Envita’s Approval for Phase I Cancer Study: Some Perspective
Last year, we reported on how Envita had submitted an application to conduct research on natural killer cell therapy after we received a warning letter from the Food and Drug Administration (FDA). Although we regarded our treatment as the practice of medicine and not within FDA’s jurisdiction, we felt that the possibilities presented by the natural killer cell therapy were promising. We complied with the FDA, submitted our request, and awaited approval to begin our study.
Well, we are excited to report that the FDA gave us its stamp of approval, and we can now begin our Phase I clinical biological trial, which involves exploring the use of the body’s own immune system to fight cancer. While gaining FDA approval for clinical trials is “business as usual” and a routine accomplishment for most hospitals, pharmaceutical corporations, governmental bodies such as the NIH, and other organizations, we would like to explain what this study means for a natural medical clinic and the field as a whole. To truly understand the significance of Envita’s clinical trial, we have to take a look at the backdrop of the current political and legal landscape.
As reported by Cancer Monthly, in March of last year, the number of clinical trials involving natural or alternative therapies was slim to none. (1) Last year at this time, there were 7,080 active clinical trials for cancer, and only 123 of them, or 1.7% were focused on naturally occurring agents. (1) Over half were focused on chemotherapy. As pointed out by Cancer Monthly, an even smaller percent was focused on whether these natural approaches alone improved survivability from cancer. Cancer Monthly commented that “alternative therapies…have been co-opted into the conventional paradigm. They are no longer seen as potentially powerful treatments in their own right, but rather ‘add-ons’ to ameliorate the side effects or improve the quality of life for patients who receive the toxic conventional treatments.” (1) A search on clinicaltrials.gov reveals that nothing much has changed. On March 3, 2009, clinicaltrials.gov showed 5,306 open cancer studies in the United States. Out of these, 11 were listed as complementary or alternative therapies. However, most of these complementary/alternative trials were extremely “soft” – involving such things as exercise.
The definition of madness is doing the same thing over and over again and expecting a different result. Yet, when you add up all the research dollars and treatment dollars that have been poured into chemotherapy, it stretches into the trillions. Meanwhile, cancer is still claiming a life every 50 seconds. And survival times have not changed drastically. In a highly controversial article published in 2004, three oncologists assessed the impact of cancer drugs on survival rates in Australia and the United States. (2) The authors analyzed the results of all randomized, controlled clinical trials performed in Australia and the U.S. that reported a statistically significant increase in 5-year survival due to the use of chemotherapy in adult cancers. Data from 1990-2004 were examined. The authors found that the overall contribution of chemotherapy to the five-year survival rate in adults was about 2%. In other words, as stated by one of the authors, Graeme Morgan, during a radio interview, “if there was no chemotherapy…the survival rate of all patients with cancer would drop from 62% to 60%.” As summarized by the authors, “despite the early claims of chemotherapy as the panacea for curing all cancers, the impact of cytotoxic chemotherapy is limited to small subgroups of patients and mostly occurs in the less common malignancies.” (2) Those unimpressive statistics makes the need for innovative treatments even more apparent. The madness of continuously pouring oodles of money into drugs that have not lived up to their reputation must stop.
This argument, of course, is not to say that chemotherapy drugs should no longer be studied or utilized when appropriate. Indeed, at Envita, we treat certain patients with chemotherapy (alongside our natural treatments), as it still has a place in helping with particular malignancies. But the limitations and harsh side effects of these drugs must be recognized- and given the number of lives that are still being claimed each minute, these drugs should not be heralded as the answer to cancer. The end goal of conducting clinical trials is supposed to be to find better and more effective ways of fighting disease. To do that, there needs to be a change in the type of interventions that are being studied.
So why haven’t we seen more rigorous natural or alternative studies being conducted to-date? Well, a lot of barriers stand in the way of getting natural and alternative studies approved. For one thing, most natural or alternative practitioners do not have the resources, motivation, or capabilities to design, sponsor, or conduct such a study. Many natural medical clinics and practitioners are also afraid of regulation or regulatory bodies. And there is a lot of stigma attached to this field, which makes approval even less of a certainty. Additional barriers are presented by the fact that the clinical trial process is a long and complicated one, involving numerous legal and regulatory hurdles. Getting a study approved can take up to five years. We are thrilled because we managed to get our study written and approved in less than three.
Case in point- a search of clinicaltrials.gov on March 3 showed that out of the 5,306 open cancer studies, 48 studies were listed as “natural.” Of those, none was sponsored by a natural medical clinic. Out of the 1065 trials involving biological products, the Burzynski Research Institute is the only sponsoring organization to appear on the list that has ties to the alternative medicine world (Burzynski’s company’s focus is on “biopharmaceuticals,” as described on its website). Indeed, Envita is one of the first natural medical clinics to be approved for a clinical trial, especially one of this type.
In addition, the field of alternative and advanced natural medicine has taken a hit since the National Center for Complementary and Alternative Medicine (NCCAM) entered the scene. As stated on its website, NCCAM is a branch of the NIH, and its main function is supposed to be exploring complementary and alternative medicine “through rigorous scientific research.” On clinicaltrials.gov, NCCAM is shown as currently sponsoring 10 clinical trials for cancer. Yet none of those studies explores truly promising or significant therapies, and none is of the type that would advance the field or garner it some credibility. The studies NCCAM is sponsoring involve such things as yoga, tai chi, massage, “energy healing,” almonds, fish oil, and walnuts. While these complementary therapies may be of help to some cancer patients, they cannot be considered viable, standalone treatments for cancer. Instead of “soft” studies on massage and walnuts, why isn’t NCCAM getting involved in more rigorous research such as the high-dose intravenous vitamin C studies currently being conducted by Mark Levine over at the main branch of the NIH and at other organizations? That’s the type of work NCCAM should be doing. Many in the alternative medical world have criticized NCCAM as not really having the field’s interests at heart. Indeed, it seems that NCCAM’s name is on some of the most negative reports of natural or alternative therapies.
And the situation is not being helped by the people being chosen to lead the NCCAM division. Josephine Briggs, M.D. is the current director. Her curriculum vitae is posted on NCCAM’s website. While her credentials are certainly impressive, it is unclear what qualifies her to hold the position that she does, other than the fact that she is interested in “the effects of antioxidants in kidney disease.” Indeed, many people have an interest in such things, but it doesn’t make them qualified to direct the governmental body that is supposedly “the Federal Government’s lead agency for scientific research on complementary and alternative medicine.”
In short, the field of advanced natural medicine will not be able to rely on NCCAM to lead it or advance it to new heights. And it is apparent that NCCAM will not be the trailblazer in finding better and more effective ways of fighting disease. Instead, the natural medical field will have to go it alone. It is Envita’s hope that our clinical trial will prove to be a significant and revolutionary step in that direction.
For information on Envita’s clinical trial, click here.
References:
(1) “Cancer Clinical Trials and Alternative Treatments.” Cancer Monthly. March 28, 2008. Accessible through cancermonthly.com
(2) Morgan, G., Ward, R., and Barton, M. The contribution of cytotoxic chemotherapy to 5-year survival in adult malignancies. Clin. Oncol. (R Coll Radiol). 2004 Dec; 16(8): 549-60.
(3) National Center for Complementary and Alternative Medicine website
