Doctors, Patients Building IUD Supply System : Recalled in U.S., Popular Birth Control Devices Being Stockpiled for Future

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.”

Two of the nation’s largest Planned Parenthood chapters--Los Angeles and Philadelphia--were among the first major organizations to quietly ignore Searle’s request that existing inventories be returned.

The Los Angeles Planned Parenthood organization had already anticipated the decision and, though a hurried attempt to augment the IUD stockpile was unsuccessful, the unit has about 300 IUDs on hand--enough to last a year or more at current rates of implantation, officials said.

‘Kind of Sad’

“Many women consider the IUD the best means of contraception,” said Dr. Lise Fortier, Planned Parenthood’s local medical director. “We are very adamant about not being paternalistic with our patients. To many people who want a means of birth control that is both convenient and discreet, the IUD is a little of both. Searle was acting solely on financial and legal considerations. It’s kind of sad, you know?”

A similar decision was made at the San Bernardino County Health Department, where officials concluded that, the Searle announcement aside, the IUD remained among the best available means of birth control. The countywide network of family clinics has about 50 IUDs left--enough, officials said, to last nine months to a year with current rates of use.

There have been scattered reports that other individual doctors and county health agencies in other states have taken the same steps. Fortier, Brooks and Brock emphasized that doctors may be reluctant to discuss their IUD decisions publicly for fear of being inundated by women seeking IUD insertions.

Neither private doctors nor Planned Parenthood have significantly raised fees they charge to insert an IUD. At California private physicians’ offices, the price ranges from about $50 to about $135. Planned Parenthood charges $35 and plans an increase to $75--but the hike is because of a change in procedure in which the organization will begin to include some laboratory work now billed separately, Fortier said.

And even today, the now-recalled IUDs are being made available for less than the cost of the Progestasert--the last remaining American intrauterine birth control method in production. The Progestasert’s maker, Alza Pharmaceuticals of Palo Alto, recently upped the price of the IUD from about $20 to $84 because of the increased costs of liability insurance, several doctors said.

Older IUDs Also Available

The situation has left Searle uncertain how many IUDs may remain in wholesale, clinic and doctors’ office inventories. There are also small numbers of older IUDs, including the Lippes Loop--a device developed several years ago--still apparently available. Los Angeles Planned Parenthood and other organizations and physicians are still providing Lippes Loops to women, according to an informal survey of local health care providers by The Times.

Steve Dickinson, the Searle official who is administering the disposition of the company’s IUDs, said Searle is aware that at least a few medical device wholesalers retained apparently significant numbers of IUDs after the recall, though he declined to identify even the cities and states where such outlets may be located.

What is left, though, is the inevitable question of what these American health care sources will do once the existing supply of IUDs runs out. And it is into this void that what might be called the Canadian Connection has emerged.

Despite the decision by Searle to pull out of the IUD business in the United States, the company has continued selling the CU-7 (popularly known as the Copper-7) in Canada. The Canadian version is made in England and comes with a printed package insert (officially called the product “labeling”) that has slightly different wording than the FDA-approved American version. But the Canadian Copper-7 is otherwise identical to what Searle sold here until Jan. 31, a Searle spokesman said.

And under a patent licensing agreement with Searle, the Canadian division of Ortho Pharmaceutical Corp. makes an IUD called the Gyne-T, which is essentially identical to the Searle Tatum-T. The patent agreement prohibits Ortho-Canada from selling its IUD south of the border, irrespective of Searle’s American marketing decisions, according to an Ortho-Canada spokesman in Toronto.

With both common types of IUD freely available in Canada, a network of clinics and doctors has begun to accommodate American women who either have IUDs they want replaced (Canadian regulators suggest replacement every two years, as opposed to the American standard of three years) or who wish to have IUDs implanted initially as an alternative to other birth control methods.

Legal End Run

In small numbers, these American women have begun traveling to Canada--primarily to Toronto and Vancouver--to make a legal end run around the Searle decision.

