Those who have followed my writings, or have read my book n of 1, know my affinity for natural products.
I believe that high-quality nutritional supplements, tailored to my body’s specific needs, played a powerful role in the ‘treatment’ and management of my leukemia. Some of the dietary supplements I have taken, in larger than modest quantities, have included green tea extract (EGCG), and curcumin, two of the most studied botanicals.
These natural agents have undergone scores of clinical trials, including some human clinical trials, and have mostly shown statistically relevant outcomes deserving of more research.
A number of dietary supplements have shown solid evidence that they support cancer care, especially effective in reducing the often deleterious side effects of cancer treatment, including nausea, fatigue, and neuropathy.
Several years ago Moshe Frenkel, MD, former founding director of MD Anderson’s integrative medicine program, was lead author on an important paper titled Integrating Dietary Supplements into Cancer Care. In addition to EGCG and curcumin, the article discusses the top 10 natural products for which the most compelling evidence exists for mechanism of action (how it works), safety, and efficacy. Glutamine, vitamin D (actually, a hormone, not a vitamin), Maitake mushrooms, fish oil, are included in that list.
The commercial challenge regarding natural products is that it is cost-prohibitive for most manufacturers to invest in the necessary research required to definitively determine the products’ usefulness to prevent, or manage, any particular disease.
Natural products, especially standalone ingredients like green tea or Maitake mushrooms, cannot be patented. Without securing intellectual property in the form of a patent, to protect an ‘asset’, dietary supplement companies have little incentive to invest in serious research and development.
A company will never recoup its investment, let alone make a reasonable profit, because there is no ‘business protection’ in the form of patenting a single natural ingredient. Pharma, on the other hand, is able to spend massive amounts in research and development because the resulting product, derived from synthesized sources, is solely theirs to market—for a set period of time—thus ensuring profitability.
There are exceptions for some unique formulations of natural products that can be patented, but this process is quite expensive. There remains only modest commercial upside potential because these non-FDA-approved products—at least those sold as dietary supplements—cannot make ‘disease’ claims: for example, “EGCG reduces white blood (leukemic) cells in some CLL patients”.
The disclosure, or warning, in the form of labeling on each bottle of dietary supplements, is as ubiquitous, though less threatening, as the notices on tobacco packaging.
Pharmaceutical companies have used natural products derived from plants as the basis for several drugs, many quite successful, over the course of decades. This paper discusses natural products as sources of new drugs over 30 years, 1981—2010, and was last updated in 2012.
Drug companies reconstitute natural products to ostensibly bring consistency to the active agents, and to ensure purity. They have done this with Lavaza (fish oil from GlaxoSmithKline), and green tea extract Polyphenon-E (green tea extract from Mitsui Norin). More reconstituted natural products are in the pipeline—on their way to becoming patented, therefore more expensive in a pharmaceutical form.
It is clear that even the most successful dietary supplement companies will not be able to—at least any time soon—invest in large placebo controlled, double-blind, randomized control trials, which is the gold standard of clinical research. Even for their protected, patented formulations, budgets for anything other than very small trials simply do not exist.
Commercial Exceptions and Steadfast Consumer Advocacy
One exception to this is Helsinn, a 40-year-old, Swiss-based, family owned pharmaceutical company. Helsinn is the global leader in the area of cancer supportive care products—meaning they have long developed drugs to help mitigate the side effects from conventional cancer care.
[In full disclosure, my firm, FON, has been a consultant to Helsinn for over a year.]
Helsinn’s vice-chairman is a proponent of cancer supportive care products through whichever delivery methods are most helpful to cancer patients—whether small molecule chemical-based pharmaceuticals, or natural products.
To that end, Helsinn created Helsinn Integrative Care as a natural products division, to address unmet patient needs.
One product for which Helsinn owns global rights is Pomi-T. Comprised of four extracts—pomegranate, curcumin, broccoli, and green tea—this polyphenol rich blend of natural agents was developed by a medical oncologist, Professor Robert Thomas from Cambridge University, to support prostate health.
Following a pharma development model, all Helsinn Integrative Care products undergo research trials. For Pomi-T, a study was done with a small group of men who had indolent, ‘watchful waiting’ prostate cancer. The statistically significant positive results of the lowering of PSA levels were captured in a paper that was subsequently peer reviewed and published in Nature Prostate.
Helsinn has continued to invest in meaningful clinical trials for their entire line of natural products to support cancer patients undergoing active treatment.
Then there is Ivelisse Page, who was just 37 years old when diagnosed with stage IV colon cancer. She chose to be treated with surgery, and also with injections of mistletoe and thymus, cimetidine, homeopathic remedies, and additional supplements.
Ms. Page went on to achieve a complete remission of her metastatic disease, as chronicled by her Johns Hopkins oncologist. She believes that mistletoe, which is frequently prescribed for cancer patients in several European countries, was key to her remarkable recovery.
Driven by her personal experience with cancer, and use of natural agents integrated into her care regimen, Ivelisse and her husband, Jimmy, founded Believe Big, a non-profit organization dedicated to educating people on natural approaches to cancer care.
Clinical research is a significant part of Believe Big’s mission. To this end, the organization has steadfastly raised the necessary half a million dollars to fund a phase 1 mistletoe clinical trial at Johns Hopkins University School of Medicine.
The mistletoe trial is now enrolling patients. Mistletoe extract manufacturer Helixor is providing high quality product for the study. This will mark the first clinical trial of intravenous mistletoe in the United States.
Until there are more commercial incentives to study natural products (as opposed to the many pharmaceuticals that are derived from plant sources and then reconstituted as patented drugs), the integration of these agents in conventional cancer care will continue to be a slow process.
However, thanks to companies like Helsinn, as well as consumer advocates such as Ivelisse and Jimmy Page, steady progress continues unabated.