Last month two angry Washington-area mothers, whose babies had suffered serious illnesses because of a deficient infant feeding formula, won a victory from the government: a law to enforce regular testing of baby formulas to ensure that they contain the right nutrients.
Their successful battle, waged during Food and Drug Administration consumer meetings, congressional hearings and by hundreds of telephone calls to scientists and bureaucrats, has been hailed as proof that the ordinary citizen, without funding or clout, can manipulate Washington to achieve something worthwhile.
But Lynn Pilot and Carol Laskin are no more ordinary citizens than Clark Kent.
They won, in the record time of one year, not just because nobody can afford to be against babies, and not just because they were articulate, squeaky-clean mothers whose children's ordeals made for prime-time consumer news. They won because, in addition to determination, they and their husbands had inside experience in every branch of the government they were prodding into action.
Pilot is a lawyer who, before she stopped working to have children, spent 2 1/2 years as a congressman's legislative and administrative assistant. Her husband, Larry, had been an FDA lawyer for 10 years, and knew the agency's regulatory powers inside out.
Laskin is a free-lance consultant on health policy whose major projects have been for the Department of Health and Human Services. Her husband Alan, a management consultant, acted as the mothers' public relations man.
"We had the access," Carol Laskin said. "Lynne and I were determined we wouldn't let it happen to anybody else. [If you live in Washington], you get aggravated, but you can call the same phone number 10 times. If you're in Iowa or Nebraska, it costs you a lot of money."
What the two women were seeking to prevent was another tragedy of the kind that befell their infant sons last year. Bradley Pilot and Benjamin Laskin were two of more than 130 babies who refused food, stopped growing and because seriously ill while being fed the Syntex formulas Neo-Mull-Soy or CHO-free.
An estimated 20,000 infants were on the formulas. Because changes in manufacturing had caused a drop in the products' content of chloride, a vital nuitrient, many babies developed blood abnormalities and may have suffered subtle but lasting retardation. Bradley Pilot is enrolled in a special school, and both he and Benjamin Laskin, as well as other affected children, are being closely studied by researchers at the National Institute of Health.
Laskin began her campaign in August 1979 after she called the FDA and learned that the agency did not require testing of baby formulas to guarantee that the ingredients matched the labels.
She told her pediatrician, who shared her astonishment and put her in touch with the mother of another of his patients. She happened to be a television consumer reporter, Lea Thompson. Thompson got to work on a story. Her report, aired last October, inflamed another Neo-Mull-Soy parent, Rep. Albert Gore Jr. (D-Tenn.), who held hearings and introduced an infant formula bill.
Meanwhile, the Children's Hospital doctor who was treating Bradley Pilot told Lynn Pilot that he knew another mother who was outraged about Neo-Mull-Soy, and gave her Laskin's number.
"He kept saying, 'You are very much alike. You are very active. I think you should call her,'" Pilot recalled. She did, and the two became fast friends over the telephone. For two months they conferred without ever having met. Laskin recalled that the first time each of them saw what the other one looked like was when both watched Thompson's report on television.
"We called each other afterward and said, 'Hey, you're cute! The kid is cute!'" she said.
From then on they were partners. "We talked on the phone 82 times a day," Laskin said."We'd call each other in the morning and say, 'Who are you going to take today?' I'd say, 'I'll take the FDA and the Center for Disease Control,' and she'd say, 'Okay, I'll take the Hill and The National Institutes of Health.'"
By November, they had generated enough publicity to sweep the last cans of recalled formula off supermarket shelves and to swamp the Center for Disease Control in Atlanta with inquiries from worried parents. Since Pilot knew from working in Congress that changing regulatory laws might take two to three years, they pressed FDA officials to strengthen their power over the formula industry by declaring that baby formula is not a food, but a drug.
To the mothers, it was a simle solution. Larry Pilot had combed the law library for precedents, and found that, when it suited the purpose, the agency had defined "drug" to include shaving cream, honey, surgical thread and bandages. Why not baby formula?
But the FDA declined, arguing that subjecting formula to the stringent regulation applied to drugs would merely raise the cost and dissuade manufacturers from producing specialized products needed by sick babies.
So Pilot and Laskin changed their tack, and began badgering Congress to broaden the FDA's authority over the formula industry. Here Pilot's experience came in handy. When she had worked on Capitol Hill, she recalled, "I used to get a little aggravated with people who were doing things like marching and driving their [members of Congress] wild." But she had learned all the moves.
They had no problem with publicity. Alan Laskin called newspapers and broadcasting stations, arranging scores of interviews. The two women were so eloquent, and their story so appealing, that reporters came in eagerly.
But the campaign, with its 16-hour days, took its toll on their families, their social lives, even their finances. The Laksins estimate that it has cost them $4,000 over the past year. Lynn Pilot recruited relatives to babysit so she could testify at hearings, and recalled moments when she was caught between a Neo-Mull-Soy mother sobbing on the telephone and her 9-year-old son pleading to be driven to soccer practice.
She said her friends would call her and say, "Are you still alive? Are you still living in town? You're still working on it, aren't you?"
Late last month, it all paid off. On Sept. 26, with the mothers and their toddlers looking on, President Carter signed legislation that sets ingredient standards for formulas, gives the FDA access to factory records and requires routing testing. Laskin and Pilot even won an amendment that forces the testing to start now, not years from now when the regulations are written.
Dr. Sanford Miller, director of the FDA's Bureau of Foods, said the two women won power for the agency that it had been trying unsuccessfully to gain since 1938. p
"They were outside the system," he said. "They could show bodies in the street. They were very articulate, intelligent ladies [who] absolutely believed in what they were doing. [But] the big thing was, they were in Washington."