Cancer Trials Can Lack Clear Information on Biopsies

Drug Trial

Story at-a-glance -

  • More than 5 percent of biopsies in cancer drug trials may cause complications, but the informed consent documents did not adequately explain this.
  • Pain, bleeding (that can be so severe it requires a blood transfusion or surgery to stop it), infection and accidental injury to a nearby organ are established biopsy risks; there’s also concern the procedure can increase the spread of cancer cells.
  • A new study also recently tested 5,000 combinations of the 100 cancer drugs approved for use in patients in an attempt to find more effective treatments; unfortunately, chemotherapy kills off your body’s healthy cells, including those in your immune system, a “side effect” that is often deadly.

By Dr. Mercola

Cancer drug trials often require participants to receive invasive procedures like biopsies, which are used to assess the drug's effectiveness but have no therapeutic value – and can pose serious risks -- for the patient.

Informed consent documents are supposed to inform study participants about these types of risks so they can make an educated decision on whether or not to participate in the trial, but a new study found this type of risk information to be seriously lacking.

Risks of Biopsies Not Clearly Stated

Writing in the Journal of Clinical Oncology, researchers stated:1

"A better representation of the risks and benefits of research biopsies in study protocols and informed consents is needed."

This was their conclusion after finding that more than 5 percent of biopsies in cancer drug trials may cause complications, but the informed consent documents did not adequately explain this. In fact, on average the consent documents had only 39 words addressing risks from invasive biopsies – less than the number of words used to address risks for simple blood draws.

Of the 745 tumor biopsies reviewed for the study, 39 resulted in complications, including lung air leaks, bleeding and other major effects that required hospitalization or surgery.

Whether you're participating in a drug trial, or considering a biopsy for another medical reason, you should know that while biopsy risks are rarely discussed, there are risks, indeed.

Serious Biopsy Complications Every Patient Should Know

During a biopsy, a piece of tissue from a tumor or organ is removed so that it can be examined under a microscope, often to determine if it is cancerous. Needle biopsies, for instance, are widely used as part of the traditional allopathic approach to diagnosing breast cancer. But they may accidentally cause malignant cells to break away from a tumor, resulting in its spreading to other areas of your body.

According to a study from the John Wayne Cancer Institute, it appears that a needle biopsy may increase the spread of cancer by 50 percent compared to patients who receive excisional biopsies, also known as lumpectomies.2

The procedure also involves a serious risk of infection. For prostate gland biopsies, specialists have begun to worry about a recent, significant increase in hard-to-treat bloodstream infections that can require weeks of treatment.

Prostate biopsies inherently pose a risk for infection because:

  • The needles that collect a tiny piece of prostate tissue can transport bacteria through your rectal wall into the prostate and bloodstream
  • The needles can spread harmful bacteria present in your gut into your bloodstream

Pain, bleeding (that can be so severe it requires a blood transfusion or surgery to stop it), infection and accidental injury to a nearby organ are established risks that are present no matter what type of biopsy you receive. And then there is the issue of its questionable effectiveness.

In the case of prostate biopsies, an estimated one-third of men who receive "negative" results for prostate cancer actually do have prostate cancer that was missed by the biopsy. For breast biopsies, estimates suggest that 17 percent of D.C.I.S. (ductal carcinoma in situ) cases found through needle biopsy are misdiagnosed. And oftentimes it is an inaccurate mammogram (mammograms carry a first-time false positive rate of up to 6 percent) that leads to the breast biopsy in the first place, making the procedure completely unnecessary.

So, certainly if you're considering taking part in a drug trial, you need to carefully assess whether the biopsy risks are worth it to you … and this is also true anytime you're faced with a recommendation of a biopsy. You must measure the potential benefits against the risks in order to make an informed decision.

