New Approved Cancer Drugs Failing Miserably

Previous Article Next Article
March 01, 2017 | 42,002 views

Story at-a-glance

  • In a rush to get medications to market, the FDA approves drugs that haven’t demonstrated effectiveness, increasing pharmaceutical profits and sparking a unique marketing ploy for a cancer tool
  • Consuming a ketogenic diet has demonstrated scientific effectiveness in prevention and treatment of cancer, reduction of hypertension, improved cognition and treatment of diabetes
  • Raising your vitamin D serum levels to 40 ng/ml may reduce your risk of all invasive cancers by as much as 67 percent. Vitamin D influences virtually every cell in your body and is crucial to reduce your risk of cancer

By Dr. Mercola

According to the National Cancer Institute, in 2012 there were 14 million new cases of cancer diagnosed and 8.2 million cancer deaths worldwide.1 They anticipate the number of newly diagnosed cases will rise to over 20 million each year within the next two decades.

These statistical trends are used to measure success of efforts to prevent or treat cancers. Mainstream medicine relies on pharmaceutical companies to develop toxins that may kill cancer cells and extend the life of those suffering from the disease.

Unfortunately, cancer cells develop in unique and highly variable processes, creating cell overgrowths that do not respond to just one or two types of medication.

Pressured by patient advocates who want earlier access to novel medications, the U.S. Food and Drug Administration (FDA) began approving cancer drugs without requisite proof they either extend the life of the patient or kill cancer cells.2

Meanwhile, emerging evidence indicates diets high in healthy fats, low in net carbs and moderate in protein are ideal to reduce insulin levels, balance leptin and ghrelin hormones, reduce obesity and even help prevent and treat cancers, as it normalizes the underlying metabolic dysfunction.

In other words, this type of nutritional plan improves your overall health, increases your energy level and improves weight loss efforts with a greater proportion of the fat removed from the abdominal cavity, also called visceral fat.3,4

Changing your diet is often financially neutral, while cancer drugs may cost upwards of $171,000 each year for treatment.5

Many Drugs Don't Live Up to the Promise

In a rush to bring medications to market, many of them are not helping patients and some are being removed. Earlier access to cancer drugs may have given patients renewed hope, but have also increased Big Pharma's financial gains without a parallel improvement in patient results.

Overall successes in the past decade have barely changed. According to a study published in the Journal of the American Medical Association (JAMA), 72 cancer therapies approved by the FDA between 2002 and 2014 improved life expectancy a mere 2.1 more months over older drugs.6

Two-thirds of the drugs approved between 2014 and 2016 have shown no evidence they extend survival. Another study reported in JAMA evaluated 18 cancer drugs, finding none helped patients live longer and only one improved life quality by relieving pain and fatigue.7

Dr. Richard Schilsky, senior vice president and chief medical officer at the American Society of Clinical Oncology, commented on the current drug therapies available to patients, saying:8

"Our patients need drugs that provide the greatest possible benefit, particularly when you put that in the context of cost. You begin to question what is the real value of a therapy, when the benefit is small, the toxicity may be similar to a previous drug and the cost is much higher."

Fast Approvals Pose Significant Problems for Patients

One challenge is that drugs are commonly tested on patients who are younger than those using the approved medications. This has meant some drugs found to extend the life of patients with liver cancer had no effect on Medicare patients once the drug was approved.

Only 33 percent of patients in cancer trials are over the age of 65,9 but the median age at diagnosis is over 62.10 A study in 2015 evaluated 36 cancer drugs approved without statistics demonstrating survival benefits.

Four years after the start of the study, only five medications demonstrated any evidence they helped survival rates for patients.11 Lowering approval standards doesn't benefit patients or doctors, but does fund pharmaceutical companies bent on developing new products for a growing market.

As if these standards were not low enough, President Trump has declared his intention to cut FDA regulations even further to speed the drug approval processes.12 Fast approvals in the past have also resulted in medications withdrawn from the market as they didn't help patients, and in some instances caused harm.13

The slow pace of progress in cancer treatments using drugs has triggered the American Society of Clinical Oncology to lower standards for medications, setting the goal to extend life or control the growth of tumors by a mere 2.5 months.14 

However, in a study published in JAMA, researchers found that only one of every five cancer drugs in use approved between 2014 and 2016 actually met this already low standard.15

Operating under stressful conditions, most patients mistakenly believe the FDA only approves extremely effective drugs and 25 percent believe the drugs approved are without serious side effects.16 Even physicians overestimate the benefits of the drugs and underestimate the risks to the patients.

