The Charge: Gynocide

Discount Dalkons

The dangers of the Dalkon Shield IUD were well known before the dump began in 1972. Only a few months after the Dalkon Shield went on the market in 1971, reports of adverse reactions began pouring into the headquarters of the manufacturer, A. H. Robins Co. (See "A Case of Corporate Malpractice," by Mark Dowie and Tracy Johnston, MJ, Nov. '76.) There were cases of pelvic inflammatory disease (an infection of the uterus that can require weeks of bed rest and antibiotic treatment), septicemia (blood poisoning), pregnancies resulting in spontaneous abortions, ectopic (tubal) pregnancies and perforations of the uterus. In a number of cases, the damage was so severe as to require a hysterectomy. There were even medical reports of Dalkon Shields ripping their way through the walls of the uterus and being found floating free in the abdominal cavity far from the uterus. According to a recent and probably conservative U.S. medical estimate, the Dalkon Shield caused over 200,000 cases of serious uterine infections in this country alone. For every million dollars in profit the manufacturer has made on the Shield, U.S. women -- those who could afford medical care at all -- spent an estimated $20 million for medical care on problems arising from its use. By 1974, there were reports of deaths clearly attributable to the Dalkon Shield -- not one or two, but 17.

The Dalkon Shield was turning out to be far more dangerous than any other IUD already on the market. Later research in Canada and Germany showed that microscopic defects helped account for the Shield's ability to slice into the uterine wall. Worse still, the "wicking effect" of its string caused it to conduct bacteria up from the vagina, through the tiny cervical opening and into the uterus. Physicians found insertion was difficult; patients found it almost unbearable. As early as February 1971, a physician wrote to A. H. Robins in reference to the insertion of the Dalkon Shield: "I have found the procedure to be the most traumatic manipulation ever perpetrated on womanhood, and I have inserted thousands of other varieties."

Sometime in 1972, with angry correspondence pouring in and the prospects for increasing U.S. sales looking bleak, A. H. Robins decided to expand its exports. With any other kind of hazardous product, the manufacturer might, at this point, have had to search out some sleazy broker to arrange a secret dump. Not so with a contraceptive device. The Office of Population within AID had a budget of $125 million to spend on the purchase and overseas distribution of contraceptives. Director R. T. Ravenholt was known to be a population control enthusiast who would ask few questions about a good deal on Dalkon Shields. It was only natural for Robins to turn to the government.

Robert W. Nickless, Robins' director of international marketing, wrote to the population office of AID to interest them in placing "this fine product" with population control programs and family planning clinics throughout the Third World. Nickless sweetened the deal with a special discount, which dramatically illustrates the double standard drug companies apply to Third World consumers: the company offered AID the Shield in bulk packages, unsterilized, at 48 percent off.

Robins made this offer knowing that the sale of nonsterile IUDs was highly irregular in the United States. One of the greatest hazards associated with the use of any IUD is the possibility of introducing bacteria into the uterus, which is particularly poorly equipped to fight infection. In the United States, IUDs are sold to doctors in individual, sterilized packages, with a sterile, disposable inserter for each device.

Careful to preserve Robins' image, Nickless emphasized that AID could not distribute the nonsterile Dalkon Shields in the U.S. The nonsterile form, he wrote in a January 1973 memo to AID, "is for the purpose of reducing price, and thereby attaining wider use [and] is intended for restricted sale to family planning/support organizations who will limit their distribution to those countries commonly referred to as 'less developed.'" Practitioners in such countries were expected by Robins to sterilize the Shields by the old-fashioned method of soaking them in a disinfectant solution.

In the United States, according to private gynecologists we interviewed, the insertion of an IUD that had merely been soaked in a disinfectant before use would possibly be grounds for a malpractice suit. Robins insists that the "sterilization" procedure it recommended was effective, but it is highly likely that few people ever read the instructions. The company attached only one set of instructions for each pack of 1,000 Shields, and those were printed in only three languages -- English, French and Spanish -- although the devices were destined for 42 countries from Ethiopia to Malaysia. Worse still -- only ten inserters were provided per 100 Shields, adding immeasurably to the possibility of infection.