In Toronto, Dr. Marion Powell of the Bay Center for Birth Control, a university hospital-affiliated clinic, described the pattern as “a slow dribble.” She said one or two American women a week are traveling there to have IUDs put in--for the equivalent of just under $15 in U.S. dollars.

“I have no idea how many (American women) go to private gynecologists (in Toronto),” Powell said. She said that when the American IUD situation first cropped up, her clinic consulted its attorneys, who concluded that providing IUDs to American women carried no special liability problem for a Canadian health care provider. There has been some IUD litigation in Canada and health facilities there see malpractice suits as a growing problem. But Canadian health officials say the problem is nowhere near as acute as it is in the United States.

Several provinces to the west, the Vancouver chapter of Planned Parenthood has begun receiving a steady number of telephone inquiries from American women. An average of about two a week appear at the Vancouver Planned Parenthood clinic to have IUDs inserted--most of them women who have planned the visit in conjunction to a vacation trip to Expo-86, said clinic director Marcene Levine.

Expecting an Increase

“We get more inquiries than we do insertions,” Levine said. “I’d expect that we will see an increase, especially for people who are in border states.

“If you look at the type of women in the U.S. who are using IUDs, the majority are in a situation where the Pill has not been recommended and they are in a single-partner relationship. Many have had children.”

Levine said that, because of limited resources, Vancouver Planned Parenthood can’t handle additional American women, but she said she is confident local private-practice gynecologists will start offering IUD insertion services to Americans. Other Vancouver observers say some local doctors have already started accepting such patients.

What Levine and Powell see as the inevitable expansion of the Canadian Connection, however, could lead to what would technically be a black market in the United States in which American doctors order IUDs from Canada and provide them to women in this country. Powell said her Toronto clinic has already received several inquiries from American doctors asking if the Bay Center would resell Canadian IUDs to American physicians.

She said the clinic has discussed such resales with both Searle and Ortho and that, while Searle voiced objections, the clinic may decide to go ahead and supply American physicians.

Powell said her clinic had received inquiries about IUD exports from doctors in Boston and Detroit. One Orange County gynecologist told The Times that, after his own stock of IUDs was exhausted about six weeks after the Searle recall announcement, he implanted a Canadian IUD mailed to a patient by a relative who happened to be a Canadian physician. The doctor said he was aware American authorities contend such activities may be unlawful but he said he saw no therapeutic risk.

Searle said it would not countenance export of its Canadian IUD because such a consent would be at odds with its original decision to get out of the American IUD business. Ortho said it could not sell directly to American doctors, either, because of patent law problems. However, such sales through an intermediary would appear to face few practical obstacles in Canada.

Concerns About Problems

In Los Angeles, Brooks said he is aware that some physicians have talked about prevailing on Canadian friends to supply IUDs to the United States, but, like several physicians questioned by The Times, he said he has concerns about possible legal problems in the United States.

The FDA said that even though the two Canadian IUDs are essentially identical to the former American products, differences in the product labeling could mean that such informal imports from Canada could be in violation of American law--since the FDA must technically approve not just the drug or device in question, but the wording of the label, too.

“It would clearly be illegal,” said an FDA compliance officer interviewed on the condition he would not be identified by name, and the drug agency “would not take it lightly.” However, the compliance officer indicated the FDA might give a low priority to seeking out doctors who import Canadian IUDs because the practical medical safety threat to women in such transactions would be minimal. The FDA noted, however, that American doctors inserting IUDs imported under technically illegal circumstances could face state licensing penalties and place themselves at risk if a woman who had one of the Canadian IUDs sued for malpractice.

However, longtime observers of the FDA in Washington speculated that a quiet, relatively small-scale quasi-black market could probably take form in the United States without substantial interference from the federal agency because any violation of law would be largely technical and there would be no significant risk of harm to patients since they would be getting licitly produced IUDs identical to what could be sold here, from legitimate physicians.

Said Brooks: “Would I handle black market IUDs from Canada? The answer is, of course, ‘no.’ ”