SHARK CARTILAGE PHASE II/III CLINICAL TRIAL PRELIMINARY RESULTS

SHARK CARTILAGE PHASE II/III CLINICAL TRIAL PRELIMINARY RESULTS show that 50% (10 out of 20) of cancer patients reported an improved quality of life, including less pain and better appetite, after at least eight weeks of follow-up. Data from the ongoing trial were presented by Charles Simone, MD, Simone Protective Cancer Center, Lawrenceville, N.J., at a June 24 Senate Appropriations/HHS Subcommittee hearing on the National Institutes of Health's Office of Alternative Medicine (OAM). Under the study protocol, patients self-administered a starting dose of 70 g of shark cartilage either orally or rectally. For those who did not respond by week six, the dose was escalated by 10 g increments. Ten of the 20 subjects required doses higher than 70 g, Simone reported. While 80 patients have been accrued for the study, only 20 have been followed for the initial eight-week follow-up period, Simone said. Patients completed self-evaluations every two weeks on a series of quality-of-life indicators, including cognitive ability, sexual dysfunction, general well-being and physical symptoms, such as fatigue, nausea and vomiting and muscle cramps. In addition to the quality-of-life assessments, patients were examined for tumor activity; four of the 20 patients showed partial or complete responses, defined in the protocol as a 50% or greater reduction in lesions, or total disappearance of tumor masses and signs of active disease. Simone has received no federal funding for the trial, although an application has been submitted to OAM under a request for applications (RFA) issued by the office in March. The researcher sought and received an informal "recommend[ation] to proceed" from the co-chairs of OAM's Committee for Pharmacologic and Biologic Treatment prior to starting the trial. Simone told the subcommittee that while the results show that shark cartilage "may not be a treatment for everyone," he said he has seen "remarkable" responses in several patients. Simone headed up a team of investigators who assessed the validity of a clinical trial conducted in Cuba involving shark cartilage in cancer patients ("The Tan Sheet" April 5, p. 7). In other testimony, Fetzer Institute president and CEO Robert Lehman recommended several specific trials that could be conducted on alternative medicines, including research on Chinese herbal preparations to treat the side effects of chemotherapy. Following Lehman's remarks, OAM Director Joseph Jacobs testified that the office "hope[s] to provide more attention to issues related to herbal and ethno-medicine." Jacobs also updated the committee on the status of efforts to increase staffing levels in the office. OAM currently consists of three doctors, one secretary and a psychiatrist who has been temporarily hired by the office. Jacobs said he expects to fill one vacancy shortly and to hire several fellows through authority provided by the NIH reauthorization bill. The bill was signed by President Clinton June 10 and provides statutory authority for the OAM. Because of an NIH-wide full-time equivalents freeze, however, OAM has not hired five clinical investigators, as stipulated in the FY 1992 HHS appropriations bill. Sen. Tom Harkin (D-Iowa) told Jacobs that "by early next week I will have something from [HHS] Secretary Shalala authorizing you" to hire the five investigators, and he urged Jacobs to be "expeditious" in doing so. Harkin also asked Jacobs about money that was given to the National Cancer Institute to conduct a multicenter trial on antineoplastons, a substance which was identified by Stanislaw Burzynski, MD, at the Burzynski Research Institute in Houston. According to Harkin, $ 750,000 of OAM's $ 2 mil. FY 1992 appropriation went to NCI for this purpose. However, "I can't find out what has happened to the money," the senator said. OAM Deputy Director Daniel Eskinazi told the subcommittee that NCI requested its existing cancer centers to submit proposals for an antineoplaston trial. He noted that a proposal from Memorial Sloan-Kettering "has been submitted recently and has been forwarded to Dr. Burzynski for his comments . . . That is where it is at the present time." Harkin expressed "frustration" at the lack of data on alternative therapies from Jacobs' office. "I'm going to keep you both (OAM and NCI) in my eyesight. And I hope that you will exercise your authority as the head of this office to . . . ask Dr. [Samuel] Broder, the head of NCI, to please submit to you what they have done with this money -- what they are doing, how they are going to proceed." Harkin pointed to "another actor in this play, the FDA." He said he plans to hold another hearing on alternative medicine by September, possibly a joint hearing between the Appropriations/HHS Subcommittee and the Agriculture Subcommittee, which has jurisdiction over FDA. In addition, OAM's Ad Hoc Panel on Alternative Medicine has scheduled a meeting for July 14-15 to discuss OAM's ongoing activities, including the progress of the RFA and other possible research initiatives by the office, as well as methodology conferences and "concerns" of the alternative medicine community. The meeting, which begins at 8:30 a.m. on both days, will be held at the Renaissance Hotel at Washington-Dulles Airport in Herndon, Va.