Gerald Zatuchni Plays Midwife to Innovations in Birth Control
In the field of fertility regulation, though, each new contraceptive technique is likely to foster new controversy. A new French steroid, RU 486, which can halt a pregnancy as much as four weeks after conception, is being called the "abortion pill" by those who oppose this method of birth control. At the same time, U.S. manufacturers of birth control devices are getting out of the market, afraid that the drift of medical liability law threatens the profitability of such familiar products as IUDs and spermicidal jellies. Dr. Zatuchni talked with Chicago correspondent Giovanna Breu about these developments.
Some doctors claim that RU 486, the so-called "month-after pill" that has been developed in France, is the most exciting new birth control method since the Pill. What do you think?
It's a step in the right direction in terms of research. But there are still problems to be solved. It is only effective in 80 to 85 percent of women if taken within six weeks of their last menstrual period.
How does RU 486 work?
It is taken for four or five days toward the end of the menstrual cycle. The theory is that if the woman is pregnant it will cause an abortion; if she is not, it will bring on menstruation.
What are its drawbacks?
In a significant number of women, the bleeding is heavy and uncontrollable, sometimes requiring emergency measures. And the prostaglandins, with which it has been combined to increase its effectiveness, can cause nausea, vomiting and diarrhea.
What are some of the other promising new contraceptive methods?
One is an implant called Norplant. Inserted surgically in the upper arm, it continuously releases hormones for up to five years. But a significant percentage of women have had abnormal bleeding with Norplant, which has been tested extensively overseas.
What else is being tested?
Fewer bleeding problems have been reported with injectable microcapsules, which are biodegradable and don't have to be surgically removed later. Researchers are now testing 30-day, 90-day, six-month and even one-year capsules that use the same hormones as birth control pills, but in lower doses. A contraceptive that's effective for several years would be useful in every part of the world, but particularly in the developing nations, where women don't see a doctor very often.
What other methods of long-term contraception are on the horizon?
We've made progress toward developing vaccines that could render a female immune to some element of the fertilization process. Here at North-western we've-isolated a sperm enzyme and, using genetic engineering, are developing a vaccine against it that may offer a form of reversible long-term contraception.
What is being developed abroad?
A French gynecologist has developed a technique that uses a fiberoptic telescope to place a small device in the fallopian tube. We're not sure how it works, but without completely blocking the tube it still prevents the egg from meeting the sperm and becoming fertilized. When the woman decides she wants to get pregnant, you take the device out, a simple procedure that can be done in the doctor's office.
What about contraceptives for men?
For men we are developing a removable plug that effectively blocks the movement of sperm through the vas deferens. Semen comes from the prostate gland, farther up, so the man still has a full ejaculation—we call it shooting blanks. In animal tests the sperm flow resumed when the blocks were removed after being in place for as long as a year, so this may lead to a cheap, easy form of reversible sterilization. Clinical tests on humans just began last month.
Anything else promising?
Another exciting development is a vaginal contraceptive that doesn't kill the sperm but just attacks the enzymes on the head of the sperm that enable it to penetrate and fertilize the egg. Because we can get away with a thousand times smaller dosage than with spermicides, we think we'll be able to avoid the messiness of a lot of cream or jelly or foam.
Haven't there also been lawsuits about currently available spermicides?
Last year a Georgia judge awarded $4.7 million to a woman who claimed that her baby's deformed arm and other defects were caused by Nonoxynol-9, the chemical compound used in most over-the-counter spermicides. All the scientific evidence shows that there was no relationship between Nonoxynol-9 and the birth defects. The Ortho Pharmaceutical Corp., which lost the Georgia case, has considered the liability issue, but the company has no plans to withdraw the product from the market. The Georgia award is reported to be larger than the company's profits on all spermicidal products. So the creams, jellies, foams and suppositories could'be discontinued the same way that G.D. Searle discontinued its Copper-7 and Tatum-T intrauterine contraceptive devices (IUDs) as of a year ago.
Why has Searle discontinued making IUDs? Were they unsafe?
No. None of their IUDs have been discontinued because they were unsafe or ineffective. But Searle, faced with an increasing number of suits, decided to discontinue its sale of IUDs in the U.S. A.H. Robins, marketer of the Dalkon Shield, filed for protection under the bankruptcy laws in 1985, after paying about $520 million to settle claims by women who allegedly suffered a variety of IUD complications.
What will be the results of all this?
Due to profit and liability considerations, American women have been deprived of a safe, effective and reasonable method of birth control. Now there will be only one hormone-releasing IUD on the market—and that company has already increased its price, now that it has a monopoly and to cover insurance costs. Birth control pills have also increased in cost because of product liability concerns.
Do you consider the Pill safe?
I think, except for women with certain risks factors—smokers over 35 or the obese—the benefits of the Pill far outweigh its disadvantages. Unfortunately its dangers have been overemphasized. All the publicity in the middle '70s about its so-called dangerous side effects had to do mostly with the original Pill, which contained very high dosages of hormones. That put a scare into American women about blood clots, strokes and the like, from which we've never really recovered. Use of the Pill, once as high as 35 percent among women in the U.S. using birth control, is down to about 22 percent.
Are the newer forms of the Pill more effective and safer?
Yes. For the last 10 years we've had pills with very low dosages of progestin and estrogen. Studies show that these pills actually provide protection against breast cancer, cancer of the ovaries and uterus, pelvic infections, some venereal diseases and severe cramps. The newest pills, the triphasics that release varying amounts of hormones each day, use even smaller doses of the same hormones. They have a high rate of effectiveness, and for those using them nausea and bloating hardly exist.
What about "natural" methods of birth control?
We've supported research on the cervical mucus dip stick, which monitors a key enzyme that can give a four-day forewarning of ovulation. Other methods provide only 24-hour warning, which is inadequate, because sperm can live in the reproductive track for three to five days.
Will any of the new methods you've described be available on the American market anytime soon?
I don't think any U.S. companies are going to make the effort to bring any of these new methods to market in the next decade. It takes a lot of money develop and adequately test a new contraceptive method, and money for this type of activity is in very short supply. Because of the product liability climate, the pharmaceutical companies are not interested in putting in $50 million to $75 million to try to develop a new method of birth control if they don't think they're going to be able to reap a profit from it. As matters stand right now, Ortho Pharmaceutical is the only major U.S. company spending any money developing birth control. It's a severe problem.