PharmaView: Shattered Trust in Manufacturing and FDA, a Renewed Faith in the Press
They say that investigative journalism is dead, even at major newspapers whose staffs and resources have been depleted as advertising and subscription revenue has dried up. Imagine my surprise, then, to find an exhaustive piece of research and writing during a recent trip to Wisconsin, courtesy of the Milwaukee Journal Sentinel.
The story, “Shattered Trust,” dominated the front page of the Sunday paper and continued across several full pages inside—6,000 words in all (and much more on the web), the result of four months of investigation led by two of the paper’s staff writers, Raquel Rutledge and Rick Barrett. (My interview with Rutledge about her eye-opening experience can be read here.)
Like any good story, it has tragedy. It begins with an account of a Texas family whose son dies during routine surgery—due to complications eventually traced back to contaminated sterile wipes. We read how the precocious two-year-old, Harry Kothari, succumbs to massive seizures and loses his life in a Houston hospital, as his parents and sister stand by helplessly and incredulously.
Rutledge and Barrett continue: “That same day, some 1,200 miles away, three investigators and a consumer safety officer with the U.S. Food and Drug Administration are dispatched to a pharmaceutical company on the edge of a suburban office park in Hartland, Wisconsin.” A good story must also have villains, and in this case it is H&P Industries—which ran the Hartland plant until a recent consent decree—and FDA itself.
H&P, owned by the Triad Group, manufactured cough syrups, creams, ointments and other health products in addition to the alcohol wipes. It had been on FDA’s radar as far back as 2000. Early in 2010, the Agency warned of possible contamination issues with the wipes. Late last year, FDA inspected the plant for weeks, the reporters note, eventually uncovering evidence of Bacillus cereus in the wipes. It also encountered “dozens of other serious problems: children's cold medicine being made without its active ingredient; workers packaging acne pads with their bare hands; a water supply that could contaminate products; dirty utensils and equipment . . . They found workers who changed the specifications of products when the products didn't meet the proper standards and sent them out anyway.”
"I had never seen an audit like that before," a former employee said. (Read here for a 483 issued in early 2010, a copy of the Agency’s January 2011 report, as well as correspondence after follow-up investigations in March 2011.)
Last January, FDA forced a voluntary recall of the wipes after other hospitals began to report finding them tainted with Bacillus cereus. (Here is another case that has recently come to light.) The Agency shut the plant down in April when it felt H&P was not fixing the problems, and issued a consent decree in June.
H&P has maintained all along that it firmly adheres to GMP and has no serious manufacturing issues, though there is evidence to the contrary. "Oh, God, people knew what was going on," one employee said. "We called attention to problems constantly. . . . We were told to keep things running at all cost. But I asked, at the cost of what? People's lives?”
This same employee said FDA was aware of the seriousness of the problem. Michael Rogers, acting director of the FDA's Office of Regional Operations, believes that the Agency took action as soon as it believed there was a real public safety concern. (This was four months after the Kothari boy died, though the cause of his death was not immediately ascertained.) "The actions that we take have to be supported with evidence," Rogers said.
For Rutledge the journalist, what was most surprising was the extent of the problems at H&P and Triad: “We didn’t just take the word of two or three workers,” she told me via email. “We heard from nearly a dozen people who worked at different plants, in a variety of areas, over many years. All told similar stories of the company’s disregard for sanitation and safety.”
FDA’s oversight “clearly fell far short of the performance an average person would expect,” she adds, and the Agency was less than helpful during the Journal Sentinel investigation. “Dealing with the FDA in terms of public records and the Freedom of Information Act is a huge hassle,” she says, and responses can take months and are often incomplete. The kicker: FDA redacted the name of the bacteria it found contaminating wipes in the H&P plant, calling it a trade secret. “We had to get our attorney to push them to release that, which they finally did two days before we published our story,” Rutledge recalls.
“Shattered Trust” gets at the heart of many problems that ail our industry. There is no single person—in this case a boy’s death to serve as a reminder of the importance of GMP and good, swift regulation. Thanks to the Milwaukee Journal Sentinel for its efforts.
