Northwestern University

Office of the President

President Morton O. Schapiro

633 Clark Street

Evanston, IL 60208

 

Dear President Schapiro:

 

              I am writing to you on behalf of the International Research Foundation for RSD/CRPS, Inc.  The Foundation supports and encourages clinical investigations and medical research conducted throughout the world for the treatment and cure of Reflex Sympathetic Dystrophy (RSD), also known as Complex Regional Pain Syndrome (CRPS).  RSD/CRPS is a chronic neurological disorder which can result in debilitating pain to those who are afflicted.  The Foundation believes you should be made aware of the matter described below, and hopes you will act to assure that the issues raised are properly addressed.

 

              By correspondence dated September 2, 2010, the Foundation informed Joseph Walsh, Ph.D., Vice President for Research at Northwestern, of its serious concerns with regard to research conducted by R. Norman Harden, M.D., Associate Professor in Physical Medicine and Rehabilitation at Northwestern University Feinberg School of Medicine, and requested, “In the interests of public safety and scientific integrity, our organization urges that Northwestern University investigate the research that was conducted by Dr. Harden at your institution.”  A copy of that correspondence is enclosed as Exhibit 1, for your ease of reference.

 

              By correspondence dated September 22, 2010, Dr. Walsh advised that these concerns had been referred to Leyla Erkan, Rehabilitation Institute of Chicago Corporate Compliance Officer.

 

              By correspondence dated September 27, 2010, Ms. Erkan advised that:

              “RIC’s Senior Vice President, General Counsel has established a Preliminary Inquiry Committee to review the substance of the allegations and determine if a formal investigation is necessary.  The Preliminary Inquiry Committee is comprised of the following individuals:

  • Patricia Sheahan, Associate General Counsel
  • Julia Campbell, Associate Compliance Officer

             

              Northwestern has published on the internet its "Policy For Reviewing Alleged Research Misconduct" and "Procedures For Reviewing Alleged Research Misconduct".

Northwestern’s procedure requires the formation of an Inquiry Committee to review evidence and determine whether or not to conduct an investigation.  The Inquiry Committee is required to include at least 3 full time faculty members with "appropriate scientific expertise to evaluate the evidence and issues related to the allegations", and having "no personal, professional, or financial conflicts of interest with the complainant  or respondent".  This was not done.  Instead, RIC appointed 2 of its employees, neither of which has any scientific or medical credentials, to investigate possible research misconduct by Dr. Harden, another RIC employee.  The conflict of interest is readily apparent.

 

              By correspondence dated October 1, 2010 to Dr. Walsh and Ms. Erkan, the Foundation asked:  “Please clarify for us if the Inquiry Committee that you established at RIC is following Northwestern University’s policy that is posted on the web, and if not, would you kindly send us a copy of their policy.”  This question has never been answered by Dr. Walsh or Ms. Erkan.

 

              By correspondence dated October 8, 2010, I advised Dr. Walsh of the Foundation’s concern that Northwestern University was ignoring its own published “Policy For Reviewing Alleged Research Misconduct” and “Procedures For Reviewing Alleged Research Misconduct”.  My correspondence concluded:

               “We are deeply concerned that failure to comply with Northwestern University’s policies and procedures will invalidate any ultimate determination that is made.  We are further concerned that the procedures being used are biased against the complainant.  I would appreciate your assurance that this matter will be handled in compliance with the policies and procedures established by Northwestern University for its research community, including RIC.  If you believe that these policies and procedures do not apply to RIC, I would appreciate your furnishing me an explanation as to why not.”  These concerns have never been answered by Dr. Walsh or Ms. Erkan.

A copy of my October 8, 2010 correspondence is enclosed as Exhibit 2, for your ease of reference.

 

              By correspondence dated October 13, 2010 to Anthony Kirkpatrick, M.D., Ph.D, the chair of the Foundation’s Scientific Advisory Committee, Ms. Julia Campbell asked:

              “Jean Holewa has been in contact with your assistant to schedule 30 minutes to speak with Patti Sheahan and myself regarding your allegations against Dr. Harden.  We understand from your assistant that you have limited availability until November.  If at all possible, we would appreciate your taking 30 minutes of time to speak with us this week or early next week.”    

