Overlaping Duke Scandal (s)

Work in progress

First let me introduce myself, my name is Danny Long, the reason I have a personal interest in this subject is on July 28th 2008 my wife Shelly Skalicky was left 24/7 dependent after an elective surgery at Duke. Her records were egregiously falsified, her trusted surgery team refused to tell us anything, all we got was a letter from Risk Management that the care was appropriate, and within the standard of care. Using colors I will try to expose some of the overlapping Scandals of Deception at Duke University (hospital).

Cancer research 2012 60 Minutes Deception at Duke, click here.
Medtronic fraud Scandal.
Shelly Skalicky medical records Scandal.

  1. April 2008 Bradford Perez, a third year medical student working in Potti's lab resigns, withdraws his name from publications, and writes a memorandum titled "Research Concerns". Duke officials convince Perez to not make a detailed report to the Howard Hughes Medical Institute, which is funding his research through Duke.
  2. Feb 22 2008  Medtronic Elects Victor Dzau, M.D. to the Board of Directors
  3. March 2008   Mrs Robinson was admitted to Duke University Medical Center and elected to undergo a surgical procedure, which was performed by Mantyh, the chief of Gastrointestinal and Colorectal Surgery at the hospital, and was assisted by Huang, a general surgery resident at the hospital.  (Aug 2013 Duke still fight responsibility) On the day following the surgery, the patient reported problems, and it was discovered that her small intestine had been connected to her vagina rather than to her rectum.
  4. May 9th 2008 Director of Duke spine surgery named in federal suit involving Medtronic.
  5. July 2008  Infuse FDA Warnings  (Medtronic product) The complications in the Infuse FDA warnings included the constriction of airways and nerves due to the swelling of throat tissues.
  6. July 28 2008 Shelly Skalicky has elective neurosurgery at Duke
  7. October 2008 Duke academic administration meet to discuss Potti. The meeting appears to have been triggered by Perez's memo.
  8. May 2, 2011 Bill Hawkins is apparently staying on board as Medtronic's CEO until his successor is found. William A. Hawkins III  Mr. Hawkins became a member of the Duke University Board of Trustees in 2011 and serves as vice chair of the Business and Finance Committee and member of the Medical Center Academic Affairs Committee.
  9. July 1st  2011  Board of Trustees Serving six-year terms on the governing body are biomedical engineer Bill Hawkins, former chairman and chief executive officer of Medtronic, Inc.; Allyson Duncan, a judge on the U.S. 4th Circuit Court of Appeals; Gerald Hassell, president of BNY Mellon;  Betsy Holden, senior adviser to McKinsey & Co.; and the Rev. Ashley Crowder Stanley, executive director of the Transition Into Ministry program.

Also, Robert Penn, president of three privately held independent oil and gas production companies, will serve a two-year term beginning July 1. Penn will complete the six-year term of Kimberly Jenkins, who vacated her position to become Duke's senior adviser to the president and provost for innovation and entrepreneurship.
  10. September 2011, a North Carolina law firm filed a malpractice suit on behalf of patients who enrolled in the Duke clinical trials. 
  11. Jan 2012 Robert Harrington will be leaving his position as the director of the Duke Clinical Research Institute, a position he has held since 2006
  12. June 2012, Gilbert Omenn, MD, PhD, who chaired the IOM committee, presented the report to a standing-room-only audience at the American Society of Clinical Oncologists (ASCO) 2012 meeting.
  13. March 21 2014 1M Fraud suit: Walker and N.C. Attorney General Roy Cooper said Duke billed health care agencies at surgeon rates for procedures performed by physician assistants. Among other allegations, Duke also billed for physician assistants being present at coronary bypass surgeries even though the assistants were not in the operating room. According to the lawsuit, Duke retaliated against Johnson when she continued to express concern to supervisors about Duke’s billing practices. 

