Mistakes Were Made

We all get a secret thrill from being scared, right? I mean, my production manager loves The Walking Dead, my wife’s a big fan of The Shining, and I’ve had the bejesus frightened out of me by Poe and Lovecraft on numerous occasions. We like to be terrified, as long as we’re not really at risk. But Fortune magazine recently managed to up the ante on zombies, axe-murderers and The Dunwich Horror with “Dirty Medicine,” its exposé of Ranbaxy (bit.ly/14o4q4w).

The writer, Katherine Eban, chronicles the awful practices that led the Indian drugmaker to fork over an unprecedented (for a generic company) $500 million to the U.S. government — $150 million in criminal fines and forfeiture, and $350 million to settle civil claims brought by the feds and the states. The shoddy manufacturing and deliberately misleading documentation at some of its sites, the use of employees as (prescription) drug mules, the attempt to get the executive director of clinical medicine and pharmacovigilance to “use her medical license to prescribe [a diabetes drug] to everyone in the company so they could record hundreds of sales”: horrifying enough, but even worse is the way in which the FDA had to plod through the nearly-decade-long investigation, at least up until the time they sent a gun-toting investigator to lead a raid of the company’s Princeton, NJ offices.

Ms. Eban does a great job of portraying the agency’s limitations (namely, that it has to have some trust in the companies it regulates), but still raises questions of why Ranbaxy drugs continued to get approved here long after it became clear that the company’s problems weren’t limited to a few bad facilities. (The settlement only cites two facilities in India, but manufacturing deficiencies have been found in numerous locations. In fact, the company’s generic Lipitor, manufactured at a U.S. site, had to be recalled because of glass particles. This occurred after Ranbaxy’s first-to-file status elapsed and the value of the generic plummeted.)

A key aspect of horror stories is fear of The Other. Over the years, I’ve had conversations with readers who’ve complained of “how they do things over there,” regarding Indian generics, and they do occasionally descend into xenophobic, protectionist rants. I’ve tried to stay unbiased. Sure, one of my favorite FDA warning letters was issued to a site in Hyderabad (1.usa.gov/1119Y1d), but one of the worst 483s I’ve ever seen was issued to a company here in the U.S. Facilities anywhere can go totally off the rails.

The thing is Ranbaxy didn’t suffer a cascade of quality problems. Ms. Eban’s article makes it quite clear that the company’s faked test results, mix-and-match manufacturing techniques, almost deliberately shoddy AIDS treatments (sent to Africa, where they likely proved useless, hastening countless deaths) and other unconscionable actions were, well, standard operating procedure, all in the name of tricking regulatory agencies. Ironically, she cites an instance where “[Ranbaxy] officials forged and backdated a standard operating procedure related to how patient data are stored, then aged the document in a ‘steam room’ overnight to fool regulators.” So at least they know what an SOP is.

There are some heroes in the article, particularly whistleblower Dinesh Thakur, who wound up with a $49 million windfall as a result of Ranbaxy’s U.S. settlement, but this horror story should fill us all with dread.

Gil Roth, Editor
groth@rodmanmedia.com / twitter.com/contractpharma