FDA dropped ball on sketchy syringes
Filed under: Conflicts of interest, Government, Hot Health Headline
According to a report by Christina Jewett of ProPublica and Deborah L. Shelton of the Chicago Tribune, the U.S. Food and Drug Administration — understaffed, overworked and increasingly reliant upon the cooperation and assistance of the industries it’s expected to oversee — allowed a North Carolina plant to ship tainted syringes which have “been linked to at least 4 deaths and 162 illnesses nationwide.”
The reporters chronicle the, the series of FDA internal safeguards that failed to catch the syringes before they were shipped.
- In October 2007, an inspector visited the plant after reports of specks of debris in fluid-filled syringes. She reported that management had a plan to deal with the problem, not noting that their sterilization method was unreliable.
- The company, AM2PAT, announced a recall a week later. This should have triggered an automatic FDA review but the overloaded agency ignores that particular fail-safe unless it judges lives to be on the line.
- In late 2007, as folks started getting sick, the FDA finally gave the plant a detailed inspection, finding a gummy brown substance on the syringe filler and brown water coming from the taps. It was closed in January 2008, but the damage had already been done.
The reporters found the regulatory failures were the cumulative effect of overwork and an increasingly heavy reliance on industry to police itself.
For this article, Gordon Harnack, a consultant who helps medical device companies prepare for inspections, reviewed more than 120 pages of FDA reports on the AM2PAT plant dating to 2005. He said inspectors didn’t look deep enough, and FDA managers were too tolerant.
“Time after time, the evidence was there that [AM2PAT] management had little intent of complying with adequate FDA regulations,” Harnack said. “In 2005, [the FDA] might have caught it. In 2007, they should have caught it. And finally when reports of deaths came in, it all became evident.”
The Propublica/Tribune report exhaustively chronicles AM2PAT’s fraud and manipulation of the system, a history of deception which the FDA failed to act on until it was too late.
Tribune: Lupron to treat autism is ‘junk science’
The Chicago Tribune’s Trine Tsouderos reports on the growing use of Lupron, a drug sometimes used to chemically castrate sex offenders, to treat autism in children. The practice’s proponents, a father and son duo with clinics across the country, call it a “miracle drug.” Mainstream scientists are not convinced. Tsouderos chronicles their ire:
Four of the world’s top pediatric endocrinologists told the Tribune that the Lupron protocol is baseless, supported only by junk science. More than two dozen prominent endocrinologists dismissed the treatment earlier this year in a paper published online by the journal Pediatrics.
The story includes warnings that the drug can “disrupt normal development, interfering with natural puberty and potentially putting children’s heart and bones at risk,” according to experts in childhood hormones. The treatment involves regular, painful shots.
Tsouderos pulls no punches — in the story the Lupron treatment is referred to as “junk medicine” that spreads “false hope” — and takes on several alternative treatments and theories surrounding autism, including links with mercury or vaccination. In addition to interviewing disapproving scientists, she also details the marketing practices of the doctors behind the Lupron treatment and questions their success stories.
Resurgent bedbugs spread through Chicago
Almost eradicated by DDT in the ’50s, bedbugs - annoying, biting pests not shown to carry disease - seem to be making a comeback in major American cities. Colleen Mastony of the Chicago Tribune reports that bedbug complaints in that city jumped last summer and have been climbing ever since.
The problem, experts say, has been exacerbated by the economy. Landlords are slow to send exterminators. And cash-strapped neighbors seem more likely to pluck infected furniture from Dumpsters. What’s more, some suspect the bugs are spreading through used-furniture outlets and online networks such as Craigslist.
“Five years ago, it wasn’t an issue,” said Arturo DelAngel, who works the complaint hot line at the Metropolitan Tenants Organization. “Now it’s bedbugs all the time, every day.”
Mastony cites reports from New York, Boston and Cincinnati and finds that the bedbug infestations may be taking on the dimensions of a national trend.
Michael Potter, an urban entomologist at the University of Kentucky, believes that bedbugs are poised to become the country’s most pressing pest problem. “We’re going to see serious increases of this pest, and it’s going to affect a lot of people,” he said.
Scientific American gets the facts about bed bugs in its Ask the Experts feature.
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