FDA Finds Falsification of Drug Trial Results Affecting Dozens of Companies
Cetero Research, an obscure clinical testing company in the pharmaceutical industry, is about to become a household name because of its role in what could be one of the most damaging drug scandals of this century.
The FDA is writing to all pharmaceutical companies that have pending new drug applications to ask if they used Cetero to generate their test results. The reason: "widespread falsification" and "manipulation of equilibration samples" at the company from 2005 to 2010, the FDA says. The fallout from the Cetero scandal could affect dozens of drugs and companies.
According to the FDA's warning letter to Cetero, an employee first raised concerns with Cetero's management in June 2007 and April 2009:
[The complainant] was aware that many of the chemists were manipulating and falsifying data associated with the samples being used within various projects.Cetero appointed a new president, Roger N. Hayes, formerly of Pfizer and Merck, in January. Now, any testing done on new drugs between 2005 and 2010 may have to be redone, the FDA says.
The FDA did not say how many companies or products it believed would be affected. The fact that its letter asks all drug companies with pending new drugs if they used Cetero suggests that the industry has not yet grasped the scale of the problem. Here's a small taste as to how many companies Cetero tested drugs for:
- In the FDA's warning letter to Cetero, it lists redacted nine studies for the months of May and December 2010 alone.
- There are currently 122 drug studies in progress in which Cetero has some role.
- In the PubMed database of clinical studies, 16 papers were authored with the help of Cetero.
- Amylin (AMLN) and Eli Lilly (the diabetes drug Byetta);
- Bristol-Myers Squibb (saxagliptin, also for diabetes);
- Johnson & Johnson (tapentadol, a painkiller);
- Merck (Nasonex, an allergy spray and taranabant (an anti-obesity candidate)
- Abbott Labs (Trilipix for cholesterol)
- Elan and Acorda Therapeutics (Ampyra, for multiple sclerosis)
- BMS and AstraZeneca (dapagliflozin for diabetes)
- Sunovion (Omnaris an allergy spray)
- UCB (Xyzal, another allergy treatment)
It doesn't end there: The FDA said there was "apparent manipulation of equilibration samples to meet predetermined acceptance criteria" at Cetero, which makes a mockery of FDA commissioner Margaret Hamburg's desire to get more drug company input into approval decisions.
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