The giant drug maker Abbott and the federal Food and Drug Administration both should hang their heads in shame as more information becomes public as to how they left millions of vulnerable infants hungry and put kids’ health at risk by wrongs involving the manufacture and distribution of a vital foodstuff — baby formula.
Millions of parents have gone into meltdown because of a nationwide shortage of the needed nutrient. It was sparked by the shutdown of Abbott’s formula-producing plant in Michigan, as well as the company’s product recall after babies got sick and died from infections involving Cronobacter sakazakii bacteria.
While Abbott has emphasized that experts have not conclusively linked the bacteria to its formula and the firm has played up its cooperation in a product recall, Robert Califf, the FDA’s chief and a doctor, ripped the company. He told a U.S. House subcommittee that agency inspectors found “egregiously unsanitary” conditions at the drug maker’s plant, the New York Times reported, quoting him, thusly:
“Frankly, the inspection results were shocking. We had no confidence in integrity of the quality program at the facility.”
He said inspectors found the plant, which produces a quarter of the nation’s supply of formula and nutritional products for adult patients, had a leaking roof, a floor with water all over it, and cracks in key production equipment — flaws that allowed persistent bacterial contamination.
While the company negotiated with regulators, Abbott now has made a point of saying that it has replaced the plant’s roof, will soon replace the floor, and has made fixes and upgrades to formula-making machinery. The firm’s mea culpas have included urgent efforts to get the plant in regulator-approved shape and back to work within a few weeks, as well as new pushes to bring in from overseas more formula supplies.
That might seem to be a good result for the FDA — except questions now abound as to why the agency failed to act until a coast-to-coast supply crisis exploded.
Members of Congress are digging into the agency and its staff as to how Abbott, which reported $7 billion in net profits and rising margins in its pediatric nutrition division before the recall, could let its Michigan plant could fall into such disrepair without inspectors raising alarms.
Whistleblower warning lost in bureaucracy
The Washington Post also reported that a whistleblower complained to the FDA weeks before inspectors acted — but that the 34-page document failed to reach Frank Yiannas, the FDA’s deputy commissioner for food policy and response, for as long as four months. The newspaper noted that the FDA bureaucracy is a mess:
“Neither of the FDA’s food policy divisions has to report to Yiannas, and neither do the agency’s food safety inspectors. Instead, they report directly to … Califf, a physician who was appointed to the top post on Feb. 17, the day Abbott recalled many of its powdered products. Before Califf was appointed, food safety problems were reported directly to Principal Deputy Commissioner Janet Woodcock, another physician who was acting commissioner when the whistleblower complaint arrived. ‘The essential thing is that you’ve got three major operating components that are reporting only to the [FDA] commissioner, who, by tradition and current reality is a physician who is focused on medical products and doesn’t have the bandwidth or the inclination to spend time providing the leadership that’s needed for the food program to be successful,’ said Michael R. Taylor, who was deputy commissioner for foods and veterinary medicine during the Obama Administration.”
The Washington Post also provided more detail about problems at the Abbott plant, reporting:
“The Sturgis plant has experienced food safety problems in the past. In September 2010, the company issued a recall of some of its Similac powered infant formula after beetles and beetle larvae were found in the finished formula, which was produced at the plant. The following month, the FDA went into the plant to investigate and cited the company for several food safety violations and a ‘failure to manufacture foods under conditions and controls necessary to minimize contamination,’ public records from the agency show. After that, the Abbott facility passed annual inspections for nearly a decade without any serious food safety findings, agency records show. That changed in 2019. During a routine inspection that year, FDA inspectors learned that Abbott had found the potentially deadly pathogen Cronobacter in its finished products. They also discovered plant workers were doing inadequate pathogen testing of formula produced at the plant.”
Want more unhappy information about the FDA and its oversight from the newspaper? There’s this:
“Inspectors also found the company had received at least 10 complaints from nurses and parents who believed Abbott’s products were making infants sick. One complaint came from a pediatric nurse who said five babies had consumed Similac Sensitive Infant Formula and that ‘all babies were projectile vomiting,’ records show. In another instance, involving three different Abbott formulas, records show an infant had a seizure and was diagnosed with a bacterial infection from a strain of the Cronobacter pathogen. The children recovered and, in each case, the company said it investigated and determined their products were not responsible, records show. Despite these findings, the FDA did not issue any restrictions on the plant and closed out the investigation. Inspectors did not return to the plant for two years, records show, and the agency cited the pandemic and the risk of spreading the coronavirus as one of the reasons.”
U.S. oversight? Nope. Self-policing.
The New York Times has reported its own detailed dig into problematic federal oversight, finding that the agency — particularly with pro-business lawmakers’ prodding — has been too quick to allow corporations to self-police:
“[W]hile most of the attention has been focused on fixing the dire supply shortfall, regulators are confronting deeper issues of safety that persist in the manufacturing of powdered infant formula. There is no comprehensive mechanism for detecting or investigating Cronobacter infections, and only one state, Minnesota, requires doctors and laboratories to report cases to the authorities. Manufacturers are left to conduct tests themselves on a relatively small sample of their production, with less than 1% of the Abbott plant’s total output required to be tested. The combination of blind spots makes it difficult to trace infections to their source and could leave families at risk of future shutdowns and infant fatalities …
“The lack of testing and public reporting makes it difficult to know how many people are infected with Cronobacter. One study estimated about 18 cases per year in U.S. infants, according to Dr. Julia Haston, an official with the federal Centers for Disease Control and Prevention. Outcomes are usually severe, she said, and up to 40% of infants who go on to get bacterial meningitis, a frequent complication, die from the infection. Cronobacter is common in dirt and water. That means it is not an unusual bug to find in homes — much less in food processing plants. But there are only a few ways it is likely to get into an infant’s body, researchers say. ‘It’s not falling from the ceiling,’ said Dr. Janine Jason, a specialist in infectious diseases who worked at the CDC for 23 years. ‘Where we know it grows well is powdered formula. It’s one of the few organisms that can survive in powdered milk or food.’”
Not good. In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be done to them and their loved ones by defective and dangerous products, including various goods that we eat and drink.
Since the outset of the pandemic, and even long before, big corporations have, with little resistance from regulators, put profits ahead of people. Big Pharma suddenly stop making desperately needed drugs that companies don’t think bring in enough revenue. Manufacturers off-shore the making of vital resources like contrast dyes for imaging services because it increases their margins, while hospitals cut exclusive deals with suppliers to get best prices — not necessarily to benefit patients.
Americans spend billions of dollars annually to safeguard their food but the news site Politico recently joined ProPublica, the Pulitzer Prize-winning investigative site, in hammering the federal government — which divides food regulation also with the U.S. Department of Agriculture — over its sluggish and poor protection of the public.
Politico’s magazine-length investigation of the FDA’s shambolic oversight of food safety included important information worth repeating:
“This government dysfunction has a real impact on people’s lives. The [federal Centers for Disease Control and Prevention] estimates that more than 128,000 people are hospitalized and 3,000 people die from foodborne illnesses each year – a toll that has not lessened after a sweeping update to food safety a decade ago.”
We have much work to do to boot the bureaucratic malaise at USDA and especially the FDA, so taxpayers know that our money is getting spent well and wisely to protect us — not big companies — and to ensure that what we eat and drink is safe, healthy, and nutritious.