ABOUT THREE YEARS AGO, DR. Joseph Goldzieher, a researcher at San Antonio’s Southwest Foundation for Research and Education, set out to determine if numerous side effects reported by women using oral contraceptives might be psychological in origin.
He recruited 76 women to use as a control group, some of whom were referred by Planned Parenthood of San Antonio, where the women were told they would be getting birth control medication from Dr. Goldzieher. Each of the 76 women had borne children; most did not want any more. But ten of those women—all poor Mexican Americans—did get more children, because unknown to them, they were given placebos, not oral contraceptives as they had been led to believe.
A minor medical furor arose when the results of the Goldzieher experiments were reported at the March 1971 meeting of the American Fertility Society. Although the results did tend to confirm the research hypothesis, and although Hungarian-born, Harvard-educated Goldzieher held, and continues to hold, a respectable reputation, he had violated one of the most important tenets of research ethics—he had failed to obtain the informed consent of his subjects. In the 1964 Declaration of Helsinki, research scientists from all over the world declared that “The nature, the purpose, and the risk of clinical research must be explained to the subject by the doctor.”
The ten women became pregnant during the course of the study, not because of the failure of the drug they were taking, but because they really hadn’t been taking any drug, and no one had told them of the extent of the risk.
Gynecologists speaking off the record have labeled the study “totally unethical.” Dr. Goldzieher defended himself at the time by saying that the women had been instructed to use vaginal cream as an added protection. It is common knowledge, however, that vaginal cream is not a very effective deterrent to pregnancy. Goldzieher concedes this himself. He admitted to a medical reporter that the pregnancy ratio turned up in his study was consistent with previous trials of vaginal cream and foam. “It just doesn’t always work all that well,” he said. Concerning the pregnancies, he said, “We could have aborted them if the abortion statute here in Texas weren’t in limbo right now. A court order overturned the law and the case is awaiting Supreme Court review. If we had a liberalized law, we’d abort them.”
Another gynecologist, Dr. Louis M. Hellman, said that the pregnancy rate in the Goldzieher study “isn’t far from what you’d expect if you provided no protection at all.”
Women’s groups protested the study and last summer, the Food and Drug Administration ( FDA) sent the physician a mild letter of rebuke for failure to obtain informed consent from his subjects, to report adverse effects, and to follow study protocols. Syntex Labs, which had jointly financed the project with the Agency for International Development ( AID), withdrew their support and a curtain of “no comments” descended around the whole affair.
That curtain is still drawn today, and Goldzieher has just received a new contract for more than $100,000 a year for further contraceptive studies. The doctor will not respond to calls concerning the study from reporters. Myron Chrisman, present director of the San Antonio affiliate of Planned Parenthood, reacts to questions concerning Goldzieher with indignation: He wasn’t there at the time, he says. No staff member will have anything to say on the subject, he adds. Planned Parenthood does not refer women into experimental studies, and does not send them to physicians who use drugs not approved by the FDA.
Alan Bloebaum, director of the Southwest Region of Planned Parenthood, isn’t running quite so scared on the subject, even though he says he has no direct knowledge of the incident. He acknowledges Planned Parenthood’s involvement, and says that Dr. Allen Guttmacher, president of Planned Parenthood, made a special trip to San Antonio to question Dr. Goldzieher on the study. Bloebaum doesn’t know what transpired at that meeting, but a check reveals that Goldzieher is still closely associated with the San Antonio affiliate and is a member of the national medical committee of Planned Parenthood.
Bloebaum also believes that the doctor and the affiliate might be able to cite some mitigating circumstances if they would speak with the press. “I personally thought that Dr. Goldzieher and the affiliate got the short end of the thing, says Bloebaum. But he offers no more details.
As for the new study, which is again being funded by AID, but without the help of Syntex Labs this time, a medical magazine reports that the project will be a metabolic and endocrine study of steroids, lipids (fats), and carbohydrates in women using oral contraceptives. The AID research advisory committee reports that this time, women in the control group will be fitted with IUDs (intrauterine devices). And, besides using Chicanas, the present AID outline proposes employing women from a number of underdeveloped countries.
The full program will be financed with $350,000 a year spread over two or three years, and reportedly, about a third of the money will go to Dr. Goldzieher’s project. The rest would be subcontracted to other organizations, but Goldzieher will be project director , overseen by AID’s Bureau for Population and Humanitarian Assistance.
THE WRITERS’ LIFE
WRITERS, ESPECIALLY TEXAS WRITERS, TEND to float around. Larry King’s ways have in the past taken him from the streets of Midland to the wilds of Washington, D.C. He is now at Princeton teaching courses in politics and writing which, as he is quick to point out, is not bad for a man who never graduated from high school.
Grover Lewis, whose prolific pen has been firing the pages of Rolling Stone for the past two years, has left Stone for good and has returned to San Antonio. He and Sherry Kafka, another San Antonio writer, had signed a contract with Straight Arrow Books, a division of Rolling Stone, to write a book about John Connally. Jann Wenner, Stone’spublisher