714-X or 714X / Gaston Naessens

714-X or 714X / Gaston Naessens

Homeopathic remedy out of Canada. Good results if the cancer is caught early. Mediocre results if the cancer is caught in a late stage.

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The camphor derivative 714-X, licensed in Canada, has been popularized as a cancer therapy via media reports on long-term remissions and "cures."

* The National Cancer Institute is evaluating a "best case" series to see if funding should be provided for further study of this controversial therapy.

History of Use

In 1980, French-born Quebec biologist Gaston Naessens obtained a Canadian patent for an experimental drug he described as an immune function stabilizer. The treatment, he asserted, would let cancer patients clear their tumors without the toxicities of conventional therapy.

Termed 714-X, the compound was a derivative of camphor. Earlier, while still in France, Naessens had developed other anticancer agents; his activities led to difficulties with the French authorities, and he was arrested and tried twice for illegally practicing medicine and pharmacy He ultimately moved to Canada in search of a less restrictive regulatory milieu.

Naessens believed that cancer cells are continuously produced in the body and require high levels of nitrogen for metabolism. If not removed by the immune system, the cancerous cells can begin to secrete co-cancerogenic K factor," which allows them to derive nitrogen from the host and supersede the actions of the immune system. 714-X was designed to interfere with the metabolism of cancer cells.

As with many unconventional cancer therapies, patients and advocates were enthusiastic but authorities remained skeptical. Through-out the 1980s, Naessens provided the drug to numerous patients in Canada and Europe until his arrest by Quebec authorities in May 1989. He was charged with negligent homicide in the death of a woman with advanced breast cancer who had undergone treatment with 714-X; he was also charged with 64 counts of practicing medicine without a license.

The case went to trial, and Naessens ultimately was found innocent, as chronicled in "The Persecution and Trial of Gaston Naessens" (Tiburon, Calif.: H.J. Kramer Inc., 1991). Health and Welfare Canada later began to permit distribution of 714-X. More than 800 physicians in Canada reportedly prescribe the drug.

Although 714-X is not licensed for use in the United States, it can be obtained for personal use from the Canadian manufacturer. Recently it has received attention through media reports about patients such as Billy Best, a Massachusetts teenager who ran away from home to avoid further chemotherapy for Hodgkin's disease. The courts ruled that he could choose his own therapy; he underwent treatment with 714-X and remains well today.
Testimonials about 714-X helped lead to the establishment of the National Institutes of Health's National Center for Complementary and Alternative Medicine. After a recurrence of his prostate cancer, former Rep. Berkley Bedell (D-Iowa) underwent treatment with 714-X in Mexico. Bedell later encouraged Sen. Tom Harkin (D-Iowa) to introduce the bill that led to the establishment of the NIH office.

The Best Case Series

There have been no clinical trials of the efficacy of 714-X; only case reports have been published. As part of a project that attempts to summarize the published data on many alternative cancer therapies, the University of Texas, Houston, Center for Alternative Medicine Research in Cancer has identified 13 published case reports on 714-X. Diagnoses in these cases included brain astrocytoma, inoperable lung cancer, ocular melanoma, and metastatic lymphoma. All patients in these cases benefited from the treatment; reported survival times were up to 12 years (www.sph.uth.tmc.edu/utcam/therapies/714x.htm).

In May 2001, prompted by the Dana-Farber Cancer Center in Boston, where some highly controversial testing of the drug had been done, the National Cancer Institute initiated efforts to scientifically evaluate 714-X. In August 2001, the manufacturer (Cerbe Distribution Inc., Rock Forest, Que.) submitted to the NCI's Office of Cancer Complementary and Alternative Medicine 16 case studies in which patients were treated successfully with the drug. Dr. Jeffrey D. White, the office's director, explained the scope and status of these investigations to this newspaper:

"My office is involved in a review of case reports provided by the company that produces 714-X. These reports include documentation, i.e., operative reports, pathology reports, and radiology reports, and clinical summaries for patients who have received 714-X. This submission of records was made to our Best Case Series Program," Dr. White said.
"Because of the many potential unidentified or unrevealed confounding factors that could exist with such cases, a Best Case Series review cannot be used to determine whether or not a particular therapy is effective. The goal of this review is to determine if there is sufficient evidence to warrant the NCI supporting research on 714-X. We are awaiting further information about these patients from the company and will not be able to complete the review until that information is provided."

