Red Flags & Free Speech
Red Flags
* It cures ALL cancers (as if it was one disease) and other diseases.
* It's based on a theory but not an actual test of the theory - a clinical trial.
* It’s "natural" it has no side effects.
* A conspiracy (greed / profit ..) explains why it isn’t prescribed by your doctor
* It’s only available in a country that lacks medical regulations.
* You can buy it online - without a doctor's prescription.
* There’s only one group or person promoting it.
* The "evidence" of benefit is cherry-picked and based on test tube / animal experiments
* The claim has not been tested in people – in predefined controlled clinical trials
* It is said to “boost the immune system”
(without defining this or providing clinical evidence showing this is effective)
* It relies on testimonials
Red Flags and Free Speech - a more detailed narrative:
While eating well and regular exercise will not cure or treat cancer, these CAN improve your general health and quality of life, providing indirect benefits associated with improved survival
Books and websites promoting unproven “cures” for cancer are abundant, protected we suppose by “free speech.” … Tragically, the belief in such claims can lead to the avoidance or delay in receiving effective treatment, proven in clinical trials.
We are most vulnerable when the claim tells us what we want and dearly wish to be true.
Being smart will not protect you from such claims (Steve Jobs). Conspiracy theories may seem compelling to anyone lacking background in the field … most of us, when first diagnosed with a cancer!
Conspiracy Theories – hiding cures?
3 in 5 adults will develop a serious cancer. Some types of cancer are cured today. A worldwide conspiracy to hide cures would have to be kept when each scientist’s child, spouse, or dear friend gets cancer.
Competing drug companies would have to deceive shareholders and intentionally undermine the products they test and submit to FDA for approval.
Natural is better?
Toxins and medicines can be man-made or derived from natural sources – from plants and animals.
Vincristine and Etoposide are examples of cancer drugs derived from plants. The molecular structure of a compound will be identical whether it’s made by a plant or synthesized by a man.
How a compound is derived will not alter its bioavailability, its affinity to the target, the importance of the target, or its good and bad effects.
For cancer drugs what counts is the affinity of the compound to the disease process. Does it bind well to the abnormal pathway … like a key fits a lock? What are the off-target effects? What’s the optimal dose and schedule?
Recognizing junk science
Theories promoted to self-treat cancer are often hijacked from the medical literature then applied prematurely or distorted … often from preclinical studies: cell culture and animal experiments.
Cell culture experiments
Cannot account for the dose that's needed to have a similar effect on cancer cells in the body
Cannot tell us if the compound is absorbed into the blood when taken orally... or if it’s merely excreted
Cannot inform about the side effects of the compound when given at the dose showing activity in the test tube (Is it feasible or safe to take that much of it?) Even if active against disease … the compound given at the wrong dose can do harm:
Tumor cells can adapt to low or subclinical doses of treatment compounds – leading to resistance. Cancer cells in a test tube are very poor models for the treatment of cancer cells in the body.
Unlike bacteria, many kinds of tumor cells are challenging to keep alive in cell culture medium.
Animal experiments:
Cannot account for the differences between the mouse and human host environment. The mouse immune system is different. The tumor cell line is different from cancers that emerge in humans.
The toxicities and activity of the compound in the mouse rarely predict what happens in humans.
What is Cancer?
Is it treatable with diet, or other life style changes?
… What is plausible as a treatment depends on the nature of the disease.
...Diabetes can be managed with a change in diet, but, unfortunately, not cancer due to the underlying nature of it.
The beginnings of cancer:
In any cell the genetic code can get damaged (called mutations) so that the instructions in the DNA "manual" are altered in ways that make abnormal types and amounts of proteins that drive the malignant behavior of the cell s .
... Instead of resting, cancer cells continue dividing; instead of dying the cells stay alive. Mutations may also turn off genes that can repair damaged DNA, or that can induce cell death when mutations in the cell are detected. The mutations that lead to cancer are numerous and are often unique to each type of cancer.
