From the time you wake up in the morning and use soap, toothpaste, mouthwashes and deoderants, through all the (nonalcoholic) beverages and food you consume during breakfast, lunch, dinner and everything in between, until the time you go to bed after dental-flossing and, perhaps, taking a pill, you are taking for granted an important and largely invisible aid to your good health:
The regulatory efforts of the Food and Drug Administration (FDA).
This often-misunderstood federal agency, chartered by Congress in 1938 to police the safety of the nation`s foods and drugs, today has regulatory authority over $570 billion in products, or roughly 25 percent of our entire gross national product, minus military spending. The FDA ”police force” is 7,000 strong, with 3,000 employees in the Parklawn, Md., headquarters and the rest in field offices scattered across the country.
The Chicago district, which covers all of Illinois, regulates almost 5,000 firms operating in the areas of drugs, food, biologics (largely blood products), medical devices and veterinary medicine. These firms number their employees in the hundreds of thousands and their budgets in the billions, while the watchdog FDA makes do with 100 employees, of whom 45 are
investigators, and a total operating budget of $5 million.
District Director Raymond Mlecko, 53, has been with the FDA for 30 years, beginning as an investigator in Chicago. After spending 15 years running the Seattle field office, he returned to Chicago in 1987 and has since overseen several major investigations.
Last July, a case that Mlecko`s staff had investigated for years produced a headline-making 19-count indictment against Bodine`s Inc., a Chicago manufacturing firm that duped consumers for eight years by peddling ”pure, unsweetened” frozen orange juice that was, in fact, loaded with beet sugar and other inferior ingredients.
It was one of the largest economic frauds in history, with Bodine`s sales rising from $5 million in 1978 to $100 million in 1984. At the peak of the scam, Bodine was selling the bogus product under 50 different names to 155 supermarkets in 36 states.
Sitting in his office on the 12th floor of Chicago`s main post office at Canal and Van Buren Streets, Mlecko reflects: ”At one time or another, we probably all drank some of this adulterated concoction. It was a very sophisticated operation, and although there was no direct threat to health, we`ll probably never know the effects. Take my case. I have high blood pressure and follow a low-sodium, high potassium diet. Real orange juice is low in sodium and high in potassium, and I drink five to six glasses a day. If I had been relying on Bodine`s `orange juice,` I would not have been getting what my diet requires.”
Mlecko likes to cite his employees` dedication and hard work, often accomplished under trying circumstances. Referring to the agency`s antiquated office space at the post office, he observes: ”This is a terrible place to work. We have to park our cars in a lot under the expressway, and we literally have to remove our hubcaps every day. Last Saturday, my new Buick was stolen. The ventilation system is corroded, and one employee required eye surgery to remove a metal fragment that flew out of the vents. My administrative assistant turned her ankle tripping over some tape holding the carpeting in place.
”At our research lab at the Illinois Institute of Technology (at 35th and State Streets), at least a dozen employees have been mugged. We all put up with it, and the government bureaucracy to boot, because we believe in what we`re doing. We believe we can make a difference.”
Consider Jeanne Morris, 27, who took a substantial cut in pay in leaving a major Chicago teaching hospital to go to work for the FDA as an
investigator. A medical technologist, Morris specializes in the investigation of blood banks, an area that has assumed new importance in the age of AIDS. During a recent visit to the blood center at Rush-Presbyterian-St. Luke`s Medical Center, Morris oversaw the operation, from the screening of potential donors and the drawing of blood, through the separation and processing of blood components, down to the final labeling of blood products approved for transfusion.
”Oh, we have our regulations and SOPs (standard operating procedures),” Morris says, ”but we`re doing much more than following a checklist. We know what we`re looking for, and I find my greatest satisfaction in finding a problem area and improving it.”
The blood center`s lab manager, Ronald Hoiberg, says, ”If we`re doing something wrong, we want to know about it, and that`s why it`s helpful to have investigators like Jeanne who know the technology.”
