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"It would be a great help if an

"But such figures prove nothing," he said. authoritative body would carry out a valid trial.”

Mr. FOGARTY. Look it over and give us an answer for the record. (The information requested follows:)

FOOD AND Drug AdministRATION STATEMENT ON JOURNAL-BULLETIN (PROVIDENCE, R.I.) ARTICLE ON ORAL CONTRACEPTIVE PILLS BY MORTON MINTZ

The articles by Mr. Morton Mintz, a reporter for the Washington Post, recently were published in the Journal-Bulletin (Providence, R.I.). They are on the subject of the oral contraceptive drugs and discuss the position of the Food and Drug Administration which has permitted these drugs to remain on the market. The articles contain a number of statements and quotations, all designed to imply that substantial dangers will result from the taking of these pills.

The oral contraceptive drugs consist of a combination of an estrogen and a progestogen in varying proportions and dosages, and were admitted to the U.S. market for contraceptive use in 1960. But it would be a mistake to consider that the therapeutic use of these compounds was only of relatively recent introduction; on the contrary, synthetic estrogens and one progestogen have been in clinical use since 1938, although some of the newer drugs in the oral contraceptives have been used only since the early 1950's.

These oral contraceptive drugs have been widely used in the United States and elsewhere in the world. The estimated number of users of such drugs in the United States has been as follows:

1961

1962.

1963

1964

1965__.

408, 000 1, 187, 000 2, 235, 000 3,950, 000 5, 000, 000

Yet, such widespread use has not led to gross public danger, as implied by Mr. Mintz.

Indeed, these combinations have also been used rather extensively for certain gynecological purposes; and, while there is not general agreement as to the rationale for such use, no unusual substantial hazards have been reported. The Bureau of Medicine has and is continuing to review this matter and has presented the subject to an Advisory Committee on Obstetrics and Gynecology. The oral contraceptive drugs produce certain side effects, although none of of these have been demonstrated to be of serious impact:

1. Nausea, sometimes with vomiting, is the most common side effect, though the incidence of this appears to be lower than reported in past years and generally clears after use of the drug following the first several cycles. 2. Headache may occur, especially with patients having migraine.

3. Certain psychological changes have been reported in some patients, but the small number of well-controlled studies in this field makes it impossible to arrive at a conclusive opinion on the matter.

The mechanism

4. The pill user's weight may either increase or decrease. of this weight gain is complex and is yet not clearly understood. Certain other systematic effects are seen:

1. The excretion of BSP (bromsulfthallin sodium) may be decreased during the taking of the oral contraceptives, as it is in late pregnancy. However, this abnormality in BSP excretion is reversible, transient, and indeed may disappear with the continued taking of the pill. There has been no conclusive evidence of liver injury in the normal human female without preexisting liver disease.

2. The oral contraceptive pills appear to produce changes in the blood clotting mechanism but the differences in the reports of different observers make it difficult to link these changes with thromboembolic disease.

3. Some authorities have found changes in carbohydrate metabolism, but there does not yet appear to be evidence that these changes produce diabetes. Indeed, evidence in birth control clinics is to the contrary.

4. Studies have indicated that functional changes are seen in certain endocrine glands during the taking of oral contraceptive drugs, but there has appeared no evidence that these changes are irreversible or produce damage to the woman.

There has been brought forward repeatedly the assertion that the taking of oral contraceptives will produce carcinoma of the cervix, body of the uterus, and the breast. Despite such claims, there still remains no conclusive evidence that this occurs in the human. With certain of these drugs and under certain conditions (such as an excessively high dosage and in certain species and strains of animals), cancer of the breast and other organs has been produced and is cause related; but similar evidence for the human female simply is lacking. There should also be kept in mind the fact that 1960 data from Vital Statistics in the United States show that death from cancer of the breast is the leading cause of death in the white female from age 40 through 49; consequently, it would not be surprising to find cases of breast cancer among oral contraceptive drug users.