Cancer treatments work by targeting differences in these cells. Chemotherapy, for example, acts by damaging rapidly dividing cells – inducing cancer cells to die. Other kinds of drugs work by binding to the driving pathways in the cancer cells that are needed for the cancer cells to grow or persist. Immune therapies work by fostering immune recognition of tumor cells, or by blocking what blocks immune rejection of the tumor cells.
Observations and testimonials are not reliable
"For centuries doctors used leeches and lancets to relieve patients of their blood. They KNEW bloodletting worked. EVERYBODY said it did. When you had a fever and the doctor bled you, you got better. EVERYONE knew of a friend or relative who had been at death’s door until bloodletting cured him. Doctors could recount thousands of successful cases."
Today we know that patients did well in spite of bloodletting, a practice based on primitive notions about the nature of diseases - attributed to bad elements in the blood.
The lesson from history is that observations (anecdotes) are not reliable as evidence. In any observation or case report, even when from a reputable source, you can't tell what would have happened if something else – or nothing was done; from observation you can't know if others are likely to be helped or harmed by the same approach.
In modern clinical research the number of participants in a study is pre-specified and assessments are made in the same way.
...One approach is compared to another in late phase testing – the patients assigned to study groups randomly. In all clinical studies you have a predefined denominator (the number of participants) that informs about the rate of good and bad effects - what others may expect … and how it compares to another established treatment.
Testimonials have all of the limitations of observations … with much less certainty about the facts: Did the person really have the medical condition? Was it a false diagnosis of a cancer?
...You don't know how the outcome was measured: Was it that the patient felt better? What tests were used to measure it? Did the benefit last a week or 2 months? You can’t know what other medical treatments were given shortly before or after.
Finally, people who provide testimonials and later die or get very sick cannot provide updates on their status.
Big Pharma Conspiracy: Are they withholding cures for cancer?
While discovery and marketing of medical products is driven by profit, companies must first prove the agent effective for a specific medical condition, which is a challenging regulatory process, involving investigators from independent hospitals, data monitoring boards, and FDA review.
... The process requires controlled studies describing the methods up front, such as the number of patients, the defined medical condition, and how outcomes are measured, both positive and adverse.
In contrast: Alternative Medicine has no such requirements. For example, we have no idea about rates of response or how a response is even defined for a given alternative practice. One in a thousand? None? We must take the practitioners word for it, or take on faith the accuracy and truth of a testimonial.
Is the conspiracy theory plausible?
Three in five Americans will get a serious cancer - including scientists, medical doctors, regulators, owners of drug companies - including, sadly, their loved ones and children. Thus, a conspiracy to hide cures for cancer would require the complicity of medical doctors and experts when their children get cancer. Would not the parents with knowledge of the conspiracy relent when their child was diagnosed? Silence under such circumstances would be unthinkable, and also criminal.
The conspiracy theory also does not explain the high cure rate for some cancers (eg. > 80% for Hodgkins disease), and that the majority of childhood cancers are cured. Is the conspiracy for some types of cancers and not others?
Further:
To know a drug cures a disease you have to test it in people -- in clinical trials.
All research involving human subjects must be vetted by ethics committees (IRBs) and an FDA. By law, all of these studies are posted on ClinicalTrials.gov with the results.
Pharma, the entity that allegedly suppressing cures, is a collective of independent
companies, which cannot make binding decisions on behalf of all.
Are we to believe that "the industry" tests and then submits drugs for FDA approval with limited potential to cure in order to keep the conspiracy alive? ... or that they are
intentionally passing on an opportunity to become wealthy and save lives for the good
of its competitors!
Would we not see the companies that have developed cures protesting such a system,
vigorously by taking strong legal action?
Are we to believe that FDA approves only drugs with limited benefit and that the agency
will reject drugs that are more effective?
Are we to believe that Congress has enacted laws to ensure independent review
of new drugs by the FDA as part of this conspiracy? Or that the American public,
through its representatives (who also get cancers), are complicit in the "conspiracy?"
And if a conspiracy existed, why would any company invest so much time and money developing and testing new cancer drugs ... when most investigational new drugs fail to demonstrate efficacy?
By Congressional statute the FDA is an independent reviewer of clinical trials submitted for marketing approval. Standards for approval include well-controlled studies of adequate size.
