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FDA to Release Implant Safety Documents

February 4, 1992

WASHINGTON (AP) _ The Food and Drug Administration will release internal Dow Corning Corp. documents that raise questions about whether the company knew of safety problems with silicone gel implants before selling them.

In a court pleading filed on its behalf Monday by the Justice Department, the FDA accused Dow Corning of foot-dragging on its promise to release the 74 internal documents.

″The public’s health and safety interests should not be made to wait until it is convenient for Dow Corning to release these documents,″ the FDA’s pleading said.

The agency said it planned to release the 74 documents, many of which have already been the subject of news stories, on Friday.

While Dow Corning said last week that it would release the documents after Feb. 10, the FDA’s pleading said that the company had reneged on an earlier public commitment to release the material by Jan. 27.

″In light of Dow Corning’s past actions, we cannot be certain that it will adhere to this new commitment,″ said the FDA. ″Dow Corning’s public relations objectives should not be permitted to further block dissemination of documents which bear on the public health and safety and which are directly relevant to immediately public deliberations on these implants.″

--- Report: India Improving, U.S. Backsliding in Population Effort

WASHINGTON (AP) - India and four other countries have slowed population growth, but the United States has ″abdicated″ its global leadership role in family planning, a private group says.

While mothers in many developing countries are having fewer children, America is in the midst of a ″baby boomlet,″ according to the Population Crisis Committee’s annual report on population winners and losers.

India, Thailand, Colombia, Morocco and Kenya were praised for their control efforts in the report issued Monday.

Panned were the United States, the Philippines, Saudi Arabia, Malawi and Haiti. They ″all represent tragic examples of failed political leadership,″ said the report.

--- FDA Warns Against Cosmetic Silicone Injections

WASHINGTON (AP) - The Food and Drug Administration has warned two doctors to stop giving patients liquid silicone injections.

The letters to Dr. Norman Orentreich of New York City and Dr. Ricardo Samitier-Cardet of Miami were the result of an FDA investigation between July and September of last year, agency spokeswoman Susan Cruzan said Monday.

Liquid silicone is sometimes given to smooth wrinkles or create pouty lips, but is not approved by the FDA for those uses.

The letters, dated Nov. 12, 1991, warned the doctors that the agency could take legal action against them if they did not stop giving the injections.

David Kessler, the FDA commissioner, has testified before Congress that medical literature alleges the liquid silicone causes swelling or lumpiness in the skin and has been associated with soft-tissue tumors.

The FDA is investigating whether breast implants filled with silicone gel pose a health risk. At the FDA’s request, sales of the implants have been suspended in the United States while the agency examines new information on their safety.

--- Neem Tree Has Powers That Should Be Studied, Report Says

WASHINGTON (AP) - The National Research Council says the neem tree has such seemingly magical powers it deserves careful scientific scrutiny.

Its leaves can make a pain-killing drugs and skin ointments. Its twigs are decay-preventing toothbrushes. And its seeds can be used to make environment- friendly insecticides.

Moreover, an extract may work as a contraceptive and oil from its seeds has antifungal and antiseptic properties and can be used in soaps and cosmetics.

No wonder researchers call it a ″wonder plant.″

A study released Monday by the National Research Council said, ″If neem lives up to its early promise, it will help to control many of the world’s pests and diseases, as well as reduce erosion, desertification, deforestation and perhaps even slow the rate of increase in population.″

The experts who reviewed the limited research conducted on the tree said many reports of its wonders appear to have some basis in truth and that the neem should be closely studied.

The report called for an orderly creation of neem plantations and laboratory research to determine the best way to harvest and process the tree’s leaves and seeds.

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