To their credit, officials within AID did express concern with at least one of the more reckless features of Robins' discount Dalkon dump. They questioned whether the Shields could be reliably inserted by the staffs of remote family planning clinics, who would not have had the benefit of an American medical education.

It should have been an embarrassing question for Robins. In the U.S., the company had repeatedly countered reports of adverse reactions by arguing that the person who had inserted the device, such as an occasional general practitioner, had been unqualified to do so. But Robins was undaunted and nimbly produced a new study which proved beyond a shadow of a doubt that any paramedic could learn to insert a Dalkon Shield in half an hour.

Reassured by this logic, AID approved the deal. Hundreds of shoe-box-sized cartons, each filled with 1,000 unsterilized Dalkon Shields paid for by the U.S. treasury, left the shores of America for clinics in Paraguay, Israel, Tunisia and 39 other countries. The dump was on. Within months, the agencies that distributed Dalkon Shields for AID, such as the International Planned Parenthood Federation, had discovered more bad news about the device. Company sales monographs and ads in medical journals had boasted of a pregnancy rate with the Shield of no more than 1.1 percent. But the reports coming in from the field told another story: pregnancy rates of 4.5 percent in Israel, 3.8 percent in the United Kingdom, 6.7 percent in Costa Rica and 6.5 percent in Yugoslavia. One clinic in Latin America reported a pregnancy rate of 14.8 percent. From a population controller's point of view, a contraceptive may, if expedient, be unsafe; but it should not, under any circumstances, be ineffective.

Disturbed by the negative reports, A. H. Robins sent Robert Nickless on a whistle-stop tour of Asia in March 1973 to counter the increasing volume of criticism and drum up new business. With him, Robins sent along an "independent expert" -- Dr. John Lesinski, a colleague at Johns Hopkins University of the Shield's inventor, Dr. Hugh Davis, and an early Dalkon Shield booster. At a typical stop, the local AID population control officer would assemble a group of physicians, and Lesinski, lending an aura of professional responsibility, would lecture, show slides, and occasionally perform demonstration insertions on a few local women.

While Nickless was peddling the Shield from Pakistan to Hong Kong, time was running out for it in the United States. In August of 1974, the FDA opened hearings on the Dalkon Shield. At that time, the FDA had little jurisdiction over medical devices like IUDs: they could investigate their safety, but they could not ban them from the market. Despite the FDA's lack of authority, the hearings were held simply because, by 1974, the carnage had become too gruesome to ignore. One critical study after another told of women who had suffered infections, septic abortions or emergency hysterectomies.

A. H. Robins had been hardened by years of fighting regulatory agencies, however, and the company went down fighting. "Throughout the entire proceedings," according to Dr. Richard Dickey, a member of the FDA's Ob/Gyn committee, "the halls of the FDA were crawling with Robins men. It was disgusting. " Finally evidence was presented at the hearings that could have undercut Robins' defenses in future product liability suits, potentially costing millions of dollars. Only then did the company give up. Robins made no attempt to resume its domestic sales, suspended at the FDA's urging.

When Robins gave in, AID was left holding the bag, or, rather, the bulk pack. International complaints about the effectiveness of the device had been bad enough. With the Shield now considered too dangerous for domestic use, AID had little choice but to issue an international recall. It was an embarrassing moment for the agency, but hardly a major setback. Even without Dalkon Shields, there would be plenty of "discount" contraceptives to dump in the Third World.

The Man Behind the Dumps

That corporations dump to make a profit is no surprise. In the case of contraceptive dumping through the foreign aid program, though, there are other motives as well. What kind of person knowingly stamped the seal of American "goodwill" on this corporate jackpot? To find out, in July 1979, we interviewed Dr. R. T. (Ray) Ravenholt, the head of AID's Office of Population from 1966 to mid-1979 and the man who most represents the government role in contraceptive dumping.

In person, he is a tall, affable Midwesterner with an engaging smile and a marked inability to sit still once he warms up to the subject at hand. No sooner had we gotten through the introductions than he bounded off to one corner of his spacious office and returned with his latest contraceptive enthusiasm: a plastic "gun-styled" laparoscopic device, which, when aimed through the vagina, shoots little plastic bands around the fallopian tubes, resulting in permanent sterilization. He demonstrated by placing one foot up on his chair and shooting bands at his shoelace. Only after he completed the simulated sterilization of his left foot were we able to bring the subject around to the Dalkon Shield.