Assertions have repeatedly been made that thromboembolic disease is related to the taking of oral contraceptive drugs. While the incidence of thrombophlebitis among all women in the childbearing age is not known with certainty, it is estimated from studies in the literature that from one to three women per thousand in this age group develop thrombophlebitis each year. Consequently, it is not surprising that thrombophlebitis is found in women taking oral contraceptive pills, just as this disease is found among the nonusers. It is not surprising that doctors report the occurrence of thrombophlebitis in women on the pill when one remembers that 5 million women are taking such pills and that the rate of this disease each year is from 1 to 3 per 1,000 women. Vital Statistics in the United States show that female deaths from thrombophlebitis have increased in the United States during the 1950-64 period but so, also, has the rate increased for the male in similar fashion.

Much the same can be said for the arterial thromboembolic diseases, such as cerebrovascular accidents. Here, the death rate for females in the United States from this cause has not significantly changed in the 1950-64 period. And it should be noted that death from stroke in the female of childbearing age is not an uncommon form of death. For instance in 1960-well before the oral contraceptives came into common use-stroke as a cause of death ranked fourth to sixth place among white females from age 25 to 39 and as first and second cause of death in nonwhite females of the same age group.

The Food and Drug Administration is continuing to evaluate the hazardsboth real and theoretical-and is interested in the continuing of research in this matter.

Many thousands of patients on these drugs have been studied in detail in birth control clinics and elsewhere and thousands continue to be studied under experimental conditions. The Agency's NDA files are filled with these reports. The funds expended in such research are very substantial. The 1 DA has studied and continues to study the medical literature, scientific reports, and adverse experiences which are funneled into the Bureau of Medicine. It has studied the report of the Wright committee, which it convened in 1963, and it has placed the matter of oral contraceptives before an Advisory Committee on Obstetrics and Gynecology which it convened in late 1965. It has noted the recent findings of the United Kingdom Committee on Drug Safety. In early 1965, when the United Kingdom Committee on Drug Safety began to study the matter of thromboembolic phenomena, the Medical Director of FDA assembled a group of experts from the National Institutes of Health, the President's Office of Science and Technology, the American Medical Association, industry, and the Bureau of Medicine of FDA to consider the possible relationship of the oral contraceptive drugs and cerebral vascular accidents. The report of this meeting was forwarded through channels to the Secretary of Health, Education, and Welfare.

The Food and Drug Administration is also sponsoring studies to evaluate the hazards of oral contraceptive drugs. The Subcommittee on Thromboembolism of the FDA Advisory Committee on Obstetrics and Gynecology presently is assisting the Medical Director with an initial pilot study of retrospective type for thromboembolic phenomena which should lead to a large retrospective study, and possibly to prospective studies, throughout the United States.

Consequently, the FDA is active in this field. While it realizes the need for continuing evaluation of the subject of oral contraceptive drugs, it concludes that the use of these products presently on the market is relatively safe when balanced off against the usefulness of these products.

The FDA continues to support the need for further studies on the oral contraceptives and indeed states that these drugs compare with the antibiotics and adrenocorticosteroids on the number of experimental studies which have already been carried out.

The FDA also realizes that there always will be differences of opinion among physicians in the use of any drug and promotes such scientific controversy on

drugs as desirable in the public interest. But in the same vein, the FDA asks for scientific proof and reasons to support opinions. While it remains aware of all the literature, including newspaper and magazine articles, the FDA must base its judgment on much stouter material.

NONPROPRIETARY OR GENERIC PRESCRIBING OF DRUGS

GAO REPORT ON PRESCRIBED DRUG COST FOR WELFARE RECIPIENTS

Mr. FOAGARTY. The Comptroller General issues his reports every now and then on what GAO finds in its auditing work.

Mr. Flood, this one talks about your great State of Pennsylvania. They made a study of Federal financial participation in the costs of prescribed drugs for welfare recipients in the State of Pennsylvania. Federal financial participation in public assistance programs administered by HEW.

