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Women tell of dangers of cosmetic treatment

Pharmaceutical companies are pushing drugs and injections to erase wrinkles and for other unapproved uses that may leave people sick and disfigured, a House panel was told Tuesday. A House Government Operations subcommittee heard emotional testimony from several women who said they suffered severe adverse reactions and illness from cosmetic treatments intended to make them look better.

The subcommittee on human resources focused on the use of three products _ Retin A, collagen and liquid silicone _ that Rep. Ted Weiss, D-N.Y., said are among hundreds of drugs and medical devices that have been promoted for unapproved purposes.

Weiss, who heads the subcommittee, said widespread use of the three products "has resulted from illegal and improper promotion" and has led to life-threatening diseases and disfigurement.

"While these risks may be acceptable if we are treating life-threatening diseases like AIDS or cancer, it is much harder to justify those risks if the potential benefits are cosmetic," he said.

It is illegal for manufacturers to promote drugs for purposes other than those the Food and Drug Administration (FDA) has approved for the label. However, doctors can use drugs for purposes beyond those on the label.

FDA Commissioner David Kessler told the subcommittee he was moving to crack down on the marketing of unapproved drug uses, such as promotional material disguised as medical literature.

Kessler said:

Retin A is approved for treating acne but not for preventing wrinkles. The FDA is concerned that chronic use of Retin A "could potentially increase the risk of skin cancer."

Collagen has been approved for certain cosmetic purposes, such as treating acne scars, but has been marketed for unapproved uses such as lip augmentation. Collagen Corp. has agreed to stop promoting this unapproved use.

Liquid silicone injections, which are used to remove wrinkles and other facial deformities, have not been approved for any use.

Kessler refused to discuss pending enforcement efforts. However, a spokesman for Johnson & Johnson confirmed that the Justice Department was investigating the alleged promotion of Retin A for unapproved uses. Retin A is marketed by Ortho Pharmaceuticals, a subsidiary of Johnson & Johnson.

"We believe that our dissemination of information about research in sun-damaged skin was proper and ensured that balanced, medically accurate information was made available to meet broad scientific, medical and public interest," a company spokesman said.

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