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5,000 Combinations Of 100 Existing Cancer Drugs Tested To Find More Effective Treatments

Whereas biopsies are one of the go-to procedures conventional medicine uses to diagnose cancer, chemotherapy is the go-to procedure to treat it. But one of the reasons why conventional cancer treatment is such a dismal failure in the United States is because it relies on chemotherapy. Despite its reputation as the gold-standard in cancer treatment, chemotherapy has an average 5-year survival success rate of just over 2 percent for all cancers, according to a study published in the journal Clinical Oncology.3

The researchers concluded:

" … it is clear that cytotoxic chemotherapy only makes a minor contribution to cancer survival. To justify the continued funding and availability of drugs used in cytotoxic chemotherapy, a rigorous evaluation of the cost-effectiveness and impact on quality of life is urgently required."

It's no secret among the cancer industry that these drugs are often ineffective, or that oftentimes the cancer patient survives not because of -- but despite -- the treatment. Moreover, it's now common for treatments to use combinations of drugs, as many cancers have become resistant to single drugs, rendering them useless. Chemotherapy often supports the more chemo-resistant and malignant cell subpopulations within tumors (e.g. cancer stem cells), as it kills both the more benign cells and/or senescent cells within the tumor that keep it slow-growing, or even harmless.

As a result, this unleashes a more aggressive, treatment-resistant type of cancer to wreak havoc on the body.

A new study recently tested 5,000 combinations of the 100 cancer drugs approved for use in patients in an attempt to find more effective treatments.4 They plan to move several of their novel combinations into clinical trials as quickly as possible, but is this really going to benefit cancer patients?

Chemo Drugs Destroy Your Healthy Cells, Including Your Immune System

Chemotherapy drugs are, by their very nature, extremely toxic and typically work against your body's natural ability to fight cancer by harming your immune system (often irreparably) instead of supporting it. Combining them into new formulations could cause any number of unforeseen consequences. Already, it's known that certain chemo drugs become so toxic when combined that they would have to be used at such a low dose they would no longer work against the cancer!

And one of the biggest drawbacks to chemotherapy of any kind is the fact that it destroys healthy cells throughout your body right along with cancer cells, a "side effect" that often leads to accelerated death, not healing. They may be warranted for very specific types of cancer, but in general they are grossly overused and overrated.

Another study, "The National Confidential Enquiry into Patient Outcome and Death (NCEPOD)", found that more than four in 10 patients who received chemotherapy toward the end of life experienced potentially fatal effects. And after reviewing data from over 600 cancer patients who died within 30 days of receiving treatment, it was found that chemotherapy hastened or caused death in 27 percent of those cases.

In the last 30 years the global cancer burden has doubled, and it will likely double again between 2000 and 2020, and nearly triple by 2030 — unless people begin to take cancer prevention seriously. We CAN turn this trend around, but to do so the medical community must stop overlooking the methods that can actually have a significant impact.

Why I Strongly Advise Avoiding Chemotherapy

I strongly advise everyone to avoid taking any chemotherapy drugs. In my experience the people who survive the chemotherapy do it in spite of the therapy not because of it. More typically, once a person starts chemo it can lead to death. It is the one form of cancer therapy that I strongly advise most to avoid.


Because the way your body fights cancer normally is through a healthy immune system, and if you take drugs to target and destroy your immune system you tend to radically reduce your likelihood of long-term survival. This is not the case for surgery and radiation, which although also overused, do not impair your immune system and may debulk the tumor enough to give your immune system a chance to fight it.

Please also be aware that avoiding chemo comes with massive responsibility and the need to do something positive. Typically this involves a radical application of my advanced nutrition plan in addition to severely limiting protein and carbs and using high-quality fats as a source of calories. This would include foods like avocados, coconut oil, butter, nuts, olive and olive oil. This will tend to lower the mTOR pathway and optimize leptin and insulin signaling.

Four Must-Know Tips for Cancer Prevention

If you're facing a health challenge, I recommend seeking out a qualified natural health consultant. When it comes to cancer, you'll want to identify someone that is well known and respected for their work in treating cancer patients. If you don't find someone locally then scour the Internet and make calls to plenty of patients that the practitioner has seen.