"Robins didn't know there was any problem with it in 1972," he insisted. When we countered that A. H. Robins had been deluged with reports of adverse reactions by that time, Ravenholt smiled patiently and explained: "You don't really know anything until you have a very, very large number of people who have used it. You might have one kind of impression from 10,000 people, another from 100,000. You might need a million -- 10 million -- before you really know."

You might, in other words, need a few medium-size nations to experiment on.

Ravenholt did concede that AID "had been hearing about infections" associated with the Dalkon Shield prior to Robins' withdrawal of the device. Then, leaning forward with enthusiasm, he confided his own theory about IUD-induced pelvic infections: "Women who frequently change sexual partners have these intercurrent low-grade infections," he told us. "The IUD can't cause an infection. The body tolerates anything that's sterile." Taken aback, we asked whether Dalkon Shield-related infections in the Third World might not have been caused by nonsterile devices, rather than by female promiscuity. "Well," he said, in a classic non sequitur, it wasn't just the Dalkon Shield that was supplied that way. The Lippes Loop [another variety of IUD] was supplied in a nonsterile form at first too."

Ravenholt has one very good reason to continue to defend the Dalkon Shield: it is still in use throughout the Third World. When the recall order was issued in 1975, AID could hope to recover stocks of unused devices from the warehouses and storage rooms of major international agencies, like the International Planned Parenthood Federation. But it could not, despite any number of memos, recall the AID-supplied Shields from the approximately 440,000 women already using the device. Nor could it hope to recover the thousands of Shields lying in the drawers of countless private practitioners and tiny rural family planning clinics.

Almost five years after the manufacturer's suspension of sales and AID's recall, Dalkon Shields are still being inserted. Dr. A. Goldsmith, a researcher for the AID-funded International Fertility Research Program and a man who could hardly be accused of harboring a consumerist bias, told us in June 1979, "I know they are still inserting the device" in Pakistan, India and possibly in South Africa.

It is impossible to know how frequently this is still taking place, but our own sources have told us of at least two cases. In Nairobi, Kenya, on the wall of the Family Planning Association clinic, there is a poster advertising the Dalkon Shield. In early May 1979, a young woman patient at this clinic was offered, among other birth control options, a Dalkon Shield. In Ottawa, Canada, Pierre Blais, senior consultant to the Bureau of Medical Devices told us, the Shield was being inserted as late as 1977 -- two years after it had been withdrawn from the U.S. market.

Finally, neither AID nor even the FDA would have any way of stopping A. H. Robins from privately dumping its own unsold stock of Dalkon Shields, if the company was of a mind to do so -- and it was. In a recent interview, Robins attorney Franklin Tatum admitted to us that his client was still selling the devices through the first quarter of 1975 -- even as they were being recalled through AID and allegedly destroyed.

The Inundation Approach

Ray Ravenholt winces slightly when he is asked about his critics, who are as numerous and diverse as any salaried civil servant could hope to acquire. "Right to lifers" head his list, along with "Catholics, Communists...." He could have added consumerists, like Ralph Nader's Health Research Group, and feminists, like the National Women's Health Network and the Feminist Women's Health Centers.

To be fair though, he is a man with a cause, and that cause is ultimately no different from the one that motivates every other hard-working professional in the State Department. "Population explosions, unless stopped, would lead to revolutions," he told the St. Louis Post-Dispatch in an April 1977 interview. Population control is required to maintain "the normal operation of U.S. commercial interests around the world.... Without our trying to help these countries with their economic and social development, the world would rebel against the strong U.S. commercial presence. The self-interest thing is the compelling element."

More liberal population controllers argue that economic development, health services and an expanded role for women are needed to motivate people to reduce family size, but Ravenholt's approach is single-mindedly contraceptive-oriented. To him, the point is to "get the contraceptives out there."

In the early 1970s Ravenholt pioneered a whole new approach to "getting them out there" -- the "inundation approach," which was to provide, among other things, a convenient dump for the Palo Alto, California-based Syntex Corporation. Contraceptive inundation means disseminating contraceptives through any outlets, to any and all takers. Trained personnel can be bypassed; educational programs can be dispensed with. Oral contraceptives were especially well-suited to the inundation approach.