They say:

A projection of the results of our examination of a random sample of prescription invoices paid by the State of Pennsylvania indicates that savings of from about $722,000 to as much as $1,502,000 could have been realized during fiscal year 1964 through maximum use of less expensive nonproprietary name drugs; the Federal share of such savings would amount to from about $354,000 to as much as $705,000.

Are those figures unreasonable? This is the Comptroller's report. Dr. GODDARD. I would not assume they are unreasonable.

are often marked differences in prices between drugs sold underMr. FOGARTY. They state:

There

The State welfare agency informed the Department in a letter dated Mary 24, 1965, that to ask physicians to prescribe generically would subject the public assistance recipients to the possibility of receiving second-class medical treatment. Is that so?

Dr. GODDARD. If this is aimed at the question of whether the drugs that are thus prescribed are second class, no.

ADMINISTRATION POLICY ON USE OF NONPROPRIETARY DRUGS

Mr. FOGARTY. The next paragraph says:

By letter dated September 10, 1965, the Assistant Secretary for Administration advised us that the Department of Health, Education, and Welfare did not fully agree with the State's observation.

Dr. GODDARD. I am not aware of the background.

Mr. CARDWELL. My recollection is that that report was at that point cleared with the Food and Drug Administration. I think it gave a comment to the Assistant Secretary.

Mr. FOGARTY. Near the end of the cover letter signed by Acting Comptroller Weitzel, it states:

In December 1965, subsequent to commenting on our findings, the Department of HEW issued a directive which enunciates as the Department's policy that nonproprietary or generic name drugs should be used by constituent operating agencies and grantees whenever it is practicable and economical.

That is the policy of the administration?
Dr. GODDARD. Yes.

STATE OF PENNSYLVANIA POSITION

Mr. FOGARTY. The thing that the State of Pennsylvania itself.

ON

NONPROPRIETARY

DRUGS

really got me was a statement by They were asked to comment of

these proposals. The one I just could not understand was this, on page 18:

The State welfare agency informed the Department in a letter dated May 24, 1965, concerning our proposal, that to ask physicians to prescribe generically would subject the public assistance recipients to the possibility of receiving second-class medical treatment. The State indicated that the majority of physicians do not prescribe generically because the newer drugs have been developed since they received their educations and it is unrealistic to expect the physicians to keep up with the newer drugs without relying on the drug companies.

If this is anywhere near what is going on, this is a terrible situation, if we have salesmen for drug companies going to the physicians' offices and telling them what kinds of pills and drugs are to be used. That is the inference I get from this.

We shall put the entire report in the record.

CONTINUING EDUCATION OF PHYSICIANS ON DRUGS

Mr. FOGARTY. Do you want to comment on that?

Dr. GODDARD. There is a proper place, I believe, for the detail man employed by the pharmaceutical manufacturer to present information to the practicing physician, but in my experience as a practicing physician this was not the only channel or means by which I obtained information on new drugs. The journals, scientific meetings I attended, all were part of the process.

As the Commissioner of the Food and Drug Administration, it is my hope that in the years ahead we can provide some way of communication with the practicing physician, also, so that we can assist, along with the medical associations and others involved in physician education, about drugs. I don't believe this should be the only way nor, in fact, do I believe it is the only way they obtain information today. Mr. FOGARTY. This is a terrible indictment, though, if it is true.

OVERLAPPING INTEREST OF PHYSICIANS IN PHARMACEUTICAL BUSINESS

Mr. DUNCAN. Is there a problem of overlapping interest in the medical practice in the pharmaceutical business? I refer to clinics and doctors who are proprietors of pharmacies.

Dr. GODDARD. This is known to be of concern and I believe the code of ethics speaks to this point.

The difficulty one may get into, carrying it by extension, should physicians own stock in pharmaceutical companies?

I don't believe an individual logically would be expected to have his prescription writing influenced by possession of stock, but I cannot say that it would not happen.

The more difficult problem is the one where a physician may have an ownership or part ownership of a pharmacy in that clinic or in that community, and it is my understanding that this is not construed to be ethical under today's terms of practice.

