DUKE CANCER CLINICAL TRIAL DANGERS
RALEIGH, NORTH CAROLINA PERSONAL INJURY LAWYER
Some Duke University Medical Center patients learned in 2010 and 2011 that their cancer treatments were based on the flawed research of Dr. Anil Potti, a discredited Duke associate professor who resigned in November after his work and credentials came under scrutiny.
The involved studies include breast and lung cancer clinical trials.
Why was the lung and breast cancer research discredited?
Dr. Anil Potti resigned as an associate professor at Duke University in November 2010, after it was discovered he embellished his credentials, including claiming to have been a Rhodes Scholar when he was not, and the underlying science of the studies was called into question by independent cancer organizations and agencies.
According to a communication from Dr. Victor J. Dzau, Chancellor for Health Affairs and CEO, Duke University Health System, "A research misconduct investigation is proceeding and several of the pivotal scientific papers related to this work have now been retracted from the medical literature."
What medical centers may have been involved?
In addition to Duke University, medical centers and hospitals in Florida, Illinois, North Carolina, South Carolina, and Virginia were also involved in recruiting patients to participate in these Duke clinical cancer trial studies.
For a complete list of centers and hospitals, click here.
Why were clinical trials allowed to continue?
The clinical trials continued after Potti’s research was discredited, according toThe News & Observer. The N&O cited that 110 patients at Duke University Medical Center are known to have been involved in Dr. Potti’s clinical cancer trials.
It appears that Duke missed opportunities to take quick action once Dr. Potti’s research was questioned more than 4 years ago, and the clinical trials were allowed to continue despite serious concerns.
According toThe News & Observer, researchers from other institutions related their issues communicating with Duke officials about Potti’s research. Keith Baggerly and Kevin Coombes, biostatisticians at MD Anderson Cancer Center in Texas, first voiced their concerns in 2006.
When they learned the Duke clinical trials were taking place, Baggerly and Coombes tried to alert officials, but it was not until 2009 that Duke stopped the trials. Unfortunately, patients at Duke had already started receiving the treatment.
Duke officials decided to restart the trials in January 2010, only to stop once again—for the last time—in July 2010.
It is important to consider comments made by Duke official, Dr. Michael Cuffe, vice president for medical affairs: “These trials should not have been done. It’s clear additional steps need to be taken. We owe it to patients.”
We are waiting to obtain copies of internal reports Duke has reported to have prepared with regards to a full review of the credentials and claims of Dr. Potti, the misconduct inquiry required by federal law and the report addressing data manipulation that may have occurred.
What are the trials in question?
The clinical cancer trials are known by the following codes and titles:
1) NCT00636441: Trial to Evaluate Genomic Expression Profiles to Direct Preoperative Chemotherapy in Early Stage Breast Cancer.
This trial is also referred to as: Randomized Phase II Trial Evaluating the Performance of Genomic Expression Profiles to Direct the Use of Preoperative Chemotherapy for Early Stage Breast Cancer.
2) NCT00509366: Study Using a Genomic Predictor of Platinum Resistance to Guide Therapy in Stage IIIB/IV Non-Small Cell Lung Cancer.
Also referred to as: Phase II Prospective Study Evaluating the Role of Pemetrexed Plus Gemcitabine Chemotherapy for the Initial Treatment of Select Stage IIIB and IV NSCLC in Patients Using a Genomic Predictor of Platinum Resistance to Guide Therapy.
3) NCT00545948: Genome-Guided Adjuvant Cisplatin With Either Vinorelbine or Pemetrexed for Early Stage Non-Small Cell Lung Cancer.
Officially referred to as: Genome-Guided Phase II Study of Cisplatin Based Adjuvant Chemotherapy With Either Vinorelbine or Pemetrexed for Early Stage Non-Small Cell Lung Cancer.
Click here for more information on the recently filed lawsuit in this matter.
Click here for detailed information on where the Duke clinical trials took place.
Click here to read The Herald-Sun's interview with attorney Thomas Henson.
Click here to read The Chronicle’s interview with attorney Thomas Henson.
Resulting News Coverage
Duke University Health System subject of suit from former clinical trial patients
Daily Tar Heel
September 15, 2011
Duke lands in court over flawed clinical trials
Nature.com
September 12, 2011
Patients sue Duke over Potti trials
The Chronicle
September 9, 2011
Duke Researchers Retract Paper From Blood; Dozens of Retractions of Potti's Work Expected
The Cancer Letter
September 9, 2011
Families sue Duke over bogus cancer research
WRAL
September 8, 2011
Duke sued over clinical trials
ABC11
September 8, 2011
HensonFuerst investigates Potti trials
The Chronicle’s
February 11, 2011
Thomas Henson discusses questionable Duke cancer treatments
The Herald-Sun
February 3, 2011
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