Hope Never Dies

by Rick Shapiro

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Proof of Evidence-Based Cancer Treatments and Drugs: The FDA “Gold Standard”—versus—Evidence for Integrative and Alternative Therapies

March 17, 2017 by Rick Shapiro Leave a Comment

Cancer may respond to integrative and/or alternative therapies (and healing agents) that are not formally "evidence-based".

Evidence-based cancer treatments, integrative and/or alternative therapies, and healing agents may be considered.

Evidence-based cancer care is a scientific discussion.

In the conventional cancer world, the Food and Drug Administration (FDA) testing procedure (generally known as “the gold standard”) prevails as the barometer to prove the safety and effectiveness of drugs, treatments, and therapies. In brief, this standard revolves around large, randomized, placebo-based, double-blind, evidence-based research studies.

FDA’s evidence-based cancer research studies

These studies often take 10-15 years to complete, from start to finish. They assess and evaluate drugs and therapies beginning with the evaluation of cancer cell lines, then proceeding to preclinical studies (animal studies, frequently mice). Animal studies are followed by phase 1 trials consisting of small groups of people (approximately 20 to 80), then phase 2 (approximately several dozens to 300), followed by phase 3 trials, which are comprised of even larger groups of people (approximately several hundred to 3,000). Each succeeding phase continues upon demonstration of safe and effective results  from the preceding phase.

These studies come with exorbitant costs over the course of their protracted time period. According to the Tufts University Medical School – Study of Drug Development (November 18, 2014), the average pre-tax cost per new prescription drug approval is approximately $2.5 billion dollars. Yes, that’s billion with a “B.”

Why do companies engage in these long-term, obscenely expensive studies? Because the reward comes in the form of patents, assuming a successful study and drug approval by the FDA. If deemed successful, a protected patent can bring the pharmaceutical company many billions of dollars during its patent-protected time frame. Quite a nice return on investment. Without the likelihood of large profits, pharmaceutical companies will not move forward with these studies to bring effective healing agents or products to market.

Pharmaceuticals and non-pharmaceuticals

Let me make one thing clear: I am NOT, I repeat, I am NOT against the use of effective cancer drugs and, in fact, very effective drugs are sometimes used in cancer treatments, including appropriate chemotherapeutic protocols. But we should not discard the notion that there are other highly beneficial medical tools, that are “outside the box” of the standard of care, i.e., outside the toolbox of pharmaceutical drugs, that can be significantly beneficial in the fight against cancer.

Logically speaking, who would choose to incur $2.5 billion of expense (and who can afford to do so), without any possibility of procuring a protected patent which promises the real possibility of billions of dollars as a return on investment? Honestly, probably no one. The real shame, is many non-pharmaceutical agents which have proven to be effective and safe, without harsh side effects, do not garner credibility or attention for their medical-healing capacity by most of the conventional medical establishment.

Proving the efficacy of integrative and alternative therapies

The FDA “gold standard” testing procedure does not apply for non-pharmaceutical agents. However, there are other methods of determining whether there is evidence-based data that indicates whether integrative and/or alternative therapies (and healing agents) may be effective in helping support a cancer patient’s immune system — and/or cytotoxically attacking or debulking cancer tumors and malignancies.

These are in the form of observational studies, other epidemiological studies, cohort studies, case-control studies, case reports, other clinical evidence, and the opinions of highly respected scientists and medical practitioners, based on their independent research and patient-centric clinical experience.

In fact, in 2012, I interviewed the CEO of a major cancer center and he admitted that there are numerous natural agents and non-evidence-based therapies that can be very beneficial to cancer patients, but his institution could not prescribe or recommend these therapies, because his cancer center was a conventional institution, and could not deviate far from its “standard of care” protocols.

Big picture: The bottom line

I can state unequivocally, based on my extensive research and experience, there are excellent integrative and alternative therapies, treatments and medical options that can have a major impact on your cancer status, your longevity, your quality of life, and your medical outcome, despite the fact they don’t have a supportive FDA study as evidence of efficacy and safety.

Read exclusive interviews with renowned cancer specialists who embrace integrative and alternative therapies and treatment.

Hope Never Dies overview

Have a Wonderful Healthy Day and Keep the Hope!

Rick Shapiro, Author 

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