TEXT OF GAO REPORT

COMPTROLLER GENERAL OF THE UNITED STATES,

Washington, D.C., February 3, 1966.

To the President of the Senate and the Speaker of the House of Representatives: Herewith is a report on our review of Federal financial participation in the costs of prescribed drugs for welfare recipients in the State of Pennsylvania.

Federal financial participation in public assistance programs is administered by the Welfare Administration, Department of Health, Education, and Welfare. On the basis of our review of expenditures made by the Pennsylvania Department of Public Welfare for prescribed drugs for welfare recipients in the State of Pennsylvania, we believe that such expenditures can be reduced through the increased use of less expensive nonproprietary (generic) name drugs, with savings accruing to both the Federal Government and the State of Pennsylvania, without adversely affecting the accomplishment of the objectives of the federally aided public assistance programs. We believe that, to avial itself of these economies, the Department should make further effort to have the States encourage physicians and pharmacists to use more extensively the less expensive nonproprietary name drugs whenever appropriate in lieu of comparable brand name drugs or the more expensive nonproprietary name drugs.

A projection of the results of our examination of a random sample of prescription invoices paid by the State of Pennsylvania indicates that savings of from about $722,000 to as much as $1,502,000 could have been realized during fiscal year 1964 through maximum use of less expensive nonproprietary name drugs; the Federal share of such savings would amount to from about $354,000 to as much as $705,000.

We proposed to the Secretary of Health, Education, and Welfare that steps be taken to bring about greater emphasis by the State of Pennsylvania aimed at the increased use of nonproprietary drugs in prescriptions for welfare recipients. In commenting on our proposal, the State welfare agency informed the Department in a letter dated May 24, 1965, that to ask physicians to prescribe generically would subject the public assistance recipients to the possibility of receiving second-class medical treatment.

By letter dated September 10, 1965, the Assistant Secretary for Administration advised us that the Department of Health, Education, and Welfare did not fully agree with the State's observation. The Assistant Secretary stated the belief that more could be done to reduce the costs of prescribed drugs provided welfare recipients in Pennsylvania. He advised us that, under authority contained in title XIX of the Social Security Act, which was enacted July 30, 1965, requirements would be developed by the Department to increase the use of medical advisory committees by the States in medical care program administration including as a high-priority objective the increased use of nonproprietary drugs in State welfare programs.

In the past, the Department has distributed to the States a pamphlet prepared by the Bureau of Family Services, Welfare Administration, and a document issued jointly by the American Public Welfare Association and the American Medical Association, which suggest guidelines that may be used by States and physicians when considering the use of nonproprietary drugs in prescriptions for welfare recipients. However, these publications are not part of the official regulations issued by the Department. The Department uses a manual entitled "Handbook of Public Assistance Administration" as an official means of providing States with guidelines and recommendations for the proper and efficient administration of public assistance programs. In our opinion, the inclusion in the handbook of a provision specifically recommending that States encourage physicians to consider the increased use of nonproprietary name drugs for welfare recipients would be conducive to effecting additional savings in the cost of drugs for welfare recipients.

Significant amounts of Federal funds are involved in public assistance payments for prescribed drugs in all States, and the possibility exists that the conditions disclosed in our review in Pennsylvania may also be present in other States. New and expanded legislation that authorizes increased Federal participation in medical care benefits to needy people accentuates the importance of effecting economies in the purchase of prescribed drugs under federally aided public assistance programs.

In December 1965, subsequent to commenting on our findings, the Department of Health, Education, and Welfare issued a directive which enunciates as the Department's policy that nonproprietary or generic name drugs should be used both by constituent operating agencies and grantees whenever it is practicable and economical. We are recommending that, in implementing the Department's enunciated policy, the Commissioner, Welfare Administration, issue a policy specifically recommending that State agencies administering federally aided public assistance programs adopt policies and procedures designed to encourage physicians to prescribe, and pharmacists to dispense, for the use of welfare re

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