Morris checks the monthly maintenance records on the sophisticated instrumentation, the expiration dates on the reagent kits (which test the blood) and the temperatures on the water baths. Donated blood must pass complicated tests to rule out the presence of the human immunodeficiency virus (HIV, the agent that causes AIDS), hepatitis (which is found in blood more frequently than the HIV virus), and syphilis.
A lab worker holds up a cell culture, showing what appear to be flecks of ”pepper” on the specimen. This is the ”RPR” (reactive plasma reagent)
test for syphilis. Antibodies in the blood that have been activated to fight the organism that cause syphilis are agglutinating or bonding to the reagent and creating the pepper effect. This screening will be followed by a second test to find the spirochete that causes syphilis, and, if confirmed, the blood will be discarded. Blood contaminated by syphilis is rare, and the HIV is being found in only 0.02 percent of all donated blood.
Still, Morris admonishes: ”We have had to educate the blood banks that if they run two tests that are reactive, or positive, for the AIDS virus, then that sample must be considered positive and withdrawn. Some centers were running multiple tests and reasoning, `Well, we had two positives and four negatives, so the positives must have been invalid.` We`ve given clear instruction: If blood is reactive twice to HIV, that blood is reactive. Period.”
Overall, about 4 percent of all donor blood will be rejected, much of it because the donors themselves will later self-defer. As the final products are typed, labeled and stored for future use, Morris observes, ”What we have here is a gift of life-and one that the patient can count on as being safe.”
John Bruederle, 48, has been with the FDA for 25 years, ever since he graduated from the University of Wisconsin with a degree in zoology, ”never having heard of FDA. I took the federal civil-service test, and a few months later I was asked if I`d like to come to work. I`ve been here ever since.”
Bruederle and his wife, Sue, both specialize in ”SVPs,” or manufacturers of small-volume parenterals (injectable drugs).
On a recent visit to Lyphomed, a drug manufacturing firm. in Melrose Park, Bruederle reinspected a firm that is a good example of the cooperative efforts between industry and the FDA. During 1987-88, Bruederle had spent almost a year performing a series of inspections that uncovered many deficiencies in the firm`s manufacturing operation. His investigations found that quality control, quality assurance and documentation procedures at Lyphomed`s Melrose Park plant were inadequate and prompted an FDA regulatory letter suspending certain operations. In May, 1988, the firm entered into a voluntary agreement with the FDA to upgrade procedures and slowed down its operation to make needed improvements. That September, the FDA found Lyphomed to be in ”substantial compliance” with Good Manufacturing Practices, or GMPs, and allowed the firm to resume its applications to manufacture additional generic drugs.
Lyphomed has received much credit (and profits) for pioneering the development of injectable and aerosolized pentamidine, one of the few drugs that is effective against AIDS, but its bread and butter has been the manufacture of the ”me-too” drugs, or generic copies of medications developed by other firms. Lyphomed`s reputation is as a reliable supplier of cost-saving drugs.
Bruederle observes, ”Our FDA `483` (inspectional report) was a financial killing to Lyphomed, but they`ve hung in there and accomplished what had to be done. By now, they should be pretty solid.”
Looking around the firm`s ”labeling cage,” he observes: ”The most important thing about this test is that the door we`ve entered had to be unlocked. This area has to be ultra-secure, with restricted access. One of the biggest problems in drug production is mislabeling, and there are millions of labels in here. They have to be released to the production line on an individual basis. This plant has four production lines, and only one drug can be manufactured on one line at any one time. The labels are brought out only when the drug run begins.”
Later, at the firm`s reserve sample room, he checks to make sure vials are inverted ”so the liquid is always in contact with the stopper. That`s the way most drugs should be stored.” Most of his work, he notes, ”is checking records. I spend more time looking at paperwork than walking around the plant. Usually, what we find is a lot of little things that can add up to a big problem.”
Returning to his olive, government standard-issue sedan with black-walled tires (no reporters allowed to ride inside), Bruederle is almost sideswiped by a Corvette barreling into the Lyphomed lot. ”He used to be one of their key quality-control guys,” the investigator says softly. ”The drug world needs a traffic cop,” Bruederle concludes. Adds district director Mlecko, ”As often as possible, we prefer the type of voluntary compliance exemplified by Lyphomed to the iron fist of regulation.”
