private research foundation that carried out extensive statistical studies on IUDs in the 1960s, expressed confidence in "those adequately tested devices now in use." However, the representatives also urged the Government to establish testing standards for IUDs and recommended 12 minimum criteria.

The Population Council is widely regarded as the wellspring of information on IUDs. When one compares the council's proposed standards, however, with the substantiation offered by the manufacturers of the three IUDs whose sales make up 95 per cent of the market-the Lippes Loop, the Saf-T-Coil, and the Dalkon Shield-only the Lippes Loop appears to come close to meeting those standards.

Dr. Charles Anello, an FDA statistician, says that most studies done on IUDS to date would not "in and of themselves" be sufficient to convince the FDA that IUDs are safe and effective. Dr. Sidney Wolfe, director of the Health Research Group of Public Citizens, a consumer-advocate organization, says this is not surprising, because, "In the absence of government regulation you don't get long-term, well-controlled studies that produce hard data. If a company has a good thing, they're damn well going to market it as quickly as possible."

THE CAMEL AND THE STONE

It has been known for centuries that a foreign body in the uterus will prevent pregnancy. (Indeed, folklore says the first IUD was a stone, placed in a camel's uterus to prevent pregnancy on long caravan journeys.) Even today, however, it is still not known why IUDs prevent pregnancy, why they produce unpleasant or even dangerous side effects, what the risk of death is, or whether IUDs cause cancer.

In part, researchers say, this is because IUDs have been in general use only about 10 years-not long enough for long-term effects to show up. But they also agree that basic research on IUDS has been minimal, with drug companies and the Government concentrating their efforts on the Pill.

The experts' consensus is that:

IUDs are less effective than the Pill but more effective than the diaphragm, condom, or chemical foam. The first-year pregnancy rates are less than one pregnancy per 1,000 women on the Pill vs. about 30 per 1,000 for IUDs. The IUD rate declines with time because the most fertile women get pregnant earliest.

Chances are 50-50 that a woman will miscarry if she becomes pregnant with an IUD in place. About 1 in 20 of such pregnancies occurs outside the uterus, either in the Falopian tubes or on an ovary.

Pain on insertion, heavy bleeding, and cramps are the most common side effects. For most women these disappear within a few months, but 15 to 20 per cent must eventually have the device removed. Another 2 to 40 per centthe figures vary wildly depending on the device used-spontaneously expel the IUD.

Infrequent but more serious side effects are uterine perforation-piercing of the uterine wall-and infection.

Young, never-pregnant women are likely to have more problems with IUDs than women who have borne children. But there is no sure way to tell which women can wear IUDs successfully, or which IUD a woman will tolerate best.

ARE RISKS UNDERESTIMATED?

This is the broad IUD picture, although not all physicians agree with the way it was painted. Dr. Russell J. Thomsen, a gynecologist at the U.S. Army Hospital in Fort Ord, Calif., argues that most IUD researchers and manufacturers underestimate side effects. They dismiss women's complaints about pain or bleeding as not serious, he alleges, and, more important, they ignore the fact that a woman who miscarries while wearing an IUD may require major surgery and risk serious infection. Thomsen also argues that the pregnancy rate exceeds the quoted 3 per cent, since many women miscarry early without realizing they were pregnant.

Dr. Jerome Abrams, a gynecologist at Muhlenberg Hospital in Plainfield, N.J., and medical adviser to Planned Parenthood Union County Area, Inc., also says IUD enthusiasts have overdrawn the picture. In last April's Journal of Reproductive Medicine Abrams wrote of his increasing disenchantment with IUDs: "There were patients who became pregnant, and there were patients who

requested removal . . . [and] there were be consoled and reassured by statistics.

expulsions. . . . We refused to We [became] cautious and skeptical as well as suspicious of claims of success by inventors and promoters."

...

THE DALKON SHIELD CRITICIZED

Why have so many other reports been enthusiastic then? "Negative results rarely seem to attract attention," Abrams speculates.

Abrams especially criticizes the newest IUD he has tried: the Dalkon Shield. This fin-shaped device with five pairs of "legs" has become one of the three most popular IUDs in America in the past two years, with sales of over two million. Its acceptance by doctors has been "dramatic," according to its manufacturer, the A. H. Robins Co., Richmond, Va.

But at the House Intergovernmental Relations Subcommittee hearings, witnesses and committee staff members questioned its claims more frequently than those of any other IUD on the market. Doctors interviewed by The National Observer criticized it more vehemently than any other. And Dr. Christopher Tietze of the Population Council, a foremost authority on IUDs, says, "In all my experience, I have never come across a device that has both so many enthusiastic supporters and so many enthusiastic detractors."

