In what was named one of the top science scandals of the year by The Scientist magazine, Duke University and one of its chief oncologists are being sued for medical malpractice and wrongful death of several breast and lung cancer patients as a result of bogus clinical trials based on forged data and the researcher’s false credentials. The lawsuit, which names Duke University and/or the Duke University Health System (DUHS), claims that it was fraudulent and negligent behavior to enroll cancer patients in a trial when it knew the chief researcher was not who he claimed to be and that much of the research was suspect.
The lawsuit claims that the defendants “engaged in a systematic plan to develop for-profit cancer tests for the primary purpose of generating billions of dollars in revenue,” and that they engaged in “conduct that was evasive, deceptive, misleading and fraudulent” instead of “actively protecting the safety and rights of patients in proper clinical trials.” The complaint describes a sordid tale of for-profit science, where the primary researchers, along with medical directors at DUHS, formed a foreign corporation to capitalize on financial gain from their research just months after the publication of their first article in June 2006, which was based on plagiarized data from another research group. Researchers from that other group read the analysis based on the plagiarized data and found it to contain numerous errors. This was followed by correspondence from other researchers who noticed similar and additional concerns.
When Duke University was informed of the misconduct and errors, it did not attempt to correct or retract the article. It did not discipline researchers, but instead supported efforts to initiate clinical trials based on this research, which was done less than six months after the publication of the first article. In seeking FDA approval for clinical trials, Duke and the researchers were informed their application contained insufficient information and data, but trials went ahead without approval.
At this point, all they seemed interested in was getting money for the trials. They wrote applications for grants and investments. Duke University actively sought out partners interested in “commercializing a novel and versatile panel of genomic predictors of chemotherapy response.” Once funding was secured, Duke went ahead with their first clinical trial in May 2007, less than a year after the first publication of the article. A second clinical trial was begun in October 2007. A third clinical trial began in April 2008.
Although Duke claimed to have conducted an exhaustive external review of the research in 2009, only a cursory review was allowed, with little access to data, software, and methodology. The result was that the external panel was unable to reproduce the results of Duke researchers. However, Duke claimed the external review had shown the science to be valid and continued enrolling patients in clinical trials. It was not until 2010 that the trials were finally and completely stopped.
According to the lawsuit, people enrolled in clinical trials were put at unnecessary risk for trials based on scientific data known to be flawed. All of them suffered and many died as a result of the fraudulent actions of Duke University and its researchers. Duke University has refused to comment on the lawsuit.
If you have been hurt or lost a loved one as a result of another person’s fraud or negligence, you may be able to receive compensation. To learn more about your legal options, please contact the Columbus personal injury lawyers at Robert W. Kerpsack, CO, LPA for a free case evaluation.