Clinical Issues

714-X usually is injected into the inguinal lymph nodes daily for 21 days, although it also is available as sublingual drops and as a solution for nebulization. No toxicities have been reported. The treatment is covered by insurance in Canada; the cost for a 3-week supply of the drug is $300 in the United States. Its license is for use by patients considered to be in the terminal phase of disease.

Records from Naessens' trials include testimonials from patients who thought 714-X led to their recovery from cancer. Patients with terminal malignancies continue to seek this treatment.

It is hoped that the best case series will begin to provide answers on whether the drug is a valuable, well-tolerated therapy, as these patients believe, or whether, as Naessens' detractors claim, 714-X belongs in the long and ignominious history book of cancer quackery.

FDA SEIZES 714X CANCER TREATMENT FILES

FDA Seizes 714X Cancer Treatment Files

Writers and Research, Inc., an information clearinghouse in Rochester, New York, reported that six federal agents from the Food and Drug Administration raided their office in early July and confiscated all 714X project information and files.
"I was on the phone when the agents first came walking in, and to be frank, I thought they were Jehovah's Witnesses. But they made a sweep of the place and took all our books and pamphlets on 714X, as well as our computers, monitors, modems, rolodexes, and other office materials," says senior vice president Judy Pixley.

Developed and manufactured in Canada by French microbiologist Gaston Naessens, 714X is an alternative serum used for treating cancer, AIDS, and other degenerative conditions. The drug is mostly composed of camphor, an ingredient that has been used for treating human ills for more than 5,000 years. Yet, it has not been approved by the FDA.
Before the raid, Writers and Research attempted to gain formal FDA approval to market 714X in the United States and to make the treatment available through informed consent. While waiting to obtain FDA approval, they continued to provide information about 714X and helped refer people to doctors who treat patients with the drug. "We're not the scientists. We're the conduits of information," says Pixley.

The FDA, however, considers it illegal to promote a drug in the United States that has not yet met FDA approval. "No scientific evidence has been provided to support any claims made for the drug," states the FDA in its "Import Alert" regarding 714X. "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 immunodeficiency virus (HIV)-related diseases, including AIDS."
According to the FDA's Regulatory Procedures Manual, Chapter 9-71, the drug 714X can be allowed entry into the United States because it is approved for sale in Canada, where it is manufactured.

Under the Canadian Emergency Drag Release Program, a Canadian physician may request, under a compassionate plea, its use for a specific patient. However if the importation of 714X into the United States is due to promotional activities in this country, all shipments can be detained by the FDA.

"We do not stand in the way of an individual seeking alternative treatment, but if an organization is promoting a product [unapproved by the FDA] then they are in violation of the Provisions of the Food, Drug and Cosmetics Act," says Arthur Whitmore, press spokesperson for the FDA.

As of this writing, the FDA has not commented on whether they will charge Writers and Research with 'promoting' 714X.
Yet in response to the FDA's search and seizure, Charles Pixley, president of Writers and Research, has retained Nancy Lord, M.D., attorney at law, to begin a class action suit and legal plaint.

"So far they have not been indicted," says Lord, "But I'm very concerned that there is going to be an indictment." Lord says, adding that she believes Writers and Research is in danger of being charged because they made themselves available to the media and were willingly telling people where they could obtain 714X. Lord says she doesn't think that in terms of a criminal indictment the FDA will make a distinction between simply providing information and promoting.
"[If they are indicted] they will be charged with promoting and "selling" 714X," Lord continues. "However, I think Charles Pixley will be acquitted because one of the things the FDA has to prove is that he committed fraud, and there is no way to prove that he did that."

Charles Pixley argues that he is protected by the First Amendment, because his organization merely provides information to those who are interested. "If our crime is introducing alternatives that aren't 'approved,' then what is the crime?" he asks. "The destruction of the written word is the highest form of tyranny there is."

"I don't think the government has the right to tell people who are dying what they should use to make them better," Lord says. "I think that our founders made a big mistake when they didn't include the freedom of medicine in the Constitution."
According to Writers and Research, all materials and equipment, except for the 714X documentation, were returned a month after the raid.

"We're not displeased that the FDA has these documents," says Caroline Ganz, vice president of Writers and Research. "Perhaps, maybe then, they'll read them."
The FDA is underestimating the American population, says Judy Pixley. "They are going by the premise that people don't have the intelligence to make up they're own minds.

"People must be allowed to educate themselves," she adds. "How can anybody make a conscious decision about their health if nobody knows all that is out there?"
Article copyright Yoga Journal L.L.C.

