According to the US FDA, Cetero Research, a North Carolina based CRO, allegedly produced fake clinical trial documents and test results over a period of 5 years. Consequently, in order to determine the authenticity of study data and understand whether new tests on drugs are required, an indeterminate number of drug companies who worked with the CRO must review their records.
The falsification was described by the FDA as “extensive” in its letter to Cetero dated July 26 thereby questioning the authenticity of all bioanalytical data produced by Cetero’s Houston bioanalytical laboratory between April 1, 2005 and June 15, 2010. The FDA said that the test samples were manipulated by Cetero in an effort to yield preferred results. No reference or recognition was provided by the FDA to any of the drugs or sponsoring drug companies whose data was affected.
The amount of data that was fabricated still remains unknown. Despite conducting its own internal investigation, the FDA established that Cetero’s inquiry was insufficient. In order to determine how many drug applications were affected, the FDA has given Cetero a turnaround time of 15 days to respond with a list of all FDA research related tests performed at the Houston laboratory over the five-year period.
Although there is no evidence regarding the safety risk of already marketed drugs, the FDA has urged drug companies to review Cetero’s work to ensure reliable and accurate test results. This could prove expensive for companies whose drugs are approved using Cetero’s fabricated test results as they might have spend for an entirely new set of clinical studies.
In a response issued by North Carolina-based Cetero late on Wednesday afternoon, the company said that the FDA was proactively contacted by the company to report its findings following an internal investigation initiated within the company. Some of the company’s clients were also contacted and informed about the situation. Cetero alleged that the company’s “rigorous scientific analysis” was disapproved and the company was discredited in the FDA letter to the company.
“The research conducted on behalf of our pharmaceutical sponsors can be, and has been, properly validated,” Cetero said.
Cetero presents itself as a privately held CRO involved in early phase trials and claims to have completed over 750 early phase clinical studies annually. The company asserts to have conducted over 20,000 pharmacology studies in its history. Although the FDA recognizes that Cetero initiated its own internal investigation, the agency says that the investigation started in 2009 only after a Cetero employee submitted a letter to the company bringing formal allegations of regulatory violations and misconduct. “Many of the chemists were manipulating and falsifying data associated with the samples being usezd within various projects,” said the employee, according to the FDA.
A third-party firm was appointed by Cetero to conduct an independent investigation. The FDA itself conducted two inspections in May and December 2010. According to Cetero’s response on Wednesday, findings of the inquiry concluded that problems were found with only six chemists who misreported the sample extraction date before analysis. In Cetero’s defence, the company explained that this was an act by the chemists to seek more money by claiming additional hours while they did not actually work.
A broader misconduct was suggested by the FDA where the agency noted that Cetero’s own internal investigation established discrepancies in date and time as there was a disparity between when Cetero lab staff was working and when test samples were studied. There were at least 875 instances where lab chemists were not even present at the facility while test samples were being extracted. Although Cetero covered up for the false claims of weekend and holiday work by attributing it to workers trying to gain overtime, the FDA noted that this justification could not be used as a cover for the falsification of weekday work records. The FDA also found fabricated data from multiple studies for multiple clinical trial sponsors in addition to inconsistent date and time records. In its response letter to the FDA dated May 24, 2010, Cetero agreed with that observation. The FDA was the opinion that the falsifications caused uncertainty in the authenticity of the remaining lab records.
Although Cetero claimed that it has been “transparent and forthcoming” with the FDA inquiry, the FDA revealed nothing to the company over 18-month investigation period until the July 26 letter. The company said that the processes used in the company today are fully FDA compliant and at par with industry standards. Despite the fact that Cetero has seven sites in North America, the FDA has identified only Houston laboratory as the site where data was fabricated. Parenthetically, the most recent press release of Cetero in April was the announcement of appointing a new executive: Pharmaceutical industry veteran James Dixon was named Cetero’s senior vice president, quality and compliance.
In the press release, Dixon quoted that: “Quality, safety and consistency are more important than ever in our industry. I am committed to building upon Cetero’s reputation as the leader in early stage clinical research and to further improving on our record of high-quality performance and reliability.”