The director of investigations is a 13-year FDA veteran, Barbara-Helene Smith, Ph.D. She thinks that her 45 investigators are ”unsung heroes.” She adds, ”I came here in March, and right off the bat we had to investigate an incident that turned out to be a homicide accomplished by putting cyanide into cough syrup.
”A few days later, we had to send 15 investigators to Philadelphia to help probe the contamination of Chilean grapes with cyanide. At one time, FDA had 162 investigators from across the country on the case. It was the height of the season for Chilean grapes, but it turned out to be a clear case of tampering. Only two grapes were found to be contaminated, but when cyanide is involved, you don`t take chances. We looked at every crate and every bunch of grapes.”
Last July, she oversaw a ”mail blitz” at O`Hare International Airport. For a solid week, investigators checked every piece of international mail for contraband, including illegal AIDS drugs, herbal remedies, diet pills and prescription drugs. Across the way, FDA investigators based at O`Hare continued their routine screening of all imported foodstuffs. Ethnic specialty foods are a special concern since recent revelations of unacceptably high levels of defective ethnic food products were found elsewhere in the country, especially products produced in Southeast Asian countries.
Much of what FDA investigators uncover is sent to the lab at IIT for study by the agency`s 19 analytical professionals. The work can be complex or simple, but it is almost always tedious and time-consuming.
Take condoms, for example. Chemist John Marchin is testing a batch of 67,000 green-tinted, ribbed-textured, reservoir-tipped condoms imported from Sweden. He is employing the agency`s simple ”gold standard”: The
prophylactic is filled with tap water and observed for leaks.
”We do our testing in stages,” he explains. ”If the first batch of 250 has zero or one defects, the shipment can be accepted; if it has five or more, it can be rejected. However, if we find two to four defective condoms among the first 250 tested, we have to move on to the the next stage and test a lot of 375. It takes me 10 to 12 hours just to test a lot of 250. If I have to do all seven stages of testing, through a maximum lot of 875, it would take at least a week.” He adds, ”Of course, they`re almost all lubricated, and I have to take off my gloves to unroll them. The gloves, by the way, are not to protect me; they`re to make sure that my hangnails don`t tear the condom!”
As Marchin observes, only two to four defective condoms are allowed per 250 tested. At the other end of his lab, where he tests latex examining and surgical gloves, the standard is more permissive; one of every five examining gloves can spring a leak and one of every 10 surgical gloves.
With the AIDS crisis, condoms are big business. Chemist Paul Smith maintains a collection of condoms seized for inspection. They come in all shapes, sizes, colors and scents. ”For some reason,” he says, ”those colored dark-red seem to sell best in vending machines, while those tinted coral do best in the drugstores.”
Malaysia makes the best latex in the world, but not the best condoms. One batch seized by the FDA includes a small moth embedded in the sheath. Another shipment from Korea, intended for U.S. entrepreneurs and ”repackers,” was rejected for springing too many holes. The Swedish shipment, it turns out, tested flawless. ”That`s why they have such a low birth rate,” observes lab director Alfred Apodaca.
At the other end of the complexity spectrum is the FDA`s test for dioxins in fish and milk. The Chicago facility is the agency`s national field lab to test for this potentially fatal toxin, which is rapidly being recognized as a possible major public-health problem.
Dressed like a French chef, physical science technician Dan Gulick takes a Long Island lobster and meticulously fillets it to expose the meat and the
”tomali,” the hepato pancreas that is considered a delicacy on the East Coast. After going through a meat grinder, the filleted lobster comes out looking like spaghetti and ready for the next step.
Chemist Smith explains: ”We have to put the lobster meat through an elaborate chemical process to isolate whatever dioxins and furans (another toxin) may be present. This `cleanup` can take a week. At this point, we move into another room, where we use a syringe to inject a minute portion of the solution into a gas chromatograph, which measures the level of dioxins or furans. The measurement will show up as a peak on a scale, and the official FDA ”level of concern” is over 50 parts per trillion. If we find dangerous levels, we then use our mass spectrometer to confirm the finding and to specifically identify the type of dioxin or furan.”
