Promoter of 714x cure-all faces prison for selling unapproved drug - Charles Pixley - Investigators' Reports

A New York book publicist has been sentenced to prison for selling an unapproved new drug espoused in a book he was promoting. The book deals with a French-born biologist living in Canada who developed a camphor-derived drug he calls 714X, which he claims can cure cancer, AIDS, and other diseases. The drug has never been approved in Canada or the United States.

Charles Pixley, 48, president of Writers & Research Inc., of Rochester, N.Y., was sentenced last July to one year and one day in prison, plus three years of supervised release and 200 hours of community service for selling 714X to Americans, including undercover FDA investigators. He arranged for the product to be brought in from Canada. He is appealing his conviction.

According to FDA forensics chemistry analysis of a sample of 714X, the product was 94 percent water, about 5 percent nitrate, 1.4 percent ammonium, less than 1 percent each ethanol, sodium and chloride, and less than one one-hundredths of a percent of camphor. A Writers & Research sales report submitted as evidence during a two-day bench trial indicated patients paid between $300 and $400 for two 6-milliliter (about 1 teaspoon) vials of 714X. According to product literature, 714X could be injected into the groin, breathed in through a nebulizer, or placed under the tongue for absorption.

While FDA believes that 714X does not pose an immediate danger to patients, its use can prevent patients from receiving proper medical treatment. Two doctors who complained to FDA about 714X expressed concern about two of their cancer patients who refused conventional therapy in lieu of treatment with 714X. Both patients died.

The agency became aware of Pixley's activities in January 1992 when a consumer called the agency's Seattle district office to inquire about 714X. The consumer heard about the treatment on a radio show and had written for and received written information from Pixley's company.

On Jan. 24 and 30, 1992, Sherry Phillips, an investigator with FDA's Buffalo district office, inspected Pixley's business, located in the front porch area of his house. She interviewed Pixley, who admitted that he brokered the sale of 714X between the Canadian manufacturer in Rock Forest, Quebec, and U.S. patients. He promoted 714X in his book, Do No Harm, which summarized the theories of 714X's inventor on the causes of disease and advocated the use of 714X. Pixley's promotional activities also included distributing flyers and other literature, giving oral presentations, and participating in radio talk shows.

Literature available at Pixley's business showed the product was promoted for various diseases. One piece of literature stated that 714X was "effective in restoring to perfect health, 75% of cases treated against AIDS, cancer, Lupus, MS [multiple sclerosis], rheumatoid arthritis, and other viral, immunological or degenerative diseases."

Invoices supplied by Pixley indicated that during a three-month period in 1992, Writers & Research arranged for U.S. patients to buy and receive 960 vials of 714X from Canada. The vials had a wholesale value of $96,000 and a retail value of $168,000. They were brought into the country by a delivery service or as undeclared personal items at the U.S.-Canadian border in Buffalo.

Following the inspection, Phillips informed Pixley that his activities violated federal law because FDA had never approved a new drug or investigational new drug (IND) application for 714X. In July 1992, FDA issued an import alert, prohibiting 714X from entering the United States.

However, Pixley continued to sell 714X, he sold some to undercover FDA investigators. In addition, the agency continued to receive inquiries and complaints about 714X from consumers and doctors. So, Phillips returned to Pixley's place of business in March 1993.

During the inspection, Pixley admitted to Phillips that he was selling 714X to U.S. patients and smuggling it in from Canada. Phillips observed an inventory of 714X on hand and collected records documenting the sale of 714X to patients across the country.

Pixley indicated to Phillips that, in partial fulfillment of the requirements for an IND application, he had formed an institutional review board, or IRB. These boards review clinical studies of investigational drugs to ensure that patients participating in the studies are not exposed to unnecessary risks. Pixley's IRB included himself and doctors who bought and prescribed 714X.

At the end of her inspection, Phillips told Pixley that his IRB did riot comply with FDA's regulations. For example, she cited him for being a member of the group, even though he had a financial interest in the drug being studied. Also, the IRB did not provide adequate informed consent or disclose potential risks of the drug to study participants. She passed on her findings to FDA's Center for Drug Evaluation and Research.

In August 1993, center representatives held an informal hearing with Pixley and informed him that his IRB did not conform with FDA regulations, that he should stop referring to Writers & Research as an IRB, and that he should file an IND application for 714. Later, the center informed Pixley that it was considering disqualifying his IRB.