714-X

[Guest guest]

Here is a start. I am going on Holidays until early in the New Year. Be back with an update on how my client is doing on 714-X...She is currently doing all of the BTG's,,using HMF replete and doing fine so far. Season's Greetings to all!! Sincerely, Heidi Mayer B.Sc. RNCP Clinical Nutritionist Cancer patients highlight new 714X controversy and the NCI agrees to review the treatment © By Chowka (June 1, 2001) A small but dedicated group of cancer patient activists in Eastern Massachusetts has helped to bring to light what they describe as a possible cover-up of promising, preliminary test results of 714X, a controversial unconventional cancer treatment from Canada, at the prestigious Dana-Farber Cancer Institute in Boston. A subsequent avalanche of media reporting about the story in the Boston area has resulted in Dana-Farber on May 21 calling on the National Cancer Institute (NCI) to undertake a formal review of 714X, which the NCI's Office of Cancer Complementary and Alternative Medicine (OCCAM) has agreed to do. The case is unique: patients decry a cover up of a promising alternative treatment and the cancer establishment responds almost immediately by

promising to review it. The whole episode illustrates the impact that people with cancer, highly motivated and using tools such as the media and the Internet, can have on getting alternative therapies tested at the highest levels of the federal government. And it suggests that a climate of openness is replacing the closed mindedness of the past in terms of national cancer policy. Key players in the still developing story include cancer patients Cheryl Cavallo and Best and 's parents, Sue and Bill Best, and OCCAM director White, MD. Best, WCVB-TV, May 2001 Best, 23, gained major national attention in 1994 when he ran away from home rather than continue to take chemotherapy for his Hodgkin's Disease. Coaxed by his parents to return to their home in a suburb south of Boston, Best chose two alternative therapies, 714X and another unconventional Canadian treatment, the herbal compound Essiac. Best was supported in his decision by his parents and by a state court, which found in 1995 that, at age 16 1/2, he was old enough to make up his own mind about his treatment options. (Dana-Farber had reported the Best family to the state's Department of Social Services for legal action when it was learned that the young man was taking 714X.) Seven years later now, Best says he is cancer free. Since the mid-1990s, Best and his parents have provided information about alternatives to many people with cancer in Massachusetts and around the country. 714X 714X is a nontoxic, relatively inexpensive alternative cancer therapy developed by "researcher-biologist" Gaston Naessens. Its chemical name is trimethylbicyclonitramineoheptane chloride. Gaston Naessens, WFXT-TV, May 2001According to a technical file at the Web site of Cerbe Inc., the Canadian company that manufactures and distributes it, 714X "contains nitrogen as its primary ingredient, camphor as its vehicle, mineral salts and 18 trace elements." It is available in both injectible and inhalable forms of

administration. The Cerbe file goes on, "714X is a product created to improve health by revitalizing the immune system and is not designed to act directly on disease releated sysmptoms. 714X supports natural defenses (including the immune system) when introduced into the lymphatic circulation." The Center for Alternative Medicine Research in Cancer at the University of Texas at Houston (UTH) describes its mechanism of action as follows: "714X is a derivative of camphor with an extra nitrogen molecule attached. Theoretically, 714X supplies the body with the nitrogen it needs to neutralize the nitrogen hungry tumor cells and stops cancer cells from producing CKF. Naessens believes that if the CKF substance is neutralized, the immune system will be able to recognize cancer cells as foreign entities and attack them. 714X also contains organic salts which fluidify the lymph to carry away the toxins accumulated during the

illness. 714X is reportedly nontoxic. . .Naessens recommends that cancer patients adopt a largely whole grain, vegetable, and fruit diet with small amounts of meat as needed." Like most proponents of alternative cancer therapies, credentialed or not (Naessens has no medical or advanced scientific degrees), Naessens has been surrounded by controversy since he began his career as a medical innovator and inventor in his native France in the 1950s. He moved to Quebec, Canada in the early 1970s. In 1989, he was tried in Canada for practicing medicine without a license but acquitted by a jury. The UTH Center reported in 1999 that 714X, developed in the 1970s, "has been legalized by the Canadian government and over 800 physicians are using this therapy for patients. . .Volume of sales is rising per COSE (7/8/96); the cost of treatment is inexpensive in Canada and usually covered by insurance; costs are $50 for 21 days