The drug Avastin is one example of a cancer medication approved without evidence of survival benefits that was later withdrawn, as the side effects appeared to outweigh the lack of established benefits.

Studies found that not only did it not help people live longer, side effects were life-threatening, including heart attack, bleeding and high blood pressure.17

Shooting for the Moon Isn't Working Either

In 2016, Dr. Patrick Soon-Shiong launched a bold collaboration of physicians, companies, researchers, academics and governmental agencies with the mission to eradicate cancer. He called it Moonshot 2020.

Their goal was to forever change the face of medicine.18 Supremely confident in his ability to make good on his promise, Soon-Shiong has even met with President Trump twice in the three months since the election, reportedly pitching the idea of a senior health care role in the administration.19

This role in a governmental agency would represent a distinct conflict of interest between administering health care policy and Soon-Shiong's private business concerns of promoting new cancer diagnostic tools. To date, there has been little progress at the core of the initiative.

The essence of the moonshot design is to aggressively promote a yet unproven diagnostic tool, called GPS Cancer, which reportedly analyzes tumors and recommends a course of treatment involving immunotherapy.20

In published statements Soon-Shiong mentions collaborators, including pharmaceutical companies Pfizer, Merck and Johns Hopkins.21

However each of those companies deny knowledge of their involvement. In their social media campaigns the moonshot team claims they will have developed a vaccine that could treat all cancer types at every stage by 2020.22

Dr. Eric Topol, geneticist who directs the Scripps Translational Science Institute, commented on Soon-Shiong's claim for a universal treatment:

"Some of his ideas may ultimately click someday, but he talks about them as if there's more support than there is. And if there is more, it sure isn't published."

Cancer Prevention and Treatment Begins Under the Sun

The number of different types and subtypes of cancer cells is very large. The idea that one vaccine or drug is able to prevent or cure this disease is not feasible.

Prevention begins by denying cancer cells the very nutrition they need to develop and grow. That's where nutritional ketosis comes in. However, the protective power of vitamin D is not to be overlooked either.

Raising your vitamin D serum levels to 40 ng/ml may reduce your risk of all invasive cancers by as much as 67 percent.23,24,25 Vitamin D influences virtually every cell in your body, and is crucial to reduce your risk of cancer.

Your organs convert vitamin D in into calcitriol, which is the hormonal or activated version of vitamin D. Your organs then use it to repair damage, including that from cancer cells. Vitamin D also triggers apoptosis (cell death) in cancer cells.

According to Cedric Garland, who holds a doctor of public health and who has published numerous studies on vitamin D, in nearly all forms of breast cancer, vitamin D affects the structure of epithelial cells.

These cells, held together by a glue-like substance called E-cadherin made mostly of vitamin D and calcium, provide structure to the cell. Without adequate vitamin D, that structure comes apart and cells do what they are programmed to do in order to survive — they go forth and multiply.

When cell proliferation gets out of control, it may result in cancer. If you have cancer in progress, the addition of vitamin D can help slow down cancer cells by replenishing E-cadherin. Once cancer growth has slowed, your immune system may be able to address the remaining cell growth more effectively.

Cancer Cells and Genes

Chromosomal damage that triggers the proliferation of cells is likely a marker of cancer growth and not the actual cause of the disease. In other words, evidence is demonstrating that something other than gene mutation is at the root of cancer cell growth. The National Atlas Genome project,26 which began in 2006, discovered that mitochondrial damage occurred first.

The primary consideration in the health of your cell mitochondria is glucose metabolism. This theory was originally proposed by Dr. Otto Warburg in the 1920s. Today, several scientists have continued the work on this metabolic theory, including Dr. Gary Fettke and molecular biologist James Watson.27 Science writer Travis Christofferson details some of this important work in his book "Tripping Over the Truth: The Return of the Metabolic Theory of Cancer Illuminates a New and Hopeful Path to a Cure."