714X Marks the Spot

When your family doctor's office calls to make an appointment for a biopsy after your recent mammogram, you think the worst. No matter how brave and sensible you are, the fear stays with you. My biopsy, actually equivalent to a small partial mastectomy, removed a mass from my left breast which had showed like a sprinkling of powder on the X-ray.
After that 1994 biopsy, the doctor said he was glad he had removed a large amount, because several invasive interductal carcinomas were on the periphery of the mass. Inside were many insitu cancers -- cancers that haven't invaded surrounding tissue. His good news was that mastectomy (removal of the entire breast) would eliminate any remaining cancer. However, losing a breast was a horrible prospect.

In December, 1992, I had been intrigued by a magazine article about Gaston Naessens, a scientist in Quebec who had invented a special microscope (the somatascope). With it, he was able to analyze living particles in live blood to detect pre-cancerous conditions. Also, prominent people from around the Western world were using a camphor-based medicinal Naessens developed called 714X. The compound is homeopathic. The active ingredients are extremely dilute and stimulate the body's innate systems of defense rather than intervene in a direct biochemical way. He had some support, but he was also persecuted by the Quebec Medical Board.

I had a difficult time finding the name and address of the Centre d'Orthobiologie Somatidienne de l'Estrie Inc (COSE), the laboratory featured in the magazine. In my search I telephoned doctors as far away as California. I finally walked into my first health store -- once I did, a spring of information became available!

I made an appointment to go to Quebec to have my blood examined. In the meantime, I was put in touch with a Dr Paul Jaconello in Toronto. He was sitting on the fence about 714X, but he ordered it for me from the Health Protection Branch of Health and Welfare Canada. He also showed me how to administer it to myself. He gave me the names of two Toronto cancer specialists who were at different ends of the philosophy and treatment pole. One was Dr Rudy Falk. Thank goodness I saw Dr Falk first that day. He was willing to go along with me but said mastectomy would be the preferred treatment. He didn't have objections to 714X. He monitored me carefully and recommended weight loss, diet modification and staying cheerful. Dr Falk didn't advise radiology treatment, but he did recommend tamoxifen, an estrogen inhibitor, which I also took. Another doctor read my pathology report and recommended immediate full mastectomy. He said if I didn't have the operation, that I'd be very, very sorry within a year.

In early November I had my appointment at Naessen's laboratory in Rock Forest, Quebec. The somatoscope showed a sparkling firmament of tiny moving shapes of all sizes and motility in a pin-prick of my blood. Because the blood was alive, I saw the big white cells destroying invaders and macrophages eating the dead invaders. It was observed I did not have advanced cancer. For $60 I received a video cassette of my own blood and one describing the whole process. There were many scary nights when I trembled at my route away from mainstream medicine. I would get up often and play those videos.

It was easy to give myself 714X. I placed an ice pack on the spot, which my doctor marked with a felt pen. In a prone position I injected a small amount gradually with a tiny insulin needle. Eventually I didn't need an ice pack and could inject quickly. Nine to 16 months of treatment are recommended as minimum if metastases are suspected.

It was less easy to pay for 714X. Prices vary widely. For a couple of years I paid $110 for a series (21 days) then the price went up to $125 plus courier ($135). I have heard of a doctor who charges $75 including courier to Madoc, Ontario and one in Kingston who is $50 within that city. In the article I read in 1992 it stated that COSE gives 714X free to physicians who administer it according to protocol. Tamoxifen is paid for by the Ontario health plan.

My estrogen, which is the enemy in breast and ovarian cancer, went down to zero. After two years, I stopped taking tamoxifen. After four years I stopped 714X.

My own local general practitioner, who was scornful of 714X when I started (he called it snake oil), recently asked me for material on it. His wife has breast cancer. He lives 50 miles from a major teaching hospital -- so much for confidence in current medical treatment.

Why am I okay and still in possession of my breasts nearly five years after biopsy? I don't know. It's impossible to tell which tooth is doing the cutting on a saw blade. But if I were to have surgery or radiology now, I would follow it with at least six months of 714X. Anybody with any kind of cancer should seriously consider getting information about 714X. Reading the material by Gaston Naessens is better than a version filtered through someone else. Take your time and get expert advice. Don't be panicked or stampeded. Call COSE (819-564-7883) and investigate. Bon chance!
Article copyright Canadian Health Reform Products Ltd.