The Multinational Monitor

NOVEMBER 1989 - VOLUME 10 - NUMBER 11


B E H I N D   T H E   L I N E S

Irradiation Update

In response to considerable community pressure, the city commissioners of Mulberry, Florida voted 4-1 on December 6,1989 to ban radiation processing in their town. More than 300 Mulberry residents attended the city council meeting. The vote thwarted plans by Vindicators of Florida, a company which sought to build a $7.5 million food irradiation facility in Mulberry. Local organizer Jan Privet said, "This victory should send a clear signal to anyone considering the radiation processing of food. Radiation-exposed food is an unwanted, unproven and unnecessary technology that must be stopped."

The proposed facility was to specialize in Florida citrus. But the Florida Citrus Commission publicly rejected radiation processing of Florida citrus due to questions about the efficacy of the process as well as strong consumer opposition. The Citrus Commission received thousands of protest letters; and opposition groups both in the United States (including Food and Water, Inc. and the National Coalition to Stop Food Irradiation) and abroad(such as the International Organization of Consumers Unions and the Food Irradiation Network of Japan) threatened to organize a boycott of all Florida citrus products if the fruit was to be irradiated.

The technique of exposing food to ionizing radiation is used to prolong shelf-life, though opponents say that, in addition to the negative long-term effects which it may have on human health, irradiation has not been proven effective for use on food. These detractors are beginning to see some results nationally as companies and states come out against irradiation.

At its annual meeting of shareholders in November, Quaker Oats Company passed a resolution, filed by a coalition of its shareholders, formulating a company policy against the irradiation of food and the purchase of irradiated food products. The resolution was jointly filed by the Sisters of St. Francis, Philadelphia, the Sisters of Mercy, St. Louis and Franklin Research and Development, Corp., Boston. Sister Helen Mullin congratulated Quaker saying, "This move reflects an important commitment to food safety and establishes Quaker Oats as a leader in this area." Quaker Oats joins H.J. Heinz and Co. and Zacky Farms in adopting this anti-irradiation policy.

In July, Rep. Douglas Bosco (D-CA) and Senate Majority Leader George Mitchell (D-ME) reintroduced federal legislation to ban the sale and distribution of irradiated foods until the National Academy of Sciences conducts studies to determine the effects such treatment will have on human health and the environment. In addition, the New York, New jersey and Maine legislatures have passed at least temporary bans on food irradiation.

Japan vs. U.S. Navy

A group of Japanese citizens, angry over the presence of U.S. nuclear weapons in the busy port of Yokosuka, has decided to sue the U.S. government for violations of the National Environmental Policy Act (NEPA) of 1970.

NEPA requires the U.S. government to prepare an Environmental Impact Statement (EIS) whenever it takes an action which might "seriously impact on the quality of the human environment." NEPA applies to military projects in the United States and also covers activities conducted by the U.S. government in foreign countries.

The Japanese group, the NEPA Coalition, discovered through the U.S. Freedom of Information Act that nuclear weapons are regularly brought into Yokosuka port and that the U.S. government has never conducted the required EIS for various activities at Yokosuka Naval Base. The coalition plans to take legal action to suspend the current plans to expand naval facilities at Yokosuka as well as to ban the entry of nuclear weapons and nuclear-propelled vessels to the port.

The United States took over the port of Yokosuka at the end of World War II and, under the terms of the japan-U.S. Security Treaty, the port has been at the disposal of the U.S. government ever since. In 1963, the United States notified Japan that it would dock nuclear-propelled sub-marines at Yokosuka. The United States will not provide safety information regarding the matter; Japan is not empowered to conduct its own safety inspections.

The coalition contends that since May 1966, US. nuclear-powered submarines have called at Yokosuka on more than 300 occasions. The coalition's concerns include the possibility of accidents in connection with the atomic reactors and environmental problems including pollution of Tokyo Bay, air and soil pollution from on-base plants and noise caused by carrier planes.

Upjohn's Fitful Sleep

A Disproportionately high incidence of reports of negative side effects among people taking Upjohn's sleep-inducing drug, Halcion including hallucinations and heightened aggressiveness, prompted a recent Food and Drug Administration (FDA) advisory committee investigation.

Halcion, the most widely prescribed sleeping aid in the world, is a benzodiazepine, one of a family of drugs marketed as tranquilizers and sleeping pills. It has been known to cause psychoses such as hallucinations, sudden confusion or delirium, mental impairment forgetfulness, slow thinking and inability to care for oneself.

Eva Kemper, spokeswoman for the FDA, says the Psychopharmacologic Committee concluded that "the only side effect that the committee considered to be shown to be increased with Halcion compared to other hypnotics was a risk of temporary amnesia." The commit-tee favors providing patient information on side-effects, particularly amnesia, for all benzodiazepine hypnotics.

