Cancer agency won't study alternative therapy

The cases of five patients who say they were cured of cancer by a controversial alternative medicine were not compelling enough to justify a government-funded study of the 714X compound, the National Cancer Institute apparently has decided.

The treatment, available in Canada under a compassionate-use program, has gained popularity in the United States through word of mouth, though it is not approved by the Food and Drug Administration. There are no published studies showing it works in humans.

’’The presented data was insufficient to recommend NCI-sponsored research using 714X in the treatment of cancer,’’ Colleen O. Lee of the NCI’s Office of Cancer Complementary and Alternative Medicine wrote in a May 17 e-mail to Gaston Naessens, a Canadian biologist and developer of the compound made from mineral salts, nitrogen-rich camphor and some trace elements.

An official statement on the decision from the NCI is expected this week. The institute reviewed 714X at the request of the Dana-Farber Cancer Institute. The respected research center had conducted laboratory tests of the compound in 1999 and then stopped the work, prompting criticism from some who thought it was blocking development of a promising drug.

The five cases, including those of Billy Best of Rockland and Katie Hartley of Duxbury, were presented to the NCI’s Drug Development Group in July 2003. Best, now 26, gained notoriety 10 years ago when he ran away from home to avoid continued chemotherapy for non- Hodgkin’s lymphoma at Dana-Farber. He is healthy today and credits 714X.

Best, now an auto mechanic who is writing a book about his experience, said he believes that the NCI is trying to ‘‘sabotage’’ the drug, but that the agency won’t succeed. ‘‘It helps too many people,’’ he said. ‘‘It’s not going to go away.’’

Hartley, now 17, was diagnosed with sarcoma of the sinuses at the age of 7. After she failed chemotherapy, her doctors told her there was nothing more they could do for her, and expected her to die. Her parents heard about Best and started Katie on 714X. She and her family say she has been cancer-free ever since.

About 4,000 patients in Canada have used the medicine with the approval of Health Canada, according to Naessens. American patients can obtain the medication by mail without a prescription from Naessens’ Cerbe Distribution of Quebec.

Health Canada approved the compassionate use of the compound after Naessens was acquitted in 1989 of charges of practicing medicine without a license and negligent homicide in connection with the death of a woman with advanced breast cancer who had been treated with 714X. Earlier in the 1980s, he was charged in France with practicing medicine without a license and paid a fine. The medication’s popularity soared after Naessens’ acquittal in Canada. In recent years, the drug has gained popularity in alternative- medicine circles and through the Internet.

But 714X has its critics. Dr. Gerard Batist, chief of oncology at McGill University in Montreal, said he was pleased by the NCI’s decision not to fund a study of the compound. ‘‘Patients should not feel that anything of any value is being taken away from them,’’ he said.

Batist said that about 10 years ago he studied several cases of patients who had used the medication, cases provided to him by Naessens.

’’It was very clear there is no benefit to anyone from anything he has done,’’ he said. ‘‘In every case, there were other explanations.’’ Batist said Health Canada was pressured into allowing the drug under compassionate use — without seeing any studies.

Naessens ‘‘had a following,’’ Batist said, ‘‘and he managed to convince Health Canada to make it available.’’

The compound is injected into or near the lymph nodes, and is said to boost the body’s immune system.

While 714X has no apparent side effects, there are no published studies to prove its efficacy. Tens of thousands of patients have used it, and many say it has cured their cancer. But skeptics say these patients may have experienced spontaneous remissions or been helped by the delayed effects of chemotherapy.

Dana-Farber researchers took an interest in 714X in 1999, but the tests were stopped soon after and Cerbe sued for breach of contract. The case was settled out of court, with the terms kept confi- dential.

Court documents revealed sharp disagreement among Dana- Farber researchers about the promise of the drug. ‘‘For the first time, our data provide scientific evidence supporting that 714X is an immune stimulus,’’ wrote Arthur B. Pardee, a researcher at Dana- Farber’s Division of Cancer Biology, and Lili Huang, a research associate, in an August 1999 letter to Dana-Farber’s director of research.

But Faye Austin, the research director, and other Dana-Farber scientists later said in interviews that any number of compounds could have produced the same response and disagreed that 714X was promising.

Dana-Farber officials nevertheless requested the NCI review of so-called ‘‘best cases’’ in May 2001, saying they were responding to growing interest from the media and from patients.

‘‘We asked the NCI to review the claims people were making about 714-X because the NCI has a special office for just that purpose. Our goal has always been to ensure that cancer patients have the best information possible about their treatment options,’’ Dana-Farber spokesman Steven Singer wrote in an e-mail last week.

In its May 17 e-mail to Naessens, the NCI stated that the overall impression of the drug development panel was that more information was needed. But the agency said it intends to submit the studied cases for publication in a scientific journal.

‘‘The goal is to make this information available to the scientific community whose individual members can then make decisions to pursue research involving the use of 714X to treat cancer,’’ Lee wrote.

Jacinte Naessens, the wife of the medication’s developer, said she believes the NCI review was done simply to take the heat off Dana-Farber. ‘‘I don’t think helping patients was the concern,’’ said Naessens, whose husband speaks no English.

Dr. Roger H. Rogers, a Canadian primary-care doctor who said he has treated about 400 cancer patients with 714X, said he is puzzled by the NCI decision.

‘‘A study is certainly warranted, because of the numbers of people who have improved on 714X,’’ said Rogers, whose practice near Vancouver integrates conventional and alternative medicine.

He said he first became aware of 714X about 15 years ago when a patient with uterine cancer persuaded him to try it on her. ‘‘I was amazed at her recovery,’’ he said. ‘‘She had tried chemo and radiation. Nothing worked.’’