and usually continued for 3 month intervals." 714X is also widely used in Japan. In the U.S., individual patients may legally import supplies of 714X directly from Cerbe for their personal use. In 2001, according to the Cerbe Web site, the cost in U.S. dollars of a 21 day supply of injectible 714X was $300. Supporters of Naessens depict him as a world class original mind. The title of a 1991 biography by the late Bird, The Galileo of the Microscope, refers to Naessens' development of a high resolution dark field microscope with magnification of 30,000X that allows examination of live blood. The Massachusetts Patients Expose an Apparent Cover-up Cheryl Cavallo, WBZ-TV, May 2001 Cheryl Cavallo of Pembroke, MA, 39, married and the mother of two children, was diagnosed with breast cancer in 1997. Despite following an aggressive conventional protocol that included a lumpectomy, a mastectomy, radiation, chemotherapy, and hormone treatments at the Dana-Farber Cancer Institute in Boston, Cavallo's cancer spread to her spine. In May 2000 she discontinued conventional treatments and concentrated on alternative therapies, including diet and Essiac. In September 2000 she started taking 714X. In an interview on May 30, Cavallo said that she was influenced to start taking 714X when she read some of the sealed records of a court case involving Cerbe, the Canadian company that manufactures and

distributes 714X, and Dana-Farber. The documents were brought to light by Sue Best in the summer of 2000. The court case related to a test of 714X that Cerbe hired Dana-Farber researchers to conduct in 1999. In a letter written August 9, 1999 to Dana-Farber's Director of Research that has since been leaked to the media, one of the researchers involved in the 714X test, Dr. Arthur B. Pardee, professor at Dana-Farber's Division of Cancer Biology, and Lili Huang, his research associate, wrote "For the first time, our data provide scientific evidence supporting that 714X is an immune stimulus. . .714X is thought to elevate the immune response and have some role in killing tumor cells. Our data provide evidence to support this theory." Pardee and Huang added, according to the Boston Herald (May 21, 2001), that their preliminary "test results 'clearly demonstrate' that 714X activates white blood cells and induces the secretion of proteins that play a role in the body's

immune defense system, including the part of the immune system that recognizes tumor cells." A Dana-Farber official, Chuck Stiles, vice chairman of the cancer biology department, replied to the Pardee-Huang letter on April 19, 1999: "I am very worried about this work." Shortly after the 714X tests began in 1999, the promise of the early results notwithstanding, they were shut down by Dana-Farber. Cerbe then sued Dana-Farber for breach of contract, alleging that, althought the tests showed "positive chemokine reactivity" for 714X, Dana-Farber peremptorily ended the tests. In the suit, Cerbe sought the return of the 714X samples it had provided to Dana-Farber as well as the test results. The suit was settled out of court in mid-2000 and a confidentiality agreement prohibits both parties from discussing the case. Nothing prevented Sue Best from publicizing the case, however (in the intervening years she has

developed a relationship with Cerbe and Naessens and she saw copies of the court documents). In mid-2000 she began sharing the news about the lawsuit and e-mailing and calling the media with the story. The Media Play a Role WFXT TV reporter-anchor Steve Avesonintroduces Fox Undercover report on 714X, May 14, 2001 During the winter of 2000-2001, Boston's NBC TV affiliate WHDH channel 7 prepared a report on the 714x-Cerbe-Dana-Farber story including interviews with Cavallo, the Bests, and others. It never aired. (Cavallo and Sue Best allege that

they were told by a reporter that someone in the station's upper management or possibly even the owner deep-sixed the story.) At that point, Sue Best began contacting other media and found interest at Boston's upstart Fox network TV channel, WFXT 25, which airs an hour of local news in prime time nightly at 10 pm. (Boston currently has a very competitive TV news environment.) After an article in the Boston Herald on April 2 and brief reports on the 11 pm news by WBZ TV channel 4 on May 1 set the stage, WFXT as part of its "Fox Undercover" series aired two segments about the 714X story on May 14 - unprecedented in length, depth, and quality for a local newscast. The report was titled "Canadian Cancer Cure." In introducing the segments, Steve Aveson, the newscast's co-anchor who also reported the story, said, "There are some patients who feel that the [Dana-Farber] Institute is keeping some of its best research a