    Read more here: http://www.newsobserver.com/2014/03/21/3721183_duke-university-health-system.html?rh=1#storylink=cpy
  14. 2015  If Robert M. Califf does in fact replace Margaret Hamburg at the FDA, odds are the agency will become more flexible with the medtech industry.  Califf is “one of the most influential cardiologists in the world and a leading authority on clinical trial design and drug regulation,” said Forbes. Critics, however, allege that he is too close to industry. He recently served on the board of directors for Portola Pharmaceuticals. In addition, he has received research grants from an array of healthcare firms, including Johnson & Johnson, Medtronic, Sanofi Aventis, Novartis, Schering Plough, Boehringer Ingelheim, and others. Califf also has a substantial background working in academia. He is the founding director of the Duke Clinical Research Institute, a contract research organization with a yearly budget of more than $100 million.

October 5th 2010 a meeting was held inside Duke to discuss the Potti misconduct, these are the participants. Below is an attempt to understand who these players were, and where they are now.

Victor Dzau, CEO and president of Duke University Health System and chancellor for health affairs,

Sally Kornbluth: (promoted) March 3, 2014 Sally Kornbluth, a prominent cell biologist with long experience leading academic programs, has been named provost at Duke University
"To be Duke's chief academic officer is both a tremendous honor and a significant challenge, and I am grateful to President Brodhead and the search committee for the chance to serve the university in this new and exciting way," said Kornbluth.
Member of  Duke faculty since 1994, Kornbluth was appointed vice dean for basic sciences at the medical school in 2006.  From 2009-2011, she also played a major role in directing the clinical research enterprise in the School of Medicine.
Ed Beckley Vice Dean of Education, responsible for overseeing the education program for the School of Medicine. Also was a strategist in the launching of Duke’s partnership with the National University of Singapore (NUS) for a sister medical school based on the Duke medical curriculum.

Nancy Andrews:  Nancy Andrews has been Dean of the Duke University School of Medicine and Vice Chancellor for Academic Affairs since October 2007. She was an investigator of the Howard Hughes Medical Institute for 13 years. [[[[[[Also,Member of the Institute of Medicine counsel since 2006]]]]]]

Wesley Byerly, (left Duke) Associate Dean for Research Support Duke University School of Medicine June 2007 – August 2012 (5 years 3 months)Durham, NC
Director, Office of Clinical Trials
University of North Carolina at Chapel Hill August 2012 – October 2012 (3 months)Chapel Hill, NC
Assistant Systemwide Compliance Officer for Research
The University of Texas System October 2012 – January 2014 (1 year 4 months)Austin, TX
Systemwide Compliance Officer (interim)
The University of Texas System February 2014 – December 2014 (11 months)Austin, TX
Associate Vice President for Research Compliance
UCONN HEALTH January 2015 – Present (2 months)Farmington, CT

News and Observer Editor and Reported Sarah Avery stunned Duke and the public with her Jan 2011"Flawed research appalls cancer patient" article in the News and Observer.  Within three months longtime News and Observer writer Sarah Avery was on Duke's payroll as media relations specialist. 

April 2011, yet another scandal was brewing for Duke and Victor Dzau. Criminal investigations were looming in federal investigations of Medtronic (medical device maker) that Victor Dzau MD sits on the board of directors, and Duke's own director of spine surgery (Robert Isaacs MD) was involved.  

An institution like Duke's  trustworthiness is defined in small moments when administrators think no one is looking.  Aug 22 2011 was one of those moments.

Victor Dzau does not attend the session, citing prior commitments. Duke representatives do not turn over Perez memo and the emails to IOM. Officials state that Duke has a "culture of openness" and there are no whistleblowers.

Aug 2011 Duke representatives meet with the IOM (Institute of Medicine) committee:
8:10 am Introductions – Committee Members, including Discovery of Process Working Group Members:
Gil Omenn, M.D., Ph.D., University of Michigan Medical School
Tom Fleming, Ph.D., University of Washington
David DeMets, Ph.D., University of Wisconsin, Madison
David Ransohoff, M.D., University of North Carolina School of Medicine and Gillings School of Global Public Health
Gail Geller, Sc.D., Johns Hopkins University