If an FDA reviewer fails to disclose a financial conflict it is a felony.
because they cannot be patented?
A natural product might be defined as a compound taken directly from its source in nature - such as from an animal or plant (a leaf from a tree). Noting here that there is no structural difference between man-made versus natural compound (made by a plant or animal).
Nor is there any inherent safety or toxicity advantage for natural compounds. We may associate "natural" with safety. But many plants and animals produce poisonous compounds in order to avoid being eaten by animals and insects, or to kill off competing plants. Consider how many common house plants are toxic to our pets.
There are many proven cancer drugs that have been purified or synthesized from natural sources, such as Taxol (yew tree), vincristine (periwinkle), and etoposide (may apple). Noting that it's unwise for patients to self treat by eating these plants.
Even natural compounds considered safe at dietary levels can be toxic at the doses needed to have therapeutic effects against cancer. Identifying the dose that can be safely given to have a treatment effect require clinical trials that gradually increase the dose and monitor for toxicity and concentrations of the compound (or the metabolites*) in the blood (PK studies).
* Some drug compounds are changed (metabolized) by the body prior to circulating in the blood
Natural compounds can be useless in their native forms due to impurities or because the native source provides an insufficient amount of the active ingredient. You might have to consume bushels of leaves to see a therapeutic effect - and your body would have to process all the impurities of those leaves as well.
* Compounds that are taken orally may be merely excreted - never reaching the blood system and hence never affecting the tumors unless, perhaps, if they are located in the colon.
Most often the active compound derived from natural products needs to be altered to optimize the binding to the treatment target or to reduce its toxicity.
...So the issue of patent law for natural products is rarely a true issue - one that inhibits the study. We can be assured if such compounds existed in the native form, the NCI or privately funded research would take action ... again because everyone is affected by cancer, every family, no matter how privileged.
And if such a compound was identified .... the clinical study would be the same: you have to first identify the safe dose and determine if there is activity at that dose, then run prospectively defined clinical studies to demonstrate it is safe and effective for a specific type of cancer.
We are not qualified to make assertions about patent law as it pertains to natural compounds. However, it appears from the following that patent law is not an insurmountable challenge for the study of natural compounds to treat disease.
... Here the questions and answers in a Supreme Court proceeding indicate that a new method of extraction, or function, or to achieve a higher concentration of a natural product can make it eligible for patent protection:
“JUSTICE GINSBURG: Mr. Hansen, Respondents say that isolating or extracting natural products, that has long been considered patentable. Examples were aspirin and whooping cough vaccine. How is this different from natural products? …….
JUSTICE ALITO: Can I take you back to Justice Ginsburg’s question, because I’m not sure you got at what troubles me about that. Suppose there is a substance, a chemical, a molecule in the leaf – the leaves of a plant that grows in the Amazon, and it’s discovered that this has tremendous medicinal purposes. Let’s say it treats breast cancer. A new discovery, a new way is found, previously unknown, to extract that. You make a drug out of that. Your answer is that cannot be patented; it’s not eligible for patenting, because the chemical composition of the drug is the same as the chemical that exists in the leaves of the plant.
MR. HANSEN: If there is no alteration, if we simply pick the leaf off of the tree and swallow it and it has some additional value, then I think it is not patentable. You might be able to get a method patent on it, you might be able to get a use patent on it, but you can’t get a composition patent.
JUSTICE ALITO: But you keep making the hypotheticals easier than they’re intended to be. It’s not just the case of taking the leaf off the tree and chewing it. Let’s say if you do that, you’d have to eat a whole forest to get the value of this. But it’s extracted and reduced to a concentrated form. That’s not patent eligible?
MR. HANSEN: No, that may well be eligible, because you have now taken what was in nature and you’ve transformed it in two ways. First of all, you’ve made it substantially more concentrated than it was in nature; and second, you’ve given it a function. If it doesn’t work in the diluted form but does work in a concentrated form, you’ve given it a new function. And by both changing its nature and by giving it a new function, you may well have patent …”
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Karl Schwartz
Caregiver, and research advocate
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