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    690823

    Dr. Ley says birth pill users must have more information. Urges full data for pill's users.

    Cohn V

    Washington Post. 1969 Dec 22; A1, A10.

    Dr. Herbert L. Ley, Jr., until three weeks ago, Food and Drug Administration Commissioner, said yesterday the government must consider action to see that the 8.5 million American women taking birth control pills get "much greater information" on their possible ill effects. This could mean giving women several hundreds of words of information on how the pill may cause blood clots, strokes and skin discoloration, and how they may be involved in liver, thyroid, urinary and vaginal problems; changes in pituitary, ovarian and other hormone functions; eye trouble; depression and suicidal urges. He said: "Speaking as a private citizen and as a concerned physician, I feel a need for greater information for the patient. Also, Ley said, his new feeling "is the crystallization of some thinking for a long period of time" about "the whole category of drugs to prevent something, given to healthy people" compounds like birth control pills, anticholesterol drugs and preventive vaccines, all of which sometimes have undesirable effects". "I think the patient has to be involved and involved very deeply in information on this new category of drugs. I think he needs to be involved in the decision on when to use them". Here, he said, he has been impressed by some arguments in a recent book, "The Doctors' Case Against the Pill" by Barbara Seaman, and its case for a patients' package insert explaining the pill's advantages and disadvantages. An announcement by Sen. Gaylord Nelson (D-Wis.) said that on Jan. 14 his Senate Monopoly Subcommittee will begin hearings to learn whether women "are being adequately informed of the pills' known hazards". "It appears evident," Nelson charges, "that a substantial number are not advised of any of the health hazards or side effects". For his part, Ley said he still stands by the September finding of an FDA advisory committee that the pill is "safe" as defined by law, and that the pills' "significant" benefits outweigh their risks. "That was a highly dependable report", he said yesterday, but "it's dated, as any report is", and "we absolutely have to look now at any new British data. Until I see hard data, however, I'm hard pressed to draw different conclusions. I may wish to revise my opinion as a private physician after I see the British data but not until".(AUTHOR'S MODIFIED)
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