The FDA Is Out to Lunch
All of his life, Paul Schwarz had been active and healthy. When his family imagined the various ways the decorated veteran of World War II might eventually die, they never imagined that the cause would be a piece of cantaloupe.
On Tuesday, September 13, 2011, Schwarz complained to his daughter Janice of abdominal pains and a slight fever. She took him to his doctor, who said it was likely a case of stomach flu. By Thursday the symptoms had worsened, and Schwarz had developed diarrhea. Janice took him to the emergency room. Once again flu was the diagnosis, and he was sent home. For a time, his condition improved. He called his son, also named Paul, that Sunday and cheerfully assured him that he’d eaten a big breakfast and felt a lot better.
But on Monday morning the younger Paul received an urgent phone call. His father had been rushed to the hospital by ambulance, unable to move his legs. In the coming weeks his behavior grew erratic, and he began thrashing in his bed, hollering, and behaving like a drunk. Usually gentle, he was combative with the nurses. "The devil has a hold of me and won’t let go," he screamed. During a lucid moment, after Schwarz’s condition had stabilized, two of his nieces visited and had an animated chat with him. But after they left, Schwarz, who normally had a sharp mind, turned to Paul and asked, "Who were those people?"
Within a month, Schwarz no longer recognized his son. By then the doctors had determined that he was suffering from invasive listeriosis, an infection caused by Listeria monocytogenes, a bacterium transmitted by eating contaminated meat, dairy products, and produce. The pathogen can lead to bacterial meningitis, an infection of the covering of the brain and spinal cord that causes headaches, confusion, and convulsions. It kills about one in six of those infected. Children, the elderly, people with depressed immune systems, and pregnant women are most vulnerable. On December 18, 2011, after a drawn-out decline, Paul Schwarz succumbed. He was 92.
Schwarz grew up in Fda City, Missouri, during the hardscrabble years of the Great Depression. In 1943, when he was 19, he married his 18-year-old sweetheart, Rosellen "Rosie" Clouse, and then marched off to serve as an infantryman in the Pacific, returning home a sergeant with two Purple Hearts. He and Rosellen purchased the house where she still lives in 1953, and raised five children. Schwarz was known for a loud, ready laugh and a twinkle in his eye that foreshadowed some practical joke. He remained active, playing golf until age 88, eating healthfully, accepting the occasional drink, and making sure that he and Rosellen, who was suffering from early-stage Alzheimer’s, took their prescribed medications. Devout Catholics, they attended church every Sunday. After Mass they would dine at the same family restaurant, where they always shared a fruit bowl -- grapes, peaches, pineapple, banana, and, fatefully, the cantaloupe.
Schwarz was only one of more than 100 patients suffering similar symptoms at the same time in 28 states. Eventually, the Centers for Disease Control (CDC) would attribute 147 illnesses, 33 deaths, and one miscarriage to listeria in the late summer and early fall of 2011, making this outbreak of food-borne illness the most lethal in the United States since 1924. The U.S. Department of Agriculture (USDA) oversees food safety for most meat and poultry products, but the Food and Drug Administration is charged with keeping the rest of our food supply safe. For the Schwarz family, the FDA had clearly dropped the ball.
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The 2011 listeria outbreak was not an isolated case. The United States is experiencing what amounts to an epidemic of food-borne illnesses. According to the CDC, there are about 48 million cases of food poisoning a year, leading to more than 128,000 hospitalizations and more than 3,000 deaths. E. coli in spinach and fruit juice, salmonella in eggs and jalapeño peppers, listeria not only in cantaloupes but in cheese and bagged lettuce -- the toll from food-borne bacteria is mind-numbing.
With the exception of E. coli infections, the rate of outbreaks from other pathogens tracked by the CDC has been rising since 2007. The decline in E. coli–related illnesses is in part the result of strong actions taken by the Department of Agriculture in 1994. Following an outbreak caused by tainted hamburger from the Jack-in-the-Box fast-food chain that killed four children, the agency declared E. coli 0157:H7, the strain that sickened the children, an adulterant, making it illegal for companies under USDA jurisdiction to sell food contaminated with the bug. Meat producers took measures to eliminate it from their facilities. But potentially fatal bacteria other than E. coli have yet to be declared adulterants.
Some of the FDA’s deficiencies can be attributed to the haphazard manner in which it has grown. In contrast to the Environmental Protection Agency, which was created in 1970 to bring all federal environmental activities into a single, powerful unit with a clear mandate, the FDA expanded and occasionally contracted over decades in response to crises and pressure from public interest groups and corporate lobbyists. The agency originated in 1852, when it consisted of a single chemist working in the Department of Agriculture. It had no regulatory duties until 1906, when muckraking journalists’ horror stories about food-processing facilities inspired passage of the Federal Food and Drugs Act. In 1937, hundreds of deaths from a new sulfa drug propelled passage of the Food, Drug, and Cosmetic Act to prevent similar health disasters. In the 1950s and 1960s, laws addressing pesticide residues, food additives, and color additives gave the agency greater control over food safety.
It would be impossible for any government agency to prevent every case of food poisoning. But there are systematic problems with the FDA that threaten the health of anyone who consumes food in the United States. In report after report, the Government Accountability Office (GAO), the investigative arm of Congress, has uncovered woeful shortcomings at the agency. Its product recall process is ineffective and confusing. It has done a poor job of dealing with the overuse of antibiotics in livestock feed. It lacks the scientific capacity to perform its duties. Even when it does uncover health violations at food-processing plants, the FDA takes enforcement action in only about half of the cases and almost never imposes fines. In the coldhearted calculus of turning a profit, it is perversely logical for corporations to risk making hundreds of people ill when the worst they can expect is a warning letter.
"It’s like doing 100 miles an hour on a lonely stretch of highway in Montana," says William Marler, a Seattle-based attorney who has represented food-poisoning victims in court for 20 years. "Yeah, you might get caught, but in reality the chances of that happening are zero."
By the time doctors diagnosed Schwarz, the FDA had zeroed in on the source of the listeria -- cantaloupe harvested from a farm in Colorado owned by the brothers Eric and Ryan Jensen. Inspectors descended on Jensen Farms three times during September 2011. Conditions could hardly have been more favorable for bacterial growth. Listeria thrives in moist areas. There was no system for pre-cooling the cantaloupes when they were brought in from the fields; this allowed condensation to form on the rinds of the melons as they were refrigerated. Water stood in puddles on the floor. The washing and drying machinery had been designed to handle potatoes, not melons, and was jerry-rigged in a way that made it all but impossible to clean. Corrosion, dirt, and "product buildup" remained on the equipment even after it had been taken apart and supposedly sanitized. Finally, Jensen washed its fruits in water only, using no chlorine or any other antimicrobial solution that might have killed the listeria before the cantaloupes reached consumers.
Jensen issued a recall, but by then the damage had been done. On October 18, more than a month after its initial investigations, the FDA issued a warning letter to the company, which would file for bankruptcy in mid-2012. If there ever was an example of too little too late, this was it.
The FDA considers fresh produce to be "high risk" and therefore a priority for inspection. But until people started dropping dead, the Jensen facility had never once in its 20-year history been inspected by the FDA. Like most produce companies, Jensen used third-party auditors to certify its handling systems. On July 25, at about the same time the first people were being sickened by contaminated cantaloupe, one such auditor, a representative of Bio Food Safety, a Texas-based company whose website advertises "quality service at an unbelievable price," visited Jensen for four hours and blessed the plant with a "superior" rating of 96 percent.
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