Senator KENNEDY. Our next witness this morning is Russell J. Thomsen, M.D. Dr. Thomsen is presently practicing obstetrics and gynecology at the Silas B. Hayes Army Hospital in Fort Ord, Calif. He was a physician at the Salt Lake City Family Planning Clinic, and prior to that, practiced obstetrics and gynecology at the U.S. Army Hospital at Fort Polk, La. He is presently a major in the Army Medical Corps.

Dr. Thomsen, welcome to the Health Subcommittee. I know you have testified previously before Congressman Fountain on these matters, and I look forward to receiving your testimony.

STATEMENT OF RUSSEL J. THOMSEN, M.D., SILAS B. HAYES ARMY HOSPITAL, FORT ORD, CALIF.

Dr. THOMSEN. Senator Kennedy, to you and the other respected Senators and staff members of the Senate Subcommittee on Health, I would like to take this opportunity to express thanks for the privilege of testifying today. While working for the past year in effecting a recognition for the need of regulations to govern the testing, manufacture, and usage of intrauterine contraceptive devices, I have become acutely aware of the failure of otherwise responsible Federal agencies to protect American women in this one part of the medical device industry.

Among other reasons for this lack of Food and Drug Administration surveillance has been the absence of specifically legislated regulatory power. The consequences of this major oversight are well demonstrated in the multimillion-dollar IUD industry.

I wish to first point out that the nature of the complications which can be caused by IUD's and the general magnitude of these complications were made matters of public record during recent hearings in May and June 1973 by the House Intergovernmental Relations Subcommittee chaired by Representative L. H. Fountain. I am sure that as the staff of the Senate Subcommittee on Health has reviewed my testimony and that of others before the Fountain committee, it has become fully aware of the complications of pain, bleeding, pregnancy with miscarriage, ectopic pregnancy, pelvic infection, uterine perforation, and even death, which can occasionally occur to otherwise healthy women using IUD's for contraception. To further elaborate on these potential IUD complications would seem redundant to the work of this committee.

However, if the magnitude of the problem is not fully understood or if that magnitude is still doubted, it seems appropriate to bring to your attention preliminary findings of a survey of major IUD complications during the first 6 months of 1973.

The study, coordinated through the Family Planning Evaluation Branch of the Federal Government's Center for Disease Control, is polling the experiences of physicians who would have reason to use IUD's in their practice of medicine. As reported in the August 20, 1973, American Medical Association News ("AMA Seeking Data on IUD's," page 20), physicians had returned "more than 8,000 questionnaires," which "showed three deaths and almost 2,000 hospitalized cases." And it must be remembered that these 8,000 responses represent

less than one-third of the physicians polled. And the three deaths and 2,000 serious IUD complications relate only to a portion of major IUD complications occurring in just the first 6 months of 1973.

These figures-regardless of how preliminary they might be-challenge this committee with the evidence of a literal epidemic of major IUD complications. It is doubtful that any responsible agency of Government can allow to remain unregulated a medical product which can cause the serious illness, hospitalization, surgical intervention, or occasional death of thousands of young and otherwise healthy American women each year.

Compelling by implication or by actual occurrence is what can occur when a medical device such as the IUD is unregulated. A few examples should suffice to validate this point.

Under current standards of nonregulation in the United States, I could take a paper clip and fashion it into an IUD. I could then begin inserting it into women without even informing them that it is an experimental and never-tested IUD. And I would not even have to inform the FDA of my newly invented IUD. I would be under no obligation to perform controlled testing of the device. No one would be responsible to check my claims for the device either claims in patient brochures or advertisements. No laws would require me to report to either the medical profession or to the FDA the notices I had received of patient injury or death caused by the IUD.

This raises the more disturbing spector of questionable research in IUD development. "Research" of a new IUD is at times limited to a small group of women, and is carried on by the inventer or promoter of that new device.

After only a few months of observation, misleading statistics are projected. These statistics are used to advertise the new device. The new IUD is then thrown on the market as if it had been thoroughly evaluated. In fact, on a realistic basis, it is the average American user of an IUD who is really the woman who is unknowingly testing the device. For it is the complication which she has which eventually might be reported in a medical journal and thereby give warning to physicians using that same device.

