ANN ARBOR, Mich. _ Despite the jackhammerlike rhythm of a mechanical ventilator, Alicia Moreno had dozed off in a chair by her 1-year-old's hospital bed, when a doctor woke her with some bad news: The common stool softener her son, Anderson, was given months earlier had been contaminated with the bacterium Burkholderia cepacia.
Suddenly, Anderson's rocky course made medical sense. B. cepacia was the same unusual bacterium mysteriously found in the boy's respiratory tract, temporarily taking him off the list for a heart transplant. The same bacterium resurfaced after his transplant and combined with a flu-like illness to infect his lungs. He's been on a ventilator ever since.
The tainted over-the-counter medicine, docusate sodium, routinely prescribed to nearly every hospitalized patient to avert constipation, caused Anderson to suffer "serious and dangerous life-threatening injuries," a lawsuit filed by his family alleges. The drug was eventually recalled, but only after a Texas hospital staff noticed an uptick in B. cepacia infections, prompting a six-month investigation that led back to the tainted drug and its Florida manufacturing plant.
"Something that was supposed to help him hurt him," Alicia Moreno said.
Since the start of 2013, pharmaceutical companies based in the U.S. or abroad have recalled about 8,000 medicines, comprising billions of tablets, bottles and vials that have entered the U.S. drug supply and made their way to patients' medicine cabinets, hospital supply closets and IV drips, a Kaiser Health News investigation shows. The recalls represent a fraction of the medicines shipped each year. But the flawed products contained everything from dangerous bacteria or tiny glass particles to mold _ or too much or too little of the drug's active ingredient.
Over the same period, 65 drug-making facilities recalled nearly 300 products within 12 months of passing a Food and Drug Administration inspection _ as was the case with the stool softener, according to a KHN analysis of recall notices and inspection records kept by the FDA.
Those recalls included more than 39,000 bottles of the HIV drug Atripla laced with "red silicone rubber particulates," nearly 37,000 generic Abilify tablets that were "superpotent," and nearly 12,000 boxes of generic Aleve (naproxen) that were actually ibuprofen, according to the recall data KHN examined.
The medicine alleged to have sickened Anderson Moreno seriously infected at least 63 other people in 12 states, according to reports by the FDA and Centers for Disease Control and Prevention. The drug was made at a PharmaTech plant in Broward County, Fla. That same plant passed an FDA inspection even while it was making bacteria-laced products, according to a KHN review of the inspection records.
PharmaTech did not respond to KHN's requests for comment. A lawyer for the drugmaker filed a motion to dismiss the lawsuit in April, but it was not granted. In follow-up court records, PharmaTech has denied claims against it.
Like other FDA commissioners before him, Scott Gottlieb has called his agency's drug oversight program the "gold standard" for safety and effectiveness.
But veteran industry consultant John Avellanet, who has trained FDA inspectors, questions how effective the FDA's drug plant inspections actually are. "It's so easy" for FDA inspectors to miss things because they're working with confusing regulatory terms and standards that are often decades out of date, Avellanet said.
Just how often people are sickened or die from tainted drugs is next to impossible to determine. No government agency tracks cases unless they're linked to a major outbreak among hospital patients. And sudden, seemingly random illnesses in disparate places are notoriously hard to link to a tainted drug. That's in part because drugmakers don't have to divulge which products are made in which manufacturing plants, since that is regarded as proprietary information.
The result: Even someone who buys drugs for a major hospital can't track down where a potentially dangerous product came from, said Erin Fox, who purchases medicines for University of Utah Health hospitals.
"Patient safety should come first," she said, adding that the KHN analysis indicates "our drug quality is probably not what we think it is," and calling it a "scary" reality. "Something does need to change if this is happening this many times and we're having patients receiving contaminated products."
The FDA declined to be interviewed for this story, but responded to written questions.
"While the FDA would prefer that no drug be distributed that later is recalled, we do not think that a recall indicates a failure of FDA inspection and surveillance programs," FDA spokesman Jeremy Kahn said in an email. He said inspectors "may not uncover all issues or practices that may eventually result in a problem leading to a recall" and that "not all recalls are the result of poor manufacturing practice."
