FDA agents have discovered that employees at the Houston office of Cetero Research tampered with records and manipulated test data. This firm has conducted research for drug companies worldwide. Chinna Pamidi, the testing facility’s president, bluntly admitted that much of the lab’s work was fraudulent, saying “You got us” when confronted by the FDA. The FDA stated that the lab’s violations were so “egregious” that studies conducted there between April 2005 and August 2009 may actually be worthless. About 100 drugs, including various types of chemotherapy and addictive prescription painkillers, were approved for sale in the United States partly because of Cetero’s fraudulent tests.
Twice the FDA has announced that drug manufacturers were required to repeat many of Cetero’s tests and submit their findings. The FDA allowed companies to miss their deadlines both times. Today, eight months after the last deadline expired and over three years after Cetero’s misconduct was discovered, the FDA has only received the required submission for 53 drugs. The FDA admits that “a few [companies] have not yet submitted new studies,” while other companies have not submitted new studies because they removed their drug from the market entirely.
Of the 53 drug submissions the FDA has received, the agency has only reviewed 21 of them. This raises concerns that patients are taking medications today that may be removed from the market tomorrow. On top of that, the FDA refuses to disclose the names of the drugs it is reassessing. The agency’s rationale is that doing so would expose “confidential commercial information.” Despite ProPublica’s request, the FDA won’t even release its 21 completed reviews. Shouldn’t concerns for patients’ health outweigh these other factors? Some experts say that by withholding this information, the FDA has failed to meet its obligation to the public.
Though now retired, lead agent Patrick Stone said that Cetero’s research never seemed quite right during his years of inspection. Other research firms would produce overwhelming amounts of trial data – with records of failed tests and meticulous explanations of how and why chemists made adjustments. Unlike the other labs, Cetero’s trials had incredibly clean records, with their documentation showing very few errors and adjustments in how they ran the trials. When Stone and his colleagues would notice holes in the data, Cetero officials would produce additional data that should have been included in the original files presented to the FDA.
Still, Stone and other FDA officers may not have detected Cetero’s tainted tests if not for a whistleblower. Cashton J. Briscoe’s job was to test blood samples prepared by Cetero chemists to see how much of a drug is in patients’ blood. Cetero had the practice of paying its chemists based on how many tests they completed in a day. Many chemists would significantly increase their income by squeezing in extra tests and cutting corners. After confronting Cetero about their alleged misconduct, Briscoe called the FDA and set up a meeting with Stone. Briscoe apparently changed his mind, didn’t show up to the meeting and clammed up. Despite Briscoe’s unwillingness to reveal more information, the incident reminded Stone of all the suspiciously flawless records he had seen at Cetero years ago.
Though this story ends on a slightly positive note – the closing of a fraudulent research firm that made its daily profit by endangering patients across the world – it also highlights the FDA’s lack of regulatory muscle. It is sad that a firm like Cetero was allowed to operate for so long under the supposedly watchful eye of the FDA, only to be exposed by one of their own. In the words of Patrick Stone, “it’s crap that we didn’t catch it five years ago. How could we let this go so long?”