 

              By correspondence dated October 14, 2010, I responded to the above request:

                  “Ms. Campbell – As legal counsel for the International Research Foundation for RSD/CRPS, Inc., Dr. Kirkpatrick has furnished me a copy of your email request to speak with him regarding Dr. Harden.  On October 8, 2010 I emailed Dr. Jay Walsh and expressed our concerns regarding RIC’s handling of the complaint in this matter.  As of this date, I have not received a response.  I am furnishing you a copy of my email correspondence to Dr. Walsh below.  Before you proceed further in this matter, I would appreciate a response to the concerns we have raised.”  No response addressing our procedural concerns was ever provided, and the questionable process initiated by RIC continued forward.

 

              By correspondence dated October 14, 2010, Dr. Walsh stated:

              “As the research in question occurred through RIC, this matter has been referred to at RIC.  Please direct all further correspondence regarding the your client’s complaint to Ms. Erkan of RIC.”  [sic.]

 

              By correspondence dated October 14, 2010, Ms. Patti Sheahan advised that,

              “The Rehabilitation Institute of Chicago (RIC) is conducting the Preliminary Inquiry in accordance with RIC policy.”  She further advised,

“Please let me know if you or the other complainants would like to provide additional information or documentation in support of your allegations.  Otherwise, a copy of the Preliminary Inquiry Committee Report will be available to you and the other complainants on Oct. 22, 2010.”   A copy of Ms. Sheahan’s correspondence is enclosed as Exhibit 3, for your ease of reference.

 

              By correspondence dated October 22, 2010, Ms. Campbell transmitted a copy of a document entitled “Preliminary Inquiry Report”, in which it is stated that, “there was adequate scientific basis and information related to the data analysis and research in question” and that an investigation into the Foundation’s allegations is not warranted.  A copy is enclosed as Exhibit 4, for your ease of reference.

 

              By correspondence to Ms. Erkan dated October 25, 2010, I pointed out each and every act of non-compliance with Northwestern’s published policy and procedures regarding allegations of research misconduct, and I requested:

               “Ms. Erkan, I would appreciate your providing me answers to the following questions:

  • If you believe that the research misconduct policies and procedures established by NU for its research community do not apply to RIC, please furnish me an explanation as to why not.  On their face, they apply to RIC.  Dr. Walsh referred me to you for an answer.
  • If RIC has its own research misconduct policies and procedures which were complied with in this matter, please furnish me a copy or direct me to a source where I can obtain a copy.
  • If RIC has a procedure in place to formally challenge the findings in the “Preliminary Inquiry Report”, please consider this correspondence as such a challenge and furnish me a copy of that procedure.

 

            Based upon the foregoing, it appears that this “Preliminary Inquiry” is a sham, it should be set aside, and a proper investigation into the Foundation’s allegations of research misconduct should be conducted in accordance with NU’s published research misconduct policies and procedures.

 

A copy of my October 25, 2010 correspondence is enclosed as Exhibit 5, for your ease of reference.  Ms. Erkan has never responded.

 

              It is abundantly clear that Northwestern University’s policies and procedures regarding allegations of research misconduct should have been followed, but were not complied with in RIC’s inquiry into the matters raised by the International Research Foundation for RSD/CRPS.  Despite multiple requests, no explanation has been furnished as to why RIC ignored the policies and procedures established for just this purpose.  RIC appointed 2 RIC employees, one an RIC attorney and the other RIC’s “associate compliance officer”, neither of which has any scientific or medical background, to inquire into possible research misconduct by RIC employee R. Norman Harden, M.D., and not surprisingly their conclusion is that an investigation is not warranted.  This is not what is contemplated by the policies and procedures promulgated by Northwestern University for the fair and unbiased investigation of allegations of research misconduct.

 

              At the very least, a proper inquiry into the concerns expressed by the International Research Foundation for RSD/CRPS, Inc., with regard to the research by R. Norman Harden, M.D., Associate Professor in Physical Medicine and Rehabilitation at Northwestern University Feinberg School of Medicine, conducted pursuant to the University’s policies and procedures regarding allegations of research misconduct, is more than warranted.  It would also seem appropriate to investigate why the published policies and procedures were not complied with in the first place. 

 

              If you require any additional information, please feel free to contact me.  I am looking forward to your prompt reply.

Sincerely,

 

Jerry H.Trachtman

JHT/me