The life cycle of an IUD is completed when it either gains general acceptability or loses so much support because of its complication rate that physicians stop inserting it-without having been warned by either the manufacturer or the FDA.

It might be argued that in this era of enlightened consumerism when both consumers and manufacturers are fully alerted to both ethical responsibilities and the realities of product liability laws, IUD inventors, and manufacturers would feel compelled to regulate themselves on a high level consistent with good medical practice. That appears to be but an illusionary assumption.

For example, when the FDA finally moved to recall the Majzlin Spring IUD in May of 1973, the files of its manufacturer contained over 70 letters of complaint and dissatisfaction with the device.

The manufacturer, Anka Research, had never bothered itself to alert the FDA or the medical profession of these letters despite knowledge by the company that disasters were occurring because of the Majzlin Spring.

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But the Majzlin Spring was manufactured on a relatively small-time basis. What about the obligations felt by major drug companies to alert the FDA and the medical profession of complications reported to them about their IUD's-obligations which would be binding by law if the IUD were controled like ethical drugs?

On June 12, 1973, in testimony before the House of Representatives Intergovernmental Relations Subcommittee, a representative of the A. H. Robbins Co., admitted that the company's files contained over 400 "unfavorable reports" against the Dalkon Shield as conveyed to the company by physicians and other persons.

None of these "unfavorable reports"-including 75 instances of uterine perforation, 28 ectopic pregnancies, and at least one death, associated with the Dalkon Shield had been voluntarily reported by A. H. Robins to the Food and Drug Administration.

And, it is more than reasonable to assume that the files of the manufacturers of the Lippes Loop and the Saf-T-Coil also contain hundreds of reports of complaints-from minor problems to fatal disasters-which were never volunteered to the FDA or the medical profession for review.

Within the vacuum of nonregulation of IUD's there has developed a vast difference between what IUD promoters and manufacturers assert through their glossy advertising and what the true facts are. This is simply because no regulatory agency is obligated to read and evaluate IUD advertising. A few examples will show what this oversight has allowed to happen.

An early patient instruction sheet for the users of Saf-T-Coil IUD, Julius Schmid Pharmaceuticals proclaimed to prospective women consumers of the device that "You have been fitted the very latest development in a method of family planning that has been in use for over 40 years. More than 1 million women throughout the world have used this method successfully."

Yet, in its May 1966, advertising of the Saf-T-Coil to physicians, the same company could not even come up with one study to confirm its exhilarated claims for the product. In fact the Saf-T-Coil was on the open market with full advertising for 2 years before the first small study regarding it was published-and not by the company.

But if Julius Schmid's efforts appear forgivable because of some frantic effort to get a product on the market in the early days of the industry, consideration should be given to the same company's advertising tactics in 1972. "What the Well-protected Nullipara Will Be Wearing in 1972: the New Saf-T-Coil Nullip," asserted a Julius Schmid advertisement. Again, no published study could be quoted by the company to back up the claims for its product.

And, in August 1973, in ads currently being run, that same company had the audacity to advertise its Nullip Saf-T-Coil as having a zero pregnancy rate, a continuation rate of 91.2 percent, and "no patient discomfort" on the basis of a preliminary study of 273 women who had the device for an average of only 3 months each.

Senator KENNEDY. In the earlier part of this hearing we found out, that if the labeling is inappropriate, the FDA has the present power to regulate in this area. Why have they not moved?

Dr. THOMSEN. I am not sure why this has not been done. Dr. Edwards' statement regarding "dear doctor" letters that the FDA has

required drug manufacturers to send out related to drugs should not be confused to mean that the FDA has been requiring device manufacturers to send out "dear doctor" letters.

As far as I know, relating to IUD's, regardless of action taken by FDA, minimal as it has been, there has been no request by the FDA to industry to send out "dear doctor" letters. That only relates to drugs which are not being considered this morning. I think that is a general misleading statement.

Senator KENNEDY. The kind of example you have given here, they have the power and the present law to move ahead?

Dr. THOMSEN. Yes; I believe they do. I believe the Fountain Committee expressed it well that this power already exists and has for some time, but has not been used.

I cannot comment on really why it has not been used aggressively. Senator KENNEDY. Why do you think this is so? Is it because the women who are adversely affected are not bringing pressure? Do you have any feel for this at all?

