Action

Action against Upjohn's marketing of Depo--Provera has taken many forms. Around the world, women's groups have opposed the promotion of the drug, and in the U.S. organizations like the National Women's Health Network, the Boston Women's Health Book Collective, the Health Research Group, and others have opposed FDA approval of contraceptive use of the drug domestically. A number of individual lawsuits have been brought against Upjohn; in addition, a class action suit is underway in California, in which the Network and eight women are charging Upjohn with consumer fraud and suing for damages and to halt distribution of Depo--Provera for unapproved uses. A national class action suit is also being planned on behalf of individual plaintiffs and the Network. "We want to stop the sale of Depo--Provera to all places where Upjohn knows or should know that it has been used for unapproved uses, including student health centers, family planning clinics, and sheltered workshops." says the Network's lawyer Sybil Shainwald.

Another area of action has been shareholders' resolutions. The United Presbyterian Church recently attempted to introduce a shareholder resolution calling on Upjohn to "cease marketing the drug overseas until it receives approval for distribution here," according to William Samplotsky-Jarman, of the Church's Mission Responsibility Through Investment Committee (MRTI).

The Presbyterian Church has been following the Depo--Provera controversy for the past five years, since the issue was raised by the MRTI Council on Women. In 1982, the church put forth a shareholder resolution requesting that Upjohn issue a report to its 21,600 stockholders describing

the history of the company's efforts to have Depo--Provera approved in the U.S. In addition, the resolution called for a risk/ benefit assessment of the drug. The New York-based Interfaith Council on Corporate Responsibility provided technical assistance in drafting and submitting the resolution, which was defeated.

Recommendations:

In addition to the litigation and other action, here are several steps that should be taken to reform the approval and regulation of drugs in the U.S., and for protecting other countries from unsafe or ineffective U.S. drug exports.

• Existing safeguards in the U.S. drug approval process should be maintained and strengthened. The Department of Health and Human Services has recently proposed speeding up the process by allowing U.S. drug approval to be based on foreign testing and company summaries of testing data, rather than raw data itself. These changes would legitimize the testing of experimental drugs in the Third World and would severely limit the FDA's ability to monitor testing. In addition, allowing companies to submit data summaries would increase companies' control over test findings.

• The industry-backed proposal to allow for the manufacture in the U.S. and export of unapproved drugs (see page 12) should be defeated.

• Once a drug has been denied approval for a particular use in the U.S. on the grounds that the drug is either ineffective or unsafe, it should be illegal for a doctor to prescribe the drug for that use. (For instance, approval of Depo--Provera as treatment for miscarriages and endometriosis was revoked in the early 1970s, and approval for use as a contraceptive was denied in 1978. Unless the FDA reverses its decisions, it should not be up to doctors' discretion to continue prescribing the drug for those uses.)

• Informed consent, with an explanation of a drug's experimental status and side effects, should be required for till patients taking a drug that is in the testing stages. (Currently, informed consent forms are required only for subjects in studies registered with the FDA. Other doctors who are not part of these studies but prescribe experimental drugs should also be required to get patients' informed consent, and submit their observations to the FDA.)

• To limit undue corporate influence over drug testing, the FDA should be responsible for contracting with independent labs for the testing of new drugs, at the drug company's expense. Labs should not know which drug company manufactured a drug, and should submit findings directly to the FDA. (Currently, either the drug company does its own lab testing of a drug, or it contracts with outside labs for that testing. The labs feed their findings to the company, which forwards them to the FDA.)

• Extensive monitoring should be required of drugs after they are on the market. This post marketing surveillance is required in countries like Holland, Sweden, and France, where companies must submit annual reports on a drug after it has been approved for use. In England, approval of a drug is provisional; after five years the drug is reviewed and approval can be revoked. Currently in the U.S., it is very difficult to recall a drug once it is put on the market.

• An international drug monitoring system should be established through an organization like the United Nations to keep track of how drugs are being marketed around the world, and to provide accurate and up-to-date information on the status of drug approval in individual countries.