The mass spectrometer can ”fingerprint” up to 50,000 chemical compounds and is an invaluable tool for the FDA investigators in Chicago, who check dioxin levels of fish shipped in from everywhere from Alaska to Boston. Dioxins are byproducts of the manufacture of paper, and many officials are concerned that the nation`s water supply could become contaminated. Thus, the fish are regularly monitored. (Potential contamination of milk is checked because of the fear of toxins coming in from the carton; to date, levels are well within safety limits.)
High dioxin levels are known to kill laboratory animals, though the unsafe human level is not yet fully known. The testing process is so laborious and time-consuming, Smith explains, because the amount of solution isolated from the fish for testing is, compared to the whole fillet, ”roughly the ratio of one second to 30,000 years!”
FDA ”filth samples” maintained in the lab include imported coffee grounds filled with insect fragments; an ice cream cone featuring tunneling beetles; and mushrooms festooned with flying maggots. ”Without an FDA,”
concludes Bruederle, ”we`d have filth and fraud and unsafe products.”
Kathleen Haas is the FDA`s ”recall coordinator.” During the last year, the Chicago district initiated four Class I (life-threatening) recalls. Three were drugs:
– An insecticide used to treat scalp lice was mislabeled as a cough syrup. A pharmacist, noting that the color and consistency of the insecticide were different than the cough syrup for which it was labeled, caught the mistake before harm was done.
– A tranquilizer was mislabeled as a children`s cough remedy. Since the preparation was not unlike the actual cough medication, a pharmacist did not catch the mistake, and at least one child ended up in the emergency room.
– A sodium-potassium solution used to restore patients` fluid and electrolyte balance was found to have been manufactured under unsterile conditions, creating the possibility that the solution could cause blood poisoning.
The only food subject to a Class I recall was a candy made in Germany. Manufactured in the shape of a pacifier, the candy was so smooth that a child sucking on it might have swallowed it whole and choked to death.
The other 44 recalls of 65 different products were not as dramatic, Haas says, but included:
Mixed nuts coated with a mold that triggers allergies; sulfites used to keep shrimp looking ”white” but that also trigger allergies; soy grits (used for additional protein in hamburger and other meats) interspersed with bits of concrete and grout and rock (a silo cap was being replaced, and the concrete fell onto the foodstuffs below); breading mix for pork tenderloin marked with duplicator ink (the machine used to stamp the box punched through into the food); and soda pop mixed with ferrous sulfate (giving it a metallic taste).
FDA investigators also recalled a defibrillator device (used to shock the heart into pumping) whose controls were mis-set in a way that allowed a maximum jolt-rather than the one desired-to be applied to the heart anytime the device was used. ”This over-jolt could kill a child or surgical patient,” Haas notes.
Haas also handles phone calls from consumers, and she values their advice. ”We once had a Class I recall triggered by a phone call from Rockford,” she said. ”Someone had noticed that a can of mushrooms in the supermarket was `swollen.` It turned out to be botulism, which can be fatal. The organism that causes botulism thrives in an environment without air, and cans of mushrooms are perfect for it. As it grows, it gives off gas and the can bulges. So, if you see a swollen can, don`t buy it. Report it!”
She adds that ”tomato paste and other foods high in acid can, if improperly stored, interact with the can and cause a `hydrogen swell.` This can make you pretty sick if you eat it, so be careful how you store your food, especially things like sauerkraut and pineapple and other foods high in acidity.”
The FDA`s consumer-affairs officer, Marie Ekvall, is a former reporter
(for the old Chicago`s American) who decided ”to join the consumer movement by working for FDA.” A 20-year veteran, she proudly reads from a letter sent to her by an exchange student from Korea. ”We`d done a presentation at her school,” Ekvall says, ”and she wrote this letter. I think it sums up our value pretty well.” The letter reads;
”Dear FDA,
You touch my life every day.
In so many ways that we take for granted.
Thank you, FDA.”