Dr. THOMSEN. I have the feeling that people in the FDA certainly want to move responsibility and also use a certain degree of caution and responsibility. Certainly, I as a physician use the IUD and I consider it a responsible medical device used appropriately and when it has been proven. I am sure that an open action by the FDA has been felt at times by them to be the type of action which might cause unwarranted precedents or unwarranted concern on the part of patients and manufacturers, I suppose. However, in a number of cases where there has been overwhelming proof that action should be taken, this action has certainly been delayed or slow in coming about.

I will say that the FDA is certainly moving in the IUD field now at a very rapid pace. Of course this is since Representative Fountain's hearings. I cannot explain exactly why specific action has not been taken in examples which are well known in the industry and to the FDA and in the profession.

If this demonstration of the hucksteristic advertising of the Saf-TCoil by Julius Schmid might tend to puff up that company's rivals, I would hasten to point out that many other IUD's-including the Dalkon Shield Nullip made by the A. H. Robbins Co., and the LEM made by G. D. Searle-were marketed with an equal lack of both testing and ethical candor.

In addition, an advertisement for the Dalkon Shield points out well how a lack of regulation of the industry permits audacious claims to come forth from the potpourri of profit-sharing optimism and failure to spend money for research.

The particular Dalkon Shield advertisement I am referencing was a nine-page, full-color effort which ran in medical journals in 1972. If anyone wants to calculate the cost of nine pages of full color advertising in national medical journals. it gives an idea of the type of promotion behind these devices.

This ad is magnanimously entitled, "The IUD That's Changing Current Thinking About Contraceptives." Now, anybody who knows anything about IUD's knows that they make most women lose more than their usual amount of menstrual blood. And anybody who claims differently should be able to back up that claim. In this particular ad,

it was claimed that because the Dalkon Shield "bends and gives with uterine contractions" it "lessens *** bleeding."

Now here is a company which sold over $6 million worth of Dalkon Shields in 2 years' time in the United States alone-in addition to marketing that device in 41 foreign countries-making a rather startling advertising claim that its product "lessens *** bleeding."

What is the proof? Had the A. H. Robbins Co. made pre and postinsertional blood counts on even one patient? No. "The patient estimates to degree of blood loss," admitted a Robbins' official before a recent congressional hearing.

Given the aura of nonregulation, IUD advertising to the medical profession has often been little less than scandalous.

Senator KENNEDY. Why do reputable medical journals accept advertising for products which have not been tested? Do they not have a professional responsibility to be sure of the quality of advertisements that they run?

Dr. THOMSEN. This is a very good question, and it is one which I have long pondered. In fact, it is one about which I have written to journals for answers, for which I have not received any reply. One might fairly ask that question.

I think that to understand the answer to that is to understand the enigma which is the medical journal industry. Medical magazines which serve as voices for the various medical specialties such as obstetrics and gynecology rely upon the advertising dollar of the drug industry for their very existence. This financial symbiosis is recognized by journal publishers such as Harper & Row, C. V. Mosby, or McGrawHill. That little financial fact is also well understood by the physicians serving as editors and consultants to such journals.

It is this financial obligation to the drug industry which will allow a medical journal to carry an article describing serious or even fatal complications of a particular IUD and also carry a full-color, misleading advertisement for the same IUD.

Senator KENNEDY. You are suggesting neither the physician, nor the patient, should really rely on the advertisements in the medical journals?

Dr. THOMSEN. That is true. Of course, the advertising for these devices per se is limited to medical journals. However, advertising can also be considered as such in the patient brochures which are also given out for doctors to give their patients by the companies. These are forms of advertising, of course, and I want to mention these right

now.

For instance, you will not find the IUD advertised in newspapers. But even the worst of those ads are innocuous compared to some of the patient brochures prepared for potential users of IUD's by the manufacturers or by family planning agencies. These pamphlets are often such an amalgam of promotion, overstatement, omissions, and even lies that the average women who reads such a pamphlet is in a poor position to give her informed consent for the insertion of an IUD.

While virtually ignoring the mention of serious side effects or complications of IUD's, patient brochures wander through a veritable forest of highly questionable assurances of which the following are typical.