Two groups of researchers who shared the results of their complementary and alternative therapies for cancer with the National Cancer Institute have received support to do additional research.
NCI is launching a campaign to encourage other complementary and alternative medicine practitioners to submit their data to its Best Case Series Program, designed to evaluate early data on alternative medicine approaches to cancer. “We want to proactively solicit submissions from complementary and alternative medicine practitioners who feel they have a successful approach to cancer treatment,” said Jeffrey D. White, M.D., director of NCI’s Office of Cancer Complementary and Alternative Medicine.
The Best Case Series Program has existed at NCI since 1991 to apply the principles of evidence-based medicine to therapies that have not yet been put to the test of rigorous clinical trials. Just four or five of a practitioner’s best successes are enough for a review. “The Best Case Series is a very crude way to look for kernels of information to see if there is any justification to go after additional data,” White said.
To date, CAM practitioners have not come rushing to NCI to submit their findings. “There are three big barriers,” admitted White. Busy practitioners often do not have the time, staff, or research expertise to pull together all of the necessary documentation (see box, next page).
Some have issues with trust in government: “Who will see my data? Will they try to close me down?” White said that the data are reviewed by staff at the National Institutes of Health and designated consultants only. “This is not a witch hunt,” he said. “We are only concerned with documenting what works and expeditiously investigating those approaches that seem promising.”
Finally, some complementary and alternative medicine practitioners question the value of subjecting their therapy to scrutiny when they are already treating patients. White responds that if their therapy is truly effective, NCI wants to more broadly disseminate its usefulness so that more patients can benefit.
Nicholas Gonzalez, M.D., who presented one of the first Best Case Series in 1993, is more blunt. He said it is the obligation of any practitioner with a successful therapy to collect data and submit it for review.
Gonzalez, a private practitioner in New York City who uses a complex nutritional regimen to treat pancreatic cancer, and two doctors of homeopathy from Calcutta, India, discussed their experiences with the NCI Best Case Series Program in June.
Data Collection Pays Off
When Gonzalez first presented his Best Case Series to NCI, he was told the documentation was not sufficient to show a clear-cut effect. The regimen includes a vegetarian diet, individualized for each patient, with vitamin and mineral supplements, oral pancreatic enzymes, and detoxification with coffee enemas and liver flushes.
The Institute encouraged Gonzalez to do a prospective study in pancreatic cancer, a cancer with particularly poor survival outcomes. He found funding from Nestle Corp. and published his results in Nutrition and Cancer in 1999. Of 11 patients with biopsy-proven advanced pancreatic cancer, nine lived 1 year, five survived 2 years, and four lived beyond 3 years. Mean survival was 17 months, compared to about 5 months for historical controls.
With those results in hand, the National Center for Complementary and Alternative Medicine is providing $1.4 million for a 5-year, phase III study at the Herbert Irving Comprehensive Cancer Center at New York’s Columbia University.
The study was designed in 1999 as a randomized, controlled trial, comparing the Gonzalez regimen with gemcitabine. But patients were unwilling to be randomly assigned to conventional chemotherapy. “Of 200 calls we received, 197 patients refused randomization,” Gonzalez said.
NCI and Columbia agreed to shift to a nonrandomized, prospective design. Patients who choose chemotherapy will be compared with those who choose the Gonzalez regimen. The endpoint is survival, with 45 patients recruited to each arm. Quality of life is also being measured.
“If you collect and organize good data, people will pay attention,” Gonzalez added. “You never know what a good Best Case Series is going to lead to.”
Prasanta Banerji and his son Pratip Banerji, doctors of homeopathy at the PBH (Prasanta Banerji Homeopathic) Research Foundation in Calcutta, India, faced many obstacles in putting together their Best Case Series.
“We are not professional researchers, but clinicians who through our experience have found something important to impart,” said Pratip Banerji, a fourth generation homeopath.
Patient flow into their private clinic is huge, often exceeding 1,000 patients per day. They lacked the manpower and procedures to gather the required data and scans. Many patients are poor and unable to get follow-up tests. Patients who pay for their own scans are not willing to give up the original, and some hospitals are unwilling to hand over original scans as well. Patient follow-up was also difficult in this large, rural country with poor communications facilities. The Banerjis were finally able to pull together 12 cases; “not our best cases,” said Pratip Banerji, but their most complete. The patients had various malignancies; seven had lung cancer.
At the Banerjis clinic, patients receive only homeopathy, the use of ultra-high dilutions of compounds, for treatment of their cancers. Unlike classical homeopathy, which individualizes the treatment for each patient, the Banerjis have standardized their approach so that all lung cancer patients receive the same prescription for their cancer. This disease-specific approach makes it easier to research from a conventional point of view, according to White. Still, patients likely receive more than one homeopathic preparation to treat various symptoms, such as chest pain or cough, along with their cancer.
At the Banerjis’ July 1999 presentation, the Cancer Advisory Panel for Complementary and Alternative Medicine, chartered in 1999 to advise NCCAM and NCI on complementary and alternative medicine research, expressed a strong willingness to lend support for further study of their homeopathic methods. The CAPCAM recommended a prospective study to monitor outcomes for new patients with lung cancer. NCI is negotiating with the Banerjis to obtain further information without disrupting their clinical practice.
A Long Road, but Worth Traveling
After first learning of the Best Case Series Program in November 1996, it took the Banerjis until March 1998 to submit their cases. NCI accepted the series as complete in March 1999, and their presentation to the CAPCAM occurred in July 1999. Pratip Banerji is still positive about the experience and is willing to submit more cases for other diseases.
“Our sole purpose in submitting the Best Case Series was to tread a positive path in the establishment of homeopathy as a well-publicized and effective mode of complementary and alternative medicine treatment,” Banerji stated in a recent e-mail. NCI’s White is hoping that other complementary and alternative medicine practitioners will make a similar commitment.