secret. . .Fox Undercover investigates why this Canadian cancer cure is banned in Boston." WFXT interviewed Best, Cavallo, and Hartley, 14, another cancer patient who has used 714X and is now cancer free, according to her mother Hartley. The segments also featured reporting from Canada and an interview with Naessens. Through a translator, Naessens said 714X "permits the natural defenses to be strong and healthy and then the body can itself fight against disease." The report prominently mentioned the positive results of the preliminary 714X tests at Dana-Farber, the sudden termination of the tests, and the Cerbe-Dana-Farber lawsuit. Naessens said that "Anything that comes - that is not actually the brainchild of the drug industry is being criticized and is being pushed aside." The report included comments by a critic of 714X,

Rosenthal, MD, past president of the American Cancer Society and currently the head of the Lenny Zakim Center for Integrated Therapies at Dana-Farber. Rosenthal would not comment directly on Dana-Farber's tests of 714X but he said in answer to a question about Naessens "He's been in jail twice; why has he been in jail twice?" Reporter Aveson observed in a voice-over that Naessens has not been in jail twice although he has been fined several times for practicing medicine without a license. The next night, May 15, apparently due to intense viewer interest, the WFXT 10 pm news repeated about one half of the previous evening's 714X feature. Another report led the WFXT 10 pm newscast on May 21. Boston stations WBZ (CBS, channel 4) and WCVB (ABC, channel 5) broadcast their own feature reports (on May 22 and 29 respectively), the Herald printed three more stories (on May 21 and 23), and the high circulation

suburban daily The Patriot-Ledger ran a feature on May 23. All of the reporting was at least objective and, in some cases, could be interpreted as casting positive light on 714X. Virtually all of the articles and TV reports prominently featured Cavallo, who, despite her ongoing battle with cancer, always appeared energetic, healthy, and articulate. She, and Best, who was also widely interviewed and usually shown riding his skateboard, were compelling advocates for 714X. The fact that 714X appeared to be the victim of actions by Dana-Farber (the summary cessation of the 1999 tests) that were suspicious at best added a hook and, in broadcasting industry parlance, gave the story "legs." The NCI is Called In Apparently, public pressure on the media and on Dana-Farber accelerated and on May 21 it was learned that Dana-Farber had

requested that the NCI conduct a test of 714X and that the NCI had agreed. Cerbe issued a statement that said "We are willing to work with the NCI immediately." According to media reports, including the Patriot-Ledger story on May 23, Dana-Farber asked for the review. According to Dana-Farber spokesman Singer, the call to the NCI went out "because we started getting a lot of questions from patients about 714X" after publicity on the drug. Singer added, "This stuff is out there being promoted to the general public as a cancer drug. While we've seen no scientific evidence (that it works), we think it makes sense for the NCI to determine if the compound merits further study." DeWaele, assistant to Cerbe's president, told the Patriot-Ledger that the company has records for hundreds of patients, and added "We're just chomping at the bit [to have the drug reviewed]." In the past, when

disputes involving testing of alternative cancer therapies at mainstream institutions came to light, the institutions would typically circle the wagons, dig in, and continue to cover up. In the view of many independent observers, such was the case when Memorial Sloan-Kettering Cancer Center in New York tested the controversial substance laetrile in the mid-1970s. These days, things have changed quite a bit and there are other options, including, in the case of 714X, sending the whole issue down to the National Cancer Institute. White, MD White, MDABC World News TonightJune 9, 2000 Since 1999, the NCI has had an Office of Cancer Complementary and Alternative Medicine (OCCAM). It works closely with the National Center for Complementary Alternative Medicine (NCCAM). OCCAM's director, White, MD, has a reputation as a fair and open-minded administrator. In 2000, White publicly defended , MD when there was criticism of the New York City clinician for being awarded a $1.4 million government grant to test an unconventional enzyme-nutrition therapy on pancreatic cancer. In a telephone interview on May 30, White told me how the NCI review of 714X is expected to go forward. "We agreed to put out a request for patient case report information through our best case series program," he explained. "We've contacted the company in Canada, Cerbe, and sent a letter to Mr. Naessens. Actually, we've already received a response from [Naessens]