8:15 am Introductions and Opening Remarks – Duke representatives
8:30 am Discussions with Duke representatives
Rob Califf, M.D., Vice Chancellor for Clinical Research and Director of Duke Translational Medicine Institute
Sally Kornbluth, Ph.D., Vice Dean for Research
Michael Cuffe, M.D., M.B.A., Vice President for Ambulatory Services, Chief Medical Officer for Duke University Health System
John Falletta, M.D., Senior Chair, Institutional Review Board
Ross McKinney, M.D., Institutional Official 2006/2007, and Chair of the Conflict of Interest Committee
William Barry, Ph.D., Assistant Professor of Biostatistics and Bioinformatics
Geoff Ginsburg, M.D., Ph.D., Director, IGSP Center for Genomic Medicine
Michael Kelley, M.D., Associate Professor of Medicine, Oncology and Cancer Protocol Committee

Sept 14 2011
 DURHAM – Duke University Health System’s Dr. Michael Cuffe, a 24-year-veteran who only recently took the top medical post for the massive health care operation is leaving.
HCA did not release compensation figures, but company CEO Richard M. Bracken received $38 million in total compensation last year, according to a Securities and Exchange filing. CFO R. Milton Johnson received $22 million, and three presidents earned a combined $40 million in 2010. Bracken’s total compensation was up more than ten-fold that of his 2008 compensation, and the compensations of the other executive officers were on similar trajectories.

Cuffe’s compensation at Duke last year was $589,504, according to Form 990 tax information.

April 2012
Dr. Robert Califf
 Clinical Trials Need Major Remodeling, Califf Says
Califf said it costs an estimated “$400 million to do a global clinical trial with industry for a chronic indication.” We could do a more efficient version for less than half that amount, he surmised.

“It’s our belief,” he concluded, “that you could markedly reduce the costs of clinical trials if you are willing and able to take the streamlined approaches that we’ve all talked about for years now.”

Aug 2nd 2012
Dr. Robert Califf
 Portola Appoints Robert M. Califf, M.D., to Board of Directors
SOUTH SAN FRANCISCO, CA--(Marketwire - Aug 2, 2012) -  Portola Pharmaceuticals, Inc., a fully integrated biopharmaceutical company, today announced the appointment of Robert M. Califf, M.D., as an independent member of its board of directors. Dr. Califf is the Donald F. Fortin, M.D., professor of cardiology at Duke University School of Medicine, vice chancellor for clinical and translational research, and director of the Duke Translational Medicine Institute (DTMI). He is also professor of medicine in the Division of Cardiology at the Duke University Medical Center and a practicing cardiologist.

Sept 16 2012
Duke University Health System’s Dr. Michael Cuffe, a 24-year-veteran who only recently took the top medical post for the massive health care operation is leaving.
HCA did not release compensation figures, but company CEO Richard M. Bracken received $38 million in total compensation last year, according to a Securities and Exchange filing. CFO R. Milton Johnson received $22 million, and three presidents earned a combined $40 million in 2010. Bracken’s total compensation was up more than ten-fold that of his 2008 compensation, and the compensations of the other executive officers were on similar trajectories.

Feb 5, 2015
Hamburg's resignation comes at a crucial time for the FDA as Congress pushes initiatives to speed new drug 
development, and food safety advocates, backed by Obama, back the creation of a separate agency combining the food safety functions of the FDA and the U.S. Department of Agriculture.  
Late last month, the agency named Dr. Robert Califf, a prominent cardiologist and researcher from Duke University, to oversee its drug, medical device and tobacco policy. Califf is viewed by many as a potential successor to Hamburg, whose resignation takes effect in March.

Dr. Robert Califf
Jan. 26, 2015

January 28, 2015
 Report Criticizes FDA’s Drug Safety Tracking
When drug manufacturers are responsible for reporting the potential side effects of the products they develop, is it any surprise that the record is less than complete?
In more than 1 in 3 industry reports, patient age was not determined, and more than 4 in 10 lacked the date of the adverse event. The ISMP said that patient age, gender and event date must be included for a report to be considered reasonably complete. Not even half of reports filed by drug makers with serious events were reasonably complete; of those filed by consumers and doctors, 85% were reasonably complete.  Drug manufacturer data so incomplete, it is basically worthless.

