It's like waiting to take a picture of something not happening.
Late in January, G. D. Searle & Co. notified doctors that because of the fear of liability suits, it was withdrawing from the market and requesting voluntary return of two of the most common, best-known intrauterine devices.
The decision followed the disastrous experience of A. H. Robins Co., forced into bankruptcy by massive damage awards in suits over its ill-fated Dalkon Shield, and appeared all but certain to eliminate the IUD as a common means of birth control for American women.
But to the surprise of many, the IUD has failed to disappear.
Only One Left in Market
Theoretically, removal by Searle of its two major IUDs, the CU-7 and Tatum-T, left only the Progestasert IUD available in the United States. And the Progestasert is not a true IUD because it is essentially a mechanism for the timed release within the body of birth control hormones. The Progestasert must also be replaced annually, versus intervals of three years or more for true IUDs.
Quietly, efficiently and resourcefully, though, U.S. women and doctors in this country and Canada have fashioned a supply system to maintain the uninterrupted availability of IUDs. For now, it would appear to be entirely or at least largely legal, but the potential for a black market has emerged, according to sources who deal with IUDs.
The system is diverse, involving American doctors in private practice, the Canadian divisions of two American drug companies (ironically including Searle's), the American and Canadian Planned Parenthood organizations and even some county public health departments.
Dr. Philip Brooks, a Los Angeles obstetrician-gynecologist who was involved in some of the original research into the IUD more than 20 years ago, had anticipated the move Searle made. In the weeks and months before the Skokie, Ill., drug company recalled all its IUDs, Brooks had quietly been assessing ways to assure a continuing supply.
He placed an order a few weeks before the Searle announcement and had begun exploring what he calls "pockets" of IUDs that remained in the supply system before Searle went public with its move. Today, Brooks said, by buying up small numbers of IUDs from doctors who did not comply with Searle's request and locating isolated batches of them in wholesale warehouses, he has amassed a six-month supply of IUDs and continues to accommodate the needs of his patients.
"I went out and pulled in as many of (them) as I could get as soon as I heard Searle was likely to cease manufacture," Brooks said. "I think there are risks and hazards to IUDs, but there are risks and hazards to pregnancy and other (forms of) contraception so that I prefer using all contraceptives for appropriate women.
"For women who have had their children, don't want any more, are monogamous, can't or don't want to take the Pill and aren't at risk of pelvic inflammatory disease, I think the IUD is a marvelous alternative to unwanted pregnancy."
Dr. Barry Brock, also of Los Angeles, was not as systematic as Brooks, but, like Brooks, when Searle announced it was pulling out of the IUD business, Brock noted that the drug company action was voluntary and was predicated not on any outbreak of complications related to the two IUDs in question, but was rooted in the anticipation of future lawsuits.
'Medically Safe' Method
So Brock, too, declined to heed Searle's request, retaining his stock of IUDs. A purchase from at least one other physician was arranged and Brock has kept up the availability of IUDs for his patients. "I practice what I think is medically safe," he said. "I don't practice for the economics of the drug company. The IUD is medically safe."
What Brooks and Brock had done was entirely legal and within the bounds of medical ethics. Since the U.S. Food and Drug Administration--which licenses drugs and medical devices for use in the United States--had not restricted or revoked the marketing clearance for the withdrawn IUDs, any doctor may continue to use them for as long as they remain available. The FDA marketing permit remains in force today, even though Searle is not making IUDs in the United States and is in the process of destroying the estimated 100,000 IUDs returned to the company after the January voluntary recall announcement, the company said.
In New York, the Planned Parenthood Federation of America referred the Searle announcement to its attorneys, who reasoned that because taking Searle IUDs off the market was not an action ordered--or even suggested--by the FDA, local chapters of the organization were free to continue using their IUDs with no fear of added liability risk.
"I heard one doctor remark that it (the letter from Searle) was sort of like if you have a car manufacturer telling you to bring your car back, you automatically do it," recalled Dr. Louise Tyrer, Planned Parenthood's national medical director. "A lot of doctors, without thinking about the consequences, just sent them all back."