In 1953, Watson was one of two scientists who pieced together the structure of DNA, initiating a flurry of activity to map the human genome and potentially reverse signs of aging and discover the root causes of disease. Today, Watson believes targeting cellular metabolism holds more promise than a gene-centered approach to cancer, which has not produced results researchers had hoped it would.28

Researchers at top cancer hospitals who are pushing for research into this metabolic theory of cancer development and subsequent treatment protocols include Dr. Craig Thompson, chief executive at Memorial Sloan Kettering Cancer Center and Peter Pedersen, biological chemistry and oncology professor at Johns Hopkins University, among others.

The metabolic theory of cancer has demonstrated positive results in treatment29 and these scientists are now attempting to discover the underlying mechanism of action.

Ketogenic Diet May Reduce Cancer Cell Growth

In this short video you'll hear from a patient given three months to live from metastatic cancer, who subsequently began a ketogenic diet. The video was shot one year after the prognosis was issued.

Essentially, Warburg discovered that in the presence of oxygen, cancer cells produce energy anaerobically, in the cytoplasm, generating lactic acid as a toxic byproduct. Energy production in the mitochondria is far more efficient but unavailable to cancer cells. This meant cancer cells are dependent on glucose to produce energy for cell repair and replication.

A ketogenic diet drastically reduces net carbohydrate intake, causing your body to burn fat as its primary fuel, thereby producing ketones, which the mitochondria in your cells can readily use for energy. Ketones burn very efficiently and produce lower amounts of free radicals compared to other fuels.

This diet has been successfully used for years to control seizure activity in children. While the typical Western diet is 55 percent carbs and 30 percent fat, a ketogenic diet to treat cancer is closer to 90 percent fat and 5 percent carbohydrates.30 However, if your aim is cancer prevention and improved health, 75 percent healthy fat, 5 percent carbs and 20 percent proteins will help you achieve your goals.

By eliminating the energy supply to cancer cells, research is finding the diet is a strong addition to cancer treatment,31 as cancer cells cannot use ketones for energy.32 A ketogenic diet also reduces the anabolic hormone, insulin, which sparks the growth of cells, including cancer cells. When insulin levels are low it may slow the growth of cancers.33 Even in a pilot trial of 16 patients with advanced metastatic disease the diet provided relief of some symptoms.34

Ketogenic Diet Offers More Advantages

A ketogenic diet offers not only advantages in the treatment of cancer, but also in the prevention of the development of abnormal cell proliferation. A ketogenic diet will help you achieve weight loss even if you consume more calories than you do now. You'll likely notice a reduction in hunger pangs and food cravings as well.

When I first started this nutritional program, I weighed 180 pounds. I ate 2,500 to 3,000 calories a day, yet dropped down to 164 pounds. I've since realized I have to eat a minimum of 3,500 to 4,000 calories a day just to maintain my ideal weight.

Interestingly, greater amounts of fat will be lost from your abdominal cavity, also called visceral fat.35 This type of fat tends to accumulate around organs and increases your risk of metabolic syndrome, leading to type 2 diabetes and heart disease. When carbohydrate intake drops and is replaced with healthy fats, triglyceride levels, another marker of heart disease, also drop.36,37

Hypertension is a risk factor for kidney disease, heart attack, stroke and other health conditions. Multiple studies have linked insulin resistance, driven by high levels of glucose and carbohydrate intake, to an increase in blood pressure.38,39,40,41 Eating a ketogenic diet reverses levels of insulin, changes cellular energy production to ketones, and helps to reduce hypertension.

Your brain also functions better when using a more efficient fuel source, i.e., fats or ketones.42,43,44 Low-carbohydrate diets are also being studied for the neuroprotective effects they may have on the development of dementia and Parkinson's disease.45 You may notice improved cognitive function as one of the first changes when you switch to a ketogenic diet. My new book Fat for Fuel, that comes out in May goes into far greater detail

How to Enter Nutritional Ketosis

In this video nutritional ketosis expert Randy Evans and I discuss how to implement this eating plan. The most efficient way to train your body to use fat for fuel is to remove most of the sugars and starches from your diet, and that's true for everyone, whether you're sedentary or an athlete. At the same time, you'll want to replace those carbs with healthy fats.

