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PALEOLITHIC KETOGENIC DIET (PKD) AS A STAND-ALONE THERAPY IN CANCER: CASE STUDIES
Abstract
Outlook for cancer patients remains poor despite ”best available treatment” which includes surgery, chemotherapy and radiotherapy in most solid cancers. Genetic profiling, attempts to use matched chemotherapy and the use of high-cost biological therapies, so far, did result in no major breakthrough (1). Metabolic therapies have been suggested as a promising alternative option. Yet, clinical group studies that have been published, provide next to no evidence for a benefit in hard clinical endpoints of cancer. Previously, we put forward (2) that the apparent ineffectivity of the ketogenic diet in cancer is likely due to two factors. First, all published studies included cancer patients that also used chemo- and/or radiation therapy. Second, all group studies used the classical version of the ketogenic diet which is based on vegetable oils and dairy, an evolutionary maladapted, erroneous version of the ketogenic diet.
Studies in animal models have suggested that the ketogenic diet may be effective in the treatment of cancer. However, human cohort studies on the ketogenic diet have, thus far, failed to show benefits in cancer survival or in any other hard clinical endpoints of the disease. This paper presents a case report of a patient with glioblastoma multiforme. The patient had initially been treated with standard oncotherapy including surgery, radiotherapy and chemotherapy. Despite standard treatment, the patient experienced a recurrence of the glioblastoma seven months later. Subsequently, the patient refused radiotherapy and chemotherapy and opted to use the paleolithic ketogenic diet (PKD) as a stand-alone therapy. Following the adoption of the PKD, progression of the disease has been completely halted. At the time of writing, the patient has remained in remission for 48 months, is without side-effects and experiences an excellent quality of life without the use of any drugs.
Studies in animal models have suggested that the ketogenic diet may be effective in the treatment of cancer. However, human cohort studies on the ketogenic diet have, thus far, failed to show benefits in cancer survival or in any other hard clinical endpoints of the disease. This paper presents a case report of a patient with glioblastoma multiforme. The patient had initially been treated with standard oncotherapy including surgery, radiotherapy and chemotherapy. Despite standard treatment, the patient experienced a recurrence of the glioblastoma seven months later. Subsequently, the patient refused radiotherapy and chemotherapy and opted to use the paleolithic ketogenic diet (PKD) as a stand-alone therapy. Following the adoption of the PKD, progression of the disease has been completely halted. At the time of writing, the patient has remained in remission for 38 months, is without side-effects and experiences an excellent quality of life without the use of any drugs.
Erickson et al. recently published a review on the use of the ketogenic diet in cancer. The authors of this reply are clinicians who bring into play an evolutionary approach in the practice of medicine and specifically have been using the paleolithic ketogenic diet in the treatment of chronic diseases since 2011. We have instituted the paleolithic ketogenic diet in approximately 4000 patients, of whom several hundred have been followed up for at least one year, and 60 cancer patients who have been followed up for at least 6 months. Previously (prior to 2011) we had been using the classic paleolithic diet, which was useful in the treatment of certain diseases but proved to be ineffective in the treatment of autoimmune diseases and cancer.
Background:
The NHS Cancer Drugs Fund (CDF) was established in 2010 to reduce delays and improve access to cancer drugs, including those that had been previously appraised but not approved by NICE (National Institute for Health and Care Excellence). After 1.3 billion GBP expenditure, a UK parliamentary review in 2016 rationalized the CDF back into NICE.
Methods:
This paper analyses the potential value delivered by the CDF according to six value criteria. This includes validated clinical benefits scales, cost-effectiveness criteria as defined by NICE and an assessment of real-world data. The analysis focuses on 29 cancer drugs approved for 47 indications that could be prescribed through the CDF in January 2015.
Results:
Of the 47 CDF approved indications, only 18 (38%) reported a statistically significant OS benefit, with an overall median survival of 3.1 months (1.4-15.7 months). When assessed according to clinical benefit scales, only 23 (48%) and 9 (18%) of the 47 drug indications met ASCO and ESMO criteria, respectively. NICE had previously rejected 26 (55%) of the CDF approved indications because they did not meet cost-effectiveness thresholds. Four drugs-bevacizumab, cetuximab, everolimus and lapatinib-represented the bulk of CDF applications and were approved for a total of 18 separate indications. Thirteen of these indications were subsequently delisted by the CDF in January 2015 due to insufficient evidence for clinical benefit-data which were unchanged since their initial approval.
Conclusions:
We conclude the CDF has not delivered meaningful value to patients or society. There is no empirical evidence to support a 'drug only' ring fenced cancer fund relative to concomitant investments in other cancer domains such as surgery and radiotherapy, or other noncancer medicines. Reimbursement decisions for all drugs and interventions within cancer care should be made through appropriate health technology appraisal processes.
The stone age diet: based on in-depth studies of human ecology and the diet of man
- W L Voegtlin
Voegtlin WL. The stone age diet: based on in-depth studies of human ecology and the diet of man. New York: Vantage Press, 1975.