DEVELOPMENT STORIES DIFFER

The Dalkon Shield was developed over several years by a well-known gynecologist and an engineer. The gynecologish, Dr. Hugh J. Davis, director of familyplanning services at Baltimore's Johns Hopkins Hospital and associate professor of obstetrics and gynecology at the Johns Hopkins University School of Medicine, says he merely tested the devices developed by engineer Irwin S. Lerner, then of Greenwich, Conn. He says Lerner approached him after hearing of his basic research on the uterus. Lerner, however, says that Davis came to him after trying unsuccessfully to design his own IUD, asked him to develop one based on Davis' research, and helped refine the device.

Whatever its inception, Lerner filed for a patent on the shield in 1968, and Davis undertook a one-year observational study.

The study's results, published in February 1970, said the shield had a pregnancy rate of 1.1 per cent, an expulsion rate of 2.3 per cent, and a 2 per cent rate of removal for pain and bleeding. This efficacy appeared to be unprecedented. Four months later the A. H. Robins Co. bought the patent from Lerner, hired Davis as a consultant, and-based on Davis' one study-began promoting the Dalkon Shield as superior to all other IUDs, particularly for never-pregnant

women.

"The only IUD anatomically engineered for optimum uterine-placement fit, tolerance, and retention," the first medical-journal ad proclaimed, displaying Davis' results prominently but nowhere mentioning that fewer than half the women in the study had used the IUD a full year.

THE SENATE HEARINGS' SCARE

Davis' study appeared prominently again in a laudatory eight-page Robins ad in 1972. "The IUD that's changing current thinking about contraceptives.. designed for superior contraception . . . designed for better retention ... designed for greater comfort," said the ad. It spoke glowingly of a pregnancy rate of 0.5 to 1.9 per cent and cited three other studies to back up this claim.

But careful examination of the studies shows that few women used the IUD for even a year. There are significant gaps on such matters as the number of women who dropped out of the studies.

While Robins was touting the shield openly in medical journals, Davis was promoting it more subtly. In January 1970, one month before his study was published, Davis testified at the well-publicized Senate hearings on the Pill-hearings that left many women anxiously seeking a safer form of contraception. Davis excoriated the Pill and praised the IUD. Some colleagues later criticized him for not making clear the extent of his involvement with IUDs.

The next year Davis published a book, Intrauterine Devices for Contraception: The IUD, that leaves the clear impression that the Dalkon Shield is preferable to all other IUDs. Yet the book doesn't mention Davis' role in developing that

device. Davis demonstrates the Dalkon Shield's "superiority" by contrasting the near-perfect results of his own one-year study of 640 women with studies on other IUDs spanning five years and involving 29 investigators and 31,767 women. Meanwhile, other doctors were finding it difficult to replicate Davis' Dalkon Shield results. Abrams, the Plainfield, N.J., gynecologist, wrote in the Journal of Reproductive Medicine:

"After two years and 110 shield insertions with only 4 expulsions and 10 removals, six pregnancies were accumulated. At approximately this time a memorandum was received from Planned Parenthood reporting six pregnancies

after only 52 Dalkon Shield insertions.

"Our dissatisfaction was reinforced by two events," Abrams added. First, medical-journal ads began recommending "supplemental contraception" during the two- or three-month "postinsertion adjustment phase," yet 8 of 12 pregnancies reported by Abrams and Planned Parenthood had occurred 3 to 11 months postinsertion. Second, an author of one of the studies publicized in the ads wrote to Abrams, saying contraceptive foam should be used from between the 7th and 17th days of the menstrual cycle each month, not just during the postinsertion adjustment phase. (This author was Davis, Abrams now says.) "Our confidence in the shield has been seriously undermined," Abrams' article noted. "We are now investigating [another] type of IUD."

PREMARKET DATA WERE SKIMPY

A Robins official now concedes that the low pregnancy-rate claims made during the Dalkon Shield ad campaign 21⁄2 years ago probably were overoptimistic. "On the information we have now, a pregnancy rate of 2 to 3 per cent [instead of 1.1 per cent] is probably about all we can expect," the official says, adding that similar rates are also expectable. from other, comparable IUDs.

The official also concedes that Robins marketed the shield without waiting “a long enough time" to collect meaningful data on it. Robins would welcome stricter Government regulation to ensure such premarket data collection "if everybody else had to do it" too. The official emphasizes, however, that the shield wasn't marketed "with any knowledge [of dangerous side effects] and has not since been found to be dangerous or unsafe."

Drug-company ads, like those for other commodities do tend to overstate the good and understate the bad, the official goes on, concluding: "But, after all, we are in business to sell the thing, to make a profit. I don't mean we're trying to go out and sell products that are going to be dangerous, fatal, or what have you. But you don't put all the bad things in big headlines."

Senator KENNEDY. Our final witness is Joel J. Nobel, M.D. Dr. Nobel is director of the Emergency Care Research Institute in Philadelphia, Pa. He has been a principal investigator for several research projects supported by the Public Health Service and is a frequent consultant to the Department of Health, Education, and Welfare and the American Heart Association, as well as many others.

Welcome to the Senate Health Subcommittee, Dr. Nobel. We look forward to receiving your testimony.

