The Multinational Monitor
The Case Against Depo-Provera 

by Amy Goodman

Over two million women around the world rely for contraception on a synthetic hormone manufactured by a U.S.-based multinational, the Upjohn Company.

The drug is depot medroxyprogesterone acetate. Upjohn's brand name for it is Depo-Provera; its nickname around the world is "The Shot." Injected into the arm or buttock in a 150 milliliter dose, one shot of Depo-Provera lasts at least three months. The women who submit themselves to these injections don't have to bother with birth control piils or diaphragms, and don't have to tell their husbands they are using a contraceptive.

They may be seriously endangering their health, though.

In the United States, because of possible safety problems Depo-Provera has never been approved for use as a contraceptive - in spite of intense efforts by Upjohn for almost 25 years to get such approval. Current law prohibits the export of drugs banned or unapproved for use in the U.S. to other countries. Upjohn gets around that restriction by producing the drug in Belgium and Canada - two of about 80 countries where Depo-Provera is registered or approved as a contraceptive.

This issue of Multinational Monitor tells the story of Depo-Provera - including its origin and testing, questions about its safety, its history in the U.S. drug approval process, and the significance of a double standard that allows the drug to be aggresively marketed to women around the world - particularly in the Third World or to minority women in developed countries - for a use not deemed safe for women in tyhe U.S.

C O N T E N T S 

Depo-Provera Problems in the U.S.
- The injectable contraceptive is marketed around the world, but was denied approval for that use in its country of origin, the U.S. Although Upjohn appealed the decision, an FDA panel has recommended that the drug remain unapproved. Now its up to the FDA commissioner to make a final decision.

A mockery of the FDA's Safety Mandate
- Contraceptive use Depo-Provera in the U.S.

The Grady Clinic Study
- A look at the largest U.S. human study of the drug.

Marketing Abroad
Depo-Provera proponents say the risk/benefit analysis in the Third World should be different from in the U.S., but they ignore factors that make Third World women especially vulnerable to the drug's side effects.

"No Problem:" Buying Depo-Provera in Mexico
- The drug is easily accessible in Mexico City pharmacies, where it's sold without any patient instructions for use, or warnings about side effects.

Zimbabwe's Change of Heart
- The government recently relaxed restrictions on the drug's use, but is watching the U.S. FDA.

Bribery In the Pharmaceutical Industry
- In 1976, an Upjohn statement to the SEC disclosed over $4 million in "questionable payments."

Setting the Record Straight
- A 1983 Upjohn memo on Depo-Provera public relations strategy.

The Politics of Population Control
- The population conference ignored key issues.

- Experiences of some women who took Depo-Provera

- What activists are doing about the drub; recommendations for policy reforms

- Including Findings of Fact by the FDA Board of Inquiry