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The agents seized all private medical Þles, and took books and booklets, research materials, business Þles and records, stock certiÞcates, Rolodex Þles and computers, including modems, monitors, keyboards and software. Their justiÞcation for the seizure of computers was that "they were used to print information on a substance that is banned in the USA." That substance is 714X.
The company, Writers and Research, Inc. has been disseminating information about 714X since 1992. In May of that year, Charles Pixley initiated an Institutional Review Board (IRB), as a normal Þrst step towards getting the drug approved for sale in the US. Pixley contacted the FDA to obtain the pertinent regulations and to start a relationship that would allow patients to get this treatment through informed consent.
A German-born physician, Dietmar Schildwaechter, MD, PhD, formerly of the University of Pennsylvania, headed the IRB. Pixley also produced a spiral-bound anthology, "Do No Harm," to explain the treatment; the book culminated in an "informed petition and consent." When this form was Þlled out, the "patrons," as Pixley calls his clients, could then receive the product. The drug was made available through C.O.S.E. in Canada.
Pixley believes he was helping patrons exercise medical freedom of choice, a concept grounded in the Constitution and common law. But from the FDA¹s point of view, he was commercializing an unapproved drug.
As the drama unfolded, FDA forbade Pixley from even mentioning the IRB in his material. On 7/17/92, the Import Operations Branch of FDA issued an Import Alert for the "automatic detention of 714X" which it described as a "Cancer/Aids Serum" [sic] and a "new drug without an approved New Drug Application (NDA)." This despite the fact that it had already allowed about 4,000 prescriptions into the US under the FDA's Personal Import Policy. Then in July 1994 came the raid.
In conversation, Mr. Naessens pointed out that neither Mr. Pixley nor his company represented him in the US or was hired to lobby on his behalf. Rather, on its own initiative, Writers and Research, Inc. has been helping people in need by facilitating access to information on 714X that could be well understood in English.
Naessens hopes to have a non-combative relationship with US regulatory authorities, including the FDA.
These are the instructions that the Food and Drug Administration issued to its agents in 1992 on how and why to stop 714X from entering the US:
"In January, 1990, Health Protection Branch of National Health and Welfare Canada issued an Issues paper on "714X: An Unproven Product." 714X was being promoted by Gaston Naessens, its inventor and manufacturer as a cure for cancer, AIDS, and other degenerative conditions. No scientiÞc evidence has been provided to support any claims made for the drug.
"The expert advisory committee on HIV therapy to the Health Protection Branch Canada deplored the use of 714X for the treatment of cancer and Human Immuno-deÞciency Virus-related disease, including AIDS.
"Canadian Food and Drug Regulations, however, permit use of an investigational drug in extenuating circumstances involving illness of a serious or life-threatening nature. Under the Canadian Emergency Drug Release Program (EDRP), a Canadian physician may request, under a compassionate plea, use of an unapproved drug for a speciÞc patient.
"During 1991, FDA has become aware of an increase in the importation of 714X. Investigation into the situation has uncovered several promotional operations soliciting individuals to purchase 714X for treatment of AIDS, cancer and other associated immune system diseases. As part of the promotional system, individuals were instructed to provide a letter indicating the drug was being taken under their doctor¹s supervision, or if they did not have a physician, the individual could be put in contact with a doctor through the promoter¹s physician referral service. The orders would then be processed through the promoter and shipped from the manufacturer in Canada.
"RPM [Regulatory Procedure Manual] Chapter 9-71, 'Coverage of Personal Imports' prohibits unapproved new drugs from entry where promotion of the product is noted, or the drug is unapproved for sale in the country where it is manufactured or distributed. Promotional activity in the U.S. removes this product from the scope of the guidance of Regulatory Procedures Manual Chapter 9-71 'coverage of Personal Importation.' Accordingly, automatically detain all shipments, commercial and personal, of 714X."
EDITOR¹S COMMENT:
The FDA offers no evidence that Naessens has ever promoted 714X as a "cure" for cancer or any other condition. In our conversations, he never did so. He has simply responded to the requests of American patients and their doctors by providing 714X on a compassionate basis. But even if FDA seeks to stop what it perceives as the commercial shipment of 714X, what justiÞcation can it offer for blocking individuals from importing it for their own personal use? This is certainly a gross violation of the right of every person, when ill, to search for and obtain any treatment they feel may beneÞt them.