STATEMENT OF JOEL J. NOBEL, M.D., DIRECTOR, EMERGENCY CARE RESEARCH INSTITUTE, PHILADELPHIA, PA.

Dr. NOBEL. Senator Kennedy, my coworkers and I at the Emergency Care Research Institute are grateful to you for the privilege of sharing our perspectives on the medical devices legislation under consideration.

My statement prepared for submission to the hearing record considers a number of areas which, in respect for your time, I will not review in detail this morning. In outline, however, these areas include

(1) Our institutional role and qualifications in the medical device area;

(2) Results of our studies in medical devices;

(3) Priorities for dealing with medical devices;

(4) Distortion of priorities by special interest groups; (5) Fixed limitations in implementing corrective action in the medical device field;

(6) Limitations of the proposed legislation; and

(7) Problems in implementing corrective action which can and must be overcome.

Because our institutional experience and our qualifications are unique, I would like to briefly explain our role in the medical device

area.

ECRI is a nonprofit agency designated by the IRS as a 501(c)3 operating foundation. It is devoted to improving patient care through scientific, technical, and education programs related to the delivery of health services. Its primary task is the assessment of health care technology: the equipment, devices, and systems used for the diagnosis, prevention, and treatment of disease in humans.

ECRI has achieved an objective working climate. It rejects both the impractical and currently in-vogue antiindustry element of the consumer movement and the selfish and parochial interests of manufacturing industries and industry-dominated standards and code-making organizations. ECRI represents the user, the hospital, the health care professional, and the patient; those who ultimately pay the cost of medical devices and the penalties for their deficiencies.

To assure an objective scientific climate and immunity to inappropriate influences, we accept no support from nor do any work for medical device or pharmaceutical companies. Our staff members are not permitted to own stock in or consult for such companies. While we are economically and emotionally detached from the medical device industry, our posture is not one of hostility. Hostility toward the medical device industry would no more lead to objective assessment of its products than would the opposite extreme of being part of industry itself. Unlike a Government agency, we are immune to any form of pressure, direct or indirect, by special interest groups. We simply do what we perceive to be in the best interest of patients.

To assure technical and scientific competence, we have a skilled interdisciplinary staff of physicians, nurses, physiologists, physicists, and biomedical, electronic, and mechanical engineers.

To assure that our activities have practical relevance to the real world of medical device users and to meet their needs for information about safety, reliability, and performance of medical devices, we operate an interactive telephone and letter technical consultation program. It handles 200 inquiries a month from hospital and health professionals throughout North America and Western Europe.

To assure that our conclusions and perspectives rest on a broad base of judgment and experience, we have developed editorial review and technical advisory boards which involve hundreds of physicians. nurses, hospital administrators, allied health professionals and engineers, and related professional societies. Our programs thus represent, in a sense, the collective intelligence of the health community.

To disseminate information, we publish Health Devices, a monthly journal which accepts no advertising or other industry support. It provides:

(1) Comparative evaluations of brand-named equipment which examine the safety, performance, reliability, and cost-effectiveness of various models.

(2) Hazard reports on medical devices by brand name and model number with specific recommendations for corrective action.

(3) Inspection and preventive maintenance procedures and documentation forms to assure adequate levels of safety and performance in medical equipment.

(4) Technical guidance on safe and effective use of health care technology.

To obtain information on the incidence and characteristics of adverse effects associated with medical devices, we operate an international hazard reporting network involving over 1,700 health care facilities and medical and surgical professional organizations such as the American Society of Internal Medicine. We mail many thousands of questionnaires to health professionals to gain the benefit of their experience. We also continually search the medical, engineering, and legal literature.

We investigate each hazard report in detail; sometimes by field studies at the site of the original problem, often by recreating the conditions in our laboratories. We communicate with the manufacturer, evolve a solution, and quickly publish the results. We provide, at the same time, specific action recommendations for correction of these problems since few things are more frustrating or useless than being presented with a statement that an essential medical tool is dangerous without being given a practical solution and alternative.

I would like to emphasize that our experience is limited to external medical devices, not implanted ones of the type we have heard so much about this morning. All of my remarks thus, apply only to such external devices. They may contact the patient or even have short-term invasive characteristics, as with blood pressure catheters, but they are a very different problem than long-term implants.

We have examined and tested, in detail, 30,000 medical devices in the past 5 years. Our organization has been directly responsible for bringing over 100 hazardous devices to broader attention and has been directly responsible for removal of at least 25 of these from the marketplace and the correction and modifications of dozens of others.

In only three cases has it been necessary to ask the assistance of the Food and Drug Administration because the manufacturer refused to take voluntary corrective action. The vast majority of medical device manufacturers have not only cooperated but, in general, have quickly acted in a technically and morally appropriate manner to correct deficiencies.

Furthermore, a number of manufacturers who have, themselves, discovered problems with their devices have not only volunteered information but asked our help in bringing both hazard and solution to broader attention. It is our experience that most medical device manufacturers perceive that candor, openness, and immediate action to elim