In the Jan. 24 episode of MedPage Today’s “Anamnesis” podcast, “Is That a Centipede I See in My Capsule?” Eban asserted that the generic form of Lipitor, prescribed for high cholesterol, is just one of the many generic drugs produced in “substandard conditions.”
“They haven't tested (generic drugs) properly. They get their approval, they're first to file, then they go back into the lab and figure out how to actually make it,” she said.
The first drug company to obtain U.S. Food and Drug Administration approval for a particular drug receives six months of market exclusivity. That was worth $600 million to Ranbaxy for its Lipitor generic (atorvastatin). To obtain exclusivity, pharma reps are sleeping in the FDA parking lot for weeks, and some are literally physically fighting each other, Eban said.
Dirty Conditions At Overseas Drug Companies
Most generic drugs come from overseas, where it’s a “free-for-all,” Eban said. One patient in New Jersey found a live bug in her pill sent by Express Scripts, one of the largest pharmacy benefit managers.
During the 10 years Eban gathered research for her book, generic drug manufacturers in China and India put on what she calls a “dog-and-pony show” displaying pristine plants.
But whistleblowers, Eban said, gave her documents and photographs indicating the “gory details of what was happening in these (generic drug) plants. The kinds of crazy decisions that were being made—like failing drugs, drugs that had glass particles in them approved to be dispensed. Broken down, rusted equipment that was leaving metallic fragments in pills — those were being dispensed.”
Eban discovered that generic drug companies test drugs secretly, delete any tests that fail, and alter test parameters to produce favorable data. The companies also swap ingredients when their drugs don’t dissolve properly, she said.
“They just haphazardly changed things up to try to get better data to show the FDA. All of this was taking place in a kind of lawless regulatory environment. They're not afraid of their own regulators,” she said.
“Our FDA has all but volunteered to be tricked because we announce our overseas inspections in advance. We give three months' notice. They (generic drug companies) send in data fabrication teams,” Eban said, adding that the FDA doesn’t carry out surprise or short-notice visits anymore.
In fact, foreign generic drug companies make high-end hotel reservations for FDA agents, picking them up at the airport in luxury vehicles and arranging massages, gold coins and trips to places like the Taj Mahal, she said.
“Once (the FDA was) walking into these plants on short notice and they were finding unbelievable stuff — like sterile manufacturing plants that are just inventing their microbial testing data … (companies) weren’t testing anything. They just invented this data,” Eban said. (Microbial testing data indicates the prevalence of disease-causing and spoilage-inducing microorganisms found in a specific sample of air, water or surfaces.)
Eban described dirty floors, employees using the same mops to clean bathrooms and the drug manufacturing areas, and lizards and snakes in the building.
“This is absolutely ongoing. There is no change and India's plants have gotten a lot of warning letters from the FDA. The Indian industry is saying, ‘This is totally in the past. It had to do with this one company, Ranbaxy. There is no evidence to support that whatsoever,’” Eban said. “We're in an anti-regulatory era, and our regulatory infrastructure is essentially being dismantled around us.”
Generic drugs don’t state their country of origin “because the companies deem it to be proprietary,” so doctors and patients have no way of knowing, she said.
Light At The End Of The Tunnel
But there is hope. Some doctors who’ve read Eban’s book told her they now believe the patients they used to think were just complainers.
Dr. Harry Lever, Eban said, developed a manufacturers’ blacklist that Cleveland Clinic pharmacists now refuse to purchase from, due to recurring problems — some as serious as formerly stable heart transplant patients landing in the emergency room with symptoms of organ rejection upon switching to a generic immunosuppressant.
One FDA investigator, Peter Baker, has snooped around and found evidence of fraud in four-fifths of the 86 inspections he did in India and China over four years.
“Without Peter Baker, our regulatory system is now set up to detect criminal behavior,” Eban said. “We need big consumer organizations like AARP, all of these great organizations to do their own testing. Where is the ranking? We rank cars. We rank washing machines. Why isn't there testing and ranking of generic (drug) manufacturers?”
One solution may be Civica Rx, a nonprofit drug manufacturer with a mission to transparently, safely and affordably produce generic drugs in the U.S.
MedPage Today Editor-in-Chief Dr. Marty Makary, who interviewed Eban in the podcast, suggested another intervention: the creation of an organization to design a credentialing and independent testing system for generic drugs.
