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PROPOSALS ON REGULATION

After dealing with multitudes of IUD related complications, after spending hundreds of hours over a period of many months gathering information on IUD research, promotion, and control, and after considerable thought into all areas of the problem, I am prepared to submit the following recommendations. I feel that other testimony and research made available to the committee will further justify my recommendations.

1. I propose that the Food and Drug Administration be requested. to take immediate action to recall the Majzlin Spring from doctors, distributers, and from Anka Research, Ltd., of Jamaica, New York. Appropriate warning notices should be distributed through the mail and media so that individual physicians will be warned to discontinue its usc. The Food and Drug Administration should also be directed to classify the Majzlin Spring in the category of an experimental "drug" with questioned safety for use in patients and subject to use only under strict Food and Drug Administration supervision and guidelines.

2. I propose that the Food and Drug Administration be directed to recall the LEM IUD produced and distributed by the Searle Laboratories division of G. D. Searle and Company of Chicago, Illinois. The LEM should be classified by the Food and Drug Administration

in the category of an experimental "drug," and its return to

open medical useage should only be permitted after Searle Laboratories

has, on the basis of rigidly controlled studies, documented the LEM to show not only adequate efficacy but acceptable limits of safety.

3. I propose that any future IUD or any IUD now being tested. but not currently marketed be classified in the category of an experimental "drug." The future marketing of any such device should only be permitted after the developer or promoter has, on the basis of rigidly controlled studies, documented that the device has shown not only adequate efficacy but acceptable limits of safety.

4. I propose that the Food and Drug Administration be directed to bring under regulation the IUDS currently having wide distribution and usage such as the Dalkon Shield, the Lippes Loop, the Saf-T-Coil. While these devices should be recognized as legitimate contraceptive aids, 211 aspects of their testing, manufacture, advertising, and usage should be open to Food and Drug Administration evaluation and control.

5. I propose that the Food and Drug Administration be directed to require the A. H. Robins Company, Julius Schmid Pharmaceuticals, and Ortho Pharmaceutical Corporation to cooperate in the funding of large scale, long-term, and controlled studies to determine the actual efficacy, total complications, and actual effective costs of contraception with their respective IUDs. These studies should be done on the basis of informed patient consent and should evaluate the following:

â.

Pregnancy, expulsion, and medical removal rates.

b. Complications requiring surgical intervention and a tabulation

of the actual surgical procedures by type, length of hospital stay, cost, and associated blood replacement or antibiotic use.

c. Complications requiring x-ray in the process of diagnosing the nature of the complication or in effecting its cure, and a tabulation of the number of x-ray procedures involved.

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d. The actual incidence of IUD-induced pain, either insertional or continuation, as indicated by the patient's need for insertional or removal premedication or pain medication for continued dysmenorrhea or by the patient's own claim of IUD related pain.

c. Hematologic studies to include pre-insertional and postinsertional measurements at appropriate intervals. These studies should include hemaglobin/hematocrit and white blood count determinations and serum iron and iron binding capacities.

f. The indicated or actual patient usage of iron supplements should be tabulated.

g.

Pre-insertional and périodic Pap smears should be done.

h. Evaluation of purported IUD-associated pelvic infections of whatever severity with appropriate bacteriological studies and a tabulation of antibiotics, hospitalization, or other treatment of such infections.

6.

I propose that the Federal Trade Commission in cooperation with the Food and Drug Administration be directed to evaluate all current and future IUD advertising or promotional material. The Federal Trade Commission should be directed to take action to cause correction of current misleading, false, or conjectural IUD advertising or

promotional material, and to require that all advertising or promotional material give a fair representation of actual IUD efficacy and the generally accepted occurrence rates for IUD complications of whatever severity. If necessary, the Federal Trade Commission should be directed to force drug companies to place corrected advertising when their present or recent advertising or promotional material is shown to have been misleading, false, or in conflict with generally accepted standards of truth in advertising.

[From the National Observer, Sept. 8, 1973]

THE IUD's UNNATURAL BIRTH

CRITICS ASSAIL CLAIMS FOR 'SAFE, SURE' BIRTH-CONTROL DEVICE

(By Barbara J. Katz)

Rita George, a 28-year-old San Francisco legal secretary, had no qualms when the gynecologist she consulted about birth control suggested an intrauterine device (IUD). Now the fastest-growing form of contraception in America, IUDs are small devices, usually made of plastic, that prevent pregnancy when placed in the uterus.

Nor did Ms. George suspect anything, she says, when the doctor-a faculty member at a well-known California medical school-said that many of his patients were quite happy with a new IUD that he, by coincidence, had helped develop. At his suggestion, Ms. George consented to wear his IUD, a fluid-filled, triangular plastic bag.

Three weeks later, Ms. George relates indignantly, she discovered that she was unknowingly taking part in a study, that the device-which was causing her a great deal of bleeding and pain-had not been approved by any medical authority or governmental body, and that it was not being publicly marketed. “I was a guinea pig-no more, no less," she recalls incredulously. She hurriedly quit the study and has since sued the doctor for malpractice.

REGULATION ALMOST NONEXISTENT

Ms. George's experience is probably not unique. For while more than three million American women wear IUDs, and possibly three million others once wore them, IUDs remain almost totally outside the realm of government regulation.

Only a few states have any regulatory say at all over IUDs. And while the U.S. Food and Drug Administration (FDA) can recall adulterated or misbranded IUDs, it has moved slowly in this area. The FDA, moreover, has no authority to review manufacturers' premarketing claims.

"Anyone-it doesn't even have to be a doctor-can go down to his basement, get a few hairpins, stick them together, and call it an IUD," says Joseph Mamana, chief of the compliance section of FDA's Office of Medical Devices. "There's nothing we can do about it until someone is injured or dies."

Legislation to give the Federal Government premarketing authority over IUDs and other medical devices has been introduced in every Congress since 1962; every bill has died in committee. As a result of this lack of regulation, a National Observer investigation has revealed, many IUDs have been promoted, sold, and inserted on the basis of studies that can only be called inadequate: shortterm, involving small numbers of patients, statistically and methodologically sus pect, and often based on the experience of only one investigator.

IN 10 YEARS, ONE RECALL

While each new IUD has been touted as an improvement over its predecessors, most have failed to live up to their claims and have been quietly removed from the market after a few months or years. Of the dozens of IUDs brought out in the past 10 years, the FDA has recalled only one, the Majzlin Spring, and then only after reports of serious complications had been appearing in the medical literature for three years. (The FDA recently classified the few new IUDs bearing heavy metals or drugs as "drugs," thereby subjecting them to premarket clearance.)

Dr. John Madry, Jr., a Melbourne, Fla., gynecologist, attacked this state of affairs at hearings held by the House Intergovernmental Relations Subcommittee of the Government Operations Committee in May and June: "American physicians in private practice appear to have unwittingly become participants in a great experiment in population control," he testified. "Yet neither physicians nor patients have been provided sufficient facts by researchers or manufacturers to allow for any IUD to have been inserted on the basis of informed advice by the physician or informed consent by the patient."

Other physicians testified that more regulation is needed, but cautioned against condemning all IUDs. Representatives of the Population Council, a

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