Jan 26 2015 
Dr. Robert Califf
 Portola Pharmaceuticals Announces Dr. Robert Califf Retires From the Board of Directors to Accept Position as Deputy Commissioner for Medical Products and Tobacco at the Food and Drug Administration (FDA)

Feb 11 2015
Dr. Robert Califf
 Respected cardiologist Dr. Robert Califf appears to be a top candidate to be the next head of the Food and Drug Administration but may face heated Senate queries over close ties to pharmaceutical companies if nominated for the post.

The Duke University cardiologist and researcher was appointed as the agency's deputy commissioner for medical products and tobacco by the FDA last month and will start in March.
He has received research grants from pharmaceutical giants Novartis, Johnson & Johnson, Lilly, Merck and Schering-Plough. He also consulted for Boehringer Ingelheim, Bayer, Bristol Myers Squibb, device giant Medtronic and other companies, according to a disclosure statement on the Duke institute website.

Feb 13 2015
Dr. Robert Califf
 Observers point to one potential successor of Hamburg's as Dr. Robert Califf, a prominent cardiologist and Duke University researcher. He was recently appointed as the FDA's deputy commissioner for medical products and tobacco.

Feb 22 2008
 Medtronic Elects Victor Dzau, M.D. to the Board of Directors
Victor Dzau

 MINNEAPOLIS – Feb. 22, 2008 – Medtronic, Inc. (NYSE: MDT) today announced that its Board of Directors unanimously voted to elect Victor Dzau, M.D., chancellor for Health Affairs at Duke University and president and CEO of the Duke University Health System, to the Board as an independent director.

April 2008
 Bradford Perez, a third year medical student working in  Potti's lab at Duke University, resigns, withdraws his name from publications, and writes a memorandum titled "Research Concerns." (Timeline of Bradford Perez)  Duke officials convince Pereze to not make a detailed report to the Howard Hughes Medical Institute, which is funding his research. 
May 9 2008  Court document about 100 neurosurgeons named in Medtronic infuse kickback deal.(Including Duke Director of spine surgery Robert Eric Isaacs MD).  The defendant Robert Isaacs has received sham consulting fees in 2006 totaling at least $42,300.00. Plaintiff alleges that he received similar amounts in the preceding 2 years. 
July 2008  Infuse FDA Warnings  (Medtronic product)
The U.S. Food and Drug Administration (FDA) issued a statement in July 2008 regarding life-threatening complications associated with Infuse bone grafts. Between 2004 and 2008, the FDA had received 38 cases of patients experiencing complications during their Infuse cervical spine fusion treatment. At the time, Infuse was not approved for cervical spine fusion. The Infuse FDA warnings were specifically targeted towards this unapproved use of Infuse.

Oct 2008  Duke academic administrators meet to discuss Potti. The meeting appears to have been triggered by Perez's memo.  January 21, 2010
Nov 2010 Anil Potti resigning from Duke in November 19th 2010 June 22 2011
Over the last year, an ongoing series of Journal Sentinel/MedPage Today investigations has raised questions about annual payments made to a core of prominent surgeons around the country who were involved either in the clinical testing of Infuse or co-authoring positive medical journal articles that failed to link the product to serious complications. (see Infuse legal actions above)
"We are extremely troubled by press reports suggesting that doctors conducting clinical trials examining the safety and effectiveness of Infuse on behalf of Medtronic were aware that Infuse,  a treatment commonly used in spinal surgery, may cause medical complications, but failed to report this in the medical literature," Baucus and Grassley wrote. "This issue is compounded by the fact that some clinical investigators have substantial financial ties to Medtronic." Duke University CEO Victor Dzau sits on the board of Medtrinic, and Duke director of spine surgery is already listed in legal action for taking money from Medtronic

Aug 2011
Dr. Robert Califf

Sally Kornbluth
Duke representatives meet with IOM committee: Robert Califf, Sally Kornbluth, Michael Cuffe, Ross McKinney, John  Falletta, Geoff Ginsberg, Michael Kelly and William Barry.
Dzau does not attend the session, citing prior commitments. Duke representatives do not turn over Perez memo and emails to IOM. Officials state that Duke has a "culture of openness" and that there are no whistle-blowers. (This will come back to haunt Duke just a few years latter)  

No comments:

Post a Comment