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Cancer drug `cures' get serious study

Posted on: Sunday, 9 March 2003, 06:00 CST

Cancer drug `cures' get serious study

Source: Boston Herald

Billy Best, the cancer patient who made national headlines when he ran away from his Norwell home nine years ago to avoid chemotherapy treatments, is now being studied by the National Cancer Institute to see if the alternative drug he took was what actually cured his disease.

Best, now 25 and living in California, where he is writing a book about his experience, is among six cancer patients who say they were cured by 714X, a controversial medication developed in Canada, and whose cases are being reviewed by NCI.

"I'm excited about it," Best said in a telephone interview. "It looks hopeful. They're going through the steps to get it approved in this country."

That would be sweet news to those who say the drug has cured them or a family member.

"We're very optimistic and pray the drug will be approved for others to use," said Julie Hartley of Duxbury, whose 15-year-old daughter, Katie, was apparently cured by the medication.

"It's a lot better than chemo and there are no side effects," said Katie, who was diagnosed with a cancer of the face at age 7. "All I felt was worse on chemo. All I felt was better on 714X."

Best was told by conventional oncologists that he would die without chemo. And Hartley was told there was nothing more they could do for her.

Today, both are cancer-free.

The drug in question has a long and checkered history. It was developed by Canadian biologist Gaston Naessens, who was convicted in Europe in 1965 of unlawfully practicing medicine. It is not approved by the FDA but is allowed in Canada as a last resort.

The drug, which is injected directly into the lymphatic system, contains mineral salts, camphor and a variety of trace elements. It is said to boost the body's immune system and repair damaged cells.

The study by the NCI's Office of Cancer Complementary and Alternative Medicine was requested in May 2001 by the Dana-Farber Cancer Institute after the NCI-affiliated cancer center was stung by criticism that it was trying to keep the promising drug under wraps.

Dana-Farber received lots of negative publicity after it was revealed that the institute's researchers had started studying the drug in a lab setting in 1999 but shut down the tests under a shroud of mystery.

The Canadian company that makes the drug, CERBE Distribution, sued, but the case was settled out of court with a confidentiality agreement.

The company's lawsuit against Dana-Farber contended that lab studies done by researcher Lili Huang in 1999 showed "positive chemokine reactivity."

The suit, which alleged breach of contract, contended that as a result of the initial test results, Huang "was hopeful that a formal collaboration. . . could occur, culminating in a publication of the results in some reputable journal."

Documents obtained by the Herald showed researchers at Dana- Farber actually were sharply split in their opinion of the lab findings.

And the institute's top researchers told the Herald in 2001 that the study was halted because the researchers doing the study didn't know exactly what was in the substance they were testing and said the company would not make independent verification of the contents of the drug possible.

For that reason and others, the Dana-Farber officials said, an agreement to continue testing the drug was not reached.

Jacinte Naessens, wife of the drug's developer, said she believes the NCI is taking its study of the drug seriously.

Although NCI announced almost two years ago it would study the drug, Naessens said she does not believe the agency is dragging its feet.

"We have a very good collaboration," she said. "There's not a bad word we can say. We can see that they are taking it seriously."

She said it has taken this long to find the "best cases" and get the necessary tumor samples, lab results and medical charts of the patients, including Best and Hartley.

"They want the original pathology slides and they are so hard to find," she said. "Every hospital has its own policy. We have the slides for three of the patients. Three more we are working on."

She said she hopes the agency soon will have all the data it needs and that a special panel of oncologists and alternative- medicine specialists will hear a presentation by the company in June.

If the panel agrees, a prospective study to follow patients starting on the therapy might begin.

Naessens said she still hopes Dana-Farber will agree to take part in such a study.

Dr. Jeffrey White, director of the NCI's Office of Cancer Complementary and Alternative Medicine, declined an interview. But in an e-mail, he said the agency asked CERBE Distribution to submit data on patients in August 2001. He said the company tried to obtain the necessary slides, test results and charts until October 2002, "when we offered to take over the process of locating and obtaining this information. We now have nearly completed the process.

"Once completed, we will have a final review and will get back to the company with our opinion and recommendation about whether or not further research is warranted and, if so, how to proceed."

Patients and their families are hopeful the agency will go forward so others can benefit from what they say is an amazing drug.

"I'm glad they have decided to research 714X and I hope they find the same promising results we experienced," Julie Hartley said.

Sue Best, Billy's mother, agreed. But though she believes the drug cured her son, she said 714X is not magical and won't necessarily cure those whose cancer is very advanced.

Best, now of Rockland, noted that another patient, Cheryl Cavallo of Pembroke, died of breast cancer in November 2001 after treatment with 714X.

However, Best said Cavallo was diagnosed with late-stage cancer and turned to the drug after conventional treatments failed. She said the drug gave Cavallo another two years of life but, in the end, couldn't work a miracle.

FDA approval would allow patients to start on the drug before their cancer has progressed to the point where it is incurable, Best said.

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