There was reason to believe that some of the medications were contaminated with bacteria, others were mislabeled, and some were too strong or not strong enough. It's likely Glaxo would have gotten away with it had it not been for a company insider: a tip from Cheryl Eckard set off a major federal investigation.
She's never told the public what she saw inside Glaxo, but now she has. Her story opens a rare window on how one company traded its good name for bad medicine.
Glaxo Response to "60 Minutes" Report:
GlaxoSmithKline [GSK] issued the following response regarding a 60 Minutes program on January 2 that focused on a manufacturing facility in Puerto Rico which was formerly owned by the company.
GSK regrets the manufacturing issues at the Cidra facility, which were inconsistent with GSK's commitment to manufacturing quality. It is important to note, however, that the issues outlined in the 60 Minutes story occurred in the past -- between 2001 and early 2005 -- and related to one manufacturing facility. GSK had been working with the U.S. Food and Drug Administration to improve the plant's performance as early as 2001, before Cheryl Eckard was sent in 2002 as part of the team to address the issues cited by the FDA.
GSK strongly disagrees with 60 Minutes' implication that patients suffered harm as a result of the Cidra issues. The FDA; the US Department of Justice; and Neil Getnick, Cheryl Eckard's attorney, all stated there was no indication that patients were harmed as a result of the production issues at Cidra. Massachusetts U.S. Attorney Carmen Ortiz herself stated: "We did not uncover any evidence that patients were harmed from these adulterated batches."
GSK's manufacturing division has a strong track record of quality and compliance with current Good Manufacturing Practice (cGMP) requirements. Various regulatory agencies - including the FDA - conduct an average of more than 100 inspections each year at over 80 GSK manufacturing sites located in over 30 countries. The FDA has raised no material issues as a result of its very thorough inspections. GSK is committed to continuous improvement in our manufacturing processes. Patients should have a high level of confidence about GSK's manufacturing and the quality of our medicines.
GSK worked to bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA. The plant was closed in 2009 due to a declining demand for the medicines made there. The company strongly rejects any claim of retaliation for whistle-blowing. In fact, employees are encouraged to report any concerns they might have to management or through a confidential compliance hotline. Issues raised are investigated, and company policy prohibits any retaliation against employees.
Eckard worked in Glaxo quality control and over ten years she had risen to become a manager of global quality assurance. Her job was to inspect plants to make sure that the drugs had the right ingredients, the right potency and met government standards for purity.
In 2002, Eckard was assigned to help lead a quality assurance team to evaluate one of Glaxo's most important plants, in Cidra, Puerto Rico. Nine hundred people worked there, making 20 drugs for patients in the U.S. But Eckard says that when she saw what was happening to some of the company's most popular drugs, she couldn't believe it.
"All the systems were broken, the facility was broken, the equipment was broken, the processes were broken. It was the worst thing I had run across in my career," she told "60 Minutes" correspondent Scott Pelley.
The worst, because so many things behind the walls of the plant were going wrong at once: Eckard says water used to make tablets was tainted with bacteria; failures on production lines made some drugs too strong, some not strong enough; and the employees were contaminating products, including the anti-bacterial ointment Bactroban, which was made in a sealed tank to prevent contamination.
"They were opening up the lid and then they were sticking their body into the tank and scraping it with like a paddle," Eckard said.
"But this product is supposed to be free of bacteria. Why would they do that?" Pelley asked.
"It saved money," Eckard replied.
As her team continued its evaluation of the plant, Eckard says she discovered something much worse than contamination: because of failures on various production lines, she says that powerful medications were getting mixed up.
"Are you saying that different kinds of drugs were packed into the same bottle?" Pelley asked.
"Yes. And that's shocking," she replied.
Eckard says a chart that she produced for company executives shows the kinds of mix-ups that were happening at Cidra. She identified nine, including Avandia diabetes pills mixed in packages with over-the-counter Tagamet antacids and Paxil antidepressants, mixed with the Avandia diabetes drug.
"When you saw these mix-ups happening, what did you do?" Pelley asked.
"I contacted the vice president of quality for North America and I told him that he needed to shut down the factory and call the FDA," Eckard said. "I urged him to stop the trucks that were leaving the dock that day."
Asked what happened then, she told Pelley, "I went back to work and waited for the news that they had called the FDA or that they had stopped shipments, and it didn't happen."