Cetero Research, a Houston-based firm that researched safety and effectiveness for drug companies throughout the world got busted. On May 3, 2010, agents from the FDA (Food and Drug Administration) visited the firm to investigate a former employee’s claim that the company fraudulently manipulated records and test data. The lead agent, Patrick Stone, explained the severity of the situation to Cetero’s president, Chinna Pamidi, who admitted to Stone that the allegations were correct. According to Stone, Pamidi literally said, “You got us.”
File boxes containting five years of data from approximately 1,400 drug trials were evaluated. Based on these records and other tell-tale evidence, the FDA announced that the lab’s violations were so blatantly “egragious” and of a “pervasive nature,” the research conducted between April 2005 and August 2009 was most likely worthless.
So what does this mean to consumers? It means that around 100 drugs, including chemotherapy compounds and addictive prescription painkillers were approved for sale in this country based partly on Cetero’s fraudulent tests. Most of these drugs were generics of name-brand drugs. Astoundingly, Cetero scientists had not even run tests on whether the ingredients in the generics were the same as the originals. These drug tests included ones for seemingly harmless generics such as ibuprofen gelatin capsules, which were sold by one of the country’s largest grocery store chains for months before the FDA was assured they were safe.
Agent Stone expected the FDA to rapidly alert patients and doctors. However, in its usual fashion, the agency was not only slow to act, it didn’t publicly announce anything. Instead, it quietly “handled” the matter. No drugs were pulled off the market. What’s more amazing is that even now, some of these drugs are still on the market even though the FDA has absolutely no idea of their safety or effectiveness.
But wait, there’s more! On two separate occasions, the FDA announced it was making drug makers reanalyze, repeat or audit Cetero’s research. They even gave them deadlines to report their findings back to the agency. However, both times, the agency allowed some of these manufacturers to extend their deadlines, while other companies simply removed their drugs from the market.
It is now April 2013 – three years after the initial “drug bust,” (so to speak). The FDA has finished reviewing only 21 of the 53 submissions. This means that many consumers of over-the-counter drugs or patients prescribed more serious drugs are taking them to this very day.
Believe it or not, the FDA is refusing to disclose the names of the drugs it’s evaluating, claiming that in doing so, it would expose “confidential commercial information. The agency defended its handling of the situation. In fact, Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, said “It is non-trivial to have to redo all this, to withdraw drugs, to alarm the public and the providers for a large range of drugs. “There are consequences. To repeat the studies requires human experimentation, and that is not totally without risk.” She also said that the potential for harm from drugs tested by Cetera was “quite low” as confirmed by the fact that there were no problems with drugs the agency had reviewed. (Remember, the number of drugs reviewed was less than half of those submitted.)
Woodcock added that an agency risk assessment found the potential for harm from drugs tested by Cetero to be “quite low,” as “confirmed” by the fact that no problems have been found in the drugs the agency has finished reviewing.
Many experts say the FDA is refusing to meet its public obligations by not disclosing its findings of the 21 completed reviews. David Kessler, who headed the FDA from 1990 to 1997 and is now a professor at the University of California said, “If there are problems with the scientific studies, as there have been in this case, then the FDA’s review of those problems needs to be transparent. FDA may be right here, but if it wants public confidence, they should be transparent. Otherwise it’s just a black box.”
So what does Stone, the former FDA investigator have to say? “They could have done more. They should have done more.” That’s an understatement, to say the least. He also said that there are thousands of bioequivalence studies done each year, each generating thousands of pages of paper records. According to Stone, “Do you really think we’re going to look at 100 percent of them? We’re going to look at maybe 5 percent if we’re lucky. Sometimes 1 percent.” I admire his candor, but am abhorred by this and so many other blatant mishaps involving dangerous drugs and medical devices by the FDA. Is it incompetence or is the FDA in bed with the drug companies? That’s another story. All I know is that it’s time for some real changes to how Big Pharma and the FDA conduct their business.