Florence Steinberg, an Upjohn spokeswoman, says the "outcome [of the FDA committee] was good for Halcion" and added that the company will be working with the FDA to strengthen language on package inserts about amnesia as a side-effect.

Upjohn has already discontinued production of the strongest dosage of Halcion pills but sales are still falling, apparently as a result of the reports of unwanted side effects. Analysts predict Halcion sales will fall to about $235 million this year from about $260 million in 1988.

Adverse reactions to the drug include an exceptional incident in Utah in which a 58-year old woman shot and killed her 83-year-old mother after taking Halcion. Two doctors testified that the drug contributed to the woman's violent behavior, and a judge dismissed murder charges against her. Upjohn contends, however, that because the woman was taking other medication at the time, Halcion was not to blame for the incident.

Contraception's Future?

In April 1989, the FDA's Fertility and Maternal Health Drugs Advisory Committee unanimously recommended that the contraceptive Norplant be approved for use in the United States, but some groups still question the safety of the drug. If FDA grants approval, Norplant, developed by the New York-based Population Council, will be distributed by Wyeth-Ayerst Laboratories.

Norplant, currently approved for marketing in 14 countries, provides protection from pregnancy for five years by means of six capsules made of synthetic progestin levonorgestrel. The capsules are inserted just under the skin of a woman's arm in a surgical procedure requiring a local anesthetic. Any specially trained physician, nurse, nurse-midwife or other trained health worker will be able to perform the insertion and the removal. The method is reversible and tests show that normal fertility returns quickly when the capsules are removed.

According to the Population Council, the most common side effect of Norplant is change in the menstrual bleeding pattern. But women using Norplant have complained about the following conditions: headache (the most frequent complaint after menstrual irregularities); nervousness; nausea; dizziness; dermatitis; acne; change of appetite; weight gain; breast tenderness; excessive facial hair growth; and hair loss. There are also complaints reported by Norplant users or discovered by physicians which may or may not be associated with the implants: breast discharge; cervicitis; mood change; depression; general malaise; weight loss; pruritis (itching); and hypertension.

Although the clinical experience is still insufficient to detect rare adverse effects, there is no evidence of cardiovascular, respiratory, central nervous system or other serious problems, nor is there any evidence of carcinogenicity associated with Norplant use. Studies show an extremely low failure rate in the first five years of use, about one woman per 200, slightly more effective than the birth control pill.

The panel's recommendation was well received by some organizations including the National Organization for Women and Planned Parenthood of America but other groups have serious concerns about the drug's safety. Health Action International representative Sybil Shainwald testified against the approval of Norplant, presenting critical evidence not otherwise submitted to the FDA. This included reports from Sweden of Norplant users who have been extremely depressed, especially

"women with prolonged bleeding." One woman had been bleeding for almost two years.

In Bangladesh, Sweden and Brazil, reports allege that women are having difficulty getting the implants re-moved. One woman was known to have cut the capsules out of her own arm.

Another concern is that women in Third World countries are not adequately informed about the method and are in effect being used as guinea pigs for the developed world. Health Action International-USA has set up a committee to monitor the FDA and to review and prepare further testimony against approval of Norplant.

In addition, the Washington, D.C.-based Women's Health Network expressed some concern over the approval of Norplant. A representative from the network stated that it was premature to approve the drug without further pre-marketing studies and without better evidence that women, especially Third World women, could have the implants removed upon request. The organization recommended an additional 15-year study of the contraceptive's effects.

Bhopal Reopened

Five years after the world's worst industrial disaster in Bhopal, India, where Union Carbide's pesticide plant exploded, spreading the deadly gas, methyl isocyanate, and killing 2,500 people, Union Carbide still has not paid compensation to the more than 260,000 people affected.

In early 1989, Union Carbide and the Ghandi government of India negotiated a $470 million deal to compensate the victims. However, victims groups have challenged the deal and newly elected Prime Minister, V.P. Singh, has been a leading opponent of the plan. The new government believes the deal vastly undercompensates the victims and will have no impact on Union Carbide's financial status. The opposition is concerned that the ruling sends a message to U.S. multinational companies that they will not be held financially responsible for future catastrophic accidents like Bhopal.

Another reason to oppose the plan is that it dismisses all criminal charges against company officials. Homicide charges were filed in November 1987 against former Union Carbide chairman Warren Anderson and other Union Carbide officials.

Victims have asked that if the proposed settlement does go through, a public interest lawsuit be filed on their behalf in the United States. Most Bhopal claims filed in the U.S. were dismissed in 1986 by a New York federal court which claimed that it was "inconvenient" for Union Carbide to defend itself in the United States.

Joanne Doroshow of the Bhopal Justice Campaign, says, "Whatever the outcome of the Bhopal case, it likely will become the measure by which multinational corporations will gauge the standard of care owed citizens here and particularly abroad for their ultrahazardous operations, and compensation owed their victims in the event of a catastrophe."

� Katherine Isaac


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