

24. Has MMC provided written justification for the moratorium on the procedure as well as ending the study to the patients who were enrolled or scheduled for surgery?

25. Has MMC taken any corrective actions or implemented sanctions against the IRB or the hospital administration or employees in connection with this matter?

26. Are such actions warranted?

27. Did MMC check with FDA to determine whether robotic mastectomy was a “significant risk” procedure involving high-risk patients that should be performed under a formal investigational surgical protocol?

28. Did MMC advise Dr. Chagares’s team that an IDE was not required? On what basis did MMC’s IRB decide that an IDE was not applicable?

29. Did MMC administrators specifically instruct Dr. Chagares not to speak with The Cancer Letter?

30. Did MMC administrators and IRB provide oversight for the development of the protocol?

31. Did MMC administrators invite Dr. Antonio Toesca to serve as proctor for Dr. Chagares?

32. MMC did not answer questions from The Cancer Letter that were sent to hospital administrators on April 7 and 8, 2019. Why were the questions not answered?

 

Monmouth officials responded May 30 with the following statement:

“Of paramount concern to Monmouth Medical Center (MMC) is patient safety. After an evaluation of the robotic mastectomy procedure, MMC promptly suspended the procedure, pending additional investigation of its risks and benefits.”

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