For the rest of you, focusing on cancer prevention is essential. Here are four advancements that have not yet been accepted by conventional medicine, but are extremely powerful cancer preventive tools nonetheless:

1.  Avoid Fructose and Sugar

It's quite clear that if you want to avoid cancer, or are currently undergoing cancer treatment, you absolutely MUST avoid all forms of sugar -- especially fructose -- and this is largely due to its relation to insulin resistance.

According to Lewis Cantley, director of the Cancer Center at Beth Israel Deaconess Medical Center at Harvard Medical School, as much as 80 percent of all cancers are "driven by either mutations or environmental factors that work to enhance or mimic the effect of insulin on the incipient tumor cells," Gary Taubes reported,5 adding:

"As it was explained to me by Craig Thompson, who has done much of this research and is now president of Memorial Sloan-Kettering Cancer Center in New York, the cells of many human cancers come to depend on insulin to provide the fuel (blood sugar) and materials they need to grow and multiply. Insulin and insulin-like growth factor (and related growth factors) also provide the signal, in effect, to do it.

The more insulin, the better they do.

Some cancers develop mutations that serve the purpose of increasing the influence of insulin on the cell; others take advantage of the elevated insulin levels that are common to metabolic syndrome, obesity and type 2 diabetes.

Some do both.

Thompson believes that many pre-cancerous cells would never acquire the mutations that turn them into malignant tumors if they weren't being driven by insulin to take up more and more blood sugar and metabolize it."

Some cancer centers, such as the Cancer Centers of America, have fully embraced this knowledge and place their patients on strict low-sugar, low-grain diets. But conventional medicine in general has been woefully lax when it comes to highlighting the health dangers of this additive.

As a standard recommendation, I strongly advise keeping your TOTAL fructose consumption below 25 grams per day, including fruits. But for most people it would also be wise to limit your fructose from fruit to 15 grams or less, as you're virtually guaranteed to consume "hidden" sources of fructose if you drink beverages other than water and eat processed food.

2.  Optimize Vitamin D

There's overwhelming evidence pointing to the fact that vitamin D deficiency plays a crucial role in cancer development. Researchers within this field have estimated that about 30 percent of cancer deaths -- which amounts to 2 million worldwide and 200,000 in the United States -- could be prevented each year simply by optimizing the vitamin D levels in the general population.

On a personal level, you can decrease your risk of cancer by MORE THAN HALF simply by optimizing your vitamin D levels with sun exposure. And if you are being treated for cancer it is likely that higher blood levels — probably around 80-90 ng/ml — would be beneficial.

If the notion that sun exposure actually prevents cancer is still new to you, I highly recommend you watch my one-hour vitamin D lecture to clear up any confusion. It's important to understand that the risk of skin cancer from the sun comes only from excessive exposure.

3.  Decrease Protein

Ideally your protein level should be around one gram of protein per pound of lean body mass. Some people are not eating enough protein, while others are eating entirely too much and thinking it's healthy. If you regularly exceed this level of protein you may activate your mTOR pathway, which has been correlated with promoting tumor growth.

4.  Exercise

If you are like most people, when you think of reducing your risk of cancer, exercise doesn't immediately come to mind. However, there is some fairly compelling evidence that exercise can slash your risk of cancer. One of the primary ways exercise lowers your risk for cancer is by reducing elevated insulin and blood sugar levels, which creates a microenvironment that discourages the growth and spread of cancer cells.

If you have cancer, exercising during and after cancer treatment can reduce your risk of dying from cancer; reduce your risk of cancer recurrence; boost energy; and minimize the side effects of conventional cancer treatment.6

It's important to include a large variety of techniques in your exercise routine, such as strength training, aerobics, core-building activities, and stretching. Most important of all, however, is to make sure you include high-intensity, burst-type exercise, such as Peak Fitness.

+ Sources and References