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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.
In July 1996, Charles Pixley, 48, president of Writers & Research Inc., of Rochester, N.Y., was sentenced in 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.
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 percent 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 not 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 714X. Later, the center informed Pixley that it was considering disqualifying his IRB.
In February 1994, Beverly Ritter, an investigator in FDA's San Francisco district office, called Writers & Research, posing as a patient. Using an alias, she ordered $22 worth of patient literature on 714X, a $15 physicians' handbook on 714X, and $400 worth of 714X. The literature and the first of what were considered two orders of 714X arrived at an undercover address within one month.
Checks FDA sent as payment for the literature and 714X were returned to FDA's undercover location, stamped as paid. The stamped information indicated the checks had been deposited to an account with a Rochester, N.Y., bank. Under subpoena, the bank provided information about the account that showed it was held in the name of Writers & Research and that between April 1, 1993, and March 31, 1994, more than $472,000 had been deposited to the account. One check made out for more than $7,000 in cash was stamped to indicate it had been credited to the account of Pixley's 714X supplier in Canada.
In July 1994, special agents with FDA's Office of Criminal Investigations requested and obtained a search warrant for Pixley's place of business. They seized various documents related to 714X, including correspondence between doctors and other clinicians; records of telephone calls from customers; product order forms; customer sales receipts; patient and physician literature, cassettes and videotapes; and copies of FDA statutes and regulations.
On Oct. 25, 1995, a grand jury for the U.S. District Court for the Western District of New York returned a 19-count indictment against Pixley and Writers & Research. Count 1 charged both parties with conspiracy to defraud FDA by selling an unapproved new drug. Counts 2 through 19 charged Pixley with illegal interstate commerce of an unapproved new drug. Counts 2 through 19 each represented a date on which an individual had received 714X.
During the bench trial April 10 and 18, 1996, U.S. District Judge Michael Telesca heard testimony from various FDA employees, including Paul Goebel, in FDA's Center for Drug Evaluation and Research, who testified on the appropriateness of IRBs, and forensics chemist Rick Flurer, Ph.D. Also, David Feigal, M.D., director of FDA's division of anti-viral drug products, and Gerald Sokol, M.D., a medical reviewer in FDA's division of oncology and pulmonary products, testified in writing that they consider 714X a new drug because it is not generally recognized among scientific experts as safe and effective. Another FDA employee, Elaine Abraham, Ph.D., also testified in writing that she had searched FDA files and found that neither IND nor new drug applications for 714X had ever been filed.
Pixley's lawyer argued that 714X is a homeopathic drug and therefore not subject to FDA regulation. As a homeopathic drug, the defense argued, 714X is considered safe and effective based on the listing of its ingredients in the Homeopathic Pharmacopoeia. However, when questioned about the chemical name (trimethylbycyclonitraminoheptane-chloride) placed on the 714X vial, defense witness Harris Coulter, Ph.D., editor and chief of the eighth edition of the Homeopathic Pharmacopoeia, said he did not understand that label and would not know the contents of the vial based on the label.
On April 19, 1996, Telesca found Pixley and Writers & Research guilty of count 1 and Pixley guilty of counts 2 through 19 of the indictment. In his decision and order, Telesca wrote that the "overwhelming proof at trial" established 714X as a drug and therefore subject to the regulations governing the marketing of new drugs in the United States.
"[T]here is absolutely no proof that 714X is a homeopathic drug," he wrote. "It was not listed as such in the Homeopathic Pharmacopoeia nor was it labelled as such on vials of the substance which were marketed to individuals."
Telesca sentenced Pixley and Writers & Research on July 9. In addition to a prison sentence, supervised release, and community service, he ordered Pixley to refrain from "possessing, distributing, or aiding in the distribution" of unapproved drugs and assessed him $500. He fined the company $1,000 and assessed it $200.
Pixley and his company appealed the verdict, asserting that (a) the district court erred in determining that 714X was not a homeopathic drug exempt from the FDA's pre-market approval requirements; (b) steps taken by the FDA to explicitly exclude 714Xfrom a personal importation exemption were illegal, thereby defeating the indictment; (c) the court constructively amended the indictment causing a prejudicial variance between the crimes charged and that for which Pixley was convicted; and (c) his convictions are contrary to a constitutionally-protected liberty interest in the use of unapproved drugs to treat diseases. On May 7, 1997, the U.S. Court of Appeals for the 2nd Circuit upheld the conviction.
Paula Kurtzweil is a member of FDA's public affairs staff. This article was originally published in the November 1996 issue of November 1996. The text was slightly modified and the last paragraph was added to reflect the outcome of his appeal.