"I must say, it is a little discouraging at times," said Dr. Aaron Malkin, 12 months after setting up the Isola Bella Oncological Multiple Therapy Clinic in a second-floor office in August 1999. During its first year the clinic received many inquiries, Malkin said in an interview, but it actually treated only "5 to 10" patients. This was a far cry from the situation in 1997 and 1998, when the "cure" developed by Italian physiologist Luigi Di Bella was attracting a firestorm of international attention. As Charlotte Gray reported in CMAJ in 1998 (158[11]:1510-12), the phones of Toronto MP Joe Volpe were then ringing 10 times a day with inquiries about DBM. Most callers wanted Volpe, an Italian-Canadian who was then parliamentary secretary to the health minister, to explain why the "miracle" cocktail was not available in Canada.

Di Bella's controversial cocktail combines bromocriptine, melatonin and somatostatin or octreotide with complementary substances, including vitamin C and shark cartilage; it is taken with low doses of chemotherapeutic agents such as cyclophosphamide.

Under immense political and popular pressure, Italian health officials supported historical studies of DBM patients and 11 uncontrolled phase II trials. The historical review, reported last year in Cancer (86:[10];2143-9), concluded that the 5-year survival rate for DBM patients was significantly lower than for patients receiving conventional therapy, with no evidence of improved survival prospects. The phase II trials, reported in the BMJ (1999;318:224-8), found insufficient efficacy to warrant further clinical trials.

Malkin thinks his Toronto clinic is the only one of its type in North America. The clinic's original advertising was limited to the Buffalo News and a Toronto-based Italian-language newspaper, but in August he began promoting the clinic and DBM on a Web site, www.oncomtc.com.

Three doctors are involved in the clinic. Malkin, an internist with a doctorate in biochemistry, was head of clinical biochemistry at Toronto's Sunnybrook Hospital from 1961 to 1992. The other physicians are DBM specialists based in Italy. Malkin meets initially with the patient, then consults with his Italian colleagues, who develop a treatment protocol that is prepared by an Italian pharmacy. Initial treatment lasts at least 3 months. "For all of these services, the Isola Bella Clinic will require a retainer of $3800 for the first month and $1300 for each month thereafter," Malkin's Web site advises.

The site acknowledges that evidence of DBM's efficacy is "anecdotal" and there is "currently no acceptable Canadian medical proof that this treatment will cure cancer."

Why, then, did he bother introducing the widely discredited protocol here? "I'm curious about the results, and I'm looking after the patient's interest," he said. "All of the information until now has been anecdotal. Di Bella and his colleagues didn't do a careful study."

Because some components of DBM have known anticancer properties, Malkin "thought it would be interesting to see what happened" during treatment. As for his own lack of patients, he says: "I'm not worried about that. I'm semi-retired. I'm doing other things."