expressing willingness to provide us the information. Hopefully, we will receive [the information] and take a look at it." White said that the review of 714X would be different, for example, than the review of case histories of the Bio-Medical Center in Tijuana, Mexico (Hoxsey Therapy) and the Livingston-Wheeler clinic in San Diego that were financially supported by the government but conducted by the University of Texas at Houston and published this past February. The NCI's review of 714X will be done in-house. According to White, "The [714X] review is done at the NIH's clinical center. We have members in the pathology department there, in the radiology department, that review the films and the path slides for us. We do have an established best case series process and that's what we're trying to implement here. The differences are that we've not dealt

directly with a company before to obtain data. We normally deal with a practitioner who has a group of patients that he or she has treated and we deal directly with them. So what we've asked the company [Cerbe] to do is to either obtain the data for us on patients they know have received the 714X or to contact physicians that they know have used this and ask them to supply the information. That's one difference. But basically we'll be asking for exactly the same material: copies of pathology reports, copies of radiographic reports. Then we'll review the actual pathology slides and the actual radiographic films." I asked White if there is a minimum number of 714X case histories required before some kind of conclusions can be reached. "Well, we have generally asked for at least four or five cases. . .It's not 100 cases. . .We'd like to see a reasonable number of high quality cases. But if it's ten cases, that would

be fine." As far as the time line, White said that Cerbe "did tell me that they're going to try to get me this information by the middle of August. I try not to hold people to those kinds of things because once they get into the process they find out how difficult it may be, but that's what they're shooting for. If they're able to do that - and again, this is going to depend on the number of cases - if it's about ten cases or something like that, then we ought to be able to get that review done in a month's time. Then we'll have to find out when the next meeting of the CAPCAM - the Cancer Advisory Panel for Complementary Alternative Medicine- is and get it [714X] scheduled on the agenda for CAPCAM review. "[CAPCAM] will have seen copies of the reports or at least a summary of the data. And then the individual cases will be discussed at the meeting, case

by case. And they [CAPCAM panel members] will make their analysis of each case. We don't put forward case series that we don't think - that they are going to just say are garbage (laughs), unless there's some compelling reason for us to do that. And I would prefer not to waste time with that. . . We're still going to make every effort we can to get the best case series." I asked White about the process that comes after the CAPCAM panel's review of the data, assuming it is positive. "What the panel would do, if they feel that it's adequate information for them to determine if . . .there's some suggestive activity here or something that needs to be followed up, then they would make a recommendation to the director of of NCCAM [the National Center for Complementary and Alternative Medicine] that NCCAM ought to support research in that area. They may

specifically say what kind of research they are talking about - clinical trial of some type or they can be as specific as they want to about that. And then, if that is the recommendation, it's up to NCCAM to act on it within their other priority areas. If this is something that they also consider to be - that they have the resources to deal with, then they'll work with NCI to figure out the appropriate mechanism." I asked White if in fact Dana-Farber had asked the NCI to review 714X and, if that was the case, if it was an unusual request. He replied, "Yes. We've not been approached by a cancer center before to investigate something like this. We actually just recently in the past seven or eight months started to advertise the existence of the best case series program. So a lot of people don't know that we actually do it. The contacts that we've gotten so far have come generally from individual practitioners. But,

yes, this is relatively unique that we that we have a cancer center recommending that we investigate this. . . "I'm glad that we're getting an opportunity to take a look at it," he added. "We've certainly received already calls from patients that feel that they've benefited from this approach." For more information, Office of Cancer Complementary and Alternative Medicine NCI Friends with Hope (Cheryl Cavallo) and Sue Best Cerbe Distribution Cerbe technical data on 714X (PDF) The Center for Alternative Medicine Research in Cancer at the University of Texas - 714X summary The Center for Alternative Medicine Research in Cancer at the University of Texas - 714X detailed information Boston media reports Boston Herald, April 2 WBZ TV, May 1 and 22 WFXT TV, May 14 Boston Herald, May 21 Boston Herald, May 21 Boston Herald, May 23 The

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