Upjohn's Drug Deception

Upjohn company "engaged in an ongoing pattern of misconduct" to ensure that the sleeping pill Halcion would remain on the market, an April 1994 internal Food and Drug Administration (FDA) report charges.

Dr. Sidney Wolfe, of Public Citizen, called for the FDA to turn over the Upjohn information to the Justice Department for a "criminal prosecution because of [the company's] clear pattern of withholding information from the FDA and misleading the agency."

The FDA report is based on information obtained during an FDA inspection of Upjohn from December 1991 through March 1992, which was abruptly stopped before investigators were finished. The investigation is described in an April 4,1994 FDA memo.

Halcion critics have charged that long-term use of the drug induces memory loss, depression, anxiety and violent behavior in some patients. Two years ago, Public Citizen called on the FDA to follow the British lead and ban Halcion. The FDA reanalyzed the data on Halcion in 1992 and concluded that it was safe, but recommended stronger warnings about potential side effects.

In their April report, FDA investigators found that prisoners in Jackson, Michigan, on whom Halcion was tested, exhibited serious adverse reactions. Thirty percent of those reactions were not reported to the FDA in the new drug application.

Upjohn was seeking approval of Halcion at a level of one milligram "even though information shows that there was an awareness that the dose was too high and caused serious side-effects in significant numbers," the report says. The report notes that Upjohn took no corrective action after Belgian and Dutch reports showed numerous adverse effects.

In the report, the FDA charges that it has uncovered Upjohn documents indicating that the company had chosen to disregard the drug's hazards in order to increase sales. FDA investigators also found that data on side effects of Halcion were misrepresented to the Japanese and French governments, even though management was informed of inaccuracies.

Upjohn categorically rejects Public Citizen's allegations that it engaged in criminal wrongdoing. In a statement, the company said "Upjohn puts nothing ahead of patients' health. ... We acknowledged that we've made some human errors in the past. Processes and systems have been implemented to prevent them from recurring."

Making Carbide Pay

In a case that could open or thousands of claims from workers exposed to radiation in the-nuclear weapons industry, the State of Kentucky Department of Workers' Claims will decide in the next several months whether to award worker's compensation benefits to the family of Joe Harding. Harding worked at a Union Carbide-operated Department of Energy (DOE) uranium enrichment plant in Paducah, Kentucky. The family is charging that the Harding's fatal cancer was caused by his routine exposure to low-level radiation.

There are currently 600,000 former Department of Energy workers who are at risk from exposures to radiation at levels similar to Harding's.

Harding died from stomach cancer at the age of 58 after working at the Paducah plant for more than 18 years. After being fired from his job in 1971, Harding received no disability compensation, accident benefits or medical expenses. The company also cancelled his life insurance.

Following Harding's death, a radio analysis of his bone tissue was performed which found a deposit of a substantial amount of uranium. On his deathbed, Harding told reporters that he breathed uranium hexafluoride on a regular basis while on the job. Harding also described how Union Carbide encouraged workers to falsify radiation levels at the plant.

The legal brief filed by Harding's lawyers charges that Harding's health rapidly deteriorated after he began working for Union Carbide. Within a year, he started breaking out in rashes and sores, a severe chronic skin condition that was never diagnosed but stayed with him the rest of his life, the brief says. Harding's stomach also began to bother him in 1954, and in 1959 he saw a doctor for an ulcer. In 1961, Harding had most of his stomach removed. Harding also had persistent respiratory problems after a gas inhalation episode in 1959, the cause of which was undiagnosed during his life.

The Energy Department has denied any definitive connection between low-level radiation exposure and cancer, and has fought workers' compensation claims related to low-level radiation. There have been 60 new radiation injury claims against the Department of Energy since 1989.

Texaco On Trial

In a decision against the indigenous people of Ecuador, a U.S. District Judge has ruled that the money damages portion of their class action suit against Texaco should be resolved in Ecuadorian courts. However, Judge Vincent Broderick, of the Southern District of New York, reserved decision on dismissing the lawsuit's claims for injunctive relief, and denied several other Texaco motions to dismiss the lawsuit.

The suit alleges that Texaco committed large-scale environmental abuses, including the inadequate disposal of hazardous wastes and the destruction of a substantial portion of Ecuador's tropical rain forest.

The decision came in response to a Texaco motion to dismiss the lawsuit. Because the events underlying the lawsuit occurred in Ecuador, Texaco's motion contended that it would be more convenient to have the case litigated there. Noting that a large class of persons from a foreign country was involved, judge Broderick agreed with Texaco.

However, before agreeing to dismiss the damage claims, Judge Broderick stated that Texaco must agree accept the jurisdiction of Ecuadorian courts and post an adequate bond to cover any liability imposed by Ecuadorian courts.

- Ben Lilliston