Confusion Reigns and Fallout Widens in Massive Fake Drug Data Scandal
Confusion and chaos will reign this week as dozens of drug companies -- including Pfizer (PFE) -- scramble to figure out which of their drug studies were conducted by Cetero Research, after the FDA said on July 26 that employees there "were manipulating and falsifying data" in clinical trials between 2005 and 2010. Some of those tests may have to be redone -- setting companies back years in their new drug launches and costing them millions of dollars in testing fees.
Dozens of drug companies have done testing work through Cetero. There are currently 122 drug studies in progress in which Cetero has some role.
Cetero, in response, has taken the high-risk, aggressive PR strategy of attacking the FDA. In a press statement late last week Cetero said the FDA action -- it is notifying all drug companies that have pending new drug applications their data may be affected -- was "difficult to understand" because the company had told the FDA about its problems two years ago, worked to clean itself up, and since then its test results have all been "properly validated":
Cetero Research, the leading provider of early phase research services, remains fully committed to maintaining the quality and integrity of the data collected in each of its facilities, including the Houston, TX, bioanalytical laboratory. It is this commitment that makes the broad action announced publicly by FDA on July 26, 2011, even more difficult to understand.
The research conducted on behalf of our pharmaceutical sponsors can be, and has been, properly validated.
Six chemists fiddling their timesheets
The company gave some background as to what went wrong inside its Houston facility:
... six chemists in its Houston facility had misreported the date that samples were extracted prior to analysis. The chemists did this to seek additional compensation through weekend pay and pay for hours when they did not actually work.It then complained that the FDA released its warning letter without telling Cetero first:
Responses were submitted to the Agency in a timely fashion, with no response until the public announcement to the press and on its safety website immediately upon receipt of an Untitled Letter on July 26, 2011, despite numerous follow up requests for resolution with the FDA.It isn't clear how many drug companies, and how many studies, are affected. An Abbott Labs (ABT) spokesperson last week insisted to BNET that "Cetero did not conduct any studies for Trilipix for Abbott," as mentioned on July 27. But that's not what this 2010 study of Trilipix in the journal Clinical Drug Investigation says. On page 1, the lead author is described as an employee of "DGD Research - a Cetero research company, San Antonio, Texas," and in the "acknowledgements" it says:
Abbott sponsored this study. Abbott was involved in the design and conduct of the study; collection, analysis and interpretation of the data; and the preparation, review and approval of the manuscript.The FDA's letter appears to cover only Cetero's Houston site, not its San Antonio site. Abbott said, "Cetero's Houston facility has not conducted any bioanalytical studies or labwork, as outlined in FDA's letter, for any Abbott products."
Client list getting longer
In other developments:
- Cetero's board members are still gathering information about the fiasco.
- Pharmalot reported that Cetero employed five executives who formerly worked for MDS Pharma Services, another testing company, that was subject to similar FDA action in January 2007. The FDA said at the time there were "questions about the validity and accuracy of test results from studies conducted by MDS Pharma from 2000 through 2004."
- Pfizer, the world's largest drug company, said it was evaluating whether any of its drugs are affected.
- Lawyers are already advertising for clients who believe they may have cases involving Cetero.
- The number of companies involved could include generic medicine makers. Outsourcing Pharma reported that Cetero was trying to expand its client list from generic makers such as Sandoz, Teva, Mylan, and Actavis to makers of new brands such as Pfizer, Bristol-Myers Squibb, Novartis, and AstraZeneca.
- Others feared that the scandal may trigger greater regulatory oversight of drug trials, adding time and money to the cost of developing new drugs.