Subject: Contraceptive Labels to Cite Inability To Stop Sexually Transmitted Diseases 
Date: Published: 4/9/93 (75 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology & Health:
    Contraceptive Labels to Cite Inability
    To Stop Sexually Transmitted Diseases
    ----
    By Rose Gutfeld
    Staff Reporter of The Wall Street Journal

    WASHINGTON -- The Food and Drug Administration, fearful that many
 young people confuse birth control and safe sex, will require labels
 on birth-control pills and certain other contraceptives stating that
 the products don't protect against such sexually transmitted
 diseases as AIDS.  
    The labels, which will begin appearing in about six months,
 reflect increasing concern by FDA Commissioner David Kessler and
 others that many young people mistakenly believe that contraceptives
 such as the pill guard against AIDS as well as pregnancy.  The new
 action was spurred in part by a recent phone call to FDA officials
 by a counselor in San Francisco who told of a girl who died of AIDS,
 never realizing the birth-control pills she had been taking weren't
 protecting her against the disease.
    "That story made such an impact on us," Ruth Merkatz, special
 assistant to the commissioner for women's health, says in an
 interview.  "We recognized we had to do something."
    Dr. Kessler says, "We have to recognize that as we educate about
 pregnancy, teenagers also need to know that avoiding pregnancy isn't
 avoiding sexually transmitting diseases."
    In addition to the HIV infection that can cause AIDS, such
 diseases as chlamydia, genital herpes, genital warts, gonorrhea,
 hepatitis B, syphilis and others can be spread through sexual
 contact.
    The FDA's action follows the recent release of a study by a
 nonprofit group, the Alan Guttmacher Institute, that criticized
 federal efforts to attack sexually transmitted diseases.  Among other
 complaints, the group said that while the government does work at
 controlling the spread of the diseases, it doesn't focus
 sufficiently on helping individuals prevent infections in the first
 place.
    All contraceptives will be required to have a statement about
 sexually transmitted diseases on the package.  Similar information
 will be contained in leaflets physicians distribute with the
 products.
    The required information will vary depending on the product.  Oral
 contraceptives, injectable devices such as Upjohn Co. 's Depo
 Provera, implantable contraceptives such as American Home Product
 Corp. 's Norplant, natural skin condoms and intrauterine devices will
 have to say that the products are designed to prevent pregnancy but
 don't prevent HIV infection and other diseases.
    The labeling requirements may ease some opposition to efforts by
 some birthcontrol advocacy groups to make oral contraceptives
 available over the counter.  Among other objections, opponents of
 making the pills nonprescription have argued that requiring women to
 visit physicians ensures that they get needed counseling, including
 information on how to avoid getting AIDS.  
    Such a change would require FDA approval, however, and Dr. 
 Kessler emphasized that the labeling requirements "have nothing to
 do" with the issue of whether to allow the pills to be sold over the
 counter.
    Labeling on natural skin condoms also will state that consumers
 should use latex condoms rather than natural skin condoms to reduce
 the risk of sexually transmitted diseases.  Latex condom labeling
 will be able to say that the products, if used properly, reduce the
 risk of HIV infection and other diseases.  Latex condoms are the only
 product allowed to make such a claim.
    The FDA still is considering what action to take regarding the
 labeling of spermicides, cervical caps, diaphragms and American Home
 Products' Today brand contraceptive sponge.

[This article is made available here by Dow Jones Co. for the
 personal and non-commercial use of callers to this bbs, in the
 hope that it will be of some help to those who are suffering
 from the disease and others who are seeking to help them.]