A dietary intake of about 50 grams or less per day of net carbs (total carbs minus fiber) while also keeping protein low-to-moderate is usually low enough to allow you to make the shift to nutritional ketosis (the metabolic state associated with an increased production of ketones in your liver; i.e., the biological reflection of being able to burn fat).

This is only a generalization, as each person responds to foods in a different way. Some people can enter into full ketosis while eating as much as 70 to 80 grams of non-fiber carbs. Others, especially if you're insulin resistant or have type 2 diabetes, may require less than 40 grams, or even as little as 30 grams per day, to get there.

To find your personal carb target, it's important to measure not just your blood glucose but also your ketones, which can be done either through urine, breath or blood. This will give you an objective measure of whether or not you're truly in ketosis, rather than just relying on counting the grams of carbohydrates you consume. Nutritional ketosis is defined as blood ketones that stay in the range of 0.5 to 3.0 mmol/L.

That said, using a nutrient tracker will radically improve your ability to understand how much and what kind of foods help you to keep to your ketogenic diet nutrient targets while also helping you to assess the nutrient value of your food choices. My first choice is Cronometer.com/mercola. That's my upgrade to the basic Cronometer nutrient tracker, and the default is set to macronutrient levels that will support nutritional ketosis.

[+]Sources and References [-]Sources and References

  • 1 National Cancer Institute Cancer Statistics
  • 2, 8, 12 USA Today February 9, 2017
  • 3 Nutrition and Metabolism, 2004;
  • 4 The Journal of Pediatrics 2003;142(3):253-258
  • 5 Memorial Sloan Kettering Cancer Center, Price and Value of Cancer Drugs
  • 6 Journal of the American Medical Association, 2014;140(12):1225-12236
  • 7, 13 Journal of the American Medical Association, 2017;177(2):276-277
  • 9 Journal of Clinical Oncology 2012;30(17):2036-2038
  • 10 National Cancer Institute, Median Age of Cancer patients at Diagnosis
  • 11 Journal of the American Medical Association 2015;175(12):1992-1994
  • 14 Journal of Clinical Oncology 2014;32(12):1277-1280
  • 15 Journal of the American Medical Association 2016;2(9):1238-1240
  • 16 Journal of the American Medical Association 2011;171(16):1463-1468
  • 17 US Food and Drug Administration November 18, 2011
  • 18, 20, 21 StatNews February 14, 2017
  • 19 StatNews January 24, 2017
  • 22 Facebook Cancer Breakthroughs 2020
  • 23 PLOS ONE, 2016; 11(4):e0152441
  • 24 PRWeb April 6, 2016
  • 25 UC San Diego Health April 6, 2016
  • 26 National Cancer Institute The Cancer Genome Atlas project
  • 27, 28 New York Times Magazine, May 12, 2016
  • 29 Frontiers in Cell and Developmental Biology 2015;3:43
  • 30 Authority Nutrition Can a Ketogenic Diet Help Fight Cancer?
  • 31 Redox Biology 2014;2:963-970
  • 32 International Journal of Cancer 2014; 135(7):1711-1720
  • 33 Nutrition and Metabolism, 2011; 8:75
  • 34 Medscape, Effects of a Ketogenic Diet on the Quality of Life in 16 Patients With Advanced Cancer
  • 35 Nutrition and Metabolism 2004; 1:13
  • 36 Journal of the American Medical Association 2004;164(19):2141
  • 37 Journal of Nutrition 2006;136(2):384
  • 38 International Journal of Hypertension 2011; Insulin Resistance, Obesity, Hypertension, and Renal Sodium Transport
  • 39 Journal of Clinical Investigation 2010; 120(5):1506
  • 40 Hypertension 2004; 43:1324
  • 41 Diabetology and Metabolic Syndrome 2014 6:12
  • 42 Epilepsy Research 2012; 100(3):304-309
  • 43 Scientific American October 1, 2013
  • 44 PsychCentral Dietary Ketosis Aids Memory in Mild Cognitive Impairment
  • 45 Behavioral Pharmacology 2006; 17(5-6):431