After a 12-year FDA investigation that entailed numerous unheeded warnings, an injunction, and a civil contempt finding, the judge found the defendant in compliance with the law at last, determining he had indeed stopped distributing an unapproved drug.
Judge Bernard A. Friedman, U.S. District Court for the Eastern District of Michigan, Southern Division, had ordered Edward J. Sopcak to appear before him last Jan. 26 to show that he had ceased the illegal activities he and his colleague, James Sheridan, had regarded as a humanitarian service.
“The formulation [for CanCell] came to James Sheridan in a dream 50 years ago,” wrote FDA compliance officer Kenneth Shelin. “For the last 50 years Mr. Sheridan has been telling people about the 80+ percent cure rate the product has in all types of cancer plus diabetes, arthritis, lupus, and that latest scourge, AIDS,” Shefin continued in a memo he wrote in June 1987 recommending injunction proceedings against Sheridan and Sopcak.
The two were manufacturing and distributing an unapproved new drug. CanCell was never proved effective against the serious illnesses for which it was promoted, and FDA never approved it for any use. CanCell presented a particular danger because Sopcak told patients to stop chemotherapy and other conventional therapies. During a December 1987 inspection, Sopcak told investigators he tells cancer patients chemotherapy is an “unapproved therapy” that “kills 100 percent of the people who use it.”
When FDA first learned about CanCell (then called Entelev) in 1980, Detroit district investigators inspected Sheridan’s house where, operating alone at the time, he manufactured the product. Sheridan, a chemist, admitted he was making and distributing the product with health claims and that about 600 people used it to treat cancer. He said he had stopped making the product, however, and did not intend to resume production. But that turned out not to be the case, and the 1980 inspection proved to be only the first step in an investigation that would continue for 10 years.
Subsequent inspections of Sheridan’s residence from June 1981 until October 1986 showed he continued to manufacture the product. During an inspection in December 1987, Sheridan said he stopped making and distributing CanCell but was referring patients to Sopcak. Sheridan still maintained that CanCell cured AIDS and told FDA officials he intended to continue promoting it as a cure for cancer, AIDS, and other serious diseases.
Sopeak had begun making CanCell in July 1984, although FDA did not lean this until investigators inspected his residence in October 1986. Follow-up inspections through March 1988 showed he continued to make the drug, despite warnings from FDA that these activities were illegal.
Over the years, Sheridan and Sopcak received numerous letters from FDA warning that their distribution of CanCell—an unapproved drug—is illegal. They were also informed of good manufacturing practice violations, which included failure to test raw materials or finished products and failure to maintain complaint files. They had no detailed written manufacturing procedures and controls or written procedures for maintaining and cleaning manufacturing equipment.
During one inspection, investigators observed Sheridan carrying out pH testing in the kitchen at the same time his wife was cooking chicken for dinner. Sopcak manufactured the product in his kitchen, too, without regard to good manufacturing practice.
Initially, the proposed defendants made half-hearted, ineffective attempts at compliance. Subsequently, however, they acknowledged their conduct was illegal but pledged nonetheless to continue it.
From 1977 to 1984, Sheridan had sponsored several studies to evaluate the safety and effectiveness of the drug, but none showed any therapeutic benefit. In April 1982, he filed an investigational new drug application with FDA, but never submitted adequate information to support it. The application has never been approved.
Sheridan and Sopcak acknowledged to FDA that they changed CanCell’s formulation over the years, as a result of frequent consultations about how to improve it. A complaint for permanent injunction filed Feb. 21, 1989, in the U.S. District Court for the Eastern District of Michigan, Southern Division, to enjoin Sheridan and Sopcak from distributing CanCell listed the active ingredients at that time as inositol, nitric acid, sodium sulfate, potassium hydroxide, sulfuric acid, and catechol.
The complaint also notes that the product had been known over the years variously as Jim’s Juice, Croconic Acid, Sheridan’s Formula, JS-114, 126-F, Entelev, and CanCell. (In a letter to FDA dated Oct. 24, 1981, Sheridan explained that the name Entelev was derived from “ENTEL—from ‘entelechy’ that part of a living process known only to God”—and “EV—from electrovalent—added just so the name would have something for everyone. “)
On June 21, 1989, Sheridan signed a consent decree of permanent injunction, agreeing to stop distributing the product. On Jan. 17, 1990, the court granted a decree of permanent injunction against Sopcak, which he appealed to the Circuit Court of Appeals in Cincinnati. The appeal was dismissed Nov. 1, 1990.
Nevertheless, defying the injunction, Sopcak continued to distribute CanCell. At a show-cause hearing Nov. 13, 1992, Judge Friedman found him to be in civil contempt and ordered him to comply with the injunction immediately. Sopcak was allowed two weeks to:
- notify all people he was supplying with CanCell that he would no longer be distributing the drug and that drugs distributed since Jan. 17, 1990, violated a court injunction; he was also to provide FDA’s Detroit district office a copy of the notice
- place a recorded message on his answering machine stating that he has been enjoined from distributing CanCell
- report to FDA by Nov. 27, 1992, the actions he has taken to comply with the order.
Sopcak’s final appearance before Judge Friedman in January 1993 satisfied the judge he was in compliance.
This article is reprinted from the May 1993 issue of FDA Consumer magazine.
This article was posted on July 25, 2005.