No woman can insert her own IUD, but -- the theory was -- if you can chew gum, you can swallow a pill. In Bangladesh, site of an intensive AID inundation program, pills are sold, usually at nominal prices and without any semblance of medical supervision, through local shops, alongside cigarettes, bananas and betel nuts.

From the beginning, AID's inundation program in Bangladesh had the markings of a biological disaster. The average Bangladeshi woman weighs 92 pounds and suffers from chronic malnutrition. Even in a 135-pound American woman, the pill is known to deplete the body's supply of vitamins A, B-6, D and folic acid (hence the special vitamins sold in the U.S. as supplements to the pill). Furthermore, no less than 90 percent of the Bangladeshi women who accepted the pill were breastfeeding. According to a study by the International Planned Parenthood Federation, babies nursed by pill-users grew at an average rate that was only two-thirds that of babies nursed by non-pill-users. Ending world hunger is the most common rationalization for the top-down approach to population control, but in Bangladesh, AID was creating its own kind of chemically induced famine.

All this preceded anything that could, strictly speaking, be called a dump. AID was, after all, distributing a pill that had been judged safe for American women. Not all birth control pills are the same, however, and in 1970 the FDA had advised physicians to prescribe only those with the lowest possible estrogen dose -- at that time, 50 micrograms. Sales of high-estrogen pills began to sag. AID had at first been following the FDA's advice, buying 50 microgram pills from G. D. Searle, Wyeth, and Parke, Davis. Then, in 1973, AID took its business to the Syntex Corporation and started buying up high-dose, 80 microgram pills. AID explained the switch as a response to "market conditions." Simply put, the high-dose pills were cheaper. According to sources at the George Washington University Medical Center (which was under contract to AID to publish the bulletin Population Reports), Syntex offered AID a better deal -- a discount on the domestically discredited, high-estrogen pills. Ravenholt bought up millions of dollars worth of Syntex's stock of 80 microgram pills -- for overseas use only, of course.

The dangers of estrogen overdosing don't dismay AID's inundation strategists. Dr. Malcolm Potts, director of the International Fertility Research Program and a key inundation planner, even sees a bright side to one pill side effect -- swollen breasts. In a paper presented at the 1977 Tokyo International Symposium on Population, Potts and two colleagues suggested as a catchy slogan for rural pill promotion: "It makes your breasts more beautiful and is good for everyone -- including the tailors who have to make bigger brassieres."

And Now: Depo-Provera

Depo-Provera, a drug unfamiliar to most Americans, because it is not available here, may determine the future of contraceptive dumping. Right now, AID is prohibited from shipping it across U.S. borders. But debates that will begin within the next few months will reopen the issue. If this dump is approved by Congress or the FDA, the informal contraceptive double standard will become official U.S. policy.

But AID is not just passively waiting for the go-ahead. Depo's manufacturer (the Upjohn Company) and AID are, even now, getting around the law and dumping the drug through both overt and covert programs. According to Upjohn, five million women in 70 countries have used Depo-Provera for contraception.

There are reasons why AID is so anxious to increase the distribution of Depo-Provera. Most birth control methods, because they depend on consumer cooperation, are considered unreliable by population controllers. Pills, condoms or diaphragms can all be forgotten or rejected. Sterilization would be ideal, but is politically risky. Depo-Provera brings new hope to planners looking for the final solution to fertility, for several reasons.

First, it is long-lasting: one injection prevents conception for three to six months. Second, it requires no effort on the part of the patient. Finally, by being injectable, it is believed to have a special appeal in the Third World, where, according to the AID-funded journal Population Reports, "injections are associated with safe, effective, modern medicine."

To the Third World consumer, a new product from the U.S. may seem to represent the latest in scientific research. But the overseas consumer of Depo doesn't know that the "latest research" is what prevented the contraceptive from being approved for use in the United States, and that is why it is being dumped.

The list of known side effects, complications and potentially lethal hazards could fill several magazine-size pages with small print. Depo-Provera causes nodules in the breasts and cancer in the reproductive organs of test animals. It causes "irregular bleeding disturbances," which have been described in one medical journal as "menstrual chaos." It reduces the body's resistance to infection. In some women it causes weight gain, headaches and dizziness. Its effects are not readily reversible: use may be followed by long-term or even permanent sterility. If injected into a pregnant woman (and almost every field study has reported the accidental injection of pregnant women), it can cause birth defects, especially congenital heart defects, and, in the case of female fetuses, masculinization and enlargement of the clitoris. Dr. J. Joseph Speidel, a colleague of Ray Ravenholt's at AID, did concede that excess bleeding induced by Depo "will be a problem where sanitary napkins are in short supply."

For 11 years, starting in 1967, Upjohn battled to get FDA approval for Depo-Provera. But in 1971, after studies done on beagle dogs showed that Depo was carcinogenic in high doses, the FDA was alarmed enough to call a halt to all clinical tests of the drug. On March 7, 1978, the FDA sent Upjohn a letter notifying the company of its final decision: Depo-Provera was "not approvable" for use in the U.S.

The population control community was outraged by the FDA's decision. AID's Ray Ravenholt called it "the tyranny of the beagle dog."

Domestic criticism of Depo-Provera has not prevented a plentiful supply from reaching the Third World. The FDA's refusal to approve Depo only meant that Upjohn could not ship the drug from its U.S. plants. It could, however, ship the drug from its Belgian subsidiary to whatever foreign commercial outlets it could find.

It has found plenty. In Belize, Central America, Depo is freely available at drugstores, despite what our correspondent reports as "many instances of amenorrhea [lack of menstrual periods] or profuse bleeding." A letter from Guatemala City to the Washington-based National Women's Health Network, related that in Honduras, El Salvador, Costa Rica, Nicaragua, Panama and the Dominican Republic "it is completely possible to buy it over the counter with no prescription."

This, apparently, is not enough for some parties. AID would like to be able to buy up huge batches of Depo at bulk rates, and Upjohn would like nothing better. Both testified to that effect to the U.S. Congress. An AID-subsidized dump could mean a four-fold increase in Upjohn's Depo sales.

There are several ways this could happen. First, AID could simply buy Depo from Upjohn's Belgian subsidiary and ship from there, as it has threatened to do. Another possibility is that Congress could pass a new drug reform act allowing for the export of nonapproved drugs. (A bill that may liberalize drug exports has recently been approved by the Senate Health Committee.) Or, the FDA could reverse its position on Depo-Provera and approve it for use in the United States, though perhaps only for special subgroups (the mentally retarded and drug addicts have been proposed). This, believe it or not, is a real possibility.

But with all eyes on Congress and the FDA, the real action is going on under the table. Increased pressure from feminist groups and mounting suspicion in some Third World countries are forcing AID, like the CIA, to carry on its more "sensitive" activities through a thick padding of front groups.

In September 1978, an elite group called the Population Roundtable met at Planned Parenthood World Population Headquarters in New York. Present were representatives of the Population Council, the International Planned Parenthood Federation, the UN Fund for Population Activities and -- unbeknownst to the invited participants -- two feminist health activists. The principle speaker was AID's Ravenholt, and, according to the two feminists present, "He stated that AID's most sensitive actions frequently cannot be spoken of publicly. He proudly reported that $12 million was secretly funneled to Mexico through Family Planning International Assistance, part of the Planned Parenthood Federation of America, and other organizations...that are AID-tainted conduits. He described this as a 'remarkable creative action.'"

AID's willingness to apply similar creativity to the Depo problem was expressed publicly in the May 1978 congressional hearings on population and development. Representative James Scheuer asked Dr. J. Joseph Speidel, then deputy director of AID's Office of Population: "If a health minister or chief of state of a foreign country requested our AID officials to provide Depo-Provera, would there be sufficient protection for our AID organization to make Depo-Provera available?"

Speidel responded: "I think our first action would be to attempt to get the appropriate supplies to them through some other routing. For example, the U.N. Fund for Population Activities might be willing to provide the needed drugs."

The U.N. Fund for Population Activities (UNFPA) has received $204 million, or 35 percent of its income, from AID since the fund's inception in 1969. In its first year of operation, a full 85 percent of UNFPA's money came from AID. Other agencies that